Registration Dossier
Registration Dossier
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EC number: 947-515-5 | CAS number: -
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 primary fatty amine ethoxylates compared to algae and daphnia. The available acute fish data for the primary fatty amine ethoxylates category which covers an alkyl chain length range from C16 to C18 reveal a comparable toxicity, independent of this alkyl chain length.
For the calculation of the PNECaquatic bulkit is considered unlikely that fish toxicity will be critical for primary fatty amine ethoxylates . Hence any additional toxicity testing with fish will not add scientific value to the ecotoxicity profile of the primary fatty amine ethoxylates 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.
For primary fatty amine ethoxylates a safety factor of 50 is applied for the derivation of the PNECaquatic,bulkInformation 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.
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