ECHA Finds 22 Labs Ready for One-Generation Reproductive Toxicity Studies

ECHA performed a similar study in 2012 and now reports that global laboratory capacity to conduct the studies has increased. The latest study was triggered by the recent change in the REACH information requirements.

The European Chemicals Agency (ECHA), after commissioning a study on global laboratory capacities to conduct extended one-generation reproductive toxicity studies, known as EOGRTS, announced Jan. 13 that it has identified 22 laboratories capable of conducting those studies. ECHA estimates that for 2016, 2018, and 2020, these laboratories could deliver the following ranges of EOGRTS with basic study design: 88-114, 94-122 and 101-131 respectively. Regarding full study designs, the ranges are 44-57, 49-63 and 61-79 for the respective years.

ECHA performed a similar study in 2012 and now reports that global laboratory capacity to conduct the studies has increased. The latest study was triggered by the recent change in the REACH information requirements, where EOGRTS replaced the previous two-generation reproductive toxicity study.

The report says ECHA's survey was completed in eight countries: India, the United Kingdom, the Netherlands, United States, Poland, Germany, Italy, and also France.

Adopted by the OECD Test Guidelines Programme in July 2011, the studies potentially generate more toxicological information from fewer animals than the two-generation reproductive toxicity study, according to the report. It says the "increased sophistication, extent and duration of F1 offspring assessments are believed to allow adequate prediction on the reproductive toxicity without the need to assess the effects on functional fertility and reproductive performance of the F1 animals. The EOGRTS include F1 neurotoxicity and immunotoxicity assessments and test parental fertility and reproductive function, in addition to pre- and post-natal effects.

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