Registration Dossier
Registration Dossier
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EC number: 204-493-5 | CAS number: 121-69-7
Carcinogenicity
Administrative data
Description of key information
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- Data is from National Toxicological Program database
- GLP compliance:
- not specified
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 2 yrs.
- Frequency of treatment:
- 5 day per week
- Post exposure period:
- no data
- Remarks:
- Doses / Concentrations:
0, 3, or 30 mg/kg/day
Basis:
no data - No. of animals per sex per dose:
- 50
- Control animals:
- yes, concurrent vehicle
- Dose descriptor:
- dose level:
- Effect level:
- 3 - 30 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: There was some evidence of carcinogenicity for male rats as indicated by increased incidence of sarcomas or osteosarcomas (combined) of the spleen
- Remarks on result:
- other: Effect type: carcinogenicity (migrated information)
- Dose descriptor:
- NOAEL
- Effect level:
- 3 - 30 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: There was no evidence of carcinogenicity in female rats
- Remarks on result:
- other: Effect type: carcinogenicity (migrated information)
- Conclusions:
- Under the conditions of these 2 yr gavage studies, there was some evidence of carcinogenic activity of N,N-dimethylaniline for male F344/N rats, as indicated by the increased incidences of sarcomas or osteosarcomas(combined) of the spleen. There was no evidence of carcinogenic activity of N,N-dimethylaniline in female rats.
- Executive summary:
Under the conditions of these 2 yr gavage studies, there was some evidence of carcinogenic activity of N,N-dimethylaniline for male F344/N rats, as indicated by the increased incidences of sarcomas or osteosarcomas(combined) of the spleen. There was no evidence of carcinogenic activity of N,N-dimethylaniline in female rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- 30 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- Data is of K2 level obtained from the National Toxicological Program database
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
N,N-dimethylaniline shows limited evidence of carcinigenicity in male rats and female mice. It is classified as Carc. 2 in the harmonised system of classification. The harmonised classification has been retained for the purpose of the Chemical Safety Assessment.
Additional information
Under the conditions of these 2 yr gavage studies, there was some evidence of carcinogenic activity of N,N-dimethylaniline for male F344/N rats, as indicated by the increased incidences of sarcomas or osteosarcomas(combined) of the spleen. There was no evidence of carcinogenic activity of N,N-dimethylaniline in female rats.
Under the conditions of these 2 yr gavage studies, there was equivocal evidence of carcinogenicity in female mice, as indicated by an increased incidence of squamous cell papillomas of the forestomach. There was no evidence of carcinogenic activity of N,N-dimethylaniline in male mice.
Justification for selection of carcinogenicity via oral route endpoint:
Under the conditions of these 2 yr gavage studies, there was some evidence of carcinogenic activity of N,N-dimethylaniline for male F344/N rats, as indicated by the increased incidences of sarcomas or osteosarcomas(combined) of the spleen. There was no evidence of carcinogenic activity of N,N-dimethylaniline in female rats
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