Fatty acids, C14-18 and C16-18-unsatd., esters with neopentyl glycol

Short-term toxicity to fish

Description of key information

No toxic effects up to the limit of water solubility for Oncorhynchus mykiss (OECD 203); read-across

Additional information

No studies are available on the short-term toxicity of Fatty acids C14-18 and C16-18 unsatd, esters with neopentyl glycol (CAS No. 85116-81-0) to fish. The assessment of short-term toxicity to fish was, therefore, based on a study conducted with the structurally similar category members 2,2-dimethyl-1,3-propanediyl dioleate (CAS No. 42222-50-4) and Fatty acids, C8-18 and C18-unsatd., esters with neopentylglycol (CAS No. 85186-86-3). This read across approach is in accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5. Grouping of substances and read across approach. Further justification is given within the endpoint summary in 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 IUCLID section 13 and the overall summary, all reliable data in the category support the hazard assessment by showing a consistent pattern of results.

The key study conducted with 2,2-dimethyl-1,3-propanediyl dioleate (CAS No. 42222-50-4) was performed, according to ISO 7346-1, in a semi-static system, using Brachydanio rerio as test organism (Gode, 2008). The fish were exposed to the nominal test concentrations of 100, 300, 1000, 3000 and 10000 mg/L, during 96 hours. The test solutions were prepared as water accommodated fractions (WAF). No blank control was used in the test. However, as no mortalities were observed at any of the test concentrations, it can be concluded that 2,2- dimethyl-1,3 -propanediyl dioaleate is not acutely toxic to fish at concentrations≤10000 mg/L. An EC50 of > 10000 mg/L is reported. Taking into account that this test is not regarded as a standard OECD 203, but as a toxicity limit screening test, a Klimisch grade 2 is justifiable.

The key study conducted with Fatty acids, C8-18 and C18-unsatd., esters with neopentyl glycol (CAS No. 85186-86-3) was performed, according to OECD Guideline 203 and GLP, in a semi-static system, using Oncorhynchus mykiss as test organism (Goodband and Mullee, 2012). The fish were exposed to the test substance at the nominal test concentration of 100 mg/L for 96 hours. The test solutions were prepared as water accommodated fractions (WAF). No mortality occurred during the study, and the LL50 (96 h) was reported to be > 100 mg/L.

Based on the available results from structurally related read-across substances (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which are characterized by a similar ecotoxicological profiles and comparable structures, it can be concluded that Fatty acids C14-18 and C16-18 unsatd, esters with neopentyl glycol will not exhibit short-term effects on fish up to the limit of water solubility.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 up to the limit of water solubility.