Registration Dossier
Registration Dossier
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EC number: 619-057-3 | CAS number: 94667-33-1
Carcinogenicity
Administrative data
Description of key information
The read-across substance was not carcinogenic to rats and mice.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 32 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- food consumption and compound intake
- histopathology: non-neoplastic
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 32 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- High quality (read-across) studies are available in the rat and mouse.
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
There was no evidence of carcinogenicity 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 and no classification is required according to CLP criteria.
Additional information
The data summarised in this section are based on Didecyldimethylammonium Chloride, a chemical and structural analogue of N,N-Didecyl-N-methyl-poly(oxyethyl)ammonium Propionate. In view of the chemical and structural similarities, it is considered that the available data are adequate for N,N-Didecyl-N-methyl-poly(oxyethyl)ammonium Propionate.
Carcinogenicity studies were conducted with Bardac 2280 (Didecyldimethylammonium Chloride in aqueous/alcohol solution). The test substance was administered in the diet to mice for 78 weeks, and in the diet to rats for 104 weeks. The NOAELs were 32-41 mg a.s./kg bw/day (750 ppm a.s.) for rats (Gill, Chun and Wagner, 1991) and 76 – 93 mg a.s./kg bw/day (500 ppm a.s.) for mice (Gill, Hermansky and Wagner, 1991). Test substance administration did not result in an increase in tumours and was not considered oncogenic in either study. Therefore, it is considered that N,N-Didecyl-N-methyl-poly(oxyethyl)ammonium Propionate will not be oncogenic (Gill, Chun and Wagner, 1991; Gill, Hermansky and Wagner, 1991).
Justification for selection of
carcinogenicity via oral route endpoint:
High quality (read-across) studies are available in the rat and
mouse. The rat study is selected as the preferred species.
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