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

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OECD SIDS o-TOLUIDINE 5. TOXICITY ID: 95-53-4 DATE: 07.01.2005 158 hematologic investigations Flag : Critical study for SIDS endpoint 03.06.2004 (157) Type : Sub-acute Species : rat Sex : male Strain : Fischer 344 Route of admin. : gavage Exposure period : 5, 10, 20 days Frequency of treatm. : once daily Post exposure period : no Doses : 0, 225 mg/kg bw per day Control group : yes Method : other: see TC Year : 1983 GLP : no Test substance : other TS: o-toluidine, purity 99.3% Remark : The study was designed to evaluate the subacute toxicity of several industrially important disubstituted anilines on selected tissues: liver, kidney, spleen, bone marrow. o-toluidine was included as positive control for the production of splenic and bone marrow effects. Result : MORTALITY - number of death: 10/30 - Time of death: 4 /in 5 day time period group 4 /in 10 day time period group 2 /in 20 day time period group TOXIC RESPONSE/EFFECTS BY DOSE LEVEL: - Clinical signs: cyanosis, thinness and rough hair coat - Body weight significantly reduced (dose group versus sham control): after 5 days: 183.2g [p
OECD SIDS o-TOLUIDINE 5. TOXICITY ID: 95-53-4 DATE: 07.01.2005 ADMINISTRATION / EXPOSURE - Duration of test/exposure: 5, 10 or 20 days - Type of exposure: gavage without vehicle at 25% of the estimated oral LD50 (900 mg/kg bw, Jacobson 1972) CLINICAL OBSERVATIONS AND FREQUENCY: - Clinical signs: daily - Mortality: daily - Body weight: at necropsy ORGANS EXAMINED AT NECROPSY: - Organ weights: liver, spleen, thyroid, urinary bladder and kidneys Microscopic: fixed organs liver, spleen, thyroid, urinary bladder, trachea and esophagus Bone marrow impressions were made from a cross section of femur Histopathological evaluation: scoring system: 0 = no effect - 4 = severe effect Data presented as means score for each group and sacrifice date: total score for sesions in each group/number of rats examined for the same group STATISTICAL METHODS: - Analysis of variance, - Dunnett's procedure - Fisher's Exact Test Reliability : (2) valid with restrictions only one dose group Flag : Critical study for SIDS endpoint 13.12.2004 (158) Type : Sub-chronic Species : rat Sex : male/female Strain : Fischer 344 Route of admin. : oral feed Exposure period : 7 weeks Frequency of treatm. : daily Post exposure period : 1 week Doses : 0, 1000 - 50000 ppm (approximately 0, 75 - 3750 mg/kg bw/d, see also freetext TC) Control group : yes, concurrent no treatment Method : other: Estimation of the maximum tolerated dose to select doses for cancerogenesis bioassay (see also freetext TC) Year : 1979 GLP : no data Test substance : other TS: o-Toluidine hydrochloride, purity > 99% Result : MORTALITY - Time of death: 4/5 males and 3/5 females died in the 50000 ppm group by week 3 on study TOXIC RESPONSE/EFFECTS BY DOSE LEVEL: - Clinical signs: no clinical signs reported - Body weight: dose dependent reduced up to 42 % of the control - Gross pathology and Histopathology: Small amounts of renal and splenic pigmentation were observed in male and female rats receiving 12500 ppm. 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 UNEP PUBLICATIONS 159
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o-TOLUIDINE CAS N°: 95-53-4 - UNEP Chemicals

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