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Short-term toxicity to fish

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Description of key information

No toxic effects to fish up to the limit of water solubility (< 1 mg/L).

Key value for chemical safety assessment

Additional information

Since no studies investigating the short-term toxicity to aquatic invertebrates of fatty acids, coco, di-and triesters with trimethylolpropane (CAS 85566-29-6) are available for this endpoint, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read across to the structurally related category members Fatty acids, 8-10 (even numbered), di- and triesters with propylidynetrimethanol (CAS 11138-60-6), Fatty acids, C8-10, triesters with trimethylolpropane (CAS 91050-89-4), Fatty acids, C16-18 (even numbered) and C18-unsatd., branched and linear, di and triesters with trimethylolpropane (former CAS 85005-23-8), Fatty acids, C8-10(even), C14-18(even) and C16-18(even)-unsatd., triesters with trimethylolpropane (former CAS 85186-89-6) and Fatty acids, C6-18, triesters with trimethylolpropane (CAS 91050-88-3) was conducted.

The read-across substances cover the lower- (CAS 11138-60-6 and CAS 91050-89-4) and the upper-end (CAS 85005-23-8 and CAS 85186-89-6) of the substance and thus allow for interpolation to fatty acids, coco, di-and triesters with trimethylolpropane (CAS 85566-29-6). This read-across is justified in detail in the overall summary (IUCLID Section 6.1) and within the category 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. Nevertheless, as it can be seen in the data matrix of the category justification in section 13 and the overall summary (IUCLID section 6.1), all reliable data in the category support the hazard assessment of each category member by showing a consistent pattern of results.

The first study with the read-across substance Fatty acids, 8-10 (even numbered), di- and triesters with propylidynetrimethanol (CAS 11138-60-6) was conducted according to OECD 203 with the zebra fish Brachydanio rerio. A limit test with a loading rate of 10000 mg/L did not result in any mortality after 96 h. Thus a LL50 (96 h) > 10000 mg/L was derived. The second study with the read-across substance Fatty acids, C8-10, triesters with trimethylolpropane (CAS 91050-89-4) was investigated in a study following OECD guideline 203 (Comber, 1991). The test was conducted with Rainbow trout (Oncorhynchus mykiss, reported as Salmo gairdneri) in a semi-static test system. The test organisms were exposed to a single test substance concentration of 1000 mg/L (limit test) for 96 hours. At test termination a LC50 >1000 mg/L based on nominal test substance concentrations was determined. The third study with the read-across substance C18-unsatd., branched and linear, di and triesters with trimethylolpropane (former CAS 85005-23-8) was conducted according to OECD 203 with Cyprinus carpio (Bogers, 1997). No mortality was recorded after 96 h and a LC50 (96 h) of > 100 mg/L (nominal) was determined. Floating test substance was observed on the surface of the medium representing a worst case. The fourth study with the read-across substance Fatty acids, C8-10(even), C14-18(even) and C16-18(even)-unsatd., triesters with trimethylolpropane (formerly CAS 85186-89-6) was performed according to OECD 203 (GLP) with the freshwater fish Leucisus idus melanotus under static conditions. No mortality was observed within the tested Water Accommodated Fractions (WAF) loading rates. A LL0 (96 h) ≥ 10000 mg/L and LL50 (96 h) > 10000 mg/L was derived. The fifth study, investigated toxic effects of the read-across substance Fatty acids, C6-18, triesters with trimethylolpropane (CAS 91050-88-3) to fish (Danio rerio) according to OECD 203. Mortality of fish caused by the test substance was determined after 24, 48, 72 and 96 hours of exposure to loading ratio 1 g/1000 g (Water Accommodated Fraction). The test substance did not increase mortality in exposed fish and mortality in control group was below 10%. The results showed that EL50 (96 h) was > 1000 mg/L.

Based on the result from five structurally related read-across 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 fatty acids, coco, di-and triesters with trimethylolpropane (CAS 85566-29-6) will not exhibit short-term effects to fish up to the limit of water solubility.