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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

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. In addition, fish are in general less sensitive to cationic surfactants as observed for linear alkyl diamines or quats compared to algae and daphnia. The available acute fish data for the diamines category which covers an alkyl chainlength range from C12 to C18 reveal a comparable toxicity, independent of this alkyl chain length. The available acute fish LC50 of 0.43 mg/L for a dodecyltriamine Y which is used as a biocide and therefore considered as one of the more toxic in the polyamines category.

For the calculation of the PNECaquatic bulk it is considered unlikely that fish toxicity will be critical for alkyl polypropylenepolyamines. Hence any additional toxicity testing with fish will not add scientific value to the ecotoxicity profile of the alkyl polypropylenepolyamines 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 and that based on the weight of evidence available on ecotoxicity data for several cationic surfactants a safety factor of 10 may be applied for the derivation of the PNECaquatic,bulk.

The use of an assessment factor of 10 is supported by the low acute to chronic ratio observed in the long-term daphnia test. The daphnia reproduction test result shows that at the highest test concentration all parental daphnids were immobile within four days, without reproduction, except for one daphnia which continued reproducing normally for the triamines, while at the next concentration there is not only no immobilisation, but there is no detrimental effect on reproduction when compared to the control. These observations result in a low acute-to-chronic ratio. A low acute-to-chronic ratio is indicative of a non-specific mode of action and is often associated with not systemic effects. This observation is consistent with the known effects of cationic surfactants on aquatic organisms, where toxicity is associated with physical binding to respiratory membranes. This explains the steep concentration curves seen and the lack of intermediate chronic effects on reproduction.