Registration Dossier
Registration Dossier
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EC number: 619-057-3 | CAS number: 94667-33-1
PBT assessment
Administrative data
PBT assessment: overall result
- Name:
- N,N-didecyl-N-methylpoly(oxyethyl)ammonium propionate
- Type of composition:
- legal entity composition of the substance
- State / form:
- liquid
- Related composition:
- N,N-didecyl-N-methylpoly(oxyethyl)ammonium propionate
- Reference substance:
- N,N-didecyl-N-methylpoly(oxyethyl)ammonium propionate
- Reference substance:
- N,N-didecyl-N-methylpoly(oxyethyl)ammonium propionate
- This additive is considered relevant for the classification and labelling of the substance
- PBT status:
- the substance is not PBT / vPvB
- Justification:
Persistence:
An OECD 302B (Zahn-Wellens) test was conducted using Didecyldimethylpoly(oxyethyl)ammonium Propionate. Elimination of didecyldimethylpoly(oxyethyl)ammonium propionate reached 80% after 28 days, representing the combined effects of physico-chemical elimination and biodegradation processes (23% and 57%, respectively). As the half-life is less than 40 days the substance is not considered to be persistent.
Bioaccumulation:
In a study conducted in accordance with U.S.EPA (1989), Bluegill fish (Lepomis macrochirus) was exposed to the test material, Bardac 22 Determined to be an appropriate read-across for Bardap 26) with radiolabelled Didecyldimethylammonium Chloride at concentrations of 0, 59.0 µg/l (actual concentration - 93 ± 32 µg/l). 220 bluegill were tested at each concentration. The test organisms were exposed to the test material in aquaria for 28 days, with an 18 day depuration period. The whole-body BCF was found to be 81. As the BCF is less than 2000, the substance is not considered to be bioaccumulative.
Toxicity:
As the lowest long-term NOEC is 0.01 mg/l the substance is not considered toxic under Annex XIII of REACH.
There was no evidence of carcinogenicity or toxicity to reproduction in studies with the structural analogue Didecyldimethylammonium Chloride, therefore it is concluded that N,N-Didecyl-N-methyl-poly(oxyethyl)ammonium Propionate will not be carcinogenic or toxic to reproduction and no classification is required according to Directive 67/548/EEC or Regulation (EC) No 1272/2008.
Based on the available data, N,N-Didecyl-N-methyl-poly(oxyethyl)ammonium Propionate, classification according to Regulation (EC) No 1272/2008 is not required.
Reference
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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