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Diss Factsheets

Ecotoxicological information

Short-term toxicity to fish

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Administrative data

Link to relevant study record(s)

Description of key information

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

Key value for chemical safety assessment

Additional information

No study is available investigating the effects of the target substance Hexanedioic acid, di-C16-18 alkyl esters (CAS 92969-90-9) on freshwater fish. Thus, in accordance with Regulation (EC) No 1907/2006 Annex XI, 1.5 a read across to the structurally related source substance Bis(tridecyl) adipate (CAS 16958-92-2) was conducted to fulfill the data requirements according to Annex VIII. 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. This read-across is justified in within the analogue justification in IUCLID Section 13.

The available study investigated the toxicity of the source substance Bis(tridecyl) adipate (CAS 16958-92-2) to saltwater fish. The study was conducted under static conditions according to OECD guideline 203 using Cyprinodon variegatus as test organism. The test material was directly added to the test vessels preparing oil-water suspensions (OWD) in a range of 500 to 5000 mg/L. Undissolved test material was not removed, which bears the problem that observed effects could be related to physical interferences rather than systemic toxicity. There is no scientific basis to define a cut off limit value for solubility below which no toxicity could occur. There may be technical difficulties to perform the test, e.g. sensitivity of the analytical method used for the determination of test concentration. Tests above the limit of solubility should not be interpreted as pelagic toxicity, but as confounded by physical effects. However, this is considered negligible for this study, because the relevant effect value (LC50) after a 96 h test period is determined to be above the highest test concentration of 5000 mg/L.

Based on the structural and chemical similarity of the target and source substance, the target substance is expected to exhibit a similar ecotoxicological profile. Therefore, it can be concluded that the target substance Hexanedioic acid, di-C16-18 alkyl esters (CAS 92969-90-9) does not cause short-term effects to fish up to the limit of water solubility.