MSC deals with testing proposals of alkenes and petroleum substances
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.
22 November 2013, Helsinki – The registrants of higher olefins and poly alpha olefins (HOPA) chose five substances for testing with the test results to be read–across to the remaining substances of the category.
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.
In both cases, conclusions on the approach can only be drawn after analysis of the test results when they are available. The registrants are expected to pay special attention to the detailed composition of the tested UVCB substances, especially when selecting the material used for testing, as well as to the composition of the UVCB substances for which the test results will be read-across to, taking into account the potential variability in the composition of the substances.
Although the MSC agreed on the required testing for alkenes and petroleum products, they could not reach agreement on the test guideline to be used for the testing of reproductive toxicity: two-generation reproductive toxicity study (OECD 416) or extended one generation reproductive toxicity study (EOGRTS, OECD 443). This element will be addressed for decision-making by the European Commission. The ECHA decisions based on the MSC agreement relating to the endpoints sub-chronic repeated dose toxicity and pre-natal developmental toxicity are to be finalised and will be sent to the registrants shortly.
Public versions of ECHA's decisions will be made available on ECHA's website.