The OECD Test Guideline 443 is a new option for investigating reproductive toxicity
Media enquiries: ECHA Press
The Extended One-Generation Reproductive Toxicity Study (EOGRTS) will, under certain conditions, fulfil the current information requirements for a "two-generation reproductive toxicity study" under REACH. ECHA has already received around 230 testing proposals for the endpoint of reproductive toxicity for phase-in substances registered by the 1 December 2010 deadline.
Helsinki, 15 February 2012 - The Extended One-Generation Toxicity Study (EOGRTS) was adopted as an OECD Test Guideline (number 443) on 28 July 2011.
ECHA has already received around 230 testing proposals for the endpoint of reproductive toxicity (Annex IX/X, 8.7.3.) for phase-in substances registered by the 1 December 2010 deadline. ECHA has to examine these testing proposals and has to issue a draft decision to registrants by 1 December 2012. The recent adoption of the OECD Test Guideline 443 will give registrants a choice between test methods when addressing this standard information requirement:
- A two-generation reproductive toxicity study (test method: EU TM B.35/OECD TG 416); or
- An extended one-generation reproductive toxicity study (OECD TG 443) including the extension of Cohort 1B to mate the F1 animals to produce the F2 generation which shall be kept until weaning. The conduct of the study should allow generation of data equivalent to the current EU TM B.35 in line with REACH provisions.
There may be cases where registrants have specific information on properties of a substance allowing justifying that it is not necessary to include the second filial generation in the EOGRTS in order to investigate adequately the reproductive toxicity of the substance. Such arguments might be used in a weight of evidence approach according to Annex XI, 1.2. of REACH to justify adapting the standard information requirements of Annex IX/X 8.7.3 for the two-generation reproductive toxicity study. It remains the responsibility of the registrant to present such arguments in their testing proposal, and they can update their registration dossier if necessary to present such justifications. These scientific arguments will be considered in the examination of the testing proposal and the subsequent decision making. Any justifications must be scientifically well established and documented in order to allow ECHA and Member States to understand and examine the approach taken.
When registrants comment on the draft decision for the testing proposal, ECHA expects that registrants will express their preference on the method they want to use, so that their preference can be considered during the decision making procedure. It should be noted that when Competent Authorities of the Member States propose amendments to ECHA's draft decision the case is referred to the ECHA Member State Committee (MSC) for agreeing on a final decision. Registrants will receive any proposal for amendments made and can take position on those. In addition, registrants will be invited to the MSC meeting that addresses the decision for their substance and will be heard there.
Registrants may change their existing testing proposals with regard to the test method they prefer to use for reproductive toxicity before they receive a draft decision by updating their registration dossier.
The approach described above is based on the ECHA Secretariats' understanding of the legally binding information requirements of the REACH Regulation concerning reproductive toxicity and how EOGRTS may be used to fulfil them. It is to be noted that at the moment there is no unanimity among Member States authorities on how to exactly implement OECD TG 443 to meet the REACH information requirements, and this is causing uncertainty for the decision making in the MSC. Parallel to this communication the European Commission is analysing the introduction of OECD TG 443 in the Test Method Regulation (EC) No 440/2008, and its implementation under REACH.