News Postings

IIVS is happy to partner with MatTek, manufacturers of 3-D reconstructed human epidermis models, to provide special discounted pricing for select OECD approved testing methods. We will be discounting $750 off the total study cost for assays conducted on groups of at least 5 test materials in the Skin Irritation Test (SIT) (OECD TG 431) or the Skin Corrosion Test (OECD TG 439). Follow the link above to read about the program in MatTek's recent newsletter. Please contact one of our study directors today to discuss how this special pricing may be applied to your projects. (MatTek terms and conditions apply.)

The DB-ALM of the European Union Reference Laboratory on Alternatives to Animal Testing (EURL ECVAM) wants to remind you, as previously announced by the European Partnership for Alternative Approaches to animal testing (EPAA), that a second survey has been launched on the use of alternative methods in the industry for the assessment of reproductive toxicity of compounds and/or formulations covering Reduction and Refinement (2Rs) methods applied for both regulatory and non-regulatory purposes. Follow the link above to the EPAA website and download the EPAA questionnaire. The deadline for responding has been extended to May 18th.

The survey has been launched in the context of the EPAA thematic review project to provide an overall picture on available alternative methods at all stages of development, validation and/or regulatory acceptance covering the 3Rs in the topic area of reproductive toxicity testing. This project was based on an extensive bibliographic review and the full content published in 2011 on the DB-ALM together with the first survey results.This second survey, in fact, follows and complements the first one that covered Replacement methods providing in this way a full picture on the use of all the 3Rs methods in industry for reproductive toxicity testing. For more information, please visit the EPAA website and the ECVAM DB-ALM website

ESTIV is welcoming the submission of abstracts for presentation as posters or oral papers during their annual meeting October16-19 in Lisbon, Portugal. Authors wishing to submit an abstract are requested to follow the abstract submission guidelines available from the ESTIV2012 website (linked above). Please consider the preliminary program to make sure your paper falls within the scope of this event. Authors will be informed about the acceptance of their abstracts to be presented as an oral or poster presentation by the 30th June 2012. All accepted abstracts will be included in the ESTIV2012 Abstract Book and distributed to all participants. Please note that presenters (poster & oral) will be required to pay registration fees. Please review the attached pdf for additional information and the preliminary program.

British American Tobacco’s (BAT) Group Research & Development (GR&D) Centre has become the newest member of the Scientific Advisory Panel of the Institute for In Vitro Sciences (IIVS). “We rely on the expertise of our panel members to help determine the direction and focus of our scientific activities,” said Dr. Rodger Curren, President of IIVS. “As companies such as BAT dedicate significant resources to the implementation and use of alternative methods, we assist them in evaluating the technology and introducing these methods to the regulatory community.” “We fully support the development and application of in vitro methods as alternatives to limit the use of in vivo studies,” said Dr. Marianna Gaca, BAT’s IIVS Scientific Advisory Panel representative. “ We hope the in vitro models we are developing will help facilitate the understanding of the biological effects of tobacco smoke and, in the future, help support the assessment of conventional and modified risk tobacco products,” she said. To read the entire press release, open the document above.

The DB-ALM of the European Union Reference Laboratory on Alternatives to Animal Testing (EURL ECVAM) wants to remind you, as previously announced by the European Partnership for Alternative Approaches to animal testing (EPAA), that a second survey has been launched on the use of alternative methods in the industry for the assessment of reproductive toxicity of compounds and/or formulations covering Reduction and Refinement (2Rs) methods applied for both regulatory and non-regulatory purposes. Please click on the pdf document above to download and answer the survey.

This questionnaire survey is part of an EPAA-initiated activity to review the state-of-the-art of development, acceptance and use of 3Rs in Reproductive Toxicity testing. A previous survey conducted in 2010 covered Replacement or non-animal in vitro methods used in industry. The present questionnaire follows and complements that survey and covers the 2Rs (Reduction and Refinement) as applicable to in vivo methods used either as stand-alone methods or as part of Integrated Testing Strategies (ITS) using a combination of in vivo and in vitro methods. It addresses the ways that the 2Rs are applied for both regulatory and non-regulatory purposes. Therefore, together with the previous questionnaire, this survey aims to provide a full picture of all the 3Rs methods used in the assessment of Reproductive Toxicity of compounds (chemicals, drugs, etc.) and/or formulations (including biologicals, i.e. proteins and vaccines).

Deadline to respond to this survey is April 13th.

The U.S. Department of Agriculture (USDA) Center for Veterinary Biologics (CVB) regularly seeks public comment on drafts of proposed guidance documents concerning all aspects of veterinary vaccines production, testing, and distribution. Draft Notice 465, which is currently available for comment, provides proposed guidance on the use of humane endpoints and methods in animal testing of biological products. The draft document includes specific guidance regarding the use of humane endpoints in biological products testing, including guidance on humane endpoints for the rabies challenge test. The draft guidance also strongly encourages the use of anesthesia for intracerebral inoculation of mice during rabies vaccine testing.

The draft guidance incorporates recommendations for refinement of rabies vaccine testing made by participants at the October 2011 NICEATM-ICCVAM workshop on alternative methods for rabies vaccine potency testing. Information about the workshop is available on the NICEATM-ICCVAM website. A summary of the workshop is posted here.

Comments on the draft proposed guidance document should be submitted by April 23, 2012, via email to cvb@aphis.usda.gov. Draft proposed CVB guidance documents and additional information about submitting comments are available on the USDA website above.

/RabiesVaccineWkspSumm-30Nov11.pdf

The US Department of Transportation Pipeline and Hazardous Materials Safety Administration (PHMSA) Office of Hazardous Materials Safety has updated all guidance documents and references on its webpage to reflect the currently accepted practice of using in vitro corrosion test methods wherever possible. Due in large part to efforts by PETA, PHMSA's website, letters of interpretation and all other materials on this issue have been updated to reflect recent amendments made to the United Nations Recommendations on the Transport of Dangerous Goods Model Regulation and OECD guidance documents. Previously-issued letters and positions have been replaced by the current position which promotes to the extend possible the use of in vitro skin corrosion test methods.

Shaping science and driving innovation: 2011 NC3Rs Annual Report

The NC3Rs has recently published its Annual Report for 2011. The report describes the work the NC3Rs as done within the scientific community to support the 3Rs and the Coalition Government's pledge to work to reduce the use of animals in science. To read the report please visit the link above.

Abstracts are currently being accepted for poster and oral presentations during the 2012 EUSAAT/Linz conference. Topics to be covered include:

• 21st century non-animal tools for basic and biomedical research (e. g. humane disease pathways, specific disease models, transgenic animals, xenotransplantation, teratoma assays to prove pluripotency of stem cells)

• Implementing of the Directive 2010/63/EU on the protection of animal used for scientific purposes (incl. position of the EU Commission, of EU member states and of animal welfare organisations, examples for the implementation)

• Progress in 3Rs research: EU FP6 & FP7 projects on alternatives and member state research funding. (e. g. status national and EU: Research topic overview and future funding policy)

• 7th amendment of EU Cosmetics Directive: Cosmetics and animal testing - an end in sight (e. g. skin regulatory acceptance, eye regualtory accaptance, sensitisation, skin models and open source)

• Chemicals: REACH and animal welfare (e. g. report on use of alternatives, views of companies, animal welfare, methods, search engines)

• 3Rs progress in other sectors (e. g. vaccine testing, replacing mouse bioassays)

• Inhalation toxicology & toxicology of nanomaterials

• 3R goes 3D! Implementation of 3D methods in toxicity testing

• GCCP - Good cell culture practice

• Ethical and & legal issues

*Free communications

To submit your lecture or your poster please use the ONLINE SUBMISSION FORM! The deadline for the submission of lectures is April 30th and the deadline for the submission of posters is May 31st.

The US Occupational Safety and Health Administration (OSHA) has released the final rule establishing its new Hazard Communication Standard that incorporates provisions of the Globally Harmonized System (GHS) of Classification and Labeling of Chemicals specifically in the workplace. The updated standard that includes GHS labeling, hazard categorization, and safety data sheet requirements, will be phased in over the next four years. It is due to be published in the Federal Register on 26 March. Read a summary of the news in Chemical Watch or click on the link above for information directly from the US Department of Labor website.

The draft recommendations for three Cell Transformation Assays (CTAs), the Syrian Hamster Embryo (SHE) CTA at pH 6.7, the SHE CTA at pH 7.0, and the BALB/c 3T3 CTA for in vitro carcinogenicity was developed following the ESAC (ECVAM Scientific Advisory Committee) opinion (No. 2011.01). Please follow the link above to view the recommendation in it's entirety. IIVS President, Dr. Rodger Curren, is currently serving on the ESAC and participated in the formation of the published opinion document that has lead to this recommendation.

The U.S. Environmental Protection Agency and L’oréal cosmetic company announced a research collaboration designed to determine if EPA’s chemical toxicity forecaster (ToxCast) can be used in systemic toxicity tests. EPA is using ToxCast to screen chemicals to understand their potential impact on processes in the human body that lead to adverse health effects. L’oréal is providing EPA $1.2 million in collaborative research funding plus robust safety data from a set of representative substances from the cosmetic sector, expanding the types of chemical use groups assessed by ToxCast. EPA will compare the ToxCast results to the L’oréal data to determine if the reliability and the relevance are appropriate for use in the safety assessment of chemicals in cosmetics. Please follow the link above to view the entire article.

A new paper published in Regulatory Toxicology and Pharmacology elaborates on guiding principles for a non-animal safety assessment concept for skin sensitization of cosmetic ingredients. to purchase the complete article, follow the link above. Please visit the skin sensitization section of our website for information specifically on the KeratinoSens Assay for Identification of Skin Sensitizers. We also have several KeratinoSens posters and manuscripts available on our Publications page.

Characterisation of skin sensitisation potential is a key endpoint for the safety assessment of cosmetic ingredients especially when significant dermal exposure to an ingredient is expected. At present the mouse local lymph node assay (LLNA) remains the ‘gold standard’ test method for this purpose however non-animal test methods are under development that aim to replace the need for new animal test data. COLIPA (the European Cosmetics Association) funds an extensive programme of skin sensitisation research, method development and method evaluation and helped coordinate the early evaluation of the three test methods currently undergoing pre-validation. In May 2010, a COLIPA scientific meeting was held to analyse to what extent skin sensitisation safety assessments for cosmetic ingredients can be made in the absence of animal data. In order to propose guiding principles for the application and further development of non-animal safety assessment strategies it was evaluated how and when non-animal test methods, predictions based on physico-chemical properties (including in silico tools), threshold concepts and weight-of-evidence based hazard characterisation could be used to enable safety decisions. Generation and assessment of potency information from alternative tools which at present is predominantly derived from the LLNA is considered the future key research area.

The next time you use shampoo, air freshener, or moisturizing cream, consider this: How do you know it's safe? In all likelihood, whatever toxicologic screening its component ingredients were subjected to involved laboratory animals, the method of choice for decades and the industry's reigning "gold standard." Yet as Bob Dylan once put it, the times, they are a-changing. Animal-based testing is expensive and time-consuming, morally and ethically troubling, and most significantly, often a poor predictor of human toxicity. Animals aren't going anywhere just yet. But their numbers are dropping. Driven both by legislative mandate and scientific need, a new suite of in vitro and cell culture-based animal-free methods are gaining a foothold in toxicology labs. Read the full article at sciencemag.org by clicking on the link above.

SkinEthic is running two training sessions covering the use of their tissue and the validated methods they are used in. Their training sessions are build up to allow in one hand, any new users to be able to feel comfortable in the 3D screening tool approaches and possibilities,and on the other hand, already trained professionals in the field of in vitro alternatives, to be updated on current validated protocols. SkinEthic’s one-day training sessions will run on March 27 and April 24. One-on-one interaction is fostered by limiting the maximum participants to 5.These sessions will be held in Lyon, France and cost € 1000 – (lunch included) VAT excluded. Please click on the link above for the registration form. Contact us Alain Alonso with questions or to register at aalonso@skinethic.com.

Cambridge research that created liver cells from stem cells has been recognized with a national prize by the National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs). These cells, known as human induced pluripotent stem cells (hIPSCs), have already attracted attention for the possibilities they offer to regenerate damaged tissues and organs. But it is their potential to reduce the number of animals used for screening potential drug treatments that led to Dr. Vallier receiving the Centre’s 3Rs prize for 2011.

The prize, sponsored by GlaxoSmithKline, of a £2,000 personal award and a £18,000 research grant, is for the scientific paper published in the last three years that contributes most to the advancement of the 3Rs (Replacement, Reduction and Refinement). Dr Vallier’s winning paper was published in The Journal of Clinical Investigation in 2010. He received his prize from Professor Paul Matthews OBE of GlaxoSmithKline at the NC3Rs Annual Science Review Meeting in London on 28 February.

London – Seeking to maximise the value of computational modelling in avoiding animal testing for the European Union's Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), the People for the Ethical Treatment of Animals (PETA) Foundation has produced a free resource for potential registrants, identifying sources of information and expertise on the use of Quantitative Structure Activity Relationships (QSARs). The short brochure "QSARs and REACH: A Guide to Sources of Information and Advice" was produced in consultation with leading experts in the field and lists publicly available online resources and selected contact points for individuals and organisations that can offer support to REACH registrants and consultants on the use of QSARs.

QSARs predict chemical behaviour directly from chemical structure and simulates adverse effects in cells, tissues and lab animals, minimising the need to use animal tests to comply with regulatory requirements for human health and ecotoxicology endpoints. The REACH regulation promotes the use of alternative methods and states that animal testing should be a last resort. The use of QSAR is specifically encouraged. However, while QSARs have already been used in many registrations, it is clear from the European Chemicals Agency's (ECHA) 2011 report, "The Use of Alternatives to Testing on Animals for the REACH Regulation", that many opportunities to use them have been missed and that, in some cases, registrants have not submitted QSAR data in accordance with REACH's requirements, leading to potential failure at the REACH compliance check, additional costs, and increased animal testing.

"QSARs, used in the context of intelligent testing strategies and in combination with a chemical category approach, have the potential to replace many animal tests for REACH – but registrants must feel confident both with the use of the technology and with integrating it into weight-of-evidence arguments that ECHA will accept", says PETA policy adviser Alistair Currie. "It's clear from our discussions with companies that those less familiar with its use feel cautious about using it to replace testing. This resource answers the need to link the experts in QSAR use for REACH with the registrants who need that expertise." The list was compiled by PETA in consultation with PETA US and contacts within industry and academia, and selection and inclusion was based entirely on expert judgment – the list contains no paid advertising. The resource is currently being distributed gratis to chemical companies, consultants and other stakeholders and is available online at the link above.

The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) recommended to Federal agencies that the murine local lymph node assay, or LLNA, may be used to categorize the potency of chemicals causing allergic contact dermatitis (ACD) in humans. Specifically, ICCVAM recommended that the LLNA may be used to categorize some substances as strong sensitizers, thus identifying those substances considered to have a significant potential for causing skin hypersensitivity resulting in ACD.

In today's Federal Register, the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) announced availability of Federal agency responses to the ICCVAM recommendations. Regulatory agencies, including FDA, EPA, CPSC, and OSHA, have indicated that they will take actions in response to the ICCVAM recommendations to encourage use of the LLNA for this purpose where appropriate.

According to the U.S. Bureau of Labor Statistics, skin diseases are the most common type of occupational illness. Many of these cases arise from repeated exposures to skin-sensitizing substances, which can lead to ACD, an immunologically mediated hypersensitivity reaction. Studies have shown that ACD has a significant adverse impact on quality of life in affected individuals.

For over 10 years, the LLNA has been accepted worldwide as a valid alternative to traditionally accepted guinea pig test methods for assessing ACD hazard potential for most testing applications. The new ICCVAM recommendation provides guidance on how to use the LLNA to categorize some chemicals and products as strong skin sensitizers. However, since only half of the known strong human skin sensitizers can be identified in this way (52% or 14 out of 27), additional testing or information will be necessary to conclude that substances are not strong skin sensitizers.

Substances with the potential to cause ACD can also be categorized with the traditional test methods using guinea pigs. However, the LLNA uses fewer animals than guinea pig test methods, requires less time to perform, provides dose-response information, and, in most cases, eliminates the potential for pain and distress in the test animal. In accordance with Animal Welfare Act regulations and the Public Health Service Policy on Humane Care and Use of Laboratory Animals, the LLNA should be routinely considered when planning animal studies that evaluate whether chemicals and products are strong sensitizers in order to minimize animal use and to avoid pain and distress.

The ICCVAM evaluation is detailed in a report entitled ICCVAM Test Method Evaluation Report: Usefulness and Limitations of the Murine Local Lymph Node Assay for Potency Categorization of Chemicals Causing Allergic Contact Dermatitis in Humans (NIH Publication No. 11-7709). In June 2011, ICCVAM forwarded recommendations to Federal agencies and made these recommendations available to the public (76 FR 18639). In accordance with the ICCVAM Authorization Act of 2000 (42 U.S.C. 285l-3), agencies have notified ICCVAM in writing of their findings, and ICCVAM is making these responses available to the public.

NICEATM and ICCVAM are also currently evaluating several in vitro and in chemico methods for their potential to further reduce and eventually replace the use of animals for ACD safety testing.

The Federal agency responses to the ICCVAM recommendations and more information about the ICCVAM evaluation of the LLNA for potency categorization can be found on the NICEATM-ICCVAM website. The ICCVAM Test Method Evaluation Report is also available. In addition, the Federal Register notice announcing the availability of Federal agency responses to the ICCVAM recommendations is available.

Allergan is pleased to announce the company has received two positive opinions regarding its fully in vitro, cell-based assay for use in the stability and potency testing of BOTOX(R) and VISTABEL(R) (Allergan's botulinum toxin type A products). he first positive opinion, from Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS), relates to VISTABEL(R) and paves the way for approval in 29 countries in the European Union. The second positive opinion was granted by the Irish Medicines Board (IMB) for BOTOX(R) and covers 14 European Union countries involved in the Mutual Recognition Process. The Medicines and Healthcare products Regulatory Agency (MHRA) have already approved the assay for BOTOX(R) vials sold in the UK. Once approval is finalized, the new assay will be utilized to release the product for sale in the relevant countries.

The China State Food and Drug Administration have issued a draft proposal for an alternative method to animal experiments when testing cosmetic ingredients for acute phototoxic effects on the skin.

ECHA (the European Chemical Agency) has announced that it is in favor of accepting the Extended One-Generation Reproductive Toxicity Study (EOGRTS) for reproductive toxicity. This test allows just one generation of animals to be used, with additional tests on a second generation required only if the first round raised concerns. The agency says that the streamlined test will, “under certain conditions”, provide sufficient safety information to replace the two-generation reproductive toxicity study. It says it has already received around 230 proposals from companies to carry out the new test.

The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) recently evaluated the usefulness of a non-animal test method that can identify substances with the potential for interacting with the estrogen receptor in vitro. As announced in today's Federal Register, ICCVAM recommended to Federal agencies that this test method, the BG1Luc ER TA, can be used as a screening test to identify substances with in vitro estrogen agonist and antagonist activity.

This issue includes how to use use in vitro methods as a pre-screen for clinical testing, international educational and outreach activities in Russia, China, and Brazil and more.

Recognizing the urgent need to drive regulatory change in those countries that still require animal testing for cosmetic and personal care products, the Institute for In Vitro Sciences, Inc (IIVS) is expanding its international outreach program. The expanded program will be designed to demonstrate to regulators and industry in these countries how alternative testing strategies for cosmetic products can be integrated into a regulatory acceptance program.

NICEATM announces availability of the report on the "International Workshop on Alternative Methods To Reduce, Refine, and Replace the Use of Animals in Vaccine Potency and Safety Testing: State of the Science and Future Directions." The report was published as a dedicated issue of the journal Procedia in Vaccinology (Volume 5, pp 1-266, 2011) and is publicly available online.

The European Coalition to End Animal Experiments (ECEAE) has issued a statement suggesting that the European Commission is likely to propose an exemption to the animal testing ban for products that contain "significant added value".

Dr. Patric Amcoff is the new Operational Manager of the European Union Reference Laboratory for Alternative Methods to Animal Testing (EURL ECVAM) as of mid-November. Before joining the European Commission, Dr. Amcoff worked for nine years at the Organization for Economic Co-operation and Development (OECD) in Paris, where he was responsible for driving the regulatory acceptance at international level of alternative testing methods and approaches for chemical and nano-safety. The mission of ECVAM is to promote the development and use of alternatives to animal testing, for use as research tools and for supporting regulatory safety assessment. ECVAM will continue to coordinate validation studies at European level and act as a focal point for exchange of information on alternative methods to animal testing in the EU. Follow the link above fore more information on Dr. Amcoff available on the ECVAM website.

ECVAM fully endorses the ESAC Opinion of these methods and has additionally provided some further suggestions concerning the CTAs.The ECVAM Recommendation is now out for public consultation until 31 December 2011. The documents that are open for public commenting are divided into two separate parts. Please note that the ESAC Opinion (Annex 1 of Part 1) and the documents in Part 2 are finalised and will not be revised or changed following this open commenting round. Please visit the IHCP Website above for instructions on submitting comments.

Dr. Gertrude-Emilia Costin, Study Director at IIVS, has been recently elected as a member of the PanAmerican Society for Pigment Cell Research (PASPCR) Council for the 2012-2014 term. More info on PASPCR Council and its activities can be found at http://paspcr.med.umn.edu/paspcr.htm.

Dr. Gertrude-Emilia Costin, IIVS Study Director, serves as editor of the PanAmerican Society for Pigment Cell Research (PASPCR) Newsletter. The Newsletter is published three times a year and is intended to serve as a regular means of communication for the members of the Society.

The latest issue of the AltTox newsletter is now available for review online. IIVS and American Society of Cellular and Computational Toxicology (ASCCT) president Rodger Curren as well as Kate Willett, Director, Regulatory Toxicology, Risk Assessment and Alternatives for the HSUS, have been named new members of the AltTox Management Team. The newsletter also includes links to recent forum postings and upcoming events. Please click on the link above to view the full newsletter.

Proteome Sciences announces that it has developed a number of novel in vitro tests for chemical compounds and substances that induce allergies when they come into contact with the skin or the respiratory system. Testing for these allergens in products including chemicals, pharmaceuticals, cosmetics and detergents will become mandatory under EU legislation. Proteome Sciences presented data from eight assays at the Sens-it-iv Scientific Congress in Brussels, 24-25 November 2011. Sens-it-iv is a European Commission project which began in 2005 and brings together companies and academic institutions with the aim of developing in vitro alternatives to animal tests, which are currently used for the risk assessment of potential skin or lung sensitizers. As well as reducing the use of animal testing, the program is aimed at improving consumer safety and benefiting the environment.

As of 28 November 2011, Novo Nordisk will no longer use living animals to test the quality of the batches of medicine coming out of Novo Nordisk's production lines. These tests have for years been required by health authorities as part of their approval of the products. "Today's achievement is a milestone in our ongoing commitment to animal ethics in Novo Nordisk. We have been working for more than a decade, in close collaboration with regulatory authorities around the world, to eliminate obsolete tests or develop and certify new laboratory assays that can be used instead of animals to evaluate the consistent quality of our marketed products," says Executive Vice President and Chief Science Officer, Mads Krogsgaard Thomsen. Novo Nordisk has a commitment to the 3R principles to 'Reduce', 'Refine' or 'Replace' the use of animal testing within the pharmaceutical industry. Therefore, a task force was established more than ten years ago with the ambitious aim to eliminate all redundant product control tests in living animals or replace them with other test methods that would guarantee the same product safety. To read more, please click on the link above.

Click the link above for links to both free and subscription downloadable content including: Editorial: Toxicity Testing: The Need for New Maps for the Future, News & Views, and articles including "Assessing the Search for Information on Three Rs Methods, and their Subsequent Implementation: A National Survey among Scientists in The Netherlands" and "A Critical Evaluation of the 2011 ECHA Reports on Compliance with the REACH and CLP Regulations and on the Use of Alternatives to Testing on Animals for Compliance with the REACH Regulation".

The NIEHS and the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) request public comments that can be considered by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and agencies' program offices in updating The NICEATM-ICCVAM Five-Year Plan (2008-2012) (ICCVAM, 2008). The current plan addresses: (1) Identification of areas of high priority for new and revised non-animal and alternative assays to reduce, refine (enhance animal well-being and lessen or avoid pain and distress), and replace the use of animals in testing and (2) research, development, translation, and validation of new and revised non-animal and other alternatives assays for integration of relevant and reliable methods into Federal agencies' testing programs. Please follow the link above for more information and for information on how to submit your comments.

Fifteen years ago, animal protection organizations launched the Coalition for Consumer Information on Cosmetics (CCIC), which administers the Leaping Bunny Program in the United States and Canada. CCIC was created to provide consumers with accurate information on cruelty-free cosmetics, personal care, and household products. The leaping bunny logo has made it easier for consumers to quickly identify which products on the shelf have met standards for being identified as cruelty free. Please read the link above for more information.

SEURAT-1 is a research initiative involving nearly 100 scientists from over 70 European organizations. In October it completed the first of six annual reports titled: "Towards the replacement of in vivo repeated dose systemic toxicity testing". The report aims to aims to inform policy makers about scientific progress relevant to the implementation of European Directives and Regulations and about essential gaps in knowledge corresponding to research needs. It contains detailed information about the scientific progress, the strategic development, and the evolution of the legislative and regulatory context in the field of repeated dose systemic toxicity testing. You can access the report by clicking on the link above.

AXLR8 is funded by the European Commission Directorate General for Research & Innovation (Health Directorate; Advanced Therapies and Systems Medicine Unit) under the 7th European RTD Framework Programme Health Theme. The newly released report includes:

• An introduction to the AXLR8 project

• An update on the activities and achievements of 3Rs-oriented projects funded under the health and environment themes of the 6th and 7th EU Research Framework Programs during the year 2010

• The AXLR8-2 workshop report, including contributions from workshop presenters and reports from break-out groups

• AXLR8 Scientific Panel recommendations for future research and innovation funding

• A directory of key projects and coordinators

To read the report, please click on the news link provided.

Woodcliff Lake, N. J. (November 07, 2011)—Dr. Anne Marie Api, Vice President of Human Health Science at the Research Institute for Fragrance Materials, Inc. (RIFM), co-wrote with Dr. Matthias Vey, Scientific Director of the International Fragrance Association (IFRA) “Regulatory and safety aspects of natural fragrance ingredients,” Chapter 6, 89-106, in the new book, Formulating, Packaging, and Marketing of Natural Cosmetic Products, edited by N. Dayan and L. Kromidas, New Jersey and Canada, John Wiley & Sons, Inc., 2011.

The chapter defines the role of natural ingredients in perfumery. It explains how natural fragrance ingredients are characterized and evaluated and the roles that RIFM and IFRA have in the evaluation process. The chapter also provides details on how natural fragrance ingredients are regulated in the framework of the IFRA Standards.

The book is available from the RIFM web site through the RIFM Online Store.

The testing of chemicals for skin irritation after an acute exposure is considered to be among the simplest of toxicology endpoints to evaluate. Historically, this process simply involved putting the chemicals of interest on the skin of a rabbit, according to the procedures described by Draize and Woodard, and observing the result. However, animal welfare concerns and uncertainty of the relevance of extrapolating rabbit test data to the human experience have brought the relevance of the rabbit test into question. With the introduction and validation of a variety of non-animal methods to identify and classify skin irritants and non-irritants, the study design process has become slightly more complex. But by considering what the project goals are, the following guidance can make the process very manageable and the resulting data extremely useful.

Martin Stephens, Ph.D., a founding member of the AltTox management team, editorial board, and moderator group, has moved from the Humane Society of the United States to the Johns Hopkins Center for Alternatives to Animal Testing, where his primary responsibility will be advancing evidence-based toxicology. Please read the attached pdf for additional information.

On 2 October 2011, Prof. Dr. med. Horst Spielmann was honored by the Deutschen Tierschutzbund (German Animal Protection Society) and was awarded with their Goldene Ehrennadel (Golden Badge of Honor) for his commitment and services towards animal protection and welfare.

Contents of the latest edition of Alternatives to Laboratory Animals with links to free articles and abstracts:

Editorial

*The Three Rs and Animal Experimentation — Documented Signs of Advancement, or of Stagnation? - Michael Balls

*News & Views : CAAT News & Views : IIVS News & Views

*News from the FAL

Comment

*The Latest Statistics of Scientific Procedures on Living Animals Reveal Little Three Rs Progress in Great Britain in 2010 - Michelle Hudson

Letter to the Editor

*Biomedical Research Involving Chimpanzees - Jarrod Bailey

Articles

*Vaginal Irritation Models: The Current Status of Available Alternative and In Vitro Tests - Gertrude-Emilia Costin, Hans A. Raabe, Robert Priston, Eric Evans and Rodger D. Curren

*Development of the EpiOcular™ Eye Irritation Test for Hazard Identification and Labelling of Eye Irritating Chemicals in Response to the Requirements of the EU Cosmetics Directive and REACH Legislation - Yulia Kaluzhny, Helena Kandárová, Patrick Hayden, Joseph Kubilus, Laurence d’Argembeau-Thornton and Mitchell Klausner

*In-house Validation of the EpiOcular™ Eye Irritation Test and its Combination with the Bovine Corneal Opacity and Permeability Test for the Assessment of Ocular Irritation - Susanne N. Kolle, Helena Kandárová, Britta Wareing, Bennard van Ravenzwaay, and Robert Landsiedel

*The Tenth Anniversary of the Björn Ekwall Memorial Foundation - Erik Walum, Hanna Tähti and Ada Kolman

Many of the studies that use animals to model human diseases are too small and too prone to bias to be trusted, says Malcolm Macleod, author of the article titled "Why animal research needs to improve".

"...The most reliable animal studies are those that: use randomization to eliminate systematic differences between treatment groups; induce the condition under investigation without knowledge of whether or not the animal will get the drug of interest; and assess the outcome in a blinded fashion. Studies that do not report these measures are much more likely to overstate the efficacy of interventions. Unfortunately, at best one in three publications follows these basic protections against bias. This suggests that authors, reviewers and editors accord them little importance..."

To read more from the article, follow the "read source" link above.

PETA has added a third category to their "do test" and "don't test" list naming companys that perform animal testing and those that don't perform any tests using animals. The new category, "Working for Regulatory Change", recognizes companies that conduct tests on animals only if they're required by government agencies, that are actively working for the replacement of animals in these tests, and that annually disclose to PETA what tests have been done and why. New York–based Colgate-Palmolive Company is the first company to meet PETA's stringent requirements and will head the "Working for Regulatory Change" list. Please follow the link for the full article.

A new ‘Dragon’s Den’-style funding scheme launched by the UK’s NC3Rs is offering public- and private-sector researchers grants totalling £4.25 million from industrial sponsors to find solutions that will contribute to the replacement, refinement and reduction of animal research in the life sciences. The National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) has worked with pharmaceutical and other sponsors including AstraZeneca, Roche and Eli Lilly to come up with six initial CRACK IT challenges, spanning research areas such as developing in vitro human-cell based models, novel non-invasive measurement techniques and whole-system in vitro testing.

The CRACK IT scheme also includes a web-based research engine for problem-solving and idea-sharing between small companies, academic researchers and industry. Follow the link for a more detailed article or view the CRACK IT website directly.

Paul Locke of the Center for Alternatives for Animal Testing at Johns Hopkins University said more must be done to require agencies including U.S. EPA, the National Institutes of Health and the Food and Drug Administration along with the chemical industry to end animal testing during a congressional briefing on Capitol Hill on Tuesday September 13th. Speaking at the briefing was Representative James Moran, who is ranking member of the House Appropriation Committee's subcommittee on Interior, Environment and Related Agencies and co-chair of the Congressional Animal Protection Caucus (CAPC). CAPC is a group staffed by both parties that seeks to raise awareness of animal welfare issues in Congress. CAPC replaced the "Friends of Animals Caucus" that had existed in previous Congresses. For more information on the briefing, follow the link to CAAT's website.

This issue of AltTox summarizes happenings at the 8th World Congress, recent forum postings, and updates to the calendar of events.

The report published on September 13th stresses the continued commitment in Europe and worldwide to find alternative approaches. It is based on the findings of scientific experts who have been assessing the availability of alternative methods and prospects for the future. The Commission's report states that full replacement of animal test methods for all endpoints will not be possible by the 2013 deadline. The lack of full alternatives does not mean that the Commission will propose postponing the deadline. Instead, the European Commission is currently assessing the impacts of the implementation of the full marketing ban by 2013 (environmental, animal welfare, economic and social) and on the basis of that assessment will decide whether or not to make a proposal in relation to the marketing ban. The Commission will announce its final decision by the end of 2011.

Via the Doctor Hadwen Trust for Humane Research, a UK based non-animal research charity, we would like to remind you that the Home Office public consultation on the transposition of the new EU Directive 2010/63/EU, on the protection of animals used for scientific purposes, into UK Law is closing soon. Comments will be accepted until September 5. For an in-depth look at the transposition and for more details on how to get involved with the public consultation, please click on the link above to be directed to the Doctor Hadwen Trust website.

PLEASE SAVE THE DATE: September 20, 10:00 AM when ASCCT will present a webinar which will be a first look at the Effectopedia: The Online Encyclopedia of Adverse Effect Pathways. Effectopedia was conceived by the International QSAR Foundation of Duluth, MN to gather and make available sources and information on what have come to be known as Adverse Outcome Pathways (AOPs). An AOP is a description of the known linkages between molecular initiation and adverse manifestation at the organism or even population level. It is similar to, but more comprehensive than, the concept of the "toxicity pathway" described in the National Academy of Sciences report "Toxicity Testing in the 21st Century: A Vision and Strategy."

Effectopedia is becoming recognized as one of the key tools necessary to implement a transition to "21st Century Toxicity". It is an open knowledge aggregation and collaboration tool that provides a means of describing adverse outcome pathways (AOPs) in an encyclopedic manner. Effectopedia is currently in the development stage, and IQF expects a first public release in April 2012. Effectopedia will be entirely open to the public and is intended to be populated by both targeted grants and voluntary contributions by the scientific community. Effectopedia has two main interfaces. The user interface provides Wiki-like search engine-optimized articles of the AOPs in a relational manner. For each AOP, there is a major overview wiki article linked to in-depth descriptions of the biological response sequences that link a chemical-induced molecular effect to the adverse outcomes needed for safety assessment. Effectopedia will also provide threshold values or dose-response linkages between intermediate biological effects and assessment endpoints.

The contributer interface of Effectopedia supplies tools for editing the content, building AOPs, and participating in discussions - one of the more important aspects for building new social networks among specialists. Please feel free to inform your colleagues about the event, and suggest they join the ASCCT in order to participate in and help support programs like this.

Contents include an editorial on Animal Experiments and Alternatives: Matters of Belief and Trust, News and Views from IIVS, ECVAM and CAAT, comments on Integrated Testing Strategies for Toxicity Employing New and Existing Technologies and Is a Compromise Possible in Russia Between Animal Advocates and Researchers Who Use Animals in Harmful Experiments?, and several articles. Click on the link above to view the full text of several of these articles and to purchase others.

ECHA has recently published two reports required by REACH Regulations: - one on the operation of REACH & CLP and one on the use of alternatives to testing chemicals on vertebrate animals. These reports, along with video interviews of ECHA staff, can be viewed at the ECHA website. The report on the use of alternatives to testing on animals was met with criticims by US and European animal protection groups who claim, among other misuses of animals, that over 100 animal experiments were conducted automatically when they should have been subjected to public consultation. Statements from ICAPO (The International Council on Animal Protection in OECD Programmes), PCRM, (the Physicians Committee for Responsible Medicine), and PETA (People for the Ethical Treatment of Animals) can be found by clicking on the links.

A recent article in Nature News describes the analysis of 200 dossiers by R. Corvida (on behalf of CAAT EU). According to Corvida significant data gaps exist in the submissions and regulators have done little to pressure industry to supply missing information. Corvida will present her findings of over 800 dossiers at the World Congress on Alternatives in August.

The International Council on Animal Protection in OECD Programmes (ICAPO)is calling for immediate action by companies and regulatory authorities worldwide to replace the traditional “two-generation” animal test for reproductive toxicity with a new “extended one-generation” method that has just been adopted by the Organisation for Economic Co-operation and Development. Although still an animal test, the new one-generation test uses approximately half the number of animals as the old two-generation method (1,400 rats per test vs. 2,600). The new OECD method was adopted on 28 July, just in time for a large number of reproductive toxicity proposals under the European chemicals regulation “REACH,” the revision of the EU testing requirements for pesticides and biocides, and increased U.S. testing of certain pesticides and industrial chemicals. To read the full press release on the ICAPO website, please click on the link above.

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 August number is now available at the link above.

The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) recently evaluated the usefulness of the murine local lymph node assay, or LLNA, for categorizing the potency of chemicals causing allergic contact dermatitis in humans. As announced in today's Federal Register, ICCVAM recommended to Federal agencies that the LLNA may be used to categorize some substances as strong sensitizers. Strong sensitizers are those substances considered to have a significant potential for causing skin hypersensitivity resulting in allergic contact dermatitis.

According to the U.S. Bureau of Labor Statistics, occupational skin diseases are the most common type of occupational illness. Many of these cases arise from repeated exposures to skin-sensitizing substances, which can lead to allergic contact dermatitis or ACD, an immunologically mediated hypersensitivity reaction. Studies have shown that ACD has a significant adverse impact on quality of life in affected individuals.

ICCVAM concluded that the LLNA can correctly categorize some substances as strong sensitizers using a criterion published in the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). However, nearly half of the known human strong sensitizers evaluated by ICCVAM were not identified using the GHS criterion. ICCVAM concluded that additional information would need to be considered to confirm whether substances that do not meet this criterion are or are not strong sensitizers.

Substances with the potential to cause ACD can also be categorized with the traditional test methods using guinea pigs. However, the LLNA uses fewer animals than guinea pig test methods, requires less time to perform, provides dose-response information, and, in most cases, eliminates the potential for pain and distress in the test animal. In accordance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals, the LLNA should be routinely considered when planning animal studies to evaluate whether chemicals and products are strong sensitizers in order to minimize animal use and to avoid pain and distress.

The ICCVAM evaluation is detailed in a report entitled "ICCVAM Test Method Evaluation Report: Usefulness and Limitations of the Murine Local Lymph Node Assay for Potency Categorization of Chemicals Causing Allergic Contact Dermatitis in Humans" (NIH Publication No. 11-7709). The ICCVAM report and recommendations have been transmitted to Federal agencies for their review and response to ICCVAM in accordance with the provisions of the ICCVAM Authorization Act of 2000, which requires agencies to review the recommendations and respond to ICCVAM within 180 days.

ICCVAM and the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) are also currently evaluating several in vitro and in chemico methods for their potential to further reduce and eventually replace the need for animals for ACD safety testing. More information about the ICCVAM evaluation of the use of the LLNA for potency categorization can be found on the NICEATM-ICCVAM Web at the link provided.

The IHCP has now one vacancy open for a senior scientist. A position description is available. If interested, applications are being accepted through August 5.

In a study commissioned by the European arm of the Center for Alternatives to Animal Testing (CAAT) at the University of Konstanz, Germany, consultant chemist Costanza Rovida has analyzed summaries of 200 dossiers submitted under the REACH program and found gaps in the data. The study states that regulators have done little to pressure industry to fill these data gaps. Some submissions relied on studies performed over 20 years ago that do not adhere to current quality standards. Of the 200 summaries, only 2 contained data from non-animal test methods. To read the full article in Nature News, please click on the link above. Also, full results on the evaluation of 800 summaries will be presented at the World Congress on Alternatives to Animal Use in the Life Sciences meeting next month in Canada.

This issue contains commentary on the recent FDA approval of Allergan's in vitro assay for botox safety and potency testing as well as links to recent forum postings and upcoming events.

The Home Office has released their annual report on animal use in the UK titled "Statistics of Scientific Procedures on Living Animals Great Britain 2010". Some points from the report are summarized below:

• Just over 3.7 million scientific procedures were started in Great Britain in 2010, increasing 3% (+105,000). This was largely due to an increase to 1.6 million procedures (+87,000, +6%) in breeding to produce genetically modified (GM) animals and harmful mutants (HM), mainly mice (+77,000).
• There was a decrease (-11%) in the numbers of procedures for safety testing (toxicology) to 391,000, with a higher proportion carried out to meet more than one legislative/regulatory requirement (72% compared with 68% in 2009). Most toxicology procedures are carried out in the commercial sector where the number of procedures also fell (-4%).
• The number of non-toxicology procedures increased 5% to 3.3 million, reflecting the higher numbers of procedures carried out in universities (+10%), particularly fundamental research. The increase for non-toxicology included further increases in cancer research (+8,700), immunological studies (+10,200), parasitology (+12,000) and pharmacology (+13,900) whilst pharmaceutical R&D continued to fall (-56,700).
• There were 1.0 million more procedures than in 2000 (+37%) mostly accounted for by breeding to produce GM and HM animals (+921,000, of which mice +811,000). Excluding such breeding, the total number of procedures was slightly higher than in 2000 (+4% or +89,000).

Please review the news link above for access to a pdf summary of the document as well as supplementary tables.

One June 24, Allergan received US FDA approval for their in vitro test for the safety and potency of Botox and Botox Cosmetic. This in vitro assay will replace the use of the LD50 test here in the US for each lot or batch of the botox products. It is hoped that total animal testing on the products can be reduced by 95% as additional agencies accept Allergan's new assay. Please take a look at the AltTox forum posting on the topic or in the news link above for Allergan's press release.

Introduced into Congress on June 24, the Safe Cosmetics Act of 2011 has now been uploaded onto the Library of Congress' website where the text can be viewed in its entirety. Comments on the bill from the Campaign for Safe Cosmetics and the Personal Care Products Council can be found on their websites. Section 624 outlines steps to limit the use of animals for testing ingredients and cosmetics. It also encourages funding for the validation of alternative test methods.

The European Chemicals Association (ECHA) has gathered data on the use of non-animal test methods in dossier submissions under REACH from June 1, 2008 thru February 28, 2011. The report is the first provided by ECHA on the use of alternatives to testing on animals since REACH came into effect. The report shows that data sharing between companies making the same material effectively reduced the amount of animal studies that would have otherwise been performed. Existing studies and non-animal (in vitro) test methods were also used to minimize the need for the performance of new animal tests under REACH. The report shows that so far very few new animal studies were conducted for the purpose of registering phase-in substances. The full report titled "The Use of Alternative to Testing On Animals For the Reach Regulation 2011" can be found by following the link above. A summary and video are available on the ECHA website.

Includes information on the new David Sainsbury Fellowship Scheme and a call for submissions to CRACK-IT® Challenges.

Several hundreds of key representatives from the European cosmetics industry gathered in Brussels to discuss the importance of the industry on the European economy and how it can build for a sustainable future. Sirpa Pietikainen, chair of Globe EU and a Member of European Parliament said, "The challenge is exponentially speeding up and that means we have more serious threats, sooner and faster, and we have to react, sooner and faster." Closing the session, Bertil Heerink, Colipa's Director-General concluded that innovation and sustainable development go hand-in-hand. “We can be proud that sustainability in our industry is clearly articulated within our Association. We can also be proud of our performance, but there is no room for complacency. Our industry needs to continue to make sustainability a reality." Select the option above to read the full article.

The Personal Care Products Council (the Council) announced today that Halyna Breslawec, Ph.D., will become the organization’s chief scientist, replacing John Bailey, Ph.D., who officially retires on July 29 after nine years of service. In her new role, Breslawec will oversee the Council’s scientific programs, technical committees and publications and will serve as the industry’s scientific liaison for several domestic and international organizations.

“Halyna’s scientific credentials and background are impressive, and we are so pleased that she will soon be managing our scientific programs,” said Lezlee Westine, Council President & CEO. “She brings a great scientific foundation and proven leadership skills to the Council and will be a wonderful asset in her work on behalf of an industry that is committed to product safety, quality, and innovation.”

Breslawec worked at the U.S. Food and Drug Administration (FDA) for more than 14 years in numerous leadership roles directing the review and approval of medical devices at both the office and division levels. She assessed clinical trials as well as the organization and structure of operational units at the Center for Devices and Radiological Health. While working in the FDA Commissioner’s office Breslawec also developed a program to implement FDA's human subject protection regulations for the clinical and academic communities.

Breslawec currently serves as Deputy Director for the Cosmetic Ingredient Review (CIR), an independent, non-profit panel of scientific and medical experts that assesses the safety of cosmetic ingredients used in the U.S. She is responsible for planning and executing CIR activities while serving as liaison between the expert panel and the CIR professional staff.Prior to joining CIR, Breslawec worked as a consultant where she was a recognized expert in FDA regulation. She helped medical device companies develop regulatory policies, evaluated clinical trials and prepared medical device applications for FDA submission.She earned a Ph.D. in pharmacognosy (medicinal chemistry) and a B.S. in biochemistry from the University of Minnesota.

For more information on cosmetic and personal care products and their ingredients, visit the link above.

Including a feature article titled "Independent or Coordinated Revolutions?", a summary of recent forum postings, and upcoming events.

Dr Andrew Bennett, Director of the FRAME Alternatives Laboratory (FAL), has been appointed a FRAME Trustee. As a result of his interest in finding human-based alternative models he was appointed Director of the FAL in 2006, where he and colleagues continue to work on primary human cell culture. Chairman of the FRAME Trustees Prof Michael Balls said: “We are all very pleased that Andrew has accepted our invitation to be a Trustee.”

The Interagency Coordinating Committee for the Validation of Alternative Methods (ICCVAM) is asking for input and data on both animal and in vitro methods used for botulinum toxin testing and non-endotoxin pyrogen testing. Please follow the link to read the full notice in the Federal Register for more details.

An article written by a number of industry scientists and published in Regulatory Toxicology and Pharmacology evaluated eight surfactants in the local lymph node assay, guinea pig maximization test, and a number of in vitro assays.

A summary article indicated that "with one exception, the chemicals are non-sensitising skin irritants. However, one particular method, the local lymph node assay (LLNA), was shown to overestimate the sensitisation potential of surfactants relative to the other methods. The scientists conclude that, as results obtained from LLNAs are considered as the gold standard for the development of new nonanimal alternative test methods, there is a need to carefully evaluate the applicability domains of test methods in order to develop reliable non-animal alternative testing strategies for sensitisation testing."

To read more about skin sensitization testing available at IIVS, please review information on the KeratinoSens Assay for Skin Sensitization and contact Dr. Kimberly Norman, knorman@iivs.org, for more information.

The European Chemicals Agency has expanded its acceptance of GLP data to include countries that are not part of the OECD Mutual Acceptance of Data system, provided that the laboratories producing the data have been inspected by a recognized GLP monitoring authority and have been found to be in compliance. Please review the news link above for additional detail.

Developed by Givaudan, the KeratinoSens assays offers a cost effective way to screen ingredients for their potential as skin sensitizers. The assay is based on the Nrf2-Keap1-ARE toxicity pathway and utilizes a reporter cell line with a luciferase gene to detect electrophilic chemicals - a feature of all skin sensitizers. The assay showed promising reproducibility and predictivity during a recent mulit-laboratory study (Natsch, e. al, 2011) and is currently under review by ECVAM. To learn more about the assay please review the attached document and contact Dr. Kimberly Norman at knorman@iivs.org.

WORKSHOP DATE: June 21, 2011

REGISTRATION DEADLINE: June 15, 2011, 4:00pm ET

The purpose of the workshop is to discuss the scientific advancements that are needed, and the technical and regulatory challenges that must be overcome, for the development of human-relevant preclinical platforms for efficacy and toxicology testing. Please see the attached pdf for additional information.

The NC3Rs is currently seeking to appoint three new members of staff:

*Program Manager - Innovation and Translation

*Communications and Media Manager

*Web Manager

For more information on these vacancies, including details of personal requirements, salary and how to apply, please visit the link provided.

The closing date for applications is 1 June 2011.

In 2010, the European Commission appointed a committee to examine the current status and future prospects of replacement test methods that could be used to comply with the European 2013 ban on using animal tests for certain toxicological endpoints. The experts concluded that there are considerable scientific hurdles that need to be overcome prior to being able to fully replace a number of animal tests. They predict that 5 specific animal test methods will not be replaceable by alternative test methods by the 2013 deadline. The full report is available in the journal "Archives of Toxicology" Volume 85, Number 5, 367-485, and can be accessed through the link. A summary of the major findings is attached to this news article as a pdf document.

US Agencies released a statement on April 14th endorsing the ICCVAM recommendations for in vitro ocular testing methods previously communicated in September 2010. ICCVAM recommends that the Cytosensor microphysiometer (CM) test method can be used as a screening test to identify some types of substances that do not need hazard labeling for eye irritation. This is the first in vitro eye safety testing method adopted for use in what is referred to as a bottom-up approach to testing. ICCVAM also recommended that the CM test method can be used to identify some types of substances that can cause severe or irreversible eye damage. Please click on the link above to read and comment on the the full article on the AltTox website.

This issue includes commentary on the Toxicity Testing in the 21st Century initiative, recent forum postings, and newly announced events. Please follow the source link for the full content.

Includes NC3Rs/Society of Biology Symposium, Charles River/NC3Rs Toxicology Workshop, NC3Rs Primate Welfare Meeting, NC3Rs Studentship Scheme and NC3Rs Roadshows. Click on the link above to view the newsletter on the NC3rs site.

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 clicking the "Read Source" link above.

Abstract submission has been extended to April 28th for the 8th World Congress on Alternatives and Animal Use in the Life Sciences. The meeting will be held August 21-25, 2011. The organizers are seeking abstracts on the following topics: Safety & Efficacy Testing of Chemicals, Pharmaceuticals & Biologicals, Policy/law on Animal Use, Public Engagement & Ethics Review, Incorporation of the Three Rs in Education & Training, Animal Welfare for Refinement & High Quality Science, and Replacement & Reduction in Basic Research. Please visit the World Congress website for more information.

R. Curren will give a talk titled "Routine Use of Alternatives in the Cosmetic and Personal Care Industries in the US" at the International Symposium on Technology and Application of Alternatives to Animal Testing held at the Guangdong CDC (China) on April 14. More information on this and other recent meetings in China on the use and implementation of alternative methods will be featured in the May issue of the IIVS e-newsletter. If you would like to receive the IIVS Update, please continue to the contact page and provide us with your information.

A pdf of the November 2010 EPAA annual conference "Reduction and Refinement: Combining Excellence in Science and Animal Welfare" is available on their website.

The European Chemicals Agency will organise its Sixth Stakeholders’ Day on 17-18 May 2011, in Helsinki. The main event consisting of plenary and one-to-one sessions will take place on 18 May at the Helsinki Exhibition and Convention Centre (Messukeskus). A registration form for the main event will be published on the ECHA website shortly. The event is open to everyone and participation is free of charge. In conjunction with the event, a day of training will take place at ECHA on 17 May focusing on in-depth training on the Chemical Safety Assessment and Reporting tool (Chesar). The training session is open to all stakeholders with some experience in chemical safety assessment.

Includes NC3Rs Research Portfolio, ARRIVE guidelines adopted by Nature, and information on the 8th World Congress on Alternatives

Non-clinical CRO CIT will distribute Stemina’s hES-based toxicity testing platform to pharmaceutical and cosmetics developers in Europe under an agreement announced in late February The deal, financial terms of which were not disclosed, will see Stemina’s DevTox human embryonic stem cell (hES) based technology used to test the toxicity of candidate compounds as an alternative to animal testing.

Developmental neurotoxicity (DNT) is an issue of growing concern in children's health worldwide. The developing human nervous system is susceptible to many toxicants, and chemical exposure during development that may cause lasting neurological deficits. Such damage can range from subtle to severe, and may impose substantial burdens on affected individuals, their families, and society. This DNT3 meeting will provide a strong platform for comprehensive discussion among diverse stakeholders from around the globe, including research scientists, government scientists, regulators, policy analysts, industry representatives, academics, and advocacy groups concerned with children's health, animal welfare, and environmental protection. The following topics will be discussed:

• DNT and neurological adverse effects
• DNT and regulatory legislation
• Biomarkers and DNT
• Gene/Environment interactions
• Molecular pathways and DNT
• Alternative methods for DNT Testing
• Automation and potential of DNT test methods

We encourage your participation in the Third International Conference on Alternatives for Developmental Neurotoxicity Testing (DNT3). We also invite you to submit an abstract on a topic relevant to the conference program for consideration as an oral presentation (deadline 31st March 2011). Taking into consideration your expertise and published papers, we are convinced that your participation and contribution will accelerate and promote the development of alternative methods for DNT assessment.

Dr. Rodger Curren will speak at the International Forum on Cosmetic Technology and Applications, the first meeting discussing alternatives to animal models in toxicology to be held in China. The meeting is being organized by the China Cosmetics Research Centre of the Beijing Technology and Business University and many interested industry parties such as Mark Kay, P&G, Colgate-Palmolive, and Johnson & Johnson. Please read the attached link for more information and details on registration.

Currently there is no widely accepted method to evaluate the antioxidant properties of skincare products. IIVS recently undertook a project to develop an in vitro method capable of evaluating the antioxidant potential of antioxidants and antioxidant skincare products in human cells. NHEKs (normal human epidermal keratinocytes) were subjected to UVA-irradiation to induce oxidative stress and then protection from oxidative stress was evaluated in cells incubated with antioxidants. Cytotoxicity was assessed concurrently using the neutral red uptake assay. Using this method, several known antioxidants and antioxidant-containing formulations were evaluated for their ROS-reducing capabilities.

The FDA published a call for comments in December on proposed changes to be made to the GLPs. The call for comments, linked to above, lists 9 specific areas which the FDA is considering for a future amendment. IIVS, along with many other companies and organizations, has submitted comments. Please read the attached document to see our perspective.

Abstract submission for this DNT3 conference has been extended until March 31, 2011. Please take the time to submit your abstracts. For more information on this event, please visit the IIVS event page.

Speaking at a workshop at the Department of Endocrinology in the University of Madras, Dr. M A Akbarsha (Director of the Mahatma Gandhi-Doerenkamp Center (MGDC), Bharatidasan University, India) summarized the IdMOC (Integrated Discrete Multiple Organ Co-Culture) procedure. The technology uses a large interconnecting chamber that contains multiple inner wells. Multiple cell types are first individually cultured in each well. Later the chamber is filled with a single universal medium. The test material is then added to this medium and its reactions to each cell type are subsequently analyzed. This technology, developed by Dr. Albert Li (managing director of Advanced Pharmaceutical Sciences, Columbia) will allow researchers to gather information on how test substances and their metabolites react with and interact with multiple cell types at once.

The National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) presented two workshops on "Best Practices for Regulatory Safety Testing" in January 2011. The workshops, "Assessing the Potential for Chemically Induced Eye Injuries" and "Assessing the Potential for Chemically Induced Allergic Contact Dermatitis," were organized by NICEATM and the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). Materials from the workshops, which were co-sponsored by the Society of Toxicology and the Society for Risk Analysis, are now available on the NICEATM-ICCVAM website at the source link above.

Materials from the workshops available on the web page include: * Program, goals, objectives, and background information for each workshop * Slides from presentations given at the workshops * Links to archived webcasts of the workshops * Abstracts of poster session presentations

About the Workshops These one-day workshops, which were each attended by over 70 scientists from government and industry, provided a practical understanding of the theory and application of available methods that can evaluate the hazard potential of chemicals and products while minimizing animal use and avoiding pain and distress. The workshops brought together scientific experts from relevant stakeholder organizations to discuss available alternative test methods for assessing chemicals and products for their ocular and allergic contact dermatitis hazard potential. Participants learned the strengths and weaknesses of available alternative test methods, became familiar with the types of data they provide, and learned how to use these data in regulatory safety assessments.

InVitro International (IVRO) is a customer and technology driven provider of non-animal testing methods. It is engaged in the development and marketing of both test kits and laboratory services. The IAS is a plate reader based computer driven upgrade from the former Eytex/Skintex methodology which has helped reduce industry costs of animal testing for safety and efficacy of ocular, skin care, personal care, and chemical products. In addition, the company also offers a series of services including protocol development (if necessary), customized contract testing services, and direct kit sales in support of product claims and compound or workplace safety. Click on the link above to read more.

U.S. Federal agencies have responded to recommendations on alternative safety testing methods to determine if chemicals and products may cause allergic skin reactions, also known as allergic contact dermatitis (ACD). The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) recently evaluated and recommended the methods, which are new versions and applications of the murine local lymph node assay (LLNA).

Responses are provided from agencies that include the Environmental Protection Agency and the Food and Drug Administration. The agency responses are being made available to the public as required by the ICCVAM Authorization Act of 2000, and as recently announced in the Federal Register (76 FR 2388).

The Humane Society of the United States presents the Russell and Burch Award to scientists who have made outstanding contributions to the advancement of alternative methods in the areas of biomedical research, testing, or higher education. Alternative methods—also known as the Three Rs—are methods that can replace or reduce the use of animals in specific procedures, or refine procedures so that animals experience less pain or suffering. Candidates for the award are judged on the scientific merit of their contribution to the alternatives field, as well as their impact and professional commitment to this field. Applicants should have a history of laboratory work that is above reproach on humane grounds. Send nominations by April 10, 2011 to ari@humanesociety.org. No special forms are necessary.

Persons nominating themselves should submit a cover letter explaining their suitability for the award, a curriculum vitae, and three published articles (preferably in PDF format) representative of their alternatives work. Persons nominating others should submit a letter explaining the nominee’s suitability for the award, and arrange to have supporting documents forwarded.

The journal ATLA (Alternatives to Laboratory Animals), which was awarded the William and Eleanor Cave Award for achievements in developing alternatives, is searching for new methods to subsidize its publishing and distribution costs. ATLA is an important journal not only for the countries leading the way in replacement of animal models in testing, but also in countries in which this field is still in its infancy. Please read the attached letter and visit FRAME's website for more information on what you can do to help this journal to keep running.

In recognition of its unique technology, rapid development, and management team, Epithelix has been awarded the 2011 innovation trophy by the Swiss and French Commercial and Industrial Chamber (CFSCI).

In light of recent concerns over the potential extension of the 2013 ban on the sale of cosmetics developed with the help of animal experimentation, members of the UK parliament are calling for the EU to uphold the original deadline. Read the full article at the source above.

Under the REACH regulation in Europe, companies are required to test many substances that had not previously been tested and submit the results in the form of a dossier to the European Chemicals Agency (ECHA). ECHA has announced that the process of dossier evaluation will become more open. They are taking steps such as publishing conclusions drawn from third party evaluations, allowing case-owners and stakeholders to be present during the evaluation discussions, and publishing Practical Guide 12 to explain to industry what the dossier evaluation process is and how they are processed.

The rule titled, "Hazardous Materials: Harmonization With the United Nations Recommendations, International Maritime Dangerous Goods Code, and the International Civil Aviation Organization Technical Instructions for the Safe Transport of Dangerous Goods by Air" brings the US regulations into line with international standards and calls for the use of In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER) (OECD guideline 430), In Vitro Skin Corrosion: Reconstructed Human Epidermis (RhE) Test Method (OECD guideline 431), and the In Vitro Membrane Barrier Test Method for Skin Corrosion (OECD guideline 435) where it previously only called for use of the rabbit test (OECD guideline 404). An excerpt from the document states:

“In our latest harmonization effort, we received over 2,200 comments in response to the NPRM (75 FR 52070, August 24, 2010). The majority of the comments received were from individuals in support of adoption of corrosivity testing methods not based on the results of live animal testing...We received over 2,200 comments additional to that received from PETA, in response to the NPRM supporting the adoption of in vitro testing methods to determine corrosivity and urging PHMSA to stop the requirement for use of methods based on live animal testing. Therefore, in this final rule we are adopting the OECD in vitro testing methods as proposed. See Section 173.137 for further discussion of such methods.”

Read the rule in the Federal Register by choosing the "Read Source" button above.