Fatty acids, C8-14, triesters with trimethylolpropane

Long-term toxicity to aquatic invertebrates

Description of key information

No effects up to the water solubility limit for Daphnia magna (OECD 211).

Additional information

Since no studies on long-term toxicity to aquatic invertebrates are available for Fatty acids, C6-18, triesters with trimethylolpropane (CAS 91050-88-3), the assessment of chronic toxicity was based on studies conducted with the category members, for which data is available, Fatty acids, C8-10 (even numbered), di-and triesters with propylidynetrimethanol (CAS 11138-60-6), Fatty acids, coco, triester with trimethylolpropane, reaction product of coconut oil fatty acids and trimethylolpropane (CAS 85566-29-6) and Fatty acids, C16-18 and C18 unsatd., triesters with trimethylolpropane (CAS 68002-78-8) as part of a read across approach. The read across is suitable due to the similar fatty acid chain length of both substances. This is in accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5. Grouping of substance and read across approach. Further justification is given within the endpoint summary 6.1 and within the analogue justification in IUCLID section 13.

The available GLP study on the long-term toxicity of the read-across substance Fatty acids, C8-10 (even numbered), di-and triesters with propylidynetrimethanol (CAS 11138-60-6) was performed according to the OECD 202, part 2 (Low, 1996). The test organism Daphnia magna was exposed to the test substance in a semi-static system for 15 days. Though the exposure time does not meet the recommended 21 days test duration for long-term tests the study is considered as valid. The requested validity criteria were fulfilled and all endpoints (e.g. survival and reproduction) could be determined. The substance did not have any effect on the mobility or reproduction of Daphnia magna at the tested concentrations. A NOELR (21 d)≥2570 mg/L is reported. The concentration is based on the water accommodated fraction (WAF).

For the second read-across substance Fatty acids, coco, triester with trimethylolpropane, reaction product of coconut oil fatty acids and trimethylolpropane (CAS 85566-29-6) a long term toxicity test on aquatic invertebrates was propsed in order to confirm that no chronic toxicity to aquatic organisms occurs for the polyol esters with medium chain lengths. In particular, fatty acids, coco, triester with trimethylolpropane, reaction product of coconut oil fatty acids and trimethylolpropane (CAS 85566-29-6) was selected as a representative test substance to cover the chain lengths of C12 and C14 within the polyol esters.

The chronic toxicity of the third read-across substance Fatty acids, C16-18 and C18-unsatd., triesters with trimethylolpropane (CAS 68002-78-8) to aquatic invertebrates was tested in a guideline study following OECD 211 (Grell, 2013). Daphnia magna were exposed to the test substance in a semi-static test system. The water accommodated fraction (WAF) was used for the preparation of the test solutions. During the exposure period of 21 days the mortality and reproduction rate of the test animals was recorded. The substance affected neither the survival rate nor the reproduction rate of D. magna. Based on the loading rate a NOELR (21 d) ≥ 0.11 g/L was determined.

Due to the structural and profile similarities of the substances, it can be concluded that toxicological long-term effects on aquatic invertebrates are not to be expected up to the limit of water solubility (0.407 mg/L) for Fatty acids, C6-18, triesters with trimethylolpropane (CAS 91050-88-3). As it can be seen in the data matrix of the category justification in section 13 and the overall endpoint summary IUCLID 6.1, all reliable data in the category support the hazard assessment of each category member by showing a consistent pattern of results, i.e. no toxic effects to aquatic organisms were observed up to the limit of water solubility.