This press release is brought to you by the ECHA.



At its last meeting from 4 to 8 November 2013, the Member State Committee (MSC) agreed for the first time on testing proposals for large groups of substances based on a read-across approach. This applies to 27 alkenes in a category approach and to 22 petroleum substances.


The proposed tests address the following endpoints: sub-chronic repeated dose toxicity (90-day), pre-natal developmental toxicity (first species) and two-generation reproductive toxicity. Although the proposed approach is considered to be plausible for assessing the listed hazards of the category members, the MSC agreed that the remaining uncertainties related to the approach need to be addressed by the registrants.


Regarding petroleum substances, the registrants proposed the testing of six of the 22 substances for two-generation reproductive toxicity, based on a read-across approach. Two of the 22 substances will also be tested for pre-natal developmental toxicity. All 22 substances represent fractions of oil refinery processes and are complex UVCB substances.


The MSC agreed that the information provided by the registrants was insufficient to support the proposed category approach. In particular, the claimed structural similarity of the proposed category members has not been substantiated by detailed compositional data. However, depending on the test results, one-to-one read-across might be possible under the condition that the structural relationship between the respective source substance and the target substance can be demonstrated.



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