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 244 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 significant. An indicated departure from linear trend is observed in male rats due to the steep decrease in survival observed in the dosed groups. CLINICAL SIGNS: No clinical signs were reported which could clearly be related to administration of the test chemical. BODY WEIGHT GAIN: Individual data were not reported. Mean body weights of both dosed male and female rats were lower than those of corresponding matched controls and were dose-related throughout the bioassay. HISTOPATHOLOGY: The following tumors were related to the administration of o-toluidine hydrochloride (control-low dose-high dose): - MULTIPLE ORGANS Sarcomas, NOS: m: 0/20-3/50-11/49; f: 0/20-1/50-2/49 Fibrosarcomas: m: 0/20-8/50-20/50; f: 0/20-1/50-0/50 Osteosarcomas: m: 0/20-3/50-5/50; f: 0/20-0/50-18/50 Mesothelioma, malignant: m 0/20-4/50-2/49; f: 0/20-0/50-0/49 - SUBCUTANEOUS TISSUE Fibromas: m: 0/20-28/50-27/49; f: 0/20-4/50-2/49 Fibrosarcomas: m: 0/20-1/50-2/49; f: 0/20-0/50-0/49 - SPLEEN Sarcomas, NOS: m: 0/20-1/49-3/42; f: 0/20-1/49-3/49 Angiosarcomas: m: 0/20-7/49-0/42; f: 0/20-7/49-9/49 Fibromas: m: 0/20-10/49-2/49; f: 0/20-4/49-6/49 - URINARY BLADDER Transitional-cell carcinoma: m: 0/20-3/50-0/44; f: 0/20-9/45-22/47 Epithelial hyperplasia: m: 0/20-9/50-7/44; f: 0/20-21/45-13/47 - MAMMARY GLAND Fibroadenoma: m: 0/20-7/50-1/49; f: 7/20-20/50-35/49 - BODY CAVITY - tunica vaginalis Mesotheliomas: m: 0/20-15/50-9/49; f: 0/20-0/50-0/49 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 study - 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, 3000, 6000 ppm (approx. 0, 225, 450 mg/kg bw/day), prepared fresh every 1 to 1-1/2 weeks Doses were chosen based on preliminary dose findig studies: see chapter 5.4: repeated dose toxicity - Administration period: - 104 weeks: for all dosed females, the male and female controls, and UNEP PUBLICATIONS
OECD SIDS o-TOLUIDINE 5. TOXICITY ID: 95-53-4 DATE: 07.01.2005 low dose group males. - 101 weeks: for males dosed with 6000 ppm due death of all male rats - no interim kill 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 animal killed at the end of study (no further details reported). - HISTOPATHOLOGY: tissues examined: - skin, lungs and bronchi, trachea, bone marrow (femur), - spleen, lymph nodes (mesenteric andsubmandibular), thymus - heart, salivary gland (paotid, sublingual, and - subaxillary), liver, pancreas, esophagus, stomach - (glandular and nonglandular), small and large intestines, - kidney, urinary bladder, pituitary, adrenal, thyroid, - parathyroid, pancreatic islets, testis, prostata, mammary - gland, uterus, ovary, brain (cerebrum and cerebellum), and - all tissue masses. Peripheral blood smears were also made - for all animals, whenever possible. STATISTICS: Product-limit procedure of Kaplan and Meier Method of Cox with Tarone's extension Fisher exact test Bonferoni inequality Cochran-Armitage test Reliability : (2) valid with restrictions Flag : Critical study for SIDS endpoint 24.05.2004 (358) (359) (159) (356) Species : mouse Sex : male/female Strain : CD-1 Route of admin. : oral feed Exposure period : 18 months Frequency of treatm. : continuously Post exposure period : 3 months Doses : 3 months: 16000, 32000 ppm (approx. 0, 2400, 4800 mg/kg bw/day), 15 months: 8000, 16000 ppm (approx. 1200, 2400 mg/kg bw/day) Result : positive Control group : yes Method : other: see freetext TC Year : 1978 GLP : no Test substance : other TS: o-Toluidine hydrochloride, purified by treatment with charcoal, purity controlled by thin layer chromatography (no further data) Result : o-toluidine was carcinogenic in all groups: UNEP PUBLICATIONS 245
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o-TOLUIDINE CAS N°: 95-53-4 - UNEP Chemicals

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