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Volume 13 Issue 3

Memorandum of Understanding Signed


To further the activities of its International Outreach Program, IIVS signed a Memorandum of Understanding (MOU) with The Humane Society of the United States (HSUS), Humane Society International (HSI), and the Human Toxicology Project Consortium (HTPC). The MOU is the product of a mutual desire by HSI, HSUS, HTPC and IIVS to collaborate toward toxicological science/policy progress in China, through education and hands-on training in the use and interpretation of OECD-accepted in vitro test guideline methods and dialogue with Chinese authorities. An example of the work supported by this effort can be found in the article below in the Outreach section of this newsletter. 


Integrated Testing Strategies for Skin Sensitization 

IIVS is pleased to announce a webinar to discuss Integrated Testing Strategies (ITS) that can be used for the replacement of animal testing in skin sensitization assessment.  Dr. Kimberly Norman of IIVS will present the technologies behind the KeratinoSens Assay, the Direct Peptide Reactivity Assay (DPRA), and the human-Cell Line Activation Test (h-CLAT).  Following inter-laboratory validation studies, ECVAM has indicated that each of these methods may be considered for inclusion in an ITS for hazard identification.  Due to the complex cascade of events underlying skin sensitization, a combination of methods will likely be necessary to achieve replacement of animals.  Along with an invited guest speaker, Dr. Norman will present some examples which describe how these methods may be used in combination with one another to predict skin sensitization hazard.  Please visit the IIVS website to register for the Integrated Testing Strategies for Skin Sensitization webinar





Updates Made to OECD Test Guidelines 431 (RHE for Skin Corrosion), 437 (BCOP), 438 (ICE) and 439 (RHE for Skin Irritation) 

The OECD has updated test guidelines for the Bovine Corneal Opacity and Permeability Assay and Reconstructed Human Epithelium for Skin Corrosion and Skin Irritation, among others. The test guidelines can be found here


OECD Test Guideline 431 addresses 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. This Test Guideline was originally adopted in 2004 and updated in 2013 to include a set of Performance Standards for the assessment of similar and modified RhE-based test methods, in accordance with the principles of Guidance Document No. 34. Other updates include the possibility to use some of the test methods for sub-categorization of corrosive chemicals, and to specify the addition of two test methods


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 Center 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 OECD Test Guideline 437 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).


The Isolated Chicken Eye (ICE) test method was also initially evaluated by ICCVAM, ECVAM, and JaCVAM in 2006 and 2010 and has also undergone a revision this year. Similar to the updates made to the BCOP test guideline, the ICE test method can now be used to identify chemicals not requiring classification according to the UN GHS system. OECD Test Guideline 438 has also been updated to include additional definitions and chemicals in the Annexes and an update to the test report elements. 


OECD Test Guideline 439 provides an in vitro procedure that may be used for the hazard identification of irritant chemicals (substances and mixtures) of UN GHS Category 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 for in vivo skin irritation testing or as a partial replacement test within a tiered testing strategy.  


Contact us if you have any questions about how these new modifications could affect your testing program.   


Training and Mentoring Quality Assurance Personnel and Study Directors
IIVS continuously strives to interact with its partners to advance the field of in vitro toxicology and is committed to being a resource for the benefit of the scientific community. We are well known for educating via our hands-on and lecture based training sessions and targeted technical workshops, but our actions to promote high quality science extend beyond those efforts.

null The Society for Quality Assurance (SQA) is an association of over 2,300 QA professionals in more than 30 countries who are dedicated to implementing Good Clinical Practices (GCPs), Good Laboratory Practices (GLPs) and Good Manufacturing Practices (GMPs) in industry, government, academia and consulting. SQA provides valuable training and networking opportunities for its members. Amanda Ulrey, Head of Quality Assurance at IIVS, was elected by her SQA peers to serve as a member of the Education Committee. In this role, she is responsible for reviewing and discussing training opportunities for SQA members. The Education Committee identifies the professional development needs of the society membership and coordinates training and professional enhancement opportunities through workshops, lectures, symposia, and online presentations. Amanda works to share the IIVS culture of quality philosophy with the SQA membership.

Mentoring is an integral part of training and IIVS is working towards becoming more involved in mentoring programs for quality assurance professionals. As an example, Amanda currently serves as the chair of the SQA Mentor Committee. This committee administers the Mentoring Program by evaluating mentor/mentee/peer partner applications and facilitating professional relationships. In addition to serving on the committee, Amanda has been a mentor to other quality assurance professionals throughout the United States, Korea and Nigeria, helping them expand their knowledge of regulatory compliance and develop the skills necessary to be a successful quality auditor. All of the IIVS QAU staff have participated in mentoring relationships and discussions within the Good Laboratory Practices (GLP) and Scientific Archiving Specialty Sections, and the Computer Validation Initiative Committee (CVIC) of SQA. For more information on the IIVS Quality Assurance Program, please visit our website.

In addition to educating quality assurance professionals, IIVS staff also strive to promote educational opportunities for other scientific professionals, such as study directors. Dr. Gertrude-Emilia Costin (IIVS Study Director) and Hans Raabe (Vice President and Director of Laboratory Services) have authored a chapter entitled "In Vitro Toxicology Models" as part of a book designed to educate new and potential study directors in the workings of a nonclinical safety testing environment. The book, titled "The Study Director in Nonclinical Studies for Drugs, Chemicals, Pesticides and Devices" (editors William J. Brock, Barbara Mounho, Lijie Fu), is scheduled for release in early 2014, and is published by John Wiley and Sons, Inc. Please visit our booth at the SOT meeting in Phoenix or keep an eye on our website for additional information. 

Chinese Society of Dermatology Meeting    


In June 2013 IIVS was represented by Dr. Quanshun Zhang, IIVS' new Manager of International Education and Outreach, and Dr. Brian Jones, the former Director of Education and Outreach, at the 19th Annual Meeting of the Chinese Society of Dermatology in Chengdu, China (Sichuan province). A presentation by Dr. Jones gave an update on the regulatory status of non-animal methods used in safety assessment, examples of how cosmetic and personal care companies utilize non-animal tests, and a description of the standards being established around the world to eliminate animal testing for the evaluation of cosmetics.


Over 9,000 dermatologists attend this conference annually including representatives from domestic and international cosmetic companies as well as those dermatologists who are selected by the CFDA as expert reviewers of functional cosmetics (skin lightening, SPF, etc.). Having a greater knowledge of non-animal test methods and how they are used within the industry will help facilitate their implementation in safety testing programs and acceptance during safety reviews.


The IIVS presentation was given during the Cosmetic Dermatology session chaired by Dr. Lai Wei, Chairman and Director - Department of Dermatology of the 3rd Affiliated Hospital of Sun Yat-Sen University - Guangzhou and Dr. Liu Wei, Head of Dermatology, General Hospital of Air Force, Vice-Chair National Standard Committee of Cosmetics - Beijing. The session was highly attended with an estimated 300 people. Many questions were posed by cosmetic company representatives from both domestic Chinese and international companies with China-branch offices. During the conference, Dr. Zhang was invited by Gala Group, one of the largest Chinese cosmetic companies, to give a further presentation about the application of in vitro methods for testing cosmetic products and ingredients at the upcoming Skin Biology Symposium scheduled for October, 2013.


Attendance at this meeting is part of IIVS' International Outreach Program and was generously supported by the Humane Society of the United States, Humane Society International, and the Human Toxicology Project Consortium.



Upcoming Events

September 24-25, 2013

Research Triangle Park, North Carolina



September 25-27, 2013
Charlottenlund, Denmark



Chemical Watch Regulatory Summit

October 8-9, 2013
Brussels, Belgium



October 14-16, 2013
London, UK

INVITROM Symposium: "In Vitro Models: The Cell is the Limit?" 

October 16, 2013
Breda, The Netherlands



October 31, 2013 
Lister Hill Auditorium, NIH

Chinese Society of Toxicology Meeting
November 12-15, 2013
Guangzhou, China

EPAA Annual Conference

November 13, 2013
Brussels, Belgium



JSAAE Annual Meeting: New Developments in Basic Science and Alternatives to Animal Experiments


December 19-21, 2013
Kyoto, Japan      

Congratulations to the 2013 ARDF Grant Recipients

IIVS has coordinated the grant review process for Alternatives Research and Development Foundation (ARDF) and has provided input into submissions for the past several years. We would like to congratulate each of this year's five recipients. The 2013 Alternatives Research Grant Program has awarded $200,000 to scientists developing alternative methods in a variety of areas of medical research, testing and education. To view the recipients, please follow this link to the ARDF website

 Cosmetic Compliance Summit 

October 14-16, 2013

London, UK


Join IIVS Study Director Dr. Kimberly Norman to discuss the implementation of the EU Cosmetic Regulation, understand the financial & time impact on your business, and develop a practical strategy for on-going compliance. Kim will be hosting a roundtable session on the use of in vitro test methods and will be available to answer questions at the IIVS booth.

2013 Cosmetic Science Symposium

October 23-24, 2013
Newark, NJ

Visit the IIVS booth at the October meeting of the Personal Care Products Council. Study Directors will be available there to discuss your in vitro testing needs.


Struggling to comply with 1223/2009? Contact us to learn what in vitro methods can be used in safety dossiers.
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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 application process closes at midnight EST on October 15, 2013. Read the full announcement on the IIVS website.

  A draft document 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 revised EURL ECVAM search guide titled "Good Search Practice on Animal Alternatives" 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 replace 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 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.
Follow this link to the full report.  

ASCCT Banner

American Society for Cellular and

Computational Toxicology




the 2nd Annual Meeting


October 31, 2013

Lister Hill Auditorium

NIH Campus 


Join us for plenary lectures by

Don Ingber, Wyss Institute; "Human Organs on Chips as Replacements for Animal Testing" and  
Tom Knudsen, US EPA; "Virtual Embryological Systems: Challenges for Predictive Toxicology"; panel discussions; and poster presentations with your colleagues in the field of non-animal test methods and computational toxicology.



Registration is Open!


Click Here for Details