Registration Dossier
Registration Dossier
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EC number: 941-593-4 | CAS number: 1623405-26-4
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
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 chain length range from C12 to C18 reveal a comparable toxicity, independent of this alkyl chain length.
For the calculation of the PNECaquatic it is considered unlikely that fish toxicity will be critical for tetramine di-C16 -18. Hence any additional long-term toxicity testing with fish will not add scientific value to the ecotoxicity profile of this substance 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 and the ecotoxicity data for several cationic surfactants a safety factor of 50 will be applied for the derivation of the PNECaquatic.
The waiving of the long-term fish test is supported by the low acute to chronic ratio observed in the long-term daphnia test. 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.
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