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

OECD SIDS o-TOLUIDINE
5. TOXICITY ID: 95-53-4
DATE: 07.01.2005
246
CONCURRENT CONTROL--LOW DOSE- HIGH DOSE--POOLED
CONTROL
Vascular tumours(significantly increased):
--- hemangiosarcomas and hemangiomas of the abdominal cavity
m: 0/14--5/14-9/11--5/99: f: 0/15--5/18-9/21--9/102
Test condition : TEST ORGANISMS
- Age: 6-8 weeks
- Acclimatisation period: 2 weeks
- Number of animals: 25 per group
ADMINISTRATION /EXPOSURE
- Vehicle: purina certified rodent diet
- Doses:
Doses were chosen based on prelimminary 30-day feeding study followed
by a 2-week recovery period (no further information)
---Initially 16000, 32000 ppm (approximately 2400, 4800 mg/kg bw/day)
over feeding period of 3 months,
---Reduction of doses after 3 months because weight gain was by 10 %
below that observed in the concurrent controls:
8000 and 16000 ppm ppm (approximately 1200, 2400 mg/kg bw/day)
OBSERVATIONS:
body weights
NECROPSY:
Animals which died during the first 6 month of treatment were discarded
without necropsy.
A complete gross necropsy was done on all animals which died after 6
month on test or were killed at the end of the study.
Tissues were fixed, sectioned, and stained by hematoxylin and eosin.
HISTOPATHOLOGY
Histopathological examinations were done on all grossly abnormal organs,
tumor masses, lung, liver, spleen, kidney, adrenal, heart, bladder, stomach,
intestines, reproductive organs
STATISTICS
Statistical analysis of tumors found was performed using the Fisher exact
testwith Bonferoni correction.
Reliability : (2) valid with restrictions
Study doesn't meet the criteria of today and reported in brief
Flag : Critical study for SIDS endpoint
24.05.2004 (354) (355) (356) (357) (150)
Species : mouse
Sex : male/female
Strain : B6C3F1
Route of admin. : oral feed
Exposure period : 103 weeks
Frequency of treatm. : continuously
Post exposure period : none
Doses : 0, 1000, 3000 ppm (approximately 0, 150, 450 mg/kg bw/day)
Result : positive
Control group : yes
Method : other: Carcinogenesis bioassay see also freetext TC
Year : 1979
GLP : no data
Test substance : other TS: o-Toluidine hydrochloride, purity: > 99 %
Result : MORTALITY AND TIME TO DEATH:
Individual data were not reported.
In each sex, the result of the Tarone test for positive dose-related trend in
mortality is not significant.
In male mice, 34/50 (68%) of the high-dose group, 43/50 (86%) of the lowdose
group, and 15/20 (75%) of the control group lived to the end of the
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