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Short-term toxicity to aquatic invertebrates

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Description of key information

No toxic effects on aquatic invertebrates up to the limit of water solubility, read across.

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Additional information

Data on the acute toxicity of the target substance Fatty acids, C18-unsatd., dimers, reaction products with fatty acids, C14-18 and C16-18-unsatd. and propylidynemethanol (CAS 162353-70-0) to aquatic invertebrates are not available. The assessment was therefore based on studies conducted with the analogue substances C18 Fatty acid, dimers, mixed ester with oleic acid and trimethylolpropane (CAS 147256-33-5) and Fatty acids, C16-18 and C18-unsatd., triesters with trimethylolpropane (CAS 68002-78-8) as part of a read across approach, which is in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5. Further justification is given within the overall summary chapter 6.1 and within the analogue justification in IUCLID section 13.

The toxicity of the source substance C18 Fatty acid, dimers, mixed ester with oleic acid and trimethylolpropane (CAS 147256-33-5) was tested according to EU method C.2 under GLP conditions (Henkel KGaA, 1997). The test organism Daphnia magna was exposed to the test substance in a static system for 48 hours. Water accommodated fractions (WAF) of 1000, 3000 and 10000 mg/L loading rate were prepared. The test concentrations were analytically determined at test start and after 24 as well as 48 hours. The measured test concentrations at test end were 0.055, 0.065 and 0.055 mg/L. Effects on the mobility of Daphnids were not observed. An EL50 (48 h) of > 1000 mg/L based on the nominal loading rates was reported. The results were confirmed in a second study on the source substance. The study was performed under static conditions according to GLP and OECD guideline 202 using Daphnia magna as test organism (Laboratoire d'Analyses de Fluides, 2012). WAFs with a loading rate between 10 and 100 mg/L were tested. TOC analysis of the test substance showed no significant amounts of carbon to be present (around limit of quantification) based on the low water solubility. The 48 h-EL50 is determined to be > 100 mg/L (WAF).

Comparable results were reported in a study on the source substanceFatty acids, C16-18 and C18-unsatd., triesters with trimethylolpropane (CAS 68002-78-8). The study was performed as a limit test according to OECD guideline 202 (Harlan Laboratories Ltd., 2012). The test organisms (Daphnia magna) were exposed to the test substance in a static system at a loading ration of 0.106 g/1000 g test substance. An EL50 >106 mg/L based on the nominal concentration of the water accommodated fraction of the test substance was reported.

Based on the results of the read across substance (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) toxic effects of Fatty acids, C18-unsatd., dimers, reaction products with fatty acids, C14-18 and C16-18-unsatd. and propylidynemethanol to aquatic invertebrates are not expected.

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