Content includes a press release on the signing of an MOU with China FDA, recent training provided in Vietnam and China, lectures in Japan and Taiwan, the announcement of a new Principal Scientist at IIVS, and more.
The National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) and the Physicians Committee for Responsible Medicine (PCRM) will cosponsor a scientific workshop on “Adverse Outcome Pathways: From Research to Regulation.” The workshop proposes to explore and discuss how interaction and collaboration among stakeholders can be initiated and maintained so that scientific progress in adverse outcome pathway (AOP) concepts may improve regulatory assessment of chemical toxicity. The Society of Toxicology endorses this workshop.
The meeting will take place from September 3–5, 2014 at the William H. Natcher Conference Center, National Institutes of Health, Bethesda, Maryland, USA. This workshop is free as is the concurrent plenary presentations webcast. Registration for the workshop or webcast along with other information and a preliminary agenda are available by following the link above.
GAITHERSBURG, MARYLAND – The Institute for In Vitro Sciences (IIVS) last week signed a Memorandum of Understanding with the National Institute for Food and Drug Control (NIFDC), a subordinate agency of the China Food and Drug Administration (CFDA). The two organizations will work collaboratively on a number of projects focused on cosmetic safety testing designed to promote in vitro (non-animal) techniques in China.
In November 2013, IIVS held a week long training workshop at the NIFDC laboratory in Beijing to teach in vitro techniques for cosmetic safety testing to Chinese regulators including those from provincial agencies. Under the new memorandum, the NIFDC will coordinate with IIVS to hold an annual training workshop titled “Techniques for In Vitro Assays for Cosmetics Testing”. Additionally the NIFDC agrees to participate in validation projects of new models or techniques developed within China.
The MOU was signed by Dr. Wang Youchun, Deputy Director-General of NIFDC and Erin Hill, Co-founder and Vice President of IIVS. “The NIFDC has a great responsibility to introduce in vitro techniques to a large number of regulators within China” states Ms. Hill. “IIVS is honored to assist them in achieving this goal. Additionally our expertise in validation projects will be helpful as new in vitro methods are developed within China.”
Since 2012, the Institute for Food and Cosmetic Control (IFCC) within the NIFDC has been responsible for the testing of cosmetics for pre-market approval, post market surveillance, and investigations in response to consumer complaints. A new in vitro laboratory is currently under construction which will be used for, among other things, hands-on training. Dr. Wang Gangli, Director of the IFCC commented, “With our expanded laboratory space and support from IIVS experts, we will be able to organize workshops to train many more scientists within China on the use of in vitro methods for testing of cosmetics.”
Following the signing ceremony IIVS visited the laboratories of the NIFDC center responsible for the testing of drugs; the National Center for Safety Evaluation of Drugs (NCSED). The center Director, Dr. Wang Jufeng, and staff discussed potential collaborations and uses of in vitro methods in the evaluation of drugs within China.
About NIFDC: NIFDC areas of responsibility cover quality control of pharmaceutical products, biological products, medical devices, food, healthy food, cosmetics, reference standards, laboratory animals, and drug safety evaluation. The Institute for Food and Cosmetics Control (IFCC), an internal institute of NIFDC, is responsible for safety evaluations of food, healthy food and cosmetics.
About IIVS: IIVS is a non-profit laboratory based organization with a mission to advance the use and regulatory acceptance of in vitro testing methods. IIVS provides laboratory testing services to industry as well as training and educational programs. www.iivs.org
Media Contact: Erin Hill - email@example.com
REACH registrants are increasing their use of alternative methods to animal testing, according to a report published by ECHA. However, NGOs say little progress has been made as the number of new animal tests has more than doubled since 2011. The report, The Use of Alternatives to Testing on Animals for the REACH Regulation, shows that by 1 October 2013, ECHA’s database contained information on 7,939 new experimental studies for those endpoints which may involve testing on vertebrate animals. Out of these, 3,052 are in vitro tests, which involves using human cells or tissue, and 4,887 are experiments on animals. Please follow the link above to Chemical Watch to read the full article.
India's CROs Opt for Computer Model Techniques to Test Cosmetics as Ban on Animal Testing Comes into Effect
India’s pre-clinical contract research organisations (CROs) are looking at in vitro test methods and considering the advanced computer modelling techniques as the Indian ban on the use of animal testing comes into effect. With the prohibition of the animal testing by the Union government and the revision of the Drugs and Cosmetics Rules 1945 inserting a new rule after 148-B with 148-C to forbid animal testing for cosmetics, research institutes are utilizing computer models which accurately predict drug reactions, techniques like the 3-dimensional human cell derived skin model, and quantitative structure activity relationships (QSARs) to help to replace the use of guinea pigs and mice in generating safety information. Please read the full article above for additional information.
Nominations are now open and entries are invited in the fields of science, lobbying, training and public awareness, as well as from young scientists. The closing date for nominations is Friday 25th July 2014. Please visit the website above for more information
..." toxicity testing experts from Humane Society International and the Institute for In Vitro Sciences have teamed up to head to China. It's the start of an intensive training program, funded as part of an $80,000 grant from Humane Society International, The Humane Society of the United States and the Human Toxicology Project Consortium. Chinese scientists will be given laboratory-based hands-on training in how to use state-of-the-art in vitro methods such as the BCOP test to assess eye irritation and the 3T3 NRU to measure phototoxicity in cosmetics instead of using live animals." To read the full article, please visit the Huffington Post UK website by following the link above.
The pre-congress workshop will address the industrial and regulatory implementation of integrated testing strategies based on in silico, in chemico and in vitro test methods for the assessment of skin sensitization hazards and potential. For this purpose, lessons learned from other areas will be presented, the definition and regulatory implementation of ITS will be given and examples of advanced strategies available on skin sensitization will be presented by speakers from different horizons (industry, academia, governmental bodies and NGOs). The session will end with round-table discussions to allow for exchanges and constructive discussions between the participants and the invited speakers. For more information, please visit the IIVS event page above.
A policy change, announced in December by the Chinese Food and Drug Administration and to take effect in June, will allow the sale of “non-specialized cosmetics” manufactured in China, such as soap, shampoo and some skin products, without being tested on animals, if they can draw on existing safety data for raw ingredients or perform European Union-validated nonanimal tests. “When the results of risk assessment produce sufficient evidence to guarantee safety, toxicity tests on the finished products may be skipped,” the new rule says. To read the full article, including a quote from IIVS Vice-President Erin Hill, please follow the link above.
"While there are a number of validated and widely-used non-animal methods for assessing a chemical’s potential to cause skin irritation or skin corrosion, the technical challenges of modeling skin sensitization in vitro have proven harder to surmount. But 2013 and early 2014 have seen several important advances, including the first formally EURL ECVAM-validated non-animal sensitization assay." Follow the link above to read the rest of this article on skin sensitization on the AltTox website.
Apply now for the ASCCT travel award! Students and young scientists wishing to attend the 9th World Congress on Alternatives and Animal Use in the Life Sciences in Prague are eligible for a $750 travel award and a 1-year ASCCT membership. Applications are due by May 23rd. Visit the American Society for Cellular and Computational Toxicology to apply.
Scientists in China are being trained in how to use state-of-the-art in vitro methods to test cosmetics instead of using live animals such as rabbits and guinea pigs, as part of an $80,000 grant from Humane Society International, The Humane Society of the United States and the Human Toxicology Project Consortium. China is the first stop on HSI’s Be Cruelty-Free Asia science tour, which will also take in Hong Kong, Japan and Taiwan. Read the rest of the press release on the HSI website.
The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) will hold a public meeting from 1-4 P.M. EDT Wednesday, June 25, 2014, at the National Institutes of Health Natcher Conference Center in Bethesda, MD. The purpose of this public meeting is to communicate progress on topics of interest to ICCVAM stakeholders and provide stakeholders with an opportunity to comment and ask questions.
The meeting will be open to the public with attendance limited only by the space available. Teleconference access will be available, but participants planning to submit comments are encouraged to attend in person to facilitate interaction. Details of the meeting and information for participants will be published in the Federal Register, posted on the NTP website above.
Travel grants are now available to students and young scientists for attendance at the 9th World Congress on Alternatives to Animal Use in the Life Sciences meeting in Prague, Czech Republic August 24-28. Please visit the website linked above to submit an application for consideration. The deadline for applications is April 30th.
Toxicokinetics (TK) refers to the absorption, distribution, metabolism and excretion (ADME) of chemical substances in the body. TK information is essential in regulatory safety assessment of chemicals. Aspects also include interspecies and route-to-route extrapolation, development of mechanistic understanding of TK processes, and better interpretation of systemic toxicity data.
Hepatic metabolic clearance plays a key role in the transformation and the elimination of chemicals from the human body and in recent times various in vitro methods for human hepatic metabolic clearance/stability have been developed. With the present survey, EURL ECVAM (the European Union Reference Laboratory for Alternatives to Animal Testing) seeks to identify in vitro human hepatic metabolic clearance/stability methods, which can contribute to the development of harmonized standards and associated international TK test guidelines. Click on the "read source" link above to begin filling out the survey for your method.
Deadline - June 30, 2014
Content includes information on a novel assay for determining eye sting, recent training workshops held at IIVS, a synopsis of global outreach activities, publication of a chapter in a new book on reduction of animal use for toxicology testing, and more .
The "Humane Cosmetics Act" (H.R. 4148) was introduced yesterday in the US Congress by Representative Jim Moran, Northern Virginia Democrat, who is Co-Chair of the House Animal Protection Caucus. According to the Humane Society of the United States, this act would 1) Make it unlawful for anyone to conduct or commission cosmetic animal testing in the U.S., and 2) Prohibit selling, offering for sale or transporting any cosmetics in interstate commerce if the final product or any component was developed or manufactured using animal testing. Under The Humane Cosmetics Act, after a one-year phase-in, animal testing would be banned. After a three-year phase-in period, the sale of animal tested cosmetics would be banned. For more information on the bill, please follow the link above.
The 9th World Congress will be held in Prague, the capital of the Czech Republic on August 24–28, 2014. The World Congress on Alternatives and Animal Use in the Life Sciences provides an exceptional forum to underline the importance of both the ethical issues of animal experimentation and the approach to the life sciences in the 21st century.You can find the scientific program linked above. Participants from many countries are encouraged to contribute to the program by submitting abstracts, exhibiting, and registering as an attendee. In the last decade there is much evidence of global acceptance of the 3R principles. WC9 will provide the opportunity to share scientific data and experience in animal use and welfare, to gain knowledge on the 3R policy, and to recognize efficient approaches in education in order to further extend the global progress in the 3Rs and to satisfy the highest scientific criteria. Please follow the link above to view the latest updates on the 9th World Congress.
The KeratinoSens in vitro test method for skin sensitisation testing, developed by Givaudan, has been evaluated by ECVAM. The full recommendation and summary data pdfs can be found by following the link above. In summary, ECVAM found that the Keap1-Nrf2-ARE pathway is relevant for assessing skin sensitization. They recommend that the KeratinoSens assay be used in combination with other assays (such as the Direct Peptide Reactivity Assay) in a Weight of Evidence (WOE) approach or as part of an Integrated Testing Strategy (ITS) for skin sensitization. The assay has good predictive capacity and was shown to be transferable between laboratories. Additional work is recommended by ECVAM to evaluate the assay's ability to relate potency catagories to human data. ECVAM states that "Respecting the provisions of Directive 2010/63/EU (EU, 2010) on the protection of animals used for scientific purposes, before embarking on animal experiments to identify substances with skin sensitisation potential, data from the KeratinoSens test method should be considered in combination with complementary information in order to reduce and possibly avoid animal testing. As provided for in Annex XI (point 1.2) of the REACH Regulation (EC, 2006), data from non-standard testing methods, such as the KeratinoSens, may be used to adapt the standard information requirement in the context of Weight-of-Evidence (WoE) judgments."
Sao Paulo became the first Brazilian state to ban the use of animal testing to determine the safety of cosmetic products and ingredients. The bill, which was signed into law last week, includes specified fines for violations of this law. Please follow the link above to read more on the Cosmetics Design website.
The Alternatives Research and Development Foundation is currently soliciting research proposals for its 2014 Alternatives Research Grant Program. Grants of up to $40,000 are available to support individual projects of scientific merit and feasibility with the potential to significantly reduce or replace laboratory animal use. Preference will be given to projects as U.S. universities and research institutions and projects that use pathway-based approaches.
More information is available on the ARDF website by following the link above . Application deadline for the grants is April 30, 2014.
For the past year Dr. Warren Casey served as Acting Director of the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) within the Division of the National Toxicology Program at the National Institute of Environmental Health Sciences. On January 7th Dr. John Bucher, Associate Director of the National Toxicology Program, Division of the National Toxicology Program/National Institute of Environmental Health Sciences announced that Dr. Casey has agreed to serve as the next permanent Director of NICEATM. IIVS wishes Dr. Casey well with his continued efforts at NICEATM, ICCVAM and ICATM.
Content includes information on an integrated testing strategy for skin sensitization, recent training activities in local Universities and in China, upcoming meetings, and more.
In an effort to make information on NICEATM and ICCVAM activities more easily available to stakeholders, NICEATM has launched a new website. located at . The new NICEATM website resides within the existing National Toxicology Program (NTP) website, reflecting NICEATM's increased involvement in NTP high-throughput screening and other activities. The new NICEATM website condenses summaries of past and current NICEATM and ICCVAM activities into a reduced number of webpages for easier navigation. A section dedicated to ICCVAM processes and activities within the new NICEATM site is located on this site as well. NICEATM Federal and contract support staff will continue to be actively involved in developing and maintaining content for the new NICEATM website. Please visit the new site by following the link above.
The European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) has recommended a cell transformation assay (CTA) for carcinogenicity testing. The in vitro test uses rodent Bhas 42 cells, which change their growing behavior when exposed to carcinogens. EURL ECVAM considers that the CTA can “provide important information on the carcinogenicity potential of substances when used within integrated approaches for assessment and testing”. The recommendation is partly based on the results of a Japanese validation study and was developed in consultation with EU regulators, stakeholders and international partners. Please follow the link above for more information.
The U.S. Environmental Protection Agency (EPA) announced the release of chemical screening data accessible through the new interactive Chemical Safety for Sustainability or iCSS Dashboard. The iCSS Dashboard provides access to data from innovative screening technologies for chemicals that are found in industrial and consumer products, food additives and drugs.
As part of this data release, EPA is announcing the ToxCast Data Challenges, a series of challenges inviting the science and technology community to work with the data and provide solutions for how the new chemical screening data can be used to predict potential health effects. Challenge winners will receive awards for their innovative research ideas. For additional information, please follow the EPA's link above.
GAITHERSBURG, MD, December 16, The Institute for In Vitro Sciences (IIVS), with support from its Industry Council for the Advancement of Regulatory Acceptance of Alternatives (ICARAA), conducted a training course on September 23-27 for in vitro safety testing methods for scientists from China’s NIFDC (National Institutes for Food and Drug Control), a division of the China Food and Drug Administration.
The training was held at the Institute for Food and Cosmetic Control (IFCC) of the National Institutes for Food and Drug Control (NIFDC) in Beijing. The goal of the training was to familiarize NIFDC scientists with the biological relevance, critical techniques and data interpretation of in vitro (non-animal) methods for safety testing. Twenty-eight participants from 18 provincial Institutes for Food and Drug Control, Institutes for Medical Device Control and Institute for Food and Drug Safety Evaluation of NIFDC attended. Lectures and hands-on laboratory sessions focused on methods for eye irritation, skin irritation and sensitization.
Wang Youchun, Vice Director-General of NIFDC spoke at the opening ceremony and emphasized that it is “very necessary to expedite training and research of in vitro cosmetic safety evaluation methods and promote in vitro safety evaluation technology application and academic exchanges in Food and Drug Control systems in order to adapt to the international cosmetics testing technology development and to meet the requirements for actual inspection work.”
The CFDA is currently responsible for the registration and subsequent post market surveillance of cosmetic products. While previous regulations have relied on animal testing, the regulatory and scientific community within China is investigating how existing knowledge of ingredients and in vitro testing could be incorporated into their regulatory framework.
“In vitro methods can provide significant technical advantages over animal models. Our training courses highlight the key technical steps that are necessary to generate relevant and reliable data,” explains Erin Hill, IIVS co-founder and Vice President for Program Development. According to NIFDC participants “the training not only facilitated the application of in vitro test methods in the domestic cosmetic industry, but also laid a solid foundation for the further academic exchange, technical cooperation and personnel training between NIFDC and IIVS.”
EURL ECVAM Releases Recommendations on the Direct Peptide Reactivity Assay (DPRA) for Skin Sensitization Testing
EURL ECVAM has fully endorsed the ECVAM Scientific Advisory Committee's (ESAC) opinion on the ECVAM coordinated validation study of the Direct Peptide Reactivity Assay (DPRA). They have found that information from peptide reactivity assays, such as the DPRA, is relevant for the assessment of the skin sensitization potential of chemicals. The DPRA is transferable to suitably equipped laboratories that are proficient in high performance liquid chromatography (HPLC) analysis, and both the within and between laboratory repeatability was quite high (87% and 75% respectively). Although full review of the assay's predictive capacity was outside the scope of this review, its accuracy of distinguishing between sensitizers and non-sensitizers is 82%. To read EURL ECVAMs' full recommendation, please follow the link above.
The German Federal Ministry of Food, Agriculture and Consumer Protection (BMELV), has awarded the BASF research team with €15,000 for their work in developing and implementing strategies for testing the local toxicity of chemicals without animal experimentation.
BASF research scientists have developed, optimized, and validated animal testing-free methods and strategies that examine substances for skin sensitization, eye irritation and skin irritation. “Not only did we develop these methods, we also validated them, which allows us to use them in our routine testing now,” said Dr. Robert Landsiedel, head of the Short-Term Toxicology Unit at BASF. Together with Dr. Susanne Kolle, head of the laboratory for applied alternative methods, and Dr. Caroline Bauch, who worked on the development of the methods as part of her doctoral thesis, Landsiedel received the prize on behalf of the entire Experimental Toxicology and Ecology team from the hands of Parliamentary Secretary of State at the German Federal Ministry of Food, Agriculture and Consumer Protection, Peter Bleser. “Research contributes greatly to restricting animal experimentation to a minimum. Our goal is to replace as many animal tests as possible by alternative methods,” Bleser explained. Please follow the link above for the complete press release.
The Lush Prize is an initiative which uses resources to bring forward the day when safety testing takes place without the use of animals. The Lush Prize focuses pressure on toxicity testing for consumer products and ingredients in a way which complements the many projects already addressing the use of animals in medical testing. The prizes themselves consist of a £250,000 annual fund that is split between recipients in several categories. IIVS was honored to receive a joint award in the training category for 2012 and was among the groups short listed for the training prize again this year. Please follow the link above to view a list of all of the prize recipients from this year's awards, presented to the winners last week in a ceremony in the UK.
On 14 November, Prof. Bas Blaauboer will be presented with the Willy van Heumen Prize by the Alternatives for Laboratory Animals Stimulus Fund Foundation. The Willy van Heumen Prize is presented every other year by the Alternatives for Laboratory Animal Testing Stimulus Fund Foundation. It is intended for individuals or institutions that have made outstanding achievements in limiting the use of laboratory animal tests and promoting the use of alternatives to animal testing. Prof. Blaauboer is Professor of Alternatives to Animal Testing in Toxicological Risk Assessment at Utrecht University’s Institute for Risk Assessment Sciences. He will receive the Willy van Heumen prize for his entire body of work, involving the 3R’s of laboratory animal testing – replacement, reduction and refinement. For more information, please follow the link above.
The international NC3Rs 3Rs Prize is awarded to highlight an outstanding original contribution to scientific and technological advances in the 3Rs in medical, biological or veterinary sciences published within the last three years. The prize is part of the NC3Rs' commitment to recognize and reward high-quality research which has an impact on the use of animals in the life sciences. Sponsored by GlaxoSmithKline, the prize consists of a grant of £18k, plus a personal award of £2k. Highly-commended entries receive a £4k grant and £1k personal award.
The 3Rs prize is for a piece of primary research published in a peer-reviewed journal in the last three years and is open to any researcher, in academia or industry. The prize is awarded to the principal investigator, research team leader, or other nominated author. The Prize is open to international groups. For further details on eligibility, see the Application Process page. A panel will assess the applications and select the winner based on the quality of the published research and its impact on the 3Rs. The deadline for application is Wednesday, December 11, 2013. For further information on the 3Rs Prize, please contact 3Rsprize@nc3rs.org.uk
Content includes details on an upcoming IIVS skin sensitization webinar, summaries of recent OECD Test Guideline Updates, recent activities in China, upcoming meetings, and more.
IIVS is honored to be short listed among others for The 2013 Lush Prize for outstanding contributions to replacing animal testing. All of the short-listed projects have contributed to advancing animal-free safety testing, through scientific research, training, lobbying or public awareness in 2012. IIVS was a co-recipient of the training award last year. This year's winners will be announced at the Lush Prize Awards which are scheduled to take place in London on November 13th 2013. Please follow the link above to the LUSH prize blog for additional information.
The EPA has launched a new web tool on chemical information called ChemView to improve access to chemical specific information developed by EPA and data submitted under the Toxic Substances Control Act (TSCA). Utilizing flexible search tools the user can access EPA assessments, hazard characterizations and information on safer chemical ingredients. In the months ahead, EPA will be adding additional chemicals, functionality and links. When fully populated, the portal will contain data for thousands of chemicals. EPA has incorporated stakeholder input into the design, and welcomes feedback on the current version of the site, linked above.
The re-elected Labor party government in Australia will commit to a national consultation on ending the importation, manufacture, sale and advertising of cosmetics and cosmetic ingredients which have undergone animal testing. This pledge would bring Australian policy in line with those of other nations such as the EU. To read the full article in Cosmetic Design, please follow the link above.
The animal welfare group, People for the Ethical Treatment of Animals (Peta) International Science Consortium, highlighted the confusion surrounding testing to comply with REACH regulations in a recent post on the AltTox forum. In her posting, Jessica Sandler director of the consortium says, "In our meetings with international corporations we are finding a lot of confusion on this issue and a number of companies are conducting in vivo skin irritation testing for REACH, especially because certain REACH Annexes state that negative in vitro results should be followed up in vivo." Please follow the link above to read the full posting on the AltTox forum and join the discussion if you aren't already registered.
The revised EURL ECVAM search guide titled "Good search practice on animal alternatives : re-edition" has been published and is available as a free download in the EU Bookshop. The EURL ECVAM Search Guide has been specifically developed to inform and support untrained database users to find high quality information on relevant alternative strategies and methods to animal experiments in an easy, yet systematic, efficient and effective way. Encouraged by the success of the first edition in 2012 the JRC has re-published an entirely updated second version
The Humane Society International (HSI) is accepting proposals for grants to prepare an in-depth narrative review of current research approaches to a disease area, critically assessing the value and limitations of animal models in health research and drug discovery (not toxicology) and proposing a new ‘roadmap’ for future research. The goal would be to publish the review in a peer-reviewed scientific journal and to contribute to dissemination of the work. The reviews should include proposals for a new ‘roadmap’ for future research to understand human disease and improve translation to the clinic, based on modern, human-specific models, tools and technologies. The full background and project description are in the attached Request for Proposals document.
Applicants (from academia, industry or the public sector) with a scientific PhD or equivalent and current or recent research and publication experience in an area of human disease, are invited to tender for one of these grants. Full details including the Request for Proposals and Application Form are available online by following this link to the Humane Society's website.
The application process closes at midnight EST on 15 October 2013.
The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) work together to promote the development, validation, and regulatory acceptance of new and revised regulatory test methods. In a February 2013 editorial in the journal Environmental Health Perspectives, National Institute of Environmental Health Sciences and NTP Director Linda Birnbaum announced upcoming significant changes to the focus and priorities of both ICCVAM and NICEATM.
A draft document now available on the NTP website, titled “A New Vision and Direction for ICCVAM,” describes the initial steps towards a new strategic direction for ICCVAM. Specifically, this document discusses (1) ICCVAM priority setting and areas for scientific focus for immediate resource investment; (2) plans to improve communications with stakeholders and the public; and (3) exploration of new paradigms for the validation and utilization of alternative toxicological methods.
NICEATM invites public comments on “A New Vision and Direction for ICCVAM.” The document will be discussed at the Sept. 24 meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM).
Links to “A New Vision and Direction for ICCVAM,” the Environmental Health Perspectives editorial, and the ICCVAM response to the editorial are available on the SACATM Background Materials page under the heading “New ICCVAM Vision and Procedures.” To submit a comment on “A New Vision and Direction for ICCVAM,” go to the NTP page and select the “Submit Comment” link beside the SACATM meeting announcement. Written comments submitted by September 10 will be considered during the discussion of the draft document at the SACATM meeting.
Click here for more information about the SACATM meeting. This page includes links to the Background Materials page, a preliminary meeting agenda, a registration form to attend the meeting, and a webcast that will be available on the day of the meeting.
Second Annual Meeting of the American Society for Cellular and Computational Toxicology
The Future is Here: Practical Application of Emerging Scientific Tools
Oct. 31, 2013, Bethesda, Md. Lister Hill Auditorium, NLM, NIH
• Invited plenaries by Donald E. Ingber, Harvard University, and Thomas Knudsen, U.S. Environmental Protection Agency • Panel discussion • Poster session and talks selected from submitted abstracts • Reception
Poster Abstract Deadline: August 31
To view the agenda, submit an abstract, or register please visit the link above.
The European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) is inviting public comments on its latest recommendations concerning two alternative test methods. The recommendations to be reviewed are for the Direct Peptide Reactivity Assay (DPRA) for skin sensitization and the Cell Transformation Assay (CTA) for predicting the the potential of chemicals to cause cancer. Both of these assays are being presented as useful in integrated testing strategies for safety assessment. The deadline for submission of comments is September 13. Please follow the link above for more information.
Scientists at the National Institute of Agrobiological Societies have developed a layer of cells that they are suspending on an ultra thin collagen sheet to be used to measure the ocular toxicity of chemicals. The new tissue performed similarly to already marketed models according to a study published in Toxicological Sciences. The human corneal epithelium (HCE) model is created by growing HCE-T cells (a HCE-derived cell strain) in a collagen vitrigel membrane chamber. For more information about this new model, please follow the link above to read the full article.
OECD Test Guideline 439 provides an in vitro procedure that may be used for the hazard identification of irritant chemicals (substances and mixtures) in accordance with UN GHS Category 2 (1) (2). In member countries or regions that do not adopt the optional UN GHS Category 3 (mild irritants), this Test Guideline can also be used to identify non-classified chemicals. Therefore, depending on the regulatory framework and the classification system in use, this Test Guideline may be used to determine the skin irritancy of chemicals either as a stand-alone replacement test forin vivo skin irritation testing or as a partial replacement test within a tiered testing strategy (4). For clarification on what this means to you and your skin irritation testing program, please contact us to speak with one of our study directors.
OECD Test Guideline 431 addresses the human health endpoint skin corrosion. It makes use of reconstructed human epidermis (RhE) (obtained from human derived non-transformed epidermal keratinocytes) which closely mimics the histological, morphological, biochemical and physiological properties of the upper parts of the human skin, i.e. the epidermis. This Test Guideline was originally adopted in 2004 and updated in 2013 to include a set of Performance Standards (PS) (Annex 1) for the assessment of similar and modified RhE-based test methods (8), in accordance with the principles of Guidance Document No. 34 (9). Other updates comprise the addition of two test methods, and the possibility to use some of the methods for the sub-categorisation among corrosive chemicals. Please follow the link above to read the full guideline, then contact us to speak to one of our study directors to determine how these updates could affect your testing program.
The Bovine Corneal Opacity and Permeability (BCOP) test method was evaluated by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), in conjunction with the European Centre for the Validation of Alternative Methods (ECVAM) and the Japanese Center for the Validation of Alternative Methods (JaCVAM), in 2006 and 2010. A new review of the data has been completed and the OECD TG has been updated. The main differences between the original 2009 version and the 2013 updated version concern, but are not limited to: the use of the BCOP test method to identify chemicals not requiring classification according to UN GHS (paragraphs 2 and 7); clarifications on the applicability of the BCOP test method to the testing of alcohols, ketones and solids (paragraphs 6 and 7) and of substances and mixtures (paragraph 8); clarifications on how surfactant substances and surfactant-containing mixtures should be tested (paragraph 28); updates and clarifications regarding the positive controls (paragraphs 39 and 40); an update of the BCOP test method decision criteria (paragraph 47); an update of the study acceptance criteria (paragraph 48); an update to the test report elements (paragraph 49); an update of Annex 1 on definitions; the addition of Annex 2 for the predictive capacity of the BCOP test method under various classification systems; an update of Annex 3 on the list of proficiency chemicals; and an update of Annex 4 on the BCOP corneal holder (paragraph 1) and on the opacitometer (paragraphs 2 and 3). Please follow the link above to read the full guideline. Contact us if you have any questions about how these new modifications could affect your testing program.
The European Union Reference Laboratory for Alternatives to Animal Testing (EURL Ecvam) has chosen 13 in vitro test facilities located across Europe as the first members of the EU Network of Laboratories for the Validation of Alternative Methods (EU-Netval).The EU-Netval is expected to play an important role in translating new tools and techniques resulting from European research initiatives into test methods that could reduce, refine or replace animal testing.To read more, follow the link above to the JRC website.
Please join us for the second annual meeting of the American Society for Cellular and Computational Toxicology on October 31 in the Lister Hill Auditorium on the NIH campus in Bethesda Maryland. A sample agenda can be found here. Follow the link above to be directed to the registration page. Click here for instructions on how to submit and abstract. The abstract submission deadline is August 31st. Authors will be notified by September 20th. Space is limited. A small number of posters will be selected for oral presentations. For additional information, please visit the ASCCT website.
The latest issue of ALTEX is available for download on the Altweb website (link above). This issue includes an article on what clinical studies tell us about pre-clinical testing and several workshop reports from meetings in the field of 3Rs and alternative testing.
A new "artificial skin" product has been launched by global technology company Greiner Bio-One. Their ThinCert cell culture inserts allow human skin cells to be cultured in a thin membrane. This allows them to develop some of the same properties as normal human skin. The ThinCert will be available in a variety of multiwell plate sizes and pore diameters depending on the needs of the customers. Read more about the new product on the Greiner Bio-One website (linked above).
ARDF is pleased to announce that its 2013 Alternatives Research Grant Program has made its selections. ARDF has awarded $200,000 to scientists developing alternative methods in a variety of areas of medical research, testing and education.
Congratulations to awardees:
Patrick D. McMullen, PhD The Hamner Institute for Health Sci ences, Research Triangle Park, NC Characterization and Visualization of Toxicity Pathways from High-Throughput in vitro Screening: An Example with the aryl-hydrocarbon receptor
Gary S. Sayler, PhD University of Tennessee, Knoxville, TN Expressing Bacterial Bioluminescence in Human Cell Lines: Engineering Autobioluminescent Reporter Cells to Screen for Oxidative Stress
Karen H. Watanabe, PhD Oregon Health & Science University, Portland, OR Formulation of a Computational Model for Ovarian Development
L. Ray Whalen, DVM, PhD Colorado St ate University, Fort Collins, CO Support for the Virtual Feline Anatomy and Virtual Equine Anatomy Programs In Development at Colorado State University, College of Veterinary Medicine and Biomedical Sciences
Matthew C. Wright, PhD Newcastle University, Newcastle Up on Tyne, UK An Unlimited Supply of Rat Hepatocytes in vitro - Replacing Animals as Donors
For additional information on this program, please follow the link above.
Principle scientists from the Tox21 project in the US and Europe's SEURAT-1 came together for a 3 day workshop at the European Commission's Joint Research Center in Italy to discuss ways in which they can cooperate and collaborate to advance the field of non-animal safety assessment. The workshop included five sessions examining ToxCast, Tox21 and SEURAT-1 research programs; the chemical inventories used by the three parties; an overview of in vitro assays and test systems that are under development; a review of computational approaches for making toxicology predictions; and how these efforts can be leveraged for use in chemical safety assessment. For more information on this meeting, please read the article linked above.
On July 1st, MatTek began commercial production of EpiOcular tissue in its European lab MatTek In Vitro Life Science Laboratories (IVLSL), located in Bratislava, Slovakia. The facility has been producing EpiDerm tissue since January 2012. According to MatTek, tissues produced in MatTek IVLSL are produced under GMP conditions. Dr. Helena Kandarova serves as director of MatTek IVLSL. For more information on the production of MatTek tissues in Europe, please follow the link above to read the full article or [visit their newly launch website here][http://www.mattek.com/].
The Food and Drug Administration has issued draft guidance on good manufacturing practices (GMPs) for cosmetic products. This document is intended to assist industry and other stakeholders by identifying standards and issues that can affect the quality and safety of cosmetic products.
The new draft guidance updates FDA’s current “Cosmetic Good Manufacturing Guidelines/Inspection Checklist.” Updates include a new section on definitions, which is intended to clarify terms contained in the guidance, and one on documentation, which notes its role in preventing errors and correcting problems that may occur during manufacture.
The guidance also is part of an effort to align international standards on cosmetic manufacturing. FDA participates in this effort through its work with the International Cooperation on Cosmetics Regulation (ICCR). The guidance includes specific recommendations on documentation, recordkeeping, buildings and facilities, equipment, personnel, raw materials, production, internal audits, laboratory controls, handling consumer complaints and reports of adverse events, and conducting recalls. It can be viewed by following the link above.
The LUSH prize consists of £250,000 prize money which will be awarded as five separate prizes of £50,000 in the catagories of: Science, Training, Public Awareness, Young Researcher, Lobbying, and the Black Box prize which is reserved for a major breakthrough in 21st Century Toxicology. For more information on the prize or to make a nomination, please visit the LUSH prize website above.
IIVS was pleased to share the 2012 LUSH prize for training. Click here to view a video of the 2012 LUSH Prize awards dinner.
Former Chairman of Trustees Professor Michael Balls has accepted the title of Honorary Life President of FRAME (Fund for the Replacement of Animals in Medical Experiments). Professor Balls recently resigned from the FRAME Trustees, although he remains honorary editor of the journal ATLA (Alternatives to Laboratory Animals) and of PiLAS (Perspectives in Laboratory Animal Science).
Professor Balls has been associated with FRAME since 1979 and during that time has played a significant part in promoting the Three Rs (Replacement, Reduction and Refinement) to the scientific community. He was instrumental in the drafting and passage through Parliament of the Animals (Scientific Procedures) Act 1986 and has received many awards and honors for his work in the search for alternatives to laboratory animals, both in the UK and overseas. The FRAME Trustees have presented him with a computer and a crystal decanter in honor of his long service.
We wish Professor Balls and FRAME all the best through this transition.
Content includes a press release on the formation of ICARAA, a scientific article on in vitro phototoxicity assays (and our upcoming webinar on the same topic), a synopsis on our recent activities in Vietnam, information about our inhalation toxicity workshop, and much more.
EURL ECVAM Releases Progress Report on the Development, Validation and Regulatory Acceptance of Alternative Methods
The report covers advances made in the field of non-animal testing since 2010, which is the last time a summary report on alternative methods was published by ECVAM. The report addresses all toxicological areas relevant to the Cosmetics Regulation and is intended to supplement the 2013 Commission Communication on the animal testing and marketing ban. EURL ECVAM feels that good progress has been made in the area of local toxicity where the science and methods are more established. Efforts in the areas of reproductive and systemic toxicology and carcinogenicity are still mainly focused on research and development of new alternative methods. Please read the attached full report for additional information.
Addressing the phototoxic potential of individual ingredients and final formulations, especially those that absorb light in the UV/visible ranges and accumulate at the skin, has been a priority in the cosmetics industry; exactly how to address this has been examined using in vitro methods such as the 3T3 Phototoxicity Assay using Neutral Red Uptake (3T3-PT-NRU) Assay and Phototoxicity Assays using a 3-dimensional reconstructed epidermal skin model (3D-PT). These assays can cover the assessment of a variety of chemicals; but sometimes choosing the right assay (or assays) can be challenging. Which assay is best suited for your testing needs or product development goals?
GAITHERSBURG, Md., May 28, 2013 — The Institute for In Vitro Sciences Inc., (IIVS) a world renowned leader in the validation, training, and application of non-animal test methods, announces the formation of ICARAA: Industry Council for the Advancement of Regulatory Acceptance of Alternatives. ICARAA was formed in response to international regulations that still require animal testing to assess the safety of cosmetic and personal care products. “Many companies have been working for decades to eliminate animal testing,” states Dr. Rodger Curren , President of IIVS. “As a non-profit organization with a mission to expand the use and acceptance of in vitro methods, IIVS is well positioned to assist international regulatory agencies in the adoption of such technologies. With the combined support of the industry partners we are able to significantly expand and sharpen our efforts.”
ICARAA activities focus on educational programs that include lectures, laboratory demonstrations, hands-on training and data interpretation. Priority is given to those in vitro tests that have been widely used by the personal care and cosmetic industries and recognized by the OECD. Currently, ICARAA is also working with a major university and a biotechnology company to help increase the number of in vitro testing laboratories in China as well as assist with the development of the technology required to conduct in vitro testing. ICARAA’s overall goal is to facilitate movement away from animal testing by China’s regulatory agencies.
ICARAA is currently comprised of a number of companies including:
British American Tobacco Group Research & Development
The Estee Lauder Companies, Inc.
Mary Kay Inc.
About the Institute for In Vitro Sciences (IIVS)
Founded in 1997 as a non-profit organization, IIVS is recognized as a leading provider of in vitro testing and training services. Rigorous scientific programs coupled with educational and outreach initiates have established IIVS as a global leader in the advancement of alternatives to animal testing. For more information please visit [www.iivs.org].[http://www.iivs.org]
SOURCE Institute for In Vitro Sciences
A bipartisan group of US senators introduced a bill to modernize the Toxic Substances Control Act (TSCA), the principal federal law governing chemicals in commerce. The bill was crafted with additional input from the chemicals industry, environmentalists and other stakeholders. Under current law, the EPA can call for safety testing only after evidence surfaces demonstrating a chemical may be dangerous. As a result, EPA has only been able to require testing for roughly 200 of the more than 84,000 chemicals currently registered in the United States, and has been able to ban only five dangerous substances since TSCA was first enacted in 1976. These shortfalls led the Government Accountability Office (GAO) to identify TSCA as a “high risk” area of the law in 2009.The new bill, titled the Chemical Safety Improvement Act (CSIA) would:
Require Safety Evaluations for All Chemicals: All active chemicals in commerce must be evaluated for safety and labeled as either “high” or “low” priority chemical based on potential risk to human health and the environment. For high priority chemicals, EPA must conduct further safety evaluations.
Protect Public Health from Unsafe Chemicals: If a chemical is found to be unsafe, the Environmental Protection Agency (EPA) has the necessary authority to take action. This can range from labeling requirements to the full phase-out or ban of a chemical.
Prioritize Chemicals for Review: The Environmental Protection Agency will have to transparently assess risk, determine safety, and apply any needed measures to manage risks.
Screen New Chemicals for Safety: New chemicals entering the market must be screened for safety and the EPA is given the authority to prohibit unsafe chemicals from entering the market.
Secure Necessary Health and Safety Information: The legislation allows EPA to secure necessary health and safety information from chemical manufacturers, while directing EPA to rely first on existing information to avoid duplicative testing.
Promote Innovation and Safer Chemistry: This legislation provides clear paths to getting new chemistry on the market and protects trade secrets and intellectual property from disclosure.
Protect Children and Pregnant Women: The legislation requires EPA to evaluate the risks posed to particularly vulnerable populations, such as children and pregnant women, when evaluating the safety of a chemical—a provision not included in existing law.
Give States and Municipalities a Say: States and local governments will have the opportunity to provide input on prioritization, safety assessment and the safety determination processes, requiring timely response from EPA, and the bill establishes a waiver process to allow state regulations or laws to remain in effect when circumstances warrant it.
To read more about this proposed legislation, please follow the link above.
The European Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) has published its recommendation on the performance of the 3T3 Neutral Red Uptake (NRU) in vitro test method for acute oral toxicity.The recommendation says that 3T3 NRU could be used to identify chemicals that do not require classification as toxicants, so called "negative" substances. This, EURL ECVAM says, will be useful for industrial chemicals under REACH, where information on acute oral toxicity is one of two health effects requiring animal tests at low production levels.The recommendation summarzses the overall performance of the 3T3 NRU test method, its applicability and limitations, and provides guidance for proper scientific use. It also suggests ways of tackling some remaining gaps to provide more complete characterisation of substances using the test method. For more information, please follow the link and visit the EURL ECVAM website.
Registration Deadline May 15 for Scientific Roadmap for the Future of Animal-free Systemic Toxicity Testing Workshop
Register to see a presentation and participate in discussions on a scientific roadmap for the future of animal-free systemic toxicity testing, at a workshop on May 30-31, 2013 at the U.S. Food and Drug Administration's Wiley Building in College Park, Maryland. The scientific roadmap was the product of an October 2011 workshop held under the auspices of the transatlantic think tank for toxicology (t4). The program includes an opportunity for public discussion of the roadmap, as well as its possible updating in light of more recent developments. Please visit the link above for the agenda, registration information, and a list of the organizing committee.
An appeal has overturned the European Chemicals Agency’s (ECHA) request for additional animal toxicity testing on the automotive air-conditioning refrigerant 2,3,3,3-tetrafluoropropene (HFO-1234yf). ECHA requested that Honeywell, manufacturers of HFO-1234yf, conduct extended safety studies in rabbits. Honeywell countered that such studies would not provide the agency with the information they were looking for and that safety could be confirmed by analyzing the current data. ECHA's board of appeal has rulled that the requested test would oppose the ECHA’s responsibility under the Reach (registration, evaluation, authorisation and restriction of chemicals) regulation to ensure that animal tests are only undertaken as a last resort, and that any testing involves the minimum number of animals. Read more by following the link above.
BCOP and ICE Assays Accepted for use to Identify Non-Irritating Materials in the Field of Eye Irritation
The OECD has revised the test guidelines for the Bovine Corneal Opacity and Permeability (BCOP) test and the Isolated Chicken Eye (ICE) test to extend the applicability domain of two in vitro methods. This is the first time that in vitro methods are accepted for the identification of non-irritant chemicals in the field of eye irritation. The revision of the two test guidelines was adopted at the OECD meeting of the Working Group of National Coordinators of the Test Guideline Programme held in Paris on 9 to 11 April 2013. They had originally been adopted in 2009 for the identification of serious eye damage/eye irritation of chemicals further to retrospective validation by the US Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) in collaboration with EURL ECVAM and the Japanese Center for the Validation of Alternative Methods (JaCVAM). Additional validation of the two tests showed their usefulness also for the identification of chemicals not requiring classification for serious eye damage/eye irritation (i.e. non-irritant chemicals), thus leading to the revision of the test guidelines under the co-lead of EURL ECVAM and the Netherlands. Please follow the link above to read the full story on the EURL ECVAM website.
Chemicals company BASF has teamed up with life sciences company Promega to jointly develop an alternative method to animal testing to detect allergic reactions in the skin to certain substances. Dr. Robert Landsiedel, head of the short term Toxicology unit at BASF states, "Combining the new method with two additional alternative methods to investigate skin sensitization allows us not only to significantly reduce the number of animal studies, but also to predict a possible allergic potential more reliably than before." This new method has been submitted to ECVAM (The European Center for the Validation of Alternative Methods) for evaluation.
Swedish researchers at Lund University have developed various in vitro test strategies to replace animal testing when determining skin allergens, thanks to a special special gene expression analysis software. To read the article on Cosmetics Design Europe's website, please follow the link above.
The latest PanAmerican Society for Pigment Cell Research (PASPCR) Newsletter is now available online.
Dr. Gertrude-Emilia Costin, Study Director at IIVS, serves as Editor of the PanAmerican Society for Pigment Cell Research (PASPCR) Newsletter which is published three times a year and is intended to serve as a regular means of communication for the members the Society. The April number is now available by following the link above.
PETA is presenting a new award—the Laurie and Carlee McGrath Award, which includes a $5,000 cash prize—to the MatTek Corporation for its development of sophisticated non-animal tests. The award is named in honor of Laurie McGrath and her mother, Carlee McGrath, whose San Diego–based McGrath Family Foundation supports PETA's work to replace animals in laboratories with non-animal methods. IIVS and MatTek have collaborated over many years and we congratulate MatTek for being recognized for their work in developing 3-dimensional human cell based tissue constructs that can be used in place of animals for various types of toxicity tests. Please follow the link above to read the full article.
The Alternatives Research & Development Foundation is currently soliciting research proposals for its 2013 Alternatives Research Grant Program. For nearly 20 years, this program has created opportunities for scientists who have interest and expertise in alternatives research.
Up to $40,000 in funding available to support individual projects
Preference given to U.S. universities and research institutions
Preference given to projects that use pathway-based approaches as exemplified by the 2007 National Academy of Sciences report, Toxicity Testing in the Twenty-first Century: A Vision and A Strategy
Deadline: Applications must be electronically submitted or postmarked by Tuesday, April 30, 2013
Recipients notified: Tuesday, July 16, 2013
Potential to significantly replace or reduce laboratory animals
Scientific merit and feasibility
To apply, please download the Guidelines for submission and Application cover page Applicants must notify ARDF via email of intent to submit a proposal by April, 23, 2013. Please see instructions in Grant Guidelines.
As the final animal testing ban deadline went into effect in Europe last week, Chinese regulatory bodies in their efforts to follow closely behind the West, have organized a workshop on in vitro alternative methods to further educate industry professionals on the Asia Pacific region. IIVS, along with two Chinese agencies, served as organizers for the event taking place March 19, 2013. Follow the link above to read more detail on the Cosmetics Design Asia website.
European Union regulators announced today that the ban on the import and sale of cosmetics containing ingredients tested on animals has gone into effect. This ban follows the EU ban on animal testing of finished cosmetic products that went into effect in 2004. Today's ban removes extensions to the deadline allowing continued use of animal testing for those endpoints for which a suitable in vitro alternative has not been found. Through this action, the EU has also pledged to put forth a greater effort to push other parts of the world, like China, to accept alternatives. To read more about this ban, please click on the link above.
The Drug Controller General of India (DCGI) is said to have called for the fast-tracking of the deletion of two animal-tests from the regulatory safety standards governing cosmetics.Products ranging from eye-liners and lipsticks to shampoos and face-washes will be affected by this change. Companies wanting to test cosmetic products or ingredients for specific effects will have to submit a non-animal testing proposal to the DCGI for approval. It is expected that the Indian cosmetic standard IS4011 will be amended to reflect the changes, as directed by DCGI. To read the full article, please follow the link above.
US scientists have created a tiny device that simulates a working human lung and could reduce the need for testing pharmaceutical compounds in animals. The “lung-on-a-chip” contains hollow channels lined with living human cells that mimic the interface between the air sacks in the lung and the blood vessels beneath, allowing scientists to study the body’s response to lung infections and diseases. The chip’s inventors at the Wyss Institute for Biologically Inspired Engineering at Harvard University have received an annual international prize for the device’s potential to gradually reduce the use of animals in drug testing. Please click on the link above to read more at The Engineer.
Read about the activities and planned future work of the Evidence-based Toxicology Collaboration in there newsletter (linked above). The newsletter includes information on recent publications, a satellite meeting during the SOT meeting, and a summary of their 2012 meeting titled "Evidence-based Toxicology: Opportunities and Challenges".
Content includes information on the Short Time Exposure Assay (and our upcoming webinar on the same topic), a synopsis on our recent activities in China and Brazil, details concerning the LUSH prize for training, our MOU with the EPAA, and much more.
Queen Mary, University of London, has created a professorial chair in animal replacement science. The position is funded by the Dr Hadwen Trust, a charity that funds investigation into ways of replacing animals in research. According to the trust, the chair will "see the UK spearhead a collaborative global search for more ethical, human-relevant alternatives to animal testing". The professor will be based at Queen Mary's Blizard Institute, where researchers already are already working on developing in vitro models using human cells and tissue. Read more by following the link above.
A new animal- and cell-free method has been developed to measure the toxic activity of Botulinum neurotoxin (BoNT), e.g. Botox. The invention will avoid the use of mouse LD50 tests for toxicity testing, e.g. in BoNT-containing pharmaceutical products such as Botox.The method uses functionalized liposomes to determine the toxin’s activity under physiological conditions. Read more by following the link above.
In a development that could lead to faster and more effective toxicity tests for airborne chemicals, scientists from Rice University and the Rice spinoff company Nano3D Biosciences have used magnetic levitation to grow some of the most realistic lung tissue ever produced in a laboratory. The research is part of an international trend in biomedical engineering to create laboratory techniques for growing tissues that are virtually identical to those found in people's bodies. In the new study, researchers combined four types of cells to replicate tissue from the wall of the bronchiole deep inside the lung. The research is available online and scheduled to appear in a future issue of the journal Tissue Engineering Part C: Methods. Read more by following the link above.
Via Frame -
Amendments to the Animals (Scientific Procedures) Act 1986 came into force on January 1. The amended version of ASPA has been introduced to align UK legislation with European Directive 2010/63/EU. The Home Office has produced guides for researchers to help them with the changes.The ‘quick start’ guide provides advice on what the revised ASPA covers and guidance to holders of establishment licences, project licences and personal licences and new licence applicants. It also provides guidance on severity classification, humane killing and the accommodation and care of animals. More detailed draft guidance, covering more topics, will be published later in January for consultation.
A transitional guide sets out details of changes that researchers must make immediately in order to comply with the new regulations. It also details changes that will happen automatically.The new law requires re-authorisation for some activities and some types of animal, and the transitional guide sets out details of those amendments. For example, all cephalopods (octopus, squid, cuttlefish and nautilus) are now protected. Under the old regulations only Octopus vulgaris was included. The new rules also increase control of breeding of some frog species and zebra fish. Increased use of fish in regulatory testing accounted for a significant rise in the number of animals used for toxicology (safety testing) in the last Home Office statistics on the use of animals in laboratories in the UK.
The next IVTIP meeting titled '2013: State of the art on alternatives from an industrial point of view: ready for regulation?' will be held in Southampton (UK) on May 14-16, 2013 hosted by British American Tobacco at their GR&D facility. Authors wishing to submit an abstract should send it to firstname.lastname@example.org (1 page, title in bold, authors with affiliations, presenting author to be underlined, 350 words maximum, Arial 10, please indicate “oral” or “poster” presentation). Deadline for submission is February 1, 2013. Please consider the meeting program on the IVTIP website (www.ivtip.org) to make sure your paper falls within the scope of this event. Authors will be informed about the acceptance of their abstracts by February 20. All accepted abstracts will be included in the IVTIP Abstract Book and distributed to all participants. Please note that all presenters will be required to register for the conference.
Exhibition spaces available
A 2010 law passed by Israel took effect January 1, 2013 banning animal testing on cosmetic products imported into the country. Much like the European Cosmetics Directive, this law governs cosmetics, toiletries and detergents and includes a ban on the marketing of cosmetics that have been tested on animals in foreign countries as well. For more information on this law, please visit the website above.
This issue contains information on the election of board of directors and a summary of the first annual meeting.
The European Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) is inviting public comments on its latest recommendation concerning the 3T3 Neutral Red Uptake cytotoxicity test method. The deadline for receipt of these comments is January 31, 2013. The assay was recently validated by EURL ECVAM for its possible use to support the identification of substances not requiring classification for acute oral toxicity. The present recommendation outlines the assay's principle, its performance characteristics (based on available information and, mainly, evidence generated during validation) and the assay's limitations and makes recommendations for its implementation within an Integrated Testing Strategy (ITS) based primarily on non-animal approaches including structure-activity relationships and biokinetic modelling. The recommendation is based on the opinion of the ECVAM EURL Scientific Advisory Committee (ESAC) which peer-reviewed the validation study (the ESAC opinion is annexed to the recommendation document). Please visit the ECVAM website for downloadable pdfs of the relevant documents and instructions on how to submit your comments.
Mathematical modelling has the potential to solve biological questions, provide new insights which benefit science and medicine, and reduce reliance on animal models. Submit a problem to the NC3Rs Maths Study Group for the opportunity to work with mathematicians in addressing your research questions.
If you are interested in participating in the Study Group please submit a proposal describing your biological problem by 14 January 2013. Proposals should be no longer than two A4 pages and should include:
A brief background to the problem
Details of the problem
Any available data for informing possible mathematical models
Questions you would like to see answered
The potential impact on animal use
Any relevant references
Proposals for problems for the Study Group to consider at the workshop should be submitted to the NC3Rs at email@example.com.
The U.S. Environmental Protection Agency Office of Pesticide Programs (U.S. EPA/OPP) and Health Canada’s Pest Management Regulatory Agency (PMRA) have cooperated on the development of a guidance document on the use of Quantitative Structure Activity Relationships [(Q)SAR] for pesticide risk assessors. This document has been developed under a North American Free Trade Agreement Technical Working Group (NAFTA TWG) project, 21st Century Toxicology: Integrated Approaches to Testing and Assessment.
The NAFTA TWG (Q)SAR Guidance Document provides an introduction to (Q)SAR and a flexible framework to assist with problem formulation for (Q)SAR, assessing the adequacy of predictions, and incorporating predictions into weight of evidence based assessments of pesticides. While the (Q)SAR Guidance Document was not designed to be a step-by-step manual, it provides useful guidance to evaluators who are reviewing predictions included in pesticide submissions or who are using (Q)SAR to help identify additional data requirements for pesticides, metabolites or degradates. Moreover, it also supplements, but does not replace, existing (Q)SAR guidance documents from the Organisation for Economic Cooperation and Development (OECD), the European Chemicals Bureau and other agencies.The NAFTA TWG (Q)SAR Guidance Document is currently available for download at the link above.
The Hamner Institutes for Health Sciences launched a partnership designed to advance a systems biology approach to the study of toxicity testing in pre-competitive research phases. Hamner said the partnership will develop human cell-based assays that map and model key cell signaling pathways in order to evaluate dose response, using toxicity pathway case studies with the goal of speeding implementation of recommendations from the National Research Council report “Toxicity Testing in the 21st Century: A Vision and a Strategy.” Partners sponsoring the research include Agilent Technologies, Illumina, Dow Chemical, Dow Corning, ExxonMobil, Unilever, and CropLife America, while the Long-Range Research Initiative of the American Chemistry Council supported earlier stages. Please click the link above to read the full article.
EU Health Commissioner Designate Receives Endorsements from ECEAE and HSI, and Criticism from the Personal Care Trade Association
Earlier this month prospective EU Health Commissioner Tonio Borg expressed his support for the current March 2013 deadlines on animal testing put in place by the European Cosmetics Directive. "The ECEAE agrees with Mr. Borg's comments that industry would not find alternative means of testing if the marketing ban is not implemented as 'necessity is the mother of invention", it says in a statement. Likewise, HSI's senior EU policy adviser, Emily McIvor, agreed. "Tonio Borg's stated aim of overseeing full implementation of the 11 March 2013 ban represents a huge step forward..." Read more about ECEAE and HSI backing of Tonio Borg.
In contrast, Cosmetics Europe has urged caution over Tonio Borg's comments saying it may 'jeopardize' progress and undermine EU leadership in global animal welfare. Organization president Fabio Franchina comments, "[Borg's] sweeping statements threaten to remove that impetus and undermine the EU's hard-won leadership in driving the development of alternatives to animal testing. Furthermore, it is completely incompatible with the EU's existing Innovation 2020 strategy." Read more about Cosmetic Europe's concerns with Borg's remarks.
Marking its commitment to international cooperation, the European Partnership for Alternative Approaches to Animal Testing (EPAA) Co‐chairs signed a Memorandum of Understanding with the Institute for In Vitro Sciences (IIVS) President Rodger Curren during their 8th annual meeting on November 16th. EPAA and IIVS have agreed to establish a strategic partnership dedicated to the international dissemination of alternative techniques for safety evaluation. EPAA will provide sponsorship of up to €100,000 over the next two years to IIVS to support training activities in key regions, including China and Brazil. R. Curren stated that “EPAA’s efforts to promote international cooperation on 3Rs will be greatly complemented by our joint activities and solid international network.” To read more about the MOU and the EPAA annual meeting, please click on the link above. You can also view a signed copy of the MOU between EPAA and IIVS.
“Strong international cooperation is the future of alternatives to animal testing”
‐ Memorandum of Understanding with US‐based Institute for In Vitro Sciences signed
‐ Researcher from Germany‐based Helmholtz Centre for Environmental Research awarded with the 3Rs Science Award 2012
16th November 2012, Brussels Centre de Conferences Albert Borschette: Today, the European Partnership for Alternative Approaches to Animal Testing (EPAA) organized its 8th Annual Conference in Brussels. EPAA is a unique collaboration between five EU Commission services and seven industry sectors ‐ animal health, chemicals, cosmetics, crop protection, fragrances, pharmaceuticals, soaps & detergents. Finding future alternatives to animal testing and ensuring their use in regulatory contexts will require stronger and greater international cooperation, delegates at the Annual European Partnership for Alternative Approaches to Animal Testing (EPAA) conference in Brussels heard today. Speaking at the conference, DG Enterprise and Industry’s Deputy Director General, Antti Peltomäki – speaking on behalf of European Commission Vice President Antonio Tajani ‐ stressed that while Europe has pioneered efforts in the 3Rs of replacing, reducing and refining animal testing, further progress for the sustainable development of innovative products worldwide lies in strengthened international cooperation.
DG Enterprise and Industry’s Director and EPAA Commission Co‐Chair, Gwenole Cozigou, echoed these remarks, concluding that 2012 has been a turning point for the EPAA. While EPAA remains committed to and works on promoting alternative approaches in Europe, it has to be ready for the global stage, and will also work towards developing synergies with other regions. In her keynote presentation, Dr Julia Scheel, EPAA’s Industry Co‐Chair, highlighted the relevance of international cooperation from an industry perspective, as reflected in EPAA’s 2012 lead theme. She reported on a number of promising activities developed or launched during 2012, such as reducing animal numbers in vaccines batch testing and advancing 3Rs in other dedicated areas of regulatory toxicology including carcinogenicity and skin sensitization.
Marking this commitment to international cooperation, the EPAA Co‐chairs signed a Memorandum of Understanding with the US based Institute for In Vitro Sciences (IIVS) President Rodger Curren. EPAA and IIVS have agreed to establish a strategic partnership dedicated to the international dissemination of alternative techniques for safety evaluation. EPAA will provide sponsorship of up to €100,000 over the next two years to IIVS to support training activities in key regions, including China and Brazil. R. Curren stated that “EPAA’s efforts to promote international cooperation on 3Rs will be greatly complemented by our joint activities and solid international network.”
The conference which attracted around 150 delegates, also heard from the US Food and Drug Administration, the Chinese State Food and Drug Administration, the OECD and European Chemicals Agency. Speakers highlighted both the potential benefits as well as the main challenges arising from implementing increased collaboration on the 3Rs. EPAA also honoured Dr Nils Klüver from the German‐based Helmholtz Centre for Environmental Research with the annual 3Rs Science Award for 2012, for his project “Systematic approach to investigate outliers of the fish embryo test to increase its predictive capacity and applicability domain for acute fish toxicity and beyond”. Dr Klüver will now further develop his method in collaboration with EPAA partners, thanks to a €100,000 grant.
The European Partnership for Alternative Approaches to Animal Testing (EPAA) is a joint initiative from the European Commission, European trade associations from seven industry sectors and individual companies (see partners here). It was launched in November 2005 with the purpose to promote the development and implementation of new 3Rs methods (replace, reduce, refine) in the field of safety testing. For further information on the EPAA or its projects
The Institute for In Vitro Sciences, Inc. is a non‐profit research and testing laboratory dedicated to the advancement of in vitro (non‐animal) methods worldwide. Founded in 1997, IIVS has worked with industry, academic laboratories and government agencies to implement in vitro testing strategies that limit animal use while supplying key information for product safety and efficacy decisions. For further information on IIVS and its programs
At an award ceremony being held in London today, two groups shared the £50,000 Lush Training Prize for making ‘outstanding contributions’ to training researchers in non-animal methods.
The winners were:
The Institute for In Vitro Sciences, USA – for their work on training researchers from Brazil to China
InterNICHE, co-ordinated from the UK – for their training work in former Soviet states, South America and Africa
The new annual Lush Training Prize, a joint project between the global handmade cosmetics company and Ethical Consumer magazine, is designed to bring forward the date when products and chemicals are no longer tested on animals.
The Training Prize provides a useful illustration of the extent of animal testing in emerging economies and the importance for campaigners of moving into these new regions.
Rob Harrison from the Lush Prize said:
“Lush Prize winners in 2012 have included scientists, campaigners, lobbyists, training specialists and young researchers from eight countries. All these people play a vital role in the global movement to replace animal testing with methods that are now widely accepted to be both more humane and effective.”
Every year, it is estimated that more than 100 million animals – including mice, rabbits and rats – are used in testing laboratories around the world.
Gaithersburg, MD, November 16, 2012: The Institute for In Vitro Sciences (IIVS), a non-profit laboratory, received the first annual Lush Training Prize during an award ceremony in London yesterday. The prize is a joint project between the global handmade cosmetics company and Ethical Consumer magazine. Designed to bring forward the date when products and chemicals are no longer tested on animals, the prize recognizes individuals or organizations who have excelled in establishing training programs to make scientists aware of the range of available non-animal testing methods.
“At IIVS we believe the change to non-animal testing methods will be hastened through education and training. Seeing, touching, using these methods firsthand and understanding the results will change perceptions and practices,” said Rodger Curren, President of IIVS, during the awards ceremony in London. “Our trainings change the fuzzy image of ‘alternatives’ into the reality of better science and the removal of animal pain and suffering.”
The Lush Training Prize is one of 5 categories the cosmetics company is recognizing. Others include the Science Prize, Young Researcher Prize, the Public Awareness Prize and the Lobbying Prize. Over 180 nominations were submitted and a panel of 10 independent judges picked the winners from a short-list compiled by the Lush Prize Team.
IIVS shares the award with InterNICHE, an international network focusing on animal use and alternatives within biological sciences, medical and veterinary medical education.
IIVS is a non-profit organization wholly dedicated to the promotion of rapid and innovative non-animal testing methods. Founded in 1997, IIVS is recognized as a leading provider of in vitro testing in support of toxicological safety evaluations. Rigorous scientific programs coupled with educational and outreach initiatives have established IIVS as a global leader in the advancement of alternatives to animal testing. For more information please visit www.iivs.org.
The European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) is renewing membership of its Scientific Advisory Committee (ESAC). ESAC is a key contributor to EURL ECVAM's workflow, notably through providing published ESAC opinions summarizing peer review advice on validation studies. ESAC opinions form the basis for issuing formal ECVAM Recommendations, summarizing the validity of alternative methods, their limitations and appropriate use.
EURL ECVAM is now launching an open call for applications for membership in the ESAC. Interested scientists with relevant competences are invited to apply. A Selection Committee composed of EURL ECVAM staff and external scientists will assess all applications for eligibility and will shortlist suitable candidates using defined selection criteria. The Selection Committee may also draw on the reserve lists created after the 2009 call for applications. Experts who are currently on the reserve list of the 2009 call do not need to reapply, unless their competence profile has changed considerably. All relevant details pursuant to the call can be found on ECVAM's website The deadline for applications is 30th November 2012.
IIVS staff recently returned from a training trip to China funded by a grant through PETA. Last week students and staff of the Beijing Technical and Business University attended a training session with IIVS that included education on the Bovine Corneal Opacity and Permeability Test. The students and staff were very enthusiastic to be part of the training. More information on the training session and the acceptance of non-animal test methods in China can be found in the article above.
The OECD QSAR toolbox is software that can be used to group chemicals into categories to help fill some of the gaps in the toxicity or ecotoxicity testing data needed to perform hazard assessment on chemicals. This tool could be a valuable addition to a tiered testing strategy that could also include follow-on in vitro testing. Version 3.0 of the software can be downloaded from the website link above.
The Organisation for Economic Co-operation and Development (OECD) has officially adopted two test guidelines for identification of substances with the potential to cause eye injury. One of these (OECD TG 405), an updated test guideline for the traditional rabbit eye test, incorporates specific procedures to avoid or minimize animal pain and distress when it necessary to use animals to identify substances with the potential to cause eye injuries. The other test guideline (OECD TG 460)provides a new method to identify substances that may cause serious eye injuries without using animals. Both guidelines, along with all of the current OECD test guidelines for the testing of chemicals) can be viewed on the OECD website by clicking on the link above.
Contents include: 3Rs Prize, David Sainsbury Fellowship Scheme, Project and Pilot Study grants and CRACK IT Challenges registration deadline. Please click on the link above to view the newsletter on the NC3R website.
Content includes information on the EPA's in vitro testing pilot program for ocular irritation testing on antimicrobial cleaning products (and our upcoming webinar on the same topic), a synopsis on our educational activities, information on a practical methods workshop for delegates from Russia, a dermal absorption workshop, and much more.
LUDWIGSHAFEN, Germany and GAITHERSBURG, Md., Oct. 23, 2012 /PRNewswire-USNewswire/ —
BASF SE, the world’s leading chemical company, has provided U.S. based Institute for In Vitro Sciences (IIVS) with equipment critical to replacing the use of animals for eye irritation testing of certain chemicals. IIVS will place the units at each of its newly developed training laboratories in Xi’an, Beijing, and Guangzhou, China.
With a long history in the development and use of non-animal methods, BASF engineered and produced the instrument, known as an opacitometer, to provide a reliable, state-of the art, and commercially available platform for the Bovine Corneal Opacity and Permeability (BCOP) assay. “We determined that development of this equipment was necessary to standardize the BCOP assay for our own internal use. Realizing that it could help scientists around the world implement this important non-animal method, we made it commercially available in 2010 at production cost,” says Dr. Susanne Kolle, Head of Applied Alternative Methods at BASF SE. “We are proud to support IIVS’ efforts to promote the use of non-animal methods in China by providing three opacitometer kits.”
IIVS, a non-profit, laboratory-based organization, has recently expanded its international outreach and training program. Dr. Rodger Curren, President of IIVS, comments on the importance of the donation. “The three BASF opacitometer kits allow our staff to rapidly train Chinese scientists and regulators using state-of-the art equipment. The BCOP assay provides a predictive and cost effective alternative to the use of live animals for eye irritation testing.”
BASF has been a contributor to IIVS since 2010 and the two organizations have collaborated on several projects including inter-laboratory validation studies of non-animal methods.
BASF is the world’s leading chemical company. Our portfolio ranges from chemicals, plastics, performance products and crop protection products to oil and gas. We combine economic success, social responsibility and environmental protection. Through science and innovation we enable our customers in almost all industries to meet the current and future needs of society. Our products and system solutions contribute to conserving resources, ensuring healthy food and nutrition and helping to improve the quality of life. We have summed up this contribution in our corporate purpose: We create chemistry for a sustainable future. BASF posted sales of about €73.5 billion in 2011 and had more than 111,000 employees as of the end of the year. BASF shares are traded on the stock exchanges in Frankfurt (BAS), London (BFA) and Zurich (AN). Further information on BASF is available on the Internet at www.basf.com. To find out more about BASF’s activities on alternatives to animal testing please visit www.alternatives.basf.com.
IIVS is a non-profit organization wholly dedicated to the promotion of rapid and innovative non-animal testing methods. Founded in 1997, IIVS is recognized as a leading provider of in vitro testing in support of toxicological safety evaluations. Rigorous scientific programs coupled with educational and outreach initiatives have established IIVS as a global leader in the advancement of alternatives to animal testing. For more information please visit www.iivs.org.
The U.S. Consumer Product Safety Commission (CPSC) has added a page to its website titled "Recommended Procedures Regarding the CPSC's Policy on Animal Testing." The page summarizes the CPSC policy on animal testing and their suggestions for the use of existing information and scientifically validated alternatives to animal testing in hazard assessment. The page also lists acceptable alternative methods for acute toxicity testing, ocular irritation testing, dermal irritation testing, and skin sensitization testing, and provides links to CPSC votes and approvals regarding animal testing policy. Please contact us to discuss strategies for implementing the CPSC's recommendations within your in vitro testing program. Click on the link above to view the page on the CPSC website.
The FDA has published a report following its most recent International Co-operation on Cosmetics Regulation meeting (ICCR-5), in which it outlines the applicability of animal testing alternatives in the four ICCR jurisdictions (Europe, Canada, Japan and the United States). The report describes the current regulatory climate in each region and it discusses a number of currently available OECD validated non-animal testing methods, such as for skin irritation testing and phototoxicity testing. It also outlines the use of tiered-testing approaches to safety assessment and the necessity of this type of testing paradigm as the focus is shifted to the use of non-animal testing methods. Click on the link above to read the report on the FDA website.
Congratulations to Dr. Horst Spielmann for receiving this year's Björn Ekwall Memorial Award. Dr. Spielmann has significantly contributed to the field of in vitro toxicology by developing non-animal tests aimed at reducing the number of animals used in experimentation such as the 3T3 phototoxicity assay and the embryonic stem cell test (EST) for determining embryotoxicity. Dr. Spielmann collaborated with Dr. Björn Ekwall over the course of several years. The Björn Ekwall Memorial Award will be awarded at the ESTIV 2012 meeting where Dr. Spielmann will deliver the Björn Ekwall Memorial Lecture titled Today Björn Ekwall would endorse the concept "Toxicology in the 21st Century".
The majority of cleaning products in the US do not undergo a pre-market registration process. However, once an “anti-microbial” claim is made for the product, it is regulated by the US Environmental Protection Agency’s Office of Pesticide Programs (US EPA OPP) and animal testing for hazard identification is required before the product can be sold. Click on the link above to view the full article.
This international workshop features presentations by representatives from around the globe who will speak on validation studies performed on the HET-CAM assay and their experiences in working with a number of materials in the assay. Registration is open to the public, but limited to 40 participants. More information, including links to the web page of the International Workshop on the HET-CAM Assay can be found by following the link above.
The Lush Training Prize aims to reward individuals and organizations involved in training researchers in non-animal methods. The training prize recognizes that many scientists involved in chemicals testing are not aware of the range of non-animal methods available or trained in using them. Establishing training programs around the world makes a huge difference to the field. The prize wishes therefore to reward individuals, teams, or organizations who have excelled in this field. The three groups on the short list are:
Institute of In Vitro Sciences
The International QSAR Foundation
The winner will be announced October 15.
Forsby, Norman et al. Article on Eye Sting Editor's Highlight in the Current Issue of Toxicological Sciences
The paper chosen for the Editor's Highlight in the October 2012, Vol. 129, No. 2 issue of Toxicological Sciences is "Using Novel In Vitro NociOcular Assay Based on TRPV1 Channel Activation for Prediction of Eye Sting Potential of Baby Shampoos" by Anna Forsby, Kimberly G. Norman, Johanna EL Andaloussi-Lilja, Jessica Lundqvist, Vincent Walczak, Rodger Curren, Katharine Martin, and Neena K. Tierney.
Editor, Michael L. Cunningham notes that "Replacing animal testing for pain induction by chemicals is a goal of animal welfare research. Forsby et al. make a significant advancement in this field by the development of the NociOccular test for baby bath and shampoo formulations. This assay is a recombinate neuronal in vitro model of activation of the Transient Receptor Potential Vanilloid type 1 channel, a well characterized pain-inducing receptor. This research opens the way for the development of future assays to predict pain induction without the use of animals."
The National Center for the Replacement, Refinement, and Reduction of Animals in Research's (NC3Rs) latest newsletter is available on the web. The 47th issue includes information on the 3Rs prize, a call for fellowships, information on current vacancies, the CRACK IT 2012 Challenges launch, and two new CRACK IT Solutions. Please click on the link above for access to this newsletter.
From the ESTIV2012 Organizing Committee - This is a friendly reminder that the Registration Deadline (15th September) for ESTIV2012 is fast approaching. This year the congress will take place October 16-19 in Lisbon, and will be co-hosted by AP Tox. ESTIV2012 will focus on the new developments in toxicity testing and the mechanism of action of chemicals and nanomaterials with a special emphasis on the following themes:
Innate immune responses in toxicity
Reproductive & developmental testing
Computational toxicity & toxicokinetics
Additional information and program is available online
Abstracts for the EUSAAT Annual Congress 2012 are now available to download from the FRAME website. The Congress (5 - 8 September) will focus on new approaches and methodologies — for example, disease models, non-animal tools for basic biomedical research, ‘-omics’ techniques and advanced 3D models. More details can be found on the FRAME website by following the link above. There is also a link to a pdf document of all of the conference abstracts on this page. The abstracts will also appear in a future issue of FRAME's scientific journal ATLA (Alternatives to Laboratory Animals)
The European Union Reference Laboratory for Alternatives to Animal Testing (EURL-ECVAM), the Institute for Health and Consumer Protection, has published two calls for grantholder positions to support EURL-ECVAM in the assessment and validation of alternative methods:
Deadline for the applications is 7 October 2012.
Subscribers to FRAME's Alternatives to Laboratory Animals (ATLA) journal may download the contents. Non-subscribers may purchase the entire issue. In addition, there are a number of free articles for review including: Editorial: The International Transport of Laboratory Animals: No Excuse for Biased Extremism of Any Kind, The Forthcoming Launch of Perspectives in Laboratory Animal Science (PiLAS), and the announcement of the Dorothy Hegarty Award Winners.
Content includes the announcement of our next webinar on skin irritation testing strategies using 3D tissue constructs, an article on the conduct of validation studies, a special workshop in Japan and much more.
This issue includes how to use in vitro methods as a pre-screen for clinical testing, international educational and outreach activities in Russia, China, and Brazil and more.
Content includes the announcement of our next webinar on the BCOP assay, strategies for identification of skin irritants and corrosives in vitro, a special workshop in Brazil, information on our January Practical Methods for In Vitro Toxicology Workshop and much more.
Content includes the announcement of a new member to our Science Advisory Panel, a scientific article on the cytosensor microphysiometer assay, announcement of our September webinar on skin sensitization and the KeratinoSens assay, a synopsis of our recent trip to the California EPA, and more.
Content of the June 2011 newsletter includes information on a non-animal test method for skin sensitization (KeratinoSens), a summary of our recent training meetings in China, and registration for and details on the expanded program for the 2012 Practical Methods for In Vitro Toxicology Workshop.
IIVS goes paperless with its first digital, e-newsletter. Content includes an overview of our re-designed website, details on our assay designed to look at topical antioxidant materials, our participation in the ECVAM ESAC committee, and more. Please let us know what you think of the new format.
The IIVS Fall/Winter 2010 newsletter contains a wrap-up of the October In Vitro Alternatives Forum, IIVS' skin sensitization program, the Axlr8 program, the founding of the American Society for Cellular and Computational Toxicology, and more.
The IIVS Summer 2010 newsletter contains valuable information on the proposed TSCA reform, the 2010 In Vitro Alternatives Forum, a formation of a new scientific society and much more.
This newsletter contains information about: * The Mouse Embryonic Stem Cell Test: Technical Challenges and Recent Advances * 2010 In Vitro Alternatives Forum * IIVS Training Workshops * and much more!
The Institute's Fall/Winter 2009 Newsletter contains information on: * Mucosal Irritation * Upcoming Events * Draize Replacement * Considering Alternatives Meeting * ECHA Clarification * 5th IWGT Workshop * ZEBET Anniversary * SAP and contributors, and * Eye Irriation Update!
This newsletter contains information about: * Alternatives Highlights - 1st Half 2009 * FRAME Celebrates 40 Years and More * OECD Draft Guideline for Skin Irritation * Meeting report - Forinvitox: from innovation to market success * and more!
Topics covered in this Institute Update include: the importance of conducting work according to GLPs, the profile of a new IIVS contributor, information on the upcoming SOT meeting and Practical Methods Workshop, and a look at the potentially promising year ahead.
View the pdf to read about recent skin irritation events, highlights from the 2008 In Vitro Alternatives Forum meeting (Spotlight on Ingredients) and the EPAA annual meeting, current progress for eye irritation models, and more.
The summer edition of IIVS Update has been mailed. Take a look at the pdf file to see our improved layout and information on the October Spotlight on Ingredients Forum, the June BCOP Histopathology Workshop, the annual Practical Methods for In Vitro Toxicology Workshop, and much more!
The IIVS Newsletter contains information on our current outreach programs, technical notes on the phototoxicity assay and information on future Institute activities. The Institute Update is published 3 times per year.
This quarters newsletter includes information on:
* ICCVAM 5 year plan, * Moscow Seminar, * Technical Notes, * QA Initiatives, * ECEAE Workshop, * Alternatives Forum, * SAP Member Highlight, * Two New IIVS Contributors, * What’s New at Our House
Take a look at our March 2007 newsletter: * 3-D Human Skin Models – The Next Generation of Tools for the In Vitro Toxicologist * Society of Toxicology Annual Meeting, * SAP Member Highlight - Dr. Marilyn Aardema, * SkinInVitro 2007 Meeting, * Development of Genotoxicity Assays in 3D Human Skin Models, * CELEBRATING 10 YEARS!, * POM Wonderful Supports IIVS’ Mission to Develop In Vitro Methods to Replace Animal Research.
Checkout our November newsletter: The Importance of Outreach, INVITOX 2006, Remembering William Russell, CAAT 25th Anniversary, Doris Day Animal League Merges with HSUS.
- Expert Users Workshop Review of the OECD Guidelines of Percutaneous Absorption (PA) In Vitro
- 13th Congress on Alternatives to Animal Testing
- Use of An Adenosine Triphosphate (ATP) Cytotoxicity Assay in Normal Human Epidermal Keratinocytes (NHEK)to Predict Systemic Toxicity In Vitro
- Practical Methods Workshop
- and more!
Have you wondered how IIVS provides reliable, reproducible in vitro testing services? Or how IIVS fosters scientific optimization, validation and implementation of alternatives to animal testing or who sponsors these activities? Learn about our Test System Monitoring and Good Laboratory Practices programs, some of our scientific outreach program activities and our sponsors in the March 2006 Newsletter.
IIVS progress on optimization of Alternative Tests, ICCVAM Expert Panel Reviews BRD Addenda, Standards for In Vitro Tests, and more.
IIVS news on
- In vitro eye irritation testing of antimicrobial products and the EPA,
- ECVAM eye irritation expert meeting,
- ICCVAM project on severe eye irritation,
- World Congress on Alternatives & Animal Use in the Life Sciences Practical Training Workshop on In Vitro Eye Irritation Methods
- and more!
Investigations on Reducing Ocular Irritation Associated with Harsh Ingredients by Altering Physicochemical Properties of the Formulation
With the upcoming implementation of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) in various forms throughout the world and a global movement towards a reduction in animal testing, more emphasis is placed on utilizing the inherent hazards of chemicals for classification and labeling; however, the assessment of the toxicity of chemical mixtures, particularly ocular irritation, can be complex. The ability to formulate mixtures to be less irritating with minor modifications to the physical form would be very beneficial. The present study used the Bovine Cornea Opacity and Permeability (BCOP) assay, which is an OECD-approved in vitro method to assess ocular irritation, to investigate how physical properties (e.g., viscosity) affect ocular irritation. We found that the BCOP in vitro scores of irritating chemicals from several classes, including strong bases, were diminished by altering the viscosity of the aqueous medium or by dosing the solution as a foam. Our data show that a 1% NaOH solution in water produced an in vitro score of 165; however, when the medium was thickened with 1% Carbopol®, the in vitro score dropped to 67.6. A change of this nature is significant, and if this were an EPA-registered antimicrobial cleaner, for example, this reduction in the BCOP score would lower the hazard category. Product form and usage can clearly impact exposure, and the present results suggest that modifications to the physical properties of chemical mixtures can alter their ocular irritation potential; perhaps by affecting exposure to the eye. Although no formal comparisons were performed in animals, the BCOP assay is an OECD-validated method to assess ocular irritation, and studies have shown that the BCOP assay does not under-predict the results of traditional animal tests; thus, there are no obvious reasons to suggest that the present results would not correlate to animals or humans.
Testing Framework for Prediction of Ocular Irritation Using the Bovine Corneal Opacity and Permeability (BCOP) Assay and Chorioallantoic Membrane Vascular Assay (CAMVA)
In vitro ocular irritation assays, such as the Chorioallantoic Membrane Vascular Assay (CAMVA) and Bovine Corneal Opacity and Permeability (BCOP) test, are routinely used by personal care products companies because they are rapid and economical to conduct, do not require the use of live animals, and provide reliable predictive data. Previous research using an extensive CAMVA and BCOP database at Kao USA Inc. has shown that ocular irritation potential for new hair shampoos, ethanol-based hair stylers, skin cleansers, and skin lotions can be reliably predicted using a decision tree that systematically compares the ingredient composition, particularly ethanol and surfactant content, of the new formulation to previously tested formulations. Because the studies comprising this original database were conducted at a single contract laboratory, a follow-up study using a second contract laboratory was conducted to demonstrate inter-laboratory reliability of the CAMVA/BCOP data-derived decision tree for prediction of ocular irritation potential. Thirty-five personal care products were tested using the CAMVA and/or BCOP assays. The ethanol and surfactant content of each test material was evaluated, and the results of the assays were compared to the decision tree-based predictions of ocular irritation potential. Our data confirmed the ocular irritation predictions made using the decision tree model for 33 of 37 test samples (89% correlation rate) and verified the inter-laboratory reliability of the CAMVA and BCOP assays when conducted using appropriate controls. Our results also strengthened the ocular irritation decision tree model by confirming that deodorants are consistently predicted not to be ocular irritants based on composition.
In Vitro Safety Profile of Personal Care Products - Use of an In Vitro Testing Platform Based on a Reconstructed Vaginal Tissue Model
One of the common goals of industry is to confirm the safety of their products. Ethical concerns have led to the use of alternative testing methods in lieu of traditional testing methods. Several studies have shown good correlation between alternative test methods, traditional testing methods and human exposure. In the current study, the safety profile of three products with potential for vaginal exposure was assessed using the reconstructed human vaginal EpiVaginal™ model (MatTek Corporation, USA); the assay negative control (sterile, deionized water) and positive control (1% Triton® -X-100) were tested alongside. To increase the confidence in the test outcome, histopathology evaluation was conducted to assess the extent of cellular damage. Two liquid products were directly applied to the EpiVaginal™ tissues, while the wet wipe product was placed in direct contact with the tissue. Vaginal irritation expressed at ET50 values (3.32 and 12.71 hours) showed a higher irritation potential for the liquid formulations compared to the wipes (>24 hours). The lower irritation potential of the wipe product may be related to the availability of a rather limited amount of the liquid formulation in the wipes compared to the liquid formulations. Histology evaluations showed good correlation between the ET50 values and change in tissue structure. The results of this in vitro test methodology confirmed the safety profile of the products, should vaginal exposure occur during use. This two-endpoint testing platform (viability and histology) provided not only a correlative interpretation of the data, but also indication of the structural changes of the tissues exposed to the test article that are relevant to human exposure. Future plans include further exploring the capability of this in vitro testing platform for screening products before entering clinical trials.
Tiered Testing Strategy Using Validated In Vitro Assays for the Assessment of Skin and Eye Corrosion/Irritation of Pharmaceutical Intermediates
The safety of workers handling solid pharmaceutical intermediates was assessed using a tiered testing strategy based on regulatory validated in vitro assays. The Top-Down approach was initiated with the in vitro skin corrosion assay (OECD TG 431) followed by the in vitro skin irritation assay (OECD TG 439) using the reconstructed human epidermis model from MatTek Corporation. Of the ten pharmaceutical intermediates tested, nine were predicted to be non-corrosive to skin and were subsequently confirmed as non-irritants. The only intermediate predicted corrosive to skin was further tested using the Corrositex® assay (OECD TG 435) and was assigned a corrosive packing group II classification. Furthermore, three intermediates predicted non-corrosive/non-irritant to skin were tested as 20% dilutions in water in the in vitro Bovine Corneal Opacity and Permeability (BCOP) assay (OECD TG 437) and they were predicted as non-irritants to the eye. Our tiered skin and eye corrosion/irritation testing strategy proved to be a very useful platform for the assessment of the potential safety risk posed to workers during the manufacturing operations used for pharmaceutical intermediates.
Background The Bovine Corneal Opacity and Permeability (BCOP) assay is an ex vivo test used to evaluate ocular irritation. According to the OECD Test Guideline (TG) 437, the BCOP assay can be used to identify chemicals which induce severe/corrosive eye irritation and those that do not require classification. However, BCOP has historically under-predicted certain anionic surfactants, when tested according to the standard liquid protocol. TG 437 specifies that liquid and solid surfactants may be tested as 10% aqueous dilutions for 10 minutes (although alternate dilutions and exposure times may be conducted with scientific rationale). The relevant guidance document (GD) No. 160 suggests that solid and concentrated liquid surfactants may be diluted to 10% for testing. However, GD No. 160 further directs that surfactant-based formulations are usually tested neat, but could be diluted with justification, imparting some confusion in identifying the most appropriate test methods. Additionally, as part of the EPA classification of ocular irritation, the BCOP assay may be used to assess anti-microbial products with cleaning claims. Such products may contain surfactants and are generally tested neat for classification purposes.
Methods Since neither the basis for selecting the appropriate surfactant test methods, nor the justification for modifications are clearly presented in TG 437 or GD No. 160, we present on the testing of a few common surfactant ingredients, including sodium lauryl sulfate (SLS), Triton X-100, and benzalkonium chloride, and surfactant based formulations in the BCOP assay using standard and modified dilutions and exposures to elucidate the impact of these variables on eye irritation prediction.
Results and Discussion As examples, in vitro scores of 20.7, 28.4, and 28.3 were obtained when testing SLS at concentrations of 50, 20, and 10% for 10 minutes, showing that irritation responses were not fully concentration-dependent. As a complement to the BCOP assay, histopathology was performed to assess the surfactant-induced corneal changes. Based upon these results, a framework for testing surfactant ingredients and surfactant-based formulations is proposed.
Background Determination of the potential for individual chemicals and product ingredients to induce allergic contact dermatitis (skin sensitization) is a key toxicological endpoint for the screening of novel ingredients used in consumer and industrial products. Although in vivo methods exist to evaluate the skin sensitization potential of chemicals, in vitro non-animal test methods have been developed using human cell lines to predict human skin sensitizers. In vitro human cell-based systems have been developed in response to international regulatory requirements prohibiting the use of animals in research, and to meet the needs of corporations proactively choosing to eliminate the use of animals in safety testing. The KeratinoSens assay was developed by Givaudan, and recently evaluated in an international multi-laboratory validation exercise. The KeratinoSens assay is a human immortalized keratinocyte cell-based reporter gene assay which is designed to identify chemicals likely to induce skin sensitization in humans. A feature of all chemical allergens is their intrinsic electrophilicity (or their potential to be transformed to electrophilic chemicals) and their reactivity with skin proteins to form haptens.
Materials and Methods Mechanistically, the intercellular Nrf-2-electrophile sensing pathway comprised of the repressor protein Keap1, the transcription factor Nrf2, and the antioxidant response element (ARE), is capable of detecting skin sensitizers. In the KeratinoSens assay, the induction of a luciferase gene, under the control of the antioxidant response element (derived from the human gene AKR1C2 gene) is determined by measuring the relative light output of treated cells. In parallel, viability of the treated cells is measured using the MTT assay.
Results and Discussion In the “ring trial” validation, 28 chemicals (19 sensitizers of varying potencies, and 9 nonsensitizers) were evaluated in 5 laboratories, and at least 3 experiments per chemical. The predictive capacity of the assay was found to be similar between labs and ranged from 85.7% to 96.4%. Subsequent application of the assay is targeted at further defining the applicability and predictivity of the assay by testing more neat chemicals, chemical mixtures, industrial solvents, and complex product matrices. Thus far, over 150 chemicals have been evaluated using the KeratinoSens assay and the results indicate a good predictive value (~79.5%). The results indicate that the KeratinoSens assay may be a relevant and reliable method for evaluating a broad range of materials. The presentation will highlight the assay performance and lessons learned from the validation program.
A TRPV1 expressing clone of the human SH-SY5Y neuroblastoma cell line (Figure 1) was obtained by stable transfection, using puromycin-containing selection medium. Prior to Ca2+ measurements the TRPV1-SH-SY5Y cells were cultured in 96-well plates to confluency. Acute increase in the intracellular free Ca2+ level was measured in a semi-HTS fluorescence reader (FlexStation II, Molecular Devices) using Fura-2/AM. The ratio of fluorescence at 340 (Ca2+-bound Fura-2)/380 (Fura-2) nm excitatory wavelengths was registered without interruption before and during the 2 min exposure to the test compounds. The mean value (% increase of basal Ca2+ level) from triplicate wells in the 96-well plate was monitored for each concentration from each experiment. The TRPV1 antagonist capsazepine was added simultaneously with each concentration of the chemicals in three sister wells to confirm TRPV1-mediated Ca2+ influx. The intracellular Ca2+ increase induced by the specific TRPV1-agonist capsaicin was set to 100% response for each experiment and the effect of the test products was calculated as percent of the capsaicin induced response. All test compounds were diluted in HKR-buffer and the addition to the cells was performed robotically during measurements by the FlexStation II reader.
Screening of Cosmetics Ingredients for Phototoxic Potential Using the In Vitro 3T3 Neutral Red Uptake Phototoxicity Test
Phototoxicity is an acute toxic response after exposure to a phototoxicant and either UV radiation or visible light (UV/VIS). Phototoxicity from substances applied topically typically occurs at the site of photo-irradiation. Phototoxicity is the result of direct cellular damage caused by a non-immunological inflammatory response. Clinically, phototoxicity resembles an exaggerated sunburn (erythema, increased skin temperature, pruritis and edema). Phototoxicity reactions have been reported for both synthetic substances and those which occur naturally (e.g., botanical extracts). Although symptoms generally subside quickly, the potential for substances used in topical products to cause phototoxicity is clearly of concern for manufacturers of cosmetics, personal care and other consumer products. Historically, the potential to cause phototoxicity from substances applied topically was evaluated by utilizing various animal models. However in 1997 the 3T3 Neutral Red Uptake Phototoxicity Test (3T3 NRU PT) was validated by ECVAM’s Scientific Advisory Committee as an in vitro method for evaluating the phototoxic potential of chemicals shown to absorb in the UV/VIS range. To illustrate the utility of the 3T3 NRU PT as a useful screening tool in the safety evaluation of potential cosmetic ingredients, the results of the evaluation of 42 botanical extracts and 25 synthetic chemicals found to absorb in the UV/VIS range are reported. Most substances evaluated were found not to be phototoxic in vitro; however, 9 substances were identified as potentially/probably phototoxic in the 3T3 NRU PT and were eliminated from further consideration for use as cosmetic ingredients. Several substances found to be non-phototoxic in the 3T3 NRU PT were formulated with other ingredients in a prototype cosmetic formulation and subject to clinical testing. No manifestations of phototoxicity were observed in any of the test subjects in the prototype formulation containing any of the substances identified as non-phototoxic in vitro.
Surfactant Responses in the Bovine Corneal Opacity and Permeability Assay: Points to Consider for In Vitro Eye Irritation Testing
The Bovine Corneal Opacity and Permeability (BCOP) assay is an ex vivo test used to evaluate the ocular irritation of a broad range of chemicals. In the regulatory classification and labeling arena, BCOP can be used to identify severe and corrosive eye irritants according to the OECD Test Guideline (TG) 437. However, BCOP has historically under-predicted certain anionic surfactants, when tested according to the standard liquid protocol. TG 437 specifies that liquid surfactants may be tested as 10% aqueous dilutions for 10 minutes (although alternate dilutions and exposure times may be conducted with scientific rationale), and the relevant guidance document (GD) No. 160 suggests that solid and concentrated liquid surfactants may be diluted to 10% for testing. However, GD No. 160 further directs that surfactant-based formulations are usually tested neat, but could be diluted with justification, imparting some confusion in identifying the most appropriate test methods. Since neither the basis for selecting the appropriate surfactant test methods, nor the justification for modifications are clearly presented in TG 437 or GD No. 160, we present on the testing of sodium lauryl sulfate (SLS) in the BCOP assay, using standard and modified dilutions and exposures, to elucidate the impact of these variables on eye irritation prediction. For example, in vitro scores of 20.7, 28.4, and 28.3 were obtained when testing SLS at concentrations of 50, 20, and 10% for 10 minutes, showing that irritation responses were not fully concentrationdependent, but demonstrated optimally at intermediate doses. When tested using modified exposure times, SLS showed time-related responses, with improvements in irritation predictions at the 20 and 30 minute exposures. Histopathology was performed to assess the surfactant-induced corneal changes. Based upon these results, a framework for testing surfactants, and surfactant-based formulations is proposed.
The inter-laboratory reproducibility of the STE test for assessing eye irritation of cosmetic products
STE test is an in vitro eye irritation test using cell viability as an end point in SIRC cells following just a 5 minute treatment, and the good correspondence has been confirmed between the STE irritation categories (non irritant [NI] and irritant [I]) and GHS categories (NC and category 1 [Cat. 1]/category 2 [Cat. 2]). Generally, cytotoxicity tests using cultured cells have an advantage of being simple, a quick procedure, and a low evaluation cost. The STE test has the advantages not only easy-to-use but also evaluable the eye irritation potential of water insoluble substances by using mineral oil as test vehicle. The STE test is planned for peer review in 2013 and may be accepted as an OECD test guideline for classifying ocular irritation. In this study, the technical transferability and inter-laboratory reproducibility of the STE test were evaluated in 3 contract research laboratories as a naive laboratory.