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EU chemicals legislation REACH was updated this week to change the requirements for one specific test that will lead to 40% fewer animals being used (1).
The test is the Extended One Generation Reproductive Toxicity Study (EOGRTS) and is a replacement for the two generation reproductive toxicity test that uses a minimum of 2200 animals (2). The EOGRTS is still an animal test but uses fewer animals because, if not ‘extended’, only one generation is bred. Estimates of the saving in animals vary as different strains of rat produce different numbers of pups, but our estimate is that a minimum of 960 animals would be used in an EOGRTS, saving 40% of animals (3).
Both tests however require animals, usually rats, to be force fed the test substance daily before being mated, during and after giving birth. The pups that are produced are also force-fed the substance until adulthood. They are then subjected to behaviour tests and are then killed. In the two generation test, these pups would not be killed but would be mated and their pups observed and then killed.
Animal tests like these have not been validated to show that they accurately predict whether industrial chemicals are likely to cause reproductive and developmental problems in humans. One review found that similar animal tests only predicted damage to human foetuses just over 50% of the time – in other words, virtually no better than tossing a coin (4).
The reduced EOGRTS method was first suggested by the US pesticide industry in 2006 (5) but was not accepted internationally until 2011 (3). It has taken years to be accepted to replace the two generation test because some EU countries did not trust the scientific reviews that have shown there is no point going to a second generation of animals (6). After four years of negotiations Europe has finally agreed that the EOGRTS can and should replace the two generation test for chemical testing under REACH. Furthermore, they were able to agree that the default requirement is that the test is not ‘extended’ to use further animals.
The legal text of REACH was finally published this week to reflect these changes (1). The ECEAE is pleased to that the legal text is very clear that the un-extended EOGRTS should be used and we hope this will mean we see fewer animals being used in chemical testing than were otherwise predicted.
However, we remain frustrated at the pace of change. We have been asking the European Commission to speed up methods that use fewer animals (or preferably no animals) for many years. We are currently urging them to speed up adoption of methods for REACH to replace the skin and eye irritation and allergy tests that do not use live animals that have also been adopted internationally, some of them before the EOGRTS (7).
Although no two generation tests have been requested by the European Chemicals Agency during these negotiations, sadly this development means that the European Commission is now likely to begin requesting the conduct of hundreds of EOGRTS for industrial chemicals. Hundreds of thousands of animals will now be tested on and killed to satisfy the REACH legislation.
1. Commission Regulation (EU) 2015/282 of 20 February 2015 amending Annexes VIII, IX and X to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards the Extended One-Generation Reproductive Toxicity Study. URL: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2015.050.01.0001.01.ENG
2. Our estimate based on the instructions within the OECD test guideline 416 Two-Generation Reproduction Toxicity, published 22 January 2001.
3. Our estimate based on the instructions within the OECD test guideline 443 Extended One-Generation Reproductive Toxicity Study, first published 28 July 2011.
4. Bailey, J.B. et al. The future of teratology research is in vitro. Biogenic Amines 2005; 19:97–145.
5. Cooper RL. et al. A tiered approach to life stages testing for agricultural chemical safety assessment. Crit Rev Toxicol 2006;36:69–98.
6. Janer, G. et al. A retrospective analysis of the two-generation study: What is the added value of the second generation? Reproductive Toxicology 24 (2007) 97–102. And Reuter U. et al. Evaluation of OECD screening tests 421 (reproduction/developmental toxicity screening test) and 422 (combined repeated dose toxicity study with the reproduction/developmental toxicity screening test). Regulat Toxicol Pharmacol 2003;38:17–26. And Myers DP. Et al. An analysis of the results from two-generation reproduction toxicity studies to assess the value of the second (F1) generation for the detection of adverse treatment-related effects on reproductive performance. Reprod Toxicol 2008, 26: 47-50.
7. OECD Test No. 437: Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants, first published 08 Sep 2009 and OECD Test No. 438: Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants, first published 08 Sep 2009 and OECD Test No. 439: In Vitro Skin Irritation, first published 23 July 2010 and OECD Test No. 442C: In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA), published 5 February 2015 and OECD Test No. 442D: In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method, published 5 February 2015.