N,N-dimethylaniline

Repeated dose toxicity: oral

Administrative data

Endpoint:

chronic toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

other: Authoritative data base

Title:

GCID : 42825

Year:

2011

Bibliographic source:

ACToR (Aggregated Computational Toxicology Resource);NTP, Technical Report No. 360, NIH Publ. No 90-2815, PB 90-227240, 1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other:

Principles of method if other than guideline:

Data is from actor database

GLP compliance:

not specified

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N,N-dimethylaniline

EC Number:

204-493-5

EC Name:

N,N-dimethylaniline

Cas Number:

121-69-7

Molecular formula:

C8H11N

IUPAC Name:

N,N-dimethylaniline

Test material form:

other: oily

Details on test material:

- Name of test material (as cited in study report): N,N-dimethylaniline
- Substance type: Organic
- Physical state: liquid

Test animals

Species:

rat

Strain:

Fischer 344

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

Exposure Period : 14 days

Frequency of treatment:

Frequency of Treatment : 5 days/week

Doses / concentrations

Remarks:

Doses / Concentrations:
93.75, 187.5, 375, 750 or 1500 mg/kg/day
Basis:
nominal in diet

No. of animals per sex per dose:

Ten males and 10 females were used in each group.

Control animals:

yes, concurrent vehicle

Results and discussion

Effect levels

Dose descriptor:

NOAEL

Effect level:

31.3 mg/kg bw (total dose)

Based on:

test mat.

Sex:

male/female

Target system / organ toxicity

Critical effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

The no observed adverse effect level (NOAEL) of N,N-dimethylaniline was found to be 31.3 mg/kg bw.

Executive summary:

No observed adverse effect level (NOAEL) of N,N-dimethylaniline was found to be 31.3 mg/kg bw. All animals survived doses of 93.75 to 375 mg/kg; all animals, apart from one male, died 6 days after a dose of 750 mg/kg and all animals died at the highest dose after 3 days. Symptoms observed were cyanosis, lethargy, slight tremor, diarrhea, discharge from nose and eyes. Splenomegaly was observed in 2 males and 1 female dosed with 93.75 mg/kg, in all animals apart from 1 female in the 187.5 mg/kg dose group, and in all animals in group given 375 mg/kg. One surviving male rat in the group given 750 mg/kg also showed splenomegaly. Extramedullary haematopoiesis and hemosiderosis were observed in the spleen of 3 males and 3 females given the dose of 375 mg/kg.