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EC number: 629-732-4
CAS number: 1224966-13-5
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.
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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