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Short-term toxicity to fish

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Description of key information

No effects up to the water solubility limit. 

Key value for chemical safety assessment

Additional information

Since no studies investigating the short-term toxicity of 2,2-bis(hydroxymethyl)propane-1,3-diyl didocosanoate (CAS 68258-72-0) to fish are available, in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5 a read-across to the structurally related source substances Fatty acids, lanolin, esters with pentaerythritol (CAS 68440-09-5) and Fatty acids, C16-18 and C18-unsatd., esters with pentaerythritol (CAS 85711-45-1) was conducted. The source substances are representative to evaluate the short-term toxicity of the target substance to fish.

The target substance 2,2-bis(hydroxymethyl)propane-1,3-diyl didocosanoate (CAS 68258-72-0) is characterized di-, tri-, tetraester of pentaerythritol an fatty acids with a chain lengths of C22. The degree of esterification is variable. However, mainly tri- and tetraesters are the result of the esterification process. Source substance Fatty acids, lanolin, esters with pentaerythritol (CAS 68440-09-5) is a pentaerythritol tetraester of long-chain linear and iso-branched fatty acids (even and odd) up to C29. Moreover, a small amount of hydroxylated fatty acids of C16 is present. Source substance Fatty acids, C16-18 and C18-unsatd., esters with pentaerythritol (CAS 85711-45-1) is a mono-, di-, tri- and/or tetraester (in a variable composition) of mainly C16 and C18 (saturated and unsaturated) up to C22 fatty acids. This read-across is justified in detail in the overall summary (IUCLID Section 6.1) and within the analogue justification in IUCLID Section 13. In this case of read-across, the best suited (highest degree of structural similarity, nearest physico-chemical properties) read-across substance was used for the assessment.

The short-term toxicity of the source substance fatty acids, lanolin, esters with pentaerythritol (CAS 68440-09-5) to freshwater fish was investigated according to OECD 203 under semi-static conditions using Oncorhynchus mykiss as test organism (Parr, 2012). A nominal loading rate of 100 mg/L was applied. The test solution was prepared by adding the appropriate amount of test substance with subsequent stirring, settling and sampling of the aqueous portions (WAFs). After the test duration of 96 h a LL50 of > 100 mg/L was determined indicating no effects up to the water solubility limit.

The short-term toxicity of the source substance fatty acids, C16-18 and C18-unsaturated, esters with pentaerythritol (CAS 85711-45-1) to freshwater fish was investigated according to OECD 203 under static conditions using Danio rerio (Muckle, 2013). A nominal loading rate of 100 mg/L was applied. A water accommodated fraction (WAF) was prepared by adding the required amount of test substance to water with subsequent stirring to ensure testing up to the water solubility limit. The lower phase was used as test medium. DOC analysis of the test substance concentrations indicated that the substance is not soluble in the test medium and the evaluation is hence based on nominal concentrations. No mortalities occurred after the test duration of 96 h resulting in an LL50 of > 100 mg/L (nominal).

Based on the available results from structurally related source substances (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which are characterized by a similar ecotoxicological profile and comparable structures, it can be concluded that 2,2-bis(hydroxymethyl)propane-1,3-diyl didocosanoate (CAS 68258-72-0) will not exhibit short-term effects to fish up to the limit of water solubility.