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 250 Route of admin. : oral feed Exposure period : 91 days Frequency of treatm. : continuously Post exposure period : Doses : 15 - 24 mg/animal (reduced for toxicity at 7.5 - 12 mg/animal) Result : Control group : Method : other: see freetext TC Year : 1947 GLP : no Test substance : other TS: no data on purity Result : 3/10 animals showed changes in the mucous membrane of the bladder with metaplasia and early epithelial proliferation Test condition : 10 rats were given a basic diet of rice flour with addition of a slice of carrot about every other day, and o-toluidine was added to the rice flour. Reliability : (4) not assignable documentation insufficient for assessment 12.02.2004 (160) (161) (356) Species : rat Sex : no data Strain : no data Route of admin. : s.c. Exposure period : 85 weeks Frequency of treatm. : once/week Post exposure period : Doses : 0, 30 mg Result : Control group : yes Method : other: no data Year : 1978 GLP : no data Test substance : other TS: no data Result : No of animals with tumors: 12/30 treated animals and 10/48 controls, no further information Test condition : No. of animals: 75 controls; 50 treated Reliability : (4) not assignable Insufficient documentation and/or Secondary literature 12.02.2004 (362) Species : rat Sex : male/female Strain : Sprague-Dawley Route of admin. : s.c. Exposure period : 24 months Frequency of treatm. : once / week Post exposure period : no Doses : 0, 25, 75 mg/kg bw/day in peanut oil Result : Control group : yes, concurrent vehicle Method : other: carcinogenicity see freetext TC Year : 1981 GLP : no Test substance : as prescribed by 1.1 - 1.4 Result : MORTALITY: no deaths occurred positive controls: significant reduced surviving time probabely due to early appearance of malignant tumours UNEP PUBLICATIONS
OECD SIDS o-TOLUIDINE 5. TOXICITY ID: 95-53-4 DATE: 07.01.2005 CLINICAL SIGNS: no differences to negative controls BODY WEIGHT: no differences to negative controls; positive control rats showed significantly reduced body weights. HISTOPATHOLOGY NON-NEOPLASTIC LESIONS - LIVER - CELL NECROSIS: 6/60 low dose-, 9/60 high-dose rats Comparison to controls: untreated controls: 4/60 peanut-oil : 4/60 Benzidin(low-mid-high dose): 5/60-23/60-33/60 TUMOUR INCIDENCE OVERVIEW ---maligne tumor: injection site control(peanut oil), m: 6/30; f: 2/30 o-toluidineHCl: low dose: m: 7/60, f: 1/30 high dose: m 14/30, f: 4/30 evaluated by the authors as statistically relvant hints to a dose related effect Test condition : TEST ORGANISMS - Age: 6 weeks - Number of animals: 30 rats/sex/group including negative controls and positive control groups ADMINISTRATION / EXPOSURE - Type of exposure: subcutan - Vehicle: peanut oil - Application volume: 1 ml/kg bw -dose selection based on determination of LD50-values - controls: ----negative control: peanut oil treated rats and --------------------- untreated rats ----positive control: benzidin treated rats(0.93, 8.33, 25 mg/kg bw/day) CLINICAL OBSERVATIONS AND FREQUENCY - Body weight: no data on frequency - Clinical signs: no data on frequency - Mortality: no data on frequency HISTOPATHOLOGY all organs and tissues suspected tumour-bearing area of injection, liver, lungs, spleen, urinary bladder, brain Conclusion : Author concluded: o-toluidine causes tumours only under extrem conditiones Reliability : (2) valid with restrictions Study doesn't meet the criteria of today: number of animals to low, application route and procedure not typical for the human situation, only 2 dosages, no GLP, no individual animal data given 25.05.2004 (151) Species : mouse Sex : no data Strain : other: CC 57 Route of admin. : s.c. Exposure period : 23 weeks Frequency of treatm. : once / week Post exposure period : Doses : 0. 5 mg Result : Control group : yes Method : other: no data Year : 1978 GLP : no data UNEP PUBLICATIONS 251
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o-TOLUIDINE CAS N°: 95-53-4 - UNEP Chemicals

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