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 230 Positive control: was functional Reliability : (1) valid without restriction Flag : Critical study for SIDS endpoint 02.06.2004 (325) Type : Sister chromatid exchange assay Species : mouse Sex : male Strain : B6C3F1 Route of admin. : i.p. Exposure period : single administration Doses : 1. trial: 0, 150, 300, 600 mg/kg bw ; 2. trial: 0, 450, 600 mg/kg bw Result : positive Method : other: according to Latt et al 1982 in Hsu(ed.): Cytogenetic assay in environmental mutagens, Totowa N.Y.: Allanheld, Osmun, pp. 29-80, see also freetext TC Year : 1989 GLP : no data Test substance : other TS: o-toluidine hydrochloride Result : 1. trial: dose dependent increase in SCE/cell, significant only at 600 mg/kg bw when compared to the negative control 2. trial: significant increased SCE's/cells only at 450 mg/kg bw when compared to the negative control the positive control was functional. Test condition : In preliminary tests the MTD was determined; doses chosen were MTD, 0.5 MTD and 0.25 MTD 2 trials were performed TEST ORGANISMS: - Bone marrow cells of mice - Age: 10 - 16 weeks - No. of animals per dose: 4 ADMINISTRATION: - Vehicle: DMSO - Administration volume: 5 ml/kg body weight - Duration of test: animals were killed 23 h after a single injections of o-toluidine and bone marrow was taken - Control groups: negative (vehicle) control group and positive (MMC) control treated with single dose of 2.5 mg Mitomycin C/kg i. - app. 50 metaphases per animal were evaluated. STATISTICAL EVALUATION: One tail trend test of Margolin; individual group means by a pairwise t-test utilizing the appropriate bonferoni correction Reliability : (2) valid with restrictions individual animal data not given, no information on GLP and substance purity Flag : Critical study for SIDS endpoint 18.05.2004 (324) Type : Unscheduled DNA synthesis Species : rat Sex : male/female Strain : Fischer 344 Route of admin. : oral feed Exposure period : 14 days Doses : 0, 500, 3000, 6000 ppm Result : positive UNEP PUBLICATIONS
OECD SIDS o-TOLUIDINE 5. TOXICITY ID: 95-53-4 DATE: 07.01.2005 Method : other: see freetext TC Year : 1994 GLP : yes Test substance : as prescribed by 1.1 - 1.4 Remark : UDS evaluation in bladder epithelial cells Result : o-toluidine induced UDS in the bladder epithelial cells of both male and female rats. When compared to control values, the nuclear grain count of the 6000 ppm males and females was 2.5- and 2 fold greater, respectively and those increases were statistically significant. The percent of cells responding was also statistically elevated in both sexes. At 3000 ppm no statistically significant increases in either parameter were observed. Test condition : Five rats per sex and dose were evaluated for UDS (excepted controls = 10 animals/sex). Doses: 500, 3000, 6000 ppm corresponding an estimated daily intake of 40.4, 238, and 449 mg/kg bw/day in males amd 43.5, 251, and 481 mg/kg bw/day in females (not adjusted for the stability of the test substance in the diet). Test substance concentrations from the 7-day stability samples were 58.8 % (500 ppm), 68 % (3000 ppm) and 66.8 % (6000 ppm) Immediately after sacrifice the urinary bladder was removed and the epithelial cells were isolated and incubated in medium containing 3Hthymidine. UDS was evaluated autoradiographically by counting silver grains over the nuclei of the urothelial cells. The percent of cells responding was also determined. Positive controls: Cells isolated from extra control rats were pooled (sexes separate) and placed in culture and treated with methyl methanesulfonate Because the results at 3000 ppm were negative, slides from rats at 500 ppm were not scored. Conclusion : The results demonstrate that oral exposure to o-toluidine causes genotoxic damage in urinary bladder epithelium. Reliability : (1) valid without restriction Flag : Critical study for SIDS endpoint 18.05.2004 (156) Type : Drosophila SLRL test Species : Drosophila melanogaster Sex : no data Strain : no data Route of admin. : other: larvae feeding Exposure period : no data Doses : no data Result : positive Method : other: no data Year : 1984 GLP : no data Test substance : other TS: no data on purity Result : positive in larves; no further information Reliability : (4) not assignable documentation insufficient for assessment, abstract only 15.07.2004 (326) Type : Inhibition of DNA-Synthesis Species : mouse Sex : no data Strain : CBA Route of admin. : i.p. UNEP PUBLICATIONS 231
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o-TOLUIDINE CAS N°: 95-53-4 - UNEP Chemicals

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