Fatty acids, rape-oil, mixed esters with 1,4:3,6-dianhydro-d-glucitol, sorbitan and sorbitol

Sediment toxicity

Description of key information

Taking all available information into account the substance is unlikely to pose a risk for sediment organisms and testing is thus omitted.

Additional information

There are no data available on the toxicity of Fatty acids, rape-oil, mixed esters with 1,4:3,6-dianhydro-d-glucitol, sorbitan and sorbitol (CAS 93334-10-2) to sediment organisms. In order to fulfil the standard information requirements set out in Annex X, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from one structurally related substance was conducted.

In accordance with Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met.” In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across).

Having regard to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC) No 1907/2006 whereby substances may be predicted as similar provided that their physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity.

Two reliable marine short-term sediment toxicity studies are available for the structurally similar substances sorbitan laurate (CAS 1338-39-2) and Sorbitan, (Z)-9-octadecenoate (2:3) (CAS 8007-43-0).

This read-across is justified as all substances share a comparable structure. Based on the specification the target substance Fatty acids, rape-oil, mixed esters with 1,4:3,6-dianhydro-d-glucitol, sorbitan and sorbitol is characterized by the alcohol components sorbitol, sorbitan and 1,4:3,6-dianhydro-d-glucitol esterified as mono (mainly), -di- or tri-ester with mainly fatty acids of C18 and C18 unsaturated. The source substance sorbitan laurate (CAS 1338-39-2) is characterized as a mono-, di- and tri-ester of sorbitol with mainly C12 fatty acids. Sorbitan, (Z)-9-octadecenoate (2:3) (CAS 8007-43-0) is an ester (mono, di and tri) of sorbitan, sorbitol and 1,4:3,6-dianhydro-d-glucitol with C18 unsaturated fatty acid. Both read-across substances allow for interpolation to the target substance as they cover the lower and the upper borders of the target substance. Further justification is given within the endpoint summary 6.1 and within the analogue justification in section 13.

Both studies were conducted according to the OSPARCOM guideline (Paris Commission Guidelines for conducting sediment toxicity tests with the amphipod Corophium volutator, 1995) and GLP (White, 1999; Hudson, 2003). In these studies, the test organism, Corophium volutator, was exposed to the test substances in a static system with natural sediment for 10 d. With sorbitan laurate an EC50 of 1141 mg/kg dw was derived, and with Sorbitan, (Z)-9-octadecenoate (2:3) no effects were observed at the highest test concentration 12391 mg/kg dw resulting in an LC50 (10 d) > 12391 mg/kg sediment dw.

The two short-term sediment tests available both show a very low toxicity. The substances are readily biodegradable and available acute and chronic data indicate no hazard to aquatic or terrestrial organisms. Long-term testing of sediment organisms is therefore not considered necessary.

A detailed reference list is provided in the technical dossier (see IUCLID, section 13) and within CSR.