o-TOLUIDINE CAS N°: 95-53-4 - UNEP Chemicals

OECD SIDS o-TOLUIDINE
5. TOXICITY ID: 95-53-4
DATE: 07.01.2005
study.
In female mice, 43/50 (86%) of the high-dose group, 39/50 (78%) of the
low-dose group, and 19/20 (95%) of the control group lived to the end of
the study.
CLINICAL SIGNS:
No clinical signs were reported which could clearly be related to
administration of the test chemical.
BODY WEIGHT GAIN:
Individual animal data were not reported.
Mean body weights of both dosed male and female mice were lower than
those of corresponding controls, particulary after week 18, and were doserelated.
HISTOPATHOLOGY:
Most common neoplasms encountered:
Control-Low Dose-High Dose:
LIVER:
Hepatocellular Carcinoma:
- m: 4/19-16/50-11/50; f: 0/20-2/49-7/50
Hepatocellular Adenoma:
- m: 1/19-3/50-3/50; f: 0/20-2/49-6/50
VASCULAR TUMOURS
Hemangiosarcoma: m: 1/20-1/50-10/50; f: 1/20-1/50-2/50
Hemangioma: m: 1/20-1/50-2/50, f: 0/20-0/50-1/50
Test condition : ANIMALS
obtained as 4-week -old weanlings , all within 3 days of the same age
housed for 2 weeks before start of the sutdy
- Number of animals:
50 per sex and dose-group, 20 control rats/sex
ANIMAL MAINTENANCE
- Diet: presterilized Wayne Sterilizable Lab Meal with 4%
fat, provided at libitum
- water provided ad libitum
- air of the animal room at a temperature of 22-24°C, relative humidity:
45-55%, room air changed 15 times per hour
- fluorescence lightening : 12 hour per day cycle
ADMINISTRATION /EXPOSURE
- Doses: 0, 1000 or 3000 ppm (approx. 0, 150 or 450 mg/kg bw/day)
prepared fresh every 1 to 1-1/2 weeks
doses were chosen based on preliminary dose finding studies: see chapter
5.4 repeated dose toxicity
- Administration period:
103 weeks: for all females and low dose group males and the controls
102 weeks: for 3000 ppm males, due to death of all male rats within this
period.
CLINICAL OBSERVATIONS:
- mortality: twice daily
- Observations for sick, tumor-bearing, and moribund - animals were
recorded daily. Clinical examinations and - palpation for masses were
performed each month
- body weights: at least once a month
NECROPSY:
- from animal killed at the end of study.
- Necropsies were also performed on all animals found death, unless
precluded in whole or in part by autolysis or cannibalization.
- GROSS AND MICROSCOPIC EXAMINATION:
of major tissues, major organs, and all gross lesions from animals killed at
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