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 264 kidneys, ovaries, heart and lung for effects on parent animals : see chapter 5.8.1 Reliability : (4) not assignable documentation insufficient for assessment, no sufficient information on methods and results Flag : Critical study for SIDS endpoint 26.05.2004 (163) Species : mouse Sex : female Strain : Balb/c Route of admin. : s.c. Exposure period : last week of pregnancy Frequency of treatm. : 4 - 5 injections Duration of test : Doses : 2 mg/animal Control group : yes Method : other: tumor development in progeny Year : 1974 GLP : no Test substance : other TS: o-tolidine see also RM Remark : This work is cited in RTECS and as second literature in MAK-Begründung 1986, but test substance is not clearly defined. In the english translation test substance is called o-tolidine. Result : After treatment with OT, half of the 16 mice studied were found to have tumors: adenomas of the lung in six and tumors of the mammary glands in five. Culturing of the kidneys of the progeny from the treated females resulted in specific hyperplastic pretoumerous alterations of the respective epithelium. Reliability : (4) not assignable Insufficient documentation and/or Secondary literature/ Test substance questionable Flag : Critical study for SIDS endpoint 26.05.2004 (363) (364) Species : mouse Sex : female Strain : Balb/c Route of admin. : s.c. Exposure period : whole period of gestation Frequency of treatm. : every 4-5 days Duration of test : Doses : 2 mg in sunflower oil/animal Control group : Method : other: see freetect ME Year : 1969 GLP : no Test substance : other TS: o-toluidine, no data on purity Method : Females were injected every 4-5 days during pregnancy. one-two days before the delivery the pregnant animals were killed and embryonic tissues were explantated in organ cultures. Explants were examined by histological and autoradiographic methods. Result : Whereas in the control cultures there was only degeneration, necrobiosis and necrosis, in the cultures from treated embryos marked irregular hyperplasia was seen from day 3 or 4 and occasionally even focal growth. Instead of necrotic glomeruli, cysts developed; the epithelium of the tubuli contoti proliferated into the lumen, the epithelial cells were hypercchromatic and mitoses could be seen UNEP PUBLICATIONS
OECD SIDS o-TOLUIDINE 5. TOXICITY ID: 95-53-4 DATE: 07.01.2005 Reliability : (4) not assignable insufficient documentation Flag : Critical study for SIDS endpoint 26.05.2004 (365) (366) 5.8.3 TOXICITY TO REPRODUCTION, OTHER STUDIES Type : other: repeated dose toxicity In vitro/in vivo : In vivo Species : rat Sex : male Strain : Fischer 344 Route of admin. : oral feed Exposure period : 13 and 26 weeks Frequency of treatm. : continuous Duration of test : 26 weeks Doses : 0, 5000 ppm (approximately 375 mg/kg bw/day) Control group : yes Method : other: comparative toxicity and carcinogenicity Year : 1992 GLP : yes Test substance : other TS: o-toluidine hydrochloride, purity 100% Remark : Comparative Toxicity and Carcinogenicity Study. In this study onitrotoluene was administered in the same manner as o-toluidine and in addition in rats pretreated with antibioticum and therefore alterated gastrointestinal flora. Results of investigations on testis find herein, others see Chapters 5.4 and 5.7 Result : TESTIS --Relative weight of testis was significantly increased with 5.07 versus 4.61 g after 13 weeks and 4.8 versus 4.2 g after 26-weeks --Degeneration of seminiferous tubules was a unilateral testicular lesion present in 5% to 10% of rats from each exposed group. At 26 weeks, 2 of 20 rats had epididymal mesothelioma (stop-exposure group) and one rat had epididymal mesothelial cell hyperplasia (continuous-exposure group). OTHER: for more information see also chapters 5.4 and 5.7 Test condition : TEST ORGANISMS - Age: 45 days - Weight at study initiation: 153 g - Number of animals: 20 control groups; 60 treated ADMINISTRATION / EXPOSURE Size of Study Groups 13-week interim: 10 control rats; 20 rats (o-toluidine hydrochloride) Stop-exposure: 20 rats (o-toluidine hydrochloride) 26-week study: 10 control rats; 20 rats (o-toluidine hydrochloride) - Type of exposure: - Post exposure period: 13 weeks after 13 weeks treatment CLINICAL OBSERVATIONS AND FREQUENCY: - Clinical signs: twice daily, reported weekly - Mortality: twice daily - Body weight: weekly - Food consumption: weekly UNEP PUBLICATIONS 265
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o-TOLUIDINE CAS N°: 95-53-4 - UNEP Chemicals

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