Fatty acids, C18-unsatd., mono- and diesters with neopentylglycol and di-and triesters with trimethylolpropane

Short-term toxicity to fish

Description of key information

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

Additional information

Since no studies investigating the short-term toxicity of fatty acids, C16-18 (even numbered) and C16-18unsatd. (even numbered), mono-, diesters with neopentyl glycol and di-, triesters with trimethylolpropane (CAS 85186-92-1) to fish are available for this endpoint, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 read across to structurally related category members was conducted. The read-across substances are representative to evaluate the toxicity to fish of fatty acids, C16-18 (even numbered) and C16-18unsatd. (even numbered), mono-, diesters with neopentyl glycol and di-, triesters with trimethylolpropane since they have a similar structure and thus cover the target substance adequately. Further justification is given within the endpoint summary 6.1 and within the category justification section 13.

A semi-static study, investigating the short-term toxicity to fish of fatty acids, C16-18 even numbered and C18-unsatd. Triesters with propylidynetrimethanol (CAS 57675-44-2), is used for read across. The study was conducted according to OECD 203 with Brachydanio rerio (Kuttler, 1997). No mortality was observed at the tested concentration of 10000 mg/L. Thus, the LC50 (96 h) was determined as > 10000 mg/L (nominal) with highly turbidity at this concentration.

One guideline study on the acute toxicity of Fatty acids, C16-18 and C18-unsatd., triesters with trimethylolpropane (CAS 68002-78-8) to fish is selected for further read across (Bouillon, 2012). The study was conducted in compliance with OECD Guideline 203. Zebra fish (Danio rerio) were exposed to the substance for 96 hours in a static test system. At the end of the exposure period LL50 values >102 mg/L was determined. The test result is based on the nominal concentration of the water accommodated fraction (WAF) of the test substance. Based on the results of the acute toxicity test toxic effects on fish are not expected up to the water solubility limit of the substance (< 0.05 mg/L; Frischmann 2012).

The acute fish toxicity study for 2,2-dimethyl-1,3-propanediyl dioleate (CAS 42222-50-4) was also selected as adequate read across substance. The study 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 (96 h) of > 10000 mg/L is reported.

Based on the result 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 profile and comparable structure, it can be concluded that fatty acids, C16-18 (even numbered) and C16-18unsatd. (even numbered), mono-, diesters with neopentyl glycol and di-, triesters with trimethylolpropane (CAS 85186-92-1) is not acutely toxic to fish up to water solubility.