Registration Dossier
Registration Dossier
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EC number: 202-870-9 | CAS number: 100-61-8
Carcinogenicity
Administrative data
Description of key information
Information is insufficient to assess the carcinogenicity capacity of N-methylaniline.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Quality of whole database:
- Data from Scientific Commitee on Occupational Exposure Limit (SCOEL)
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
Information is insufficient to assess the carcinogenicity capacity of N-methylaniline. N-methylaniline is not classified for carcinogenicity according to annex VI of CLP Regulation (EC n.1272/2008).
Additional information
As indicated in SCOEL/SUM/178 of December 2012 for N-methylaniline information is insufficient to assess the carcinogenic and reprotoxic capacity of N-methylaniline. However, two main studies are reported by SCOEL.
In the first one (see White et all, J NatI Cancer Inst 12:777-787, 1952) haemorrhagic foci in the liver, but no tumours in this or any other organ were found in 20 male and 20 female Osborne-Mendel rats after oral treatment with 0.06 % N-methylaniline hydrochloride in food for a period of 272–758 days. No control group was described in this study.
In the second one (see Greenblatt et all, J Natl Cancer Inst 46:1029-1034, 1971), 20 male and 20 female Swiss mice received N-methylaniline in food (1950 mg/kg food) for 28 weeks followed by a posttreatment period of 12 weeks. The incidence of lung adenomas in the N-methylaniline-treated group was not different from control data. No other tumours were observed .Because of the short exposure period, small group size, and absence of control group in the rat study, no definite conclusions can be drawn from these results.
As a secondary amine, N-methylaniline may be converted to the corresponding N-nitroso compound under certain conditions. Many of these N-nitrosoamines are mutagenic. Corresponding data on the mutagenicity of N-nitroso-N-methylamine were not available. The incidence of lung adenomas was increased significantly when the N-methylaniline treated animals also received sodium nitrite (NaNO2) at 0.1 % in drinking water 5 times/week . It was concluded that carcinogenic nitrosamines were formed from N-methylaniline in vivo.
Justification for selection of carcinogenicity via oral route endpoint:
Adverse effect observed but information is insufficient to assess the carcinogenicity capacity of N-methylaniline
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