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Volume 13, Issue 2
IIVS Forms Industry Council to Advance Regulatory Acceptance of Non-Animal Testing Methods

IIVS announces the formation of ICARAA: Industry Council for the Advancement of Regulatory Acceptance of Alternatives. ICARAA was formed in response to international regulations that still require animal testing to assess the safety of cosmetic and personal care products. "Many companies have been working for decades to eliminate animal testing," states Dr. Rodger Curren, President of IIVS. "As a non-profit organization with a mission to expand the use and acceptance of in vitro methods, IIVS is well positioned to assist international regulatory agencies in the adoption of such technologies. With the combined support of the industry partners we are able to significantly expand and sharpen our efforts."

In Vitro Phototoxicity Assays
phototox dilutions
The 3T3 neutral red uptake phototoxicity assay evaluates multiple dilutions of each test article for the potential to cause a cytotoxic effect in the presence of UVA.

Identifying the phototoxic potential of individual chemicals and final formulations is a priority in the cosmetics and personal care products industries.  In vitro methods such as the 3T3 Neutral Red Uptake Phototoxicity Test (3T3 NRU PT) and Phototoxicity Assays using 3-dimensional reconstructed human epidermis models (RhE-PT) can be used to determine the phototoxic potential of  a variety of chemicals; but sometimes choosing the right assay (or assays) can be challenging. Which assay is best suited for your testing needs or product development goals? Let's uncover some of the key components of each assay, including general overviews, advantages, and limitations.  


Follow this link to read the entire phototoxicity article.  


phototoxicity webinar banner  

Workshop Report - Inhalation Toxicity: Pathways to Better Methods
Identifying toxicity to the respiratory system from inhaledinhalation tox meeting graphic agents relies on  models that can mimic the anatomy and physiology of the human respiratory system and its responses to chemical exposures. Current animal models used for regulatory purposes provide practical, ethical, and scientific challenges; therefore extensive efforts have been and continue to be made to develop in vitro and in silico approaches. However, no single approach or combination of approaches used in screening or hazard identification has been accepted by regulatory agencies.


One difficulty in establishing the scientific credibility of in vitro and in silico approaches has been the ability to clearly describe why the non-animal approaches are relevant to the in vivo response. Recently the OECD has tried to address this issue by developing the concept of Adverse Outcome Pathways (AOPs). This approach relies on identifying individual "key" molecular, cellular and organ-specific events which lead to known apical toxicity effects. Developing in vitro or in silico assays which address the individual events in an AOP makes it easier to develop a comprehensive non-animal testing strategy whose scientific relevance can be more easily understood.  


This three day workshop, co-sponsored by IIVS, the Physicians Committee for Responsible Medicine (PCRM) and the Alternatives Research and Development Foundation (ARDF), focused on surveying promising alternative methods to delineate key AOPs and identify gaps in knowledge that should be addressed with additional research. Attendees included experts in respiratory toxicology, model development and exposure systems who represented broad segments of industry, research institutions, academia and government.


The first day consisted of lectures considering how the (mostly) in vivo data generated to fulfill safety assessment and/or regulatory needs in the chemical, pharmaceutical, personal care, and environmental health sectors are used. In addition work to model and measure the dosimetry of compounds in various sections of the respiratory system were also explored. Lectures providing overviews of the most promising in vitro models of the respiratory tract - from monolayer to co-culture and three dimensional systems - finished out the day.


The second day considered computational approaches, which can be used to sort, group, or prioritize many substances; place single substances into a hazard or risk assessment context; or provide evidence to delineate AOPs. The day concluded with lectures on the concept of AOPs as an overarching framework to organize chemical effect and biological pathway knowledge in order to identify key pieces of molecular information necessary to predict apical effects without in vivo testing.


Breakout sessions were formed to address common themes uncovered through the given lectures. Areas of interest identified by the attendees which deserved further attention were issues of dosimetry, delineating an AOP for respiratory sensitization and general recommendations such as standardizing the quality of in vitro data presented in peer reviewed journals. Breakout groups will continue to work collaboratively over the coming months to more fully develop their recommendations, which will subsequently be published. Participants plan to submit a proposal to develop an AOP for respiratory sensitization to the OECD in early summer; if added to the OECD work plan, the AOP will be developed collaboratively over the coming months.    

Cruelty Free International (CFI) Supports IIVS to Introduce Alternative Testing Methods to Vietnam    


Vietnam map and flag
Cruelty Free International (CFI) has provided funding to IIVS to provide training in Vietnam regarding non-animal safety testing methods used for cosmetics. Vietnam is part of the ASEAN organization (Association of South East Asian Nations) and still requires animal testing for cosmetics in certain circumstances.  


IIVS staff have visited Vietnam to speak with scientists, tour laboratory facilities, and discuss the feasibility of conducting a hands-on and lecture training for select alternative methods. In a press release on CFI's website, Michelle Thew, Chief Executive stated, "I am delighted the Vietnamese authorities have responded to our call to move away from using animals to test cosmetics. This collaboration marks a steep change in the country's reliance on animal testing and represents real progress for animals, bringing us a significant step closer to a ban on animal testing for cosmetics in ASEAN."


Funds from CFI are being used as part of IIVS' International Outreach Program (IOP) which facilitates information exchange and actively addresses regulatory policy in countries where animal testing is still required. The IIVS IOP is desinged to provide guidance, assistance and training to government agencies, domestic and international companies, and other interested parties seeking to implement and support non-animal testing methods. To learn more about the IIVS IOP program and additional international activities, please follow this link.     



Upcoming Events
Call For Papers: 
  • 18th European Congress on Alternatives to Animal Testing - EUSAAT 2013 / Linz 2013

September 15 - 18, 2013  

Linz, Austria 
Abstract submission deadlines have been extended for the 2013 EUSAAT/Linz conference.
Lecture submissions will be accepted until June 3rd. Poster submissions will be accepted until June 15th.

  • 2nd Annual Meeting of the American Society for Cellular and Computational Toxicology
October 31, 2013 
Lister Hill Auditorium, NIH


May 30-31, 2013
College Park, Maryland 
Providence, Rhode Island

September 1-4, 2013 
Interlaken, Switzerland

September 15-18, 2013
Linz, Austria

American Chemical Society Meeting  
September 8-12, 2013 
Indianapolis, Indiana

IIVS' Dr. Rodger Curren will present the "Role of education and training in supporting science-based policy development".

American Society for Cellular and Computational Toxicology 
October 31, 2013 
Lister Hill Auditorium, NIH  


EURL ECVAM Releases Progress Report on the Development, Validation and Regulatory Acceptance of Alternative Methods

The report covers advances made in the field of non-animal testing since the last summary report issued by ECVAM in 2010. 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 for access to the full ECVAM progress report.

Congratulations to MatTek for Winning the Laurie and Carlee McGrath Award

PETA presented a new award - the Laurie and Carlee McGrath Award, which includes a $5,000 cash prize - to the MatTek Corporation for its development of sophisticated non-animal tests. The award is named in honor of Laurie McGrath and her mother, Carlee McGrath, whose San Diego-based McGrath Family Foundation supports PETA's work to replace animals in laboratories with non-animal methods. IIVS congratulate MatTek for being recognized for their work in developing 3-dimensional human cell based tissue constructs that can be used in place of animals for a variety of toxicity tests.

Society for In Vitro Biology (SIVB) Meeting
June 15-19, 2013

Join IIVS' Hans Raabe in Providence,  Rhode Island for this year's annual SIVB meeting. The program will give participants a unique learning experience in cell culture and biotechnology.


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 OECD has revised the test guidelines for the Bovine Corneal Opacity and Permeability (BCOP) and the Isolated Chicken Eye (ICE) tests to extend their applicability domains. These methods are the first in vitro assays accepted for the identification of chemicals not irritating to the eye.

Read more on the acceptance of these assays for identifying non-irritants here.

EU Ban on Cosmetics with Animal-Tested Ingredients Goes into Effect

 The final phase of the European Union ban on the import and sale of cosmetics containing ingredients tested on animals went into effect March 2013. This ban follows the EU ban on animal testing of finished cosmetic products that went into effect in 2004. To read the ban (1223 2009), click here. 

US senators have introduced a bill to modernize the Toxic Substances Control Act (TSCA), the principal federal law governing chemicals in commerce.  Under current law, the EPA can require safety testing only after evidence suggests a chemical may be dangerous. As a result, the  EPA has only required testing for roughly 200 of the more than 84,000 chemicals currently registered in the US, and has banned only five dangerous substances since TSCA was first enacted in 1976. In 2009 the Government Accountability Office (GAO) identified TSCA as a "high risk" area paving the way for proposed reforms.
To read what the proposed Chemical Safety Improvement Act (CSIA) covers, please follow this link. 

  The European Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) has published its recommendation on the performance of the 3T3 Neutral Red Uptake (NRU) in vitro test method for acute oral toxicity.The recommendation states that 3T3 NRU could be used to identify chemicals that do not require classification as toxicants, so called "negative" substances. The recommendation summarzses the overall performance of the 3T3 NRU test method, its applicability and limitations, and provides guidance for proper scientific use. It also suggests ways of tackling some remaining gaps to provide more complete characterization of substances using the test method. For more information, please follow the link and visit the EURL ECVAM website.

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American Society for Cellular and

Computational Toxicology




the 2nd Annual Meeting


October 31, 2013

Lister Hill Auditorium

NIH Campus 


Registration and Abstract Submission Now Open!


Click Here for Details