Sorbitan monolaurate, ethoxylated

Sediment toxicity

Description of key information

EC50 (10d) = 1141 mg/kg dw for Corophium volutator (OSPARCOM guideline); read-across

Additional information

Justification for grouping of substances and read-across

According to the standard requirements set in Regulation (EC) No. 1907/2006, Annexes VII, VIII and IX information regarding the effects of the substance on sediment organisms does not need to be presented at this tonnage band (100-1000 t/y). Nevertheless, in accordance with the Guidance on information requirements and chemical safety assessment, Chapter R7.b (ECHA, 2012), for substances with high adsorption potential, the sediment compartment should also be considered. There are no data available for the sediment toxicity of Sorbitan monolaurate, ethoxylated (CAS 9005-64-5). Therefore, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related substances 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.

The ecotoxicological parameters for sediment toxicity are presented in the table below.

Table 2. Ecotoxicological parameters for sediment toxicity

CAS No.	Sediment toxicity
Target substance
9005-64-5	RA: CAS 1338-39-2 RA: CAS 8007-43-0
Source substances
1338-39-2	LC50 (10d) = 1141 mg/kg sediment dw
8007-43-0	LC50 (10d) > 12391 mg/kg sediment dw

 

The above mentioned substances are considered to be similar on the basis of the structural similar properties and/or activities. The available endpoint information is used to predict the same endpoints for Sorbitan monolaurate, ethoxylated (CAS No. 9005-64-5).

A detailed analogue approach justification is provided in IUCLID Section 13.

Sediment toxicity

Two reliable marine short-term sediment toxicity studies are available for the read-across substances Sorbitan laurate (CAS No. 1338-39-2) and Sorbitan, (Z)-9-octadecenoate (2:3) (CAS No. 8007-43-0). 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 substance in a static system with natural sediment for 10 days. With Sorbitan laurate an EC50 of 1141 mg/kg was derived, and with Sorbitan, (Z)-9-octadecenoate (2:3) no effects were observed at the highest test concentration 12.391 mg/kg.

According to the Guidance on information requirements and chemical safety assessment Chapter R.7b: Endpoint specific guidance (ECHA, 2008), a long-term study on sediment organisms should be conducted if the Chemical safety assessment indicates a need to further investigate the effects of the substance on sediment organisms. This is not the case for the Sorbitan esters category members. The two short-term sediment tests available within the Sorbitan esters category show a low toxicity. Additionally, 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.