Non-animal Methods for Toxicity Testing

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Author Topic: OECD TG443-Extended 1-Generation Reproductive Toxicity Study officially approved  (Read 27097 times)
Kristie Sullivan
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« on: August 04, 2011, 11:37:08 pm »

Companies, Regulatory Authorities Can Spare Millions of Animals in Labs With New OECD Test Method, Says Animal Protection Coalition

Aug. 4, 2011

PARIS—The International Council on Animal Protection in OECD Programmes (ICAPO) [1] 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 [2]. 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. Within these programs it is estimated that millions of animals could be killed for reproductive toxicity testing alone. The extended one-generation test introduces a number of new parameters designed to better identify “endocrine disrupting” chemicals, and provides for the optional assessment of neurological and immune system parameters when warranted. By assessing all of these parameters in combination rather than as separate studies, animal use can be reduced by up to 70 percent.
“This guideline will go a long way towards reducing the number of animals killed in toxicity testing until non-animal alternatives can be developed,” says ICAPO representative Kate Willett, PhD.
Adds ICAPO representative Troy Seidle: “It is absolutely crucial that authorities worldwide pro-actively call for this test method to be used in lieu of the traditional version, and that companies begin to use it, without delay.”
Adoption by the 34 member nations of the OECD follows a series of rigorous studies, which found that “the second generation mating and offspring will very rarely provide critical information” [3]. In other words, the vast majority of reproductive toxicants are identified in the first generation.
As OECD invited experts, ICAPO provided scientific expertise that helped create the new guideline and ensure its acceptance. In addition, ICAPO member groups are engaged in individual lobbying efforts to ensure regional acceptance of the new protocol across relevant industry sectors.

Contact: Kristie Sullivan,


1. ICAPO comprises 11 animal protection groups from Europe, Asia, and North America for a combined representation of more than 20 million citizens, and is dedicated to the replacement, reduction, and refinement of animals in OECD guidelines and other programs. Online at

2. OECD Test Guideline 443: Extended One-Generation Reproductive Toxicity Study. Online at;

3. Combined retrospective analysis of 498 rat multi-generation reproductive toxicity studies: on the impact of parameters related to F1 mating and F2 offspring. Aldert Piersma et al. Reproductive Toxicology 2011; 31:392-401. Online at
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