Registration Dossier
Registration Dossier
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EC number: 203-756-1 | CAS number: 110-31-6
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- fish early-life stage toxicity
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Description of key information
Key value for chemical safety assessment
Additional information
According to EC 1907/2006, Annex IX, Column 2, long-term toxicity testing shall be proposed if the chemical safety assessment according to Annex I indicates the need to investigate further the effects on aquatic organisms. Amides, C16 and C18-C20 (even numbered, unsaturated), N,N’-ethylenebis did not exert toxicity to any of the aquatic organisms used in the experimental studies available (acute toxicity to invertebrates, algae, microorganisms, and acute toxicity to fish), including Daphnia after 21 days of exposure (long-term study). Since there is no indication that fish sensitivity would be greater than that of Daphnia, similar results for long-term fish studies can be expected.
Furthermore, the substance exhibits a log Koc of > 5 (OECD 121) and is poorly water soluble (< 0.01 mg/L). The Guidance on information requirements and chemical safety assessment, Chapter R7.B (ECHA, 2017) states that once insoluble chemicals enter a standard STP, they will be extensively removed in the primary settling tank and fat trap and thus, only limited amounts will get in contact with activated sludge organisms. Nevertheless, once this contact takes place, these substances are expected to be removed from the water column to a significant degree by adsorption to sewage sludge (Guidance on information requirements and chemical safety assessment, Chapter R.7a, (ECHA, 2008)). Thus, discharged concentrations of these substances into the aqueous/sediment compartment are likely to be negligible. Considering this one can assume that the availability of Amides, C16 and C18-C20 (even numbered, unsaturated), N,N’-ethylenebis in the aquatic environment is generally very low, which reduces the probability of chronic exposure to aquatic organisms in general.
In addition, the low BCF value (< 6.2) indicates a low potential for bioaccumulation. Therefore, bioaccumulation could be excluded for Amides, C16 and C18-C20 (even numbered, unsaturated), N,N’-ethylenebis, which reduces the possibility of chronic exposure to aquatic organisms additionally.
Overall, no chronic aquatic toxicity is expected and thus, no chronic fish toxicity testing is needed.
In conclusion, based on following facts, no long-term testing with fish is needed:
· - No acute and chronic toxicity to aquatic organisms observed.
· - No indication of higher sensitivity for fish.
· - A removal from the water column to a significant degree by adsorption to sewage sludge
· - A low bioavailability
· - A low potential for bioaccumulation
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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