Decanoic acid, mixed esters with neopentyl glycol and octanoic acid

Short-term toxicity to fish

Description of key information

No 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 Decanoic acid, mixed esters with neopentyl glycol and octanoic acid (CAS No. 70693-32-2) to fish. The assessment of short-term toxicity to fish was, therefore, based on studies conducted with the structurally similar category members Heptanoic acid, ester with 2,2-dimethyl-1,3-propanediol (CAS No. 68855-18-5), Fatty acids, C8-18 and C18-unsatd., esters with neopentyl glycol (CAS No. 85186-86-3) and Decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate (CAS No. 11138-60-6). This read across approach 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 category justification in Section 13.

The key study conducted with Heptanoic acid, ester with 2,2-dimethyl-1,3-propanediol (CAS No. 68855-18-5) was performed, according to OECD Guideline 203 and GLP, in a semi-static system, using Oncorhynchus mykiss as test organism (Parr, 2012). During 96 hours, the fish were exposed to the nominal test concentrations of 100% v/v, corresponding to a measured concentration of 0.086 mg/L. This was the highest attainable concentration, due to the poor solubility of the test substance. The test solutions were prepared using a solvent, and undissolved test material was removed by filtration. No mortality occurred during the study, and the EC50 was reported to be > 0.086 mg/L.

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 EC50 was reported to be > 100 mg/L.

The key study conducted with Decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate (CAS No. 11138-60-6) was performed, according to OECD Guideline 203 and GLP, in a semi-static system, using Brachydanio rerio as test organism (Kuttler, 1998). The fish were exposed to the test substance at nominal test concentrations of 10000 mg/L for 96 hours. The test solutions were prepared as water accommodated fractions (WAF). No mortality occurred during the study, and the EC50 was reported to be > 1000 mg/L.

Thus, based on the above mentioned result, and due to the structural and profile similarities of the substances, as are explained with in the overall endpoint summary 6.1 it can be concluded that no short-term effects on fish are expected up to the limit of water solubility for Decanoic acid, mixed esters with neopentyl glycol and octanoic acid.

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.