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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Guideline for 28-day repeat dose toxicity testing of chemicals (Japan)Japanese
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Reference substance name:
3,5-Dimethylanilin
IUPAC Name:
3,5-Dimethylanilin

Test animals

Species:
rat
Strain:
Crj: CD(SD)
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:
28
Frequency of treatment:
1 per day
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
10
Basis:
no data
Remarks:
Doses / Concentrations:
60
Basis:
no data
Remarks:
Doses / Concentrations:
360
Basis:
no data
No. of animals per sex per dose:
6 and 12 (0,360 mg/kg)
Control animals:
yes, concurrent vehicle

Results and discussion

Effect levels

Dose descriptor:
NOEL
Effect level:
10 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

Abstract from original report from JECDB-Database 2012:

3,5-Dimethylaniline was studied for oral toxicity in rats in a 28-day repeat dose toxicity test at doses of 0, 10, 60 and 360 mg/kg.

Cyanosis, blanching, salivation, exophthalmos and staggering gait were observed in males and/or females of the 360 mg/kg group, along with decreased body weight gain and food consumption. Urinalysis showed increase in urine volume, increases in sodium, potassium and chloride excretion, and decreases in osmotic pressure and specific gravity in males and females of the 360 mg/kg group. Hematological examination showed increases in methemoglobin and reticulocytes, and decreases in erythrocytes, hemoglobin and hematocrit in males and females of the 60 mg/kg and 360 mg/kg groups. Further, increase in leukocytes in males and females of the 360 mg/kg group, increase in segmented neutrophils in males of the 360 mg/kg group, and shortening of activated partial thromboplastin time in females of the 360 mg/kg group were detected. Blood chemical examination showed increases in total bilirubin, GOT, GPT, phospholipids and inorganic phosphorus in males and females of the 360 mg/kg group. Further, decreases in potassium and chloride in males of the 360 mg/kg group, and increases in total cholesterol and calcium in females of the 360 mg/kg group were detected. Spleen weights were increased in males and females of the 60 mg/kg and 360 mg/kg groups, and the thyroid, liver and kidney weights in both sexes of the 360 mg/kg group. In addition, the testis weights were increased in the 360 mg/kg group. Histopathologically, hemosiderin deposits in the liver and spleen, and extramedullary hematopoiesis of the spleen were apparent in males and females of the 60 mg/kg and 360 mg/kg groups. Hemosiderin deposits in the kidney and extramedullary hematopoiesis in the liver were also observed in males and females of the 360 mg/kg group. Hypertrophy of hepatocytes and follicular cells in the thyroid was noted in males of the 60 mg/kg group and males and females of the 360 mg/kg group. In the kidney, papillary necrosis was observed in males and females of the 360 mg/kg group, and hyaline droplets in the tubular epithelium in males of the 360 mg/kg group. In the recovery test, papillary necrosis in the kidney, and hemosiderin deposit in the liver, spleen and kidney persisted in males and females of the 360mg/kg group. However, the other changes observed during the administration period demonstrated recovery. The NOEL is considered to be 10 mg/kg/day for males and females.

3,5-Dimethylaniline induced structural chromosomal aberrations in CHL/IU cells at the highest concentration (900μg/ml) after a 6 hr short-term treatment with and without exogenous metabolic activation. Polyploidy was not induced under the conditions of the present study.

Applicant's summary and conclusion