Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT Assessment is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2014).
Persistence (P) Assessment:
The substance Amides, C18, branched and linear is not readily biodegradable according to OECD criteria and thus is to be considered as potentially persistent. However, based on read-across data a low persistency of the substance is anticipated.
Bioaccumulation (B) Assessment:
Bioaccumulation in aquatic organisms is not expected. The substance will enzymatically hydrolysed to ammonia and fatty acids. A bioaccumulation of the products of hydrolysis is not expected. This is supported by the low BCF values ranging from 146.3 – 151.2 L/kg (BCFBAF v3.01, Arnot-Gobas, including biotransformation, upper trophic). Based on the available information, the substance does not meet the B or vB criteria.
Toxicity (T) Assessment:
Amides, C18, branched and linear is considered not toxic. Long-term toxicity testing with Daphnia magna resulted in a NOEC of ≥ 100 mg/L (nominal). The substance is furthermore not classified as carcinogenic, mutagenic or toxic for reproduction nor is there any evidence of chronic toxicity according to the 2nd ATP of Regulation (EC) No. 1272/2008 (CLP) and Directive 67/548/EEC. The criteria for “T” based on mammalian effects are therefore not met.
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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