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Short-term toxicity to aquatic invertebrates

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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 aquatic invertebrates 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., tetraesters with pentaerythritol (CAS 68604-44-4) was conducted. The source substances are representative to evaluate the short-term toxicity of the target substance to aquatic invertebrates.

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., tetraesters with pentaerythritol (CAS 68604-44-4) is characterised as a tetraester of pentaerythritol with mainly C18 unsaturated 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 aquatic invertebrates was investigated according to OECD 202 (GLP) using Daphnia magna (Parr, 2012). The test solutions were prepared by adding the appropriate amount of test substance with subsequent stirring, settling and sampling of the aqueous portions (WAFs). A loading rate WAF of 100 mg/L was tested under static exposure conditions. No immobilisation was observed in the treatment and the control throughout the test period of 48 h. Hence, the EL50 (48 h) is determined to be > 100 mg/L based on the nominal loading rate.

The short-term toxicity of the source substance Fatty acids, C16-18 and C18-unsatd., tetraesters with pentaerythritol (CAS 68604-44-4) to aquatic invertebrates was investigated in a study performed under static conditions according to EU Method C.2 (GLP) using Daphnia magna as test organism (Wierich, 1998). The WAF was prepared by adding the appropriate amount of test substance to test medium with subsequent stirring and filtering. A nominal loading rate of 100 mg/L was tested, corresponding to a measured concentration of < 10 mg/L (detection limit). No immobilization was observed in the treatment and the control throughout the test period of 48 h. Hence, the EL50 (48 h) is determined to be > 100 mg/L based on the nominal loading rate.

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 structure, it can be concluded that 2,2-bis(hydroxymethyl)propane-1,3-diyl didocosanoate will not exhibit short-term effects to aquatic invertebrates up to the limit of water solubility.