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Ecotoxicological information

Long-term toxicity to fish

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Description of key information

The safety assessment according to Annex 1 does not indicate the need to investigate further the effects on aquatic organisms. Therefore no chronic fish testing is required.

Key value for chemical safety assessment

Additional information

A further refinement of the effect assessment may be considered necessary based on the outcome of the chemical safety assessment. Based on the currently available data the safety assessment according to Annex 1 does not indicate the need to investigate further the effects on aquatic organisms. In addition, fish are in general less sensitive to cationic surfactants when compared to algae and daphnia. The available acute fish data for the primary fatty amine ethoxylates are used for read-across as a worst-case. A justification for read across is included in IUCLID chapter 13. For the primary fatty amine ethoxylates category which consists of di (2 -hydroxyethyl) amines with alkyl chain lengths ranging from C10 to C18 saturated and unsaturated, a comparable fish toxicity was observed independent of the alkyl chain length.

For the calculation of the PNECaquatic bulk it is considered unlikely that fish toxicity will be critical for primary fatty amine propoxylates. Hence any additional toxicity testing with fish will not add scientific value to the ecotoxicity profile of the primary fatty amine propoxylates other than for obtaining a lower assessment factor. It is therefore concluded that for scientific reasons and in accordance to REACH legislation further testing on fish has to be avoided for reasons of animal welfare. This means that it is proposed to waive the long term fish unless a further refinement of the effect assessment is considered necessary based on the outcome of the chemical safety assessment.

Like for primary fatty amine ethoxylates a safety factor of 50 is considered to be applicable for the derivation of the PNECaquatic,bulk of the primary fatty amine propoxylates.