Registration Dossier
Registration Dossier
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EC number: 616-248-3 | CAS number: 75627-31-5
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
Description of key information
The chemical safety assessment indicates that a long term study into fish toxicity need not be conducted. Therefore long term fish testing has been waived in order to avoid unnecessary vertebrate testing.In accordance with column 2 of REACH Annex IX, the study shall be proposed if the chemical safety assessment according to Annex I indicates the need to investigate further the effects on aquatic organisms. The risk characterisation does not indicate the need to investigate further the effects on aquatic organisms as all RCR’s to all environmental compartments are well below 1. As the only exposure scenario is assessed to be safe no further long-term testing is proposed for the aquatic compartments.
Key value for chemical safety assessment
Additional information
A supporting study on long term toxicity to fish is available for N-[2-hydroxy-3-(C12-16-alkyloxy)propyl]-N-methyl glycinate. The results of this study have been read-across to Nonylphenol ethoxylate, sarcosine derivative. The 28d-LOEC for Oncorhynchus mykiss was reported as 0.18 mg/L based on the nominal active ingredient concentration. The 28d-NOEC was 1 mg/L on the same basis. These values were determined in a study according to OECD TG 215 under GLP conditions. The results were assigned reliability 2 amongst others due to experimental difficulties with the analytical measurement of the test concentrations (multiple sampling points below the LOQ). The reported NOEC and LOEC are therefore based on nominal test concentrations.
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.
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