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 248 the end of study (no further details reported) - HISTOPATHOLOGY tissues examined: - skin, lungs and bronchi, trachea, bone marrow (femur), - spleen, lymph nodes (mesenteric and submandibular), - thymus, heart, salivary gland (parotid, sublingual, and - subaxillary), liver, pancreas, esophagus, stomach - (glandular and nonglandular), small ang 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 Conclusion : In conclusion, o-toluidine hydrochloride is considered to be carcinogenic in male and female B6C3Fl mice. This is based on the increased incidences of hepatocellular neoplasms in female mice and hemangiosarcomas in high-dose males and of females exposed to the compound. Reliability : (2) valid with restrictions Flag : Critical study for SIDS endpoint 24.05.2004 (159) (360) (356) Species : rat Sex : male Strain : Fischer 344 Route of admin. : oral feed Exposure period : 72 weeks Frequency of treatm. : continuously Post exposure period : approx. 20 weeks Doses : 0, 4000 ppm (mean daily dose per rat - 0.062g, calculated from food consumption) Result : Control group : yes, concurrent no treatment Method : other: carcinogenicity see freetext TC Year : 1982 GLP : no data Test substance : other TS: o-Toluidine hydrochloride, purified by recrystallization: m.p.: 216-218°C Result : ---mean daily food consumption/rat: 15.5 g in the treatment group versus 17.9 g in controls ---mean daily dose: 0.062 g 0-toluidine hydrochloride Mortality: treatment-group: no death up to month 14; month 22: 6/30 surviving rats control-group: no death up to month 12; month 22: 18/30 surviving control rat Mean Body weights: at onset: 132g of dosed rats as well as of controls after 1 year: 454 g(dosed rats) versus 400 g (control rats) after 93 weeks: 474 g (dosed rats) versus 411 g (control rats) Tumor incidences Number of rats necropsied: 30 dosed rats, 27 control rats UNEP PUBLICATIONS
OECD SIDS o-TOLUIDINE 5. TOXICITY ID: 95-53-4 DATE: 07.01.2005 Number of animals with tumors: treatment group versus controls: Liver Hepatoma 2/30 vs 0/27; Adenoma 1/30 vs 1/27 Urinary Bladder Papilloma 3/30 vs 0/27; Carcinoma 1/30 vs 0/30 Skin Fibroma 25/30 vs 1/27 Spleen - Fibroma 10/30 vs 0/30 Mammary tumors Fibroadenoma 11/30 vs 0/27; Adenocarcinoma 2/30 vs 0/27 Peritoneal tumors Mesothelioma 5/30 vs 2/27; Sarcoma 9/30 vs 0/27 Testis - Leydig cell 24/30 vs 24/27 Miscellaneous 12/30 vs 14/27 Test condition : TEST ORGANISMS - Age: 8 weeks at the study start - Weight at study initiation: 132 g - Number of animals: 30 male rats/group ANIMAL MAINTENANCE Housing: 3 rats/cage Diet: NIH-07, ad libitum Water: ad libitum Room air: 21°C, relative humidity: 50 % lightening: light/dark cycle of 12-h duration ADMINISTRATION / EXPOSURE - Administration of TS: 72 weeks - Duration of test: 93 weeks - Post exposure period: approx. 20 weeks - Vehicle: diet (NIH-07) - Concentration in vehicle: 0.028 mol/kg feed = 4g/kg feed = 4000 ppm CLINICAL OBSERVATIONS AND FREQUENCY - Body weight: mean data recorded at the onset, after 1 year and after 73 weeks - Food consumption: in 3 animals/group over a 2 days period every 3 weeks - Clinical signs: no data - Mortality: recorded monthly from month 8 to month 22 of the test period ORGANS EXAMINED AT NECROPSY (MACROSCOPIC AND MICROSCOPIC): - All remaining animals were killed after 93 test weeks. - Upon necropsy, gross lesions and representative samples of major organs (no details specified) were fixed in 10% buffered formalin and processed for microscopic evaluation. STATISTICS: STATISTICAL METHODS: significance was evaluated by the chi-squaretest Reliability : (2) valid with restrictions study doesn't meet the criteria of today: too short in uration, to small number of animals , only one dose, reported in brief Flag : Critical study for SIDS endpoint 03.06.2004 (361) (356) Species : rat Sex : no data Strain : other: no data UNEP PUBLICATIONS 249
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o-TOLUIDINE CAS N°: 95-53-4 - UNEP Chemicals

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