Registration Dossier

Diss Factsheets

Administrative data

Link to relevant study record(s)

Description of key information

Key value for chemical safety assessment

Additional information

Experimental data on the long-term toxicity of fatty acids, C16-18, isononyl esters (CAS 91031-57-1) to fish are not available. However, the chemical safety assessment carried out according to Annex I of Regulation (EC) No 1907/2006 does not indicate the need to further investigate the long-term toxicity to fish. Therefore, no further long-term toxicity test to fish is proposed in accordance to Annex VIII, 9.1.3., column 2.

According to the Guidance on information requirements and chemical safety assessment Chapter R.7b: Endpoint specific guidance, R.7.8.5.3 (ECHA, 2017), long-term testing of fish should only be conducted if it represents the most sensitive taxonomic group. The Guidance states that if aquatic invertebrates are likely to be more sensitive than fish and algae or the relative sensitivity of invertebrates cannot be predicted, long-term testing on Daphnia sp. should be preferred instead of fish.
The environmental hazard related to the target substance can be expected to be low based on the available data for aquatic toxicity. By means of the read-across approach, reliable effect concentrations are available for the acute aquatic toxicity to three trophic levels (aquatic algae, invertebrates and fish) and chronic aquatic toxicity to two trophic levels (aquatic invertebrates and algae), as well as for the toxicity to activated sludge microorganisms. Experimental results from the studies performed with the selected source substances showed no acute or chronic effects to aquatic organisms including activated sludge microorganisms up to the limit of water solubility (< 1 mg/L). Based on the results from structurally related source substances (in accordance with Regulation (EC) No 1907/2006 Annex XI, 1.5) which are characterized by a similar ecotoxicological profile, long-term effects of fatty acids, C16-18, isononyl esters on fish are not to be expected. Thus, and for reasons of animal welfare, long-term testing on fish is not proposed.