Registration Dossier
Registration Dossier
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EC number: 629-742-9 | CAS number: 1226892-49-4
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
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 the alkyl amidoamines/imidazolines compared to algae and daphnia.
For the calculation of the PNECaquatic bulk it is considered unlikely that fish toxicity will be critical for the alkyl amidoamines/imidazolines.In addition, the three available long-term daphnia reproduction tests for the imidazolines in general show that the parent daphnia die before effects are observed on reproduction, resulting 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.
Hence any additional toxicity testing with fish will not add scientific value to the ecotoxicity profile of the alkyl amidoamines/imidazoline 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 test unless a further refinement of the effect assessment is considered necessary based on the outcome of the chemical safety assessment. For alkyl amidoamines/imidazoline a safety factor of 10 is applied for the derivation of the PNECaquatic,bulk
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