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A survey on the current costs and practicalities of following two new OECD guidelines for testing chemicals has been published on the European Chemicals Agency’s (ECHA) website.
The “Report on Survey of Worldwide Contract Research Organizations: Costs and Practicalities of Two New OECD Guidelines for Testing Chemical Substances OECD 443, Extended One-Generation Reproductive Toxicity Study, and OECD 488, Transgenic Rodent Somatic and Germ Cell Mutation Assay” was commissioned by ECHA in November 2011.
These two new OECD test guidelines are important for companies complying with REACH because they potentially can provide the higher-tier information required by the legislation on the impact of chemicals on human beings. For example, the extended one-generation reproductive toxicity study (EOGRTS) will, under certain conditions, fulfill the current information requirements for a “two-generation reproductive toxicity study” under REACH.
The report gives overall conclusions for the current cost, capability and capacity of contract research organizations worldwide to undertake the two new studies, based largely on the findings of a survey and the author’s own experience and knowledge. In brief, at this relatively early stage after the release of the OECD guidelines, the test methods are more expensive than the previous standard tests and the test house capacity to undertake them is still limited, in particular of the Transgenic Rodent Somatic and Germ Cell Mutation Assay.