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 172 Type : Chromosomal aberration test System of testing : Chinese hamster lung (CHL) fibroblast cells Test concentration : 0, 1000, 1250, 1500 µg/ml in DMSO Cycotoxic concentr. : preliminary test, 50% growth inhibition at 1500 µg/ml Metabolic activation : with and without Result : positive Method : other: Chromosomal aberration test according Ishidate and Odashima 1977 Year : 1985 GLP : no data Test substance : other TS: o-toluidine, no data on purity Result : o-toluidine induced structural aberrations with or without metabolic activation. Minimum effective dose was 1000 µg/ml. Toluidine also induced polyploid cells with relatively low frequencies. Test condition : Cells were treated 24 and 48 hours with test chemical at least 3 doses including the 50% cell growth inhibition dose. Metabolic activation: S9 mix liver homogenates from PCB induced rats Controls: solvent control Positive controls: N'-methyl-N'-nitro-N-nitrosoguanidine; mitomycin C; benz[a]pyrene; dimethylnitrosamine Reliability : (2) valid with restrictions no data on purity and no information on GLP Flag : Critical study for SIDS endpoint 21.05.2004 (178) (180) (181) Type : Sister chromatid exchange assay System of testing : Chinese hamster ovary (CHO) cells Test concentration : -S9-mix: (1) 0, 1.6, 5, 16, 50, 160, 500 µg/ml; (2)0, 25, 50, 100, 250, 500 µg/ml +S9-mix: (1) 0, 16, 50, 160, 500, 1600, 5000 µg/ml; (2) 0, 500, 700, 1000, 1500, 2000 µg/ml Cycotoxic concentr. : -S9-mix: > 500 µg/ml; +S9-mix: >= 2000 µg/ml Metabolic activation : with and without Result : positive Method : other: see freetext TC Year : 1985 GLP : no data Test substance : other TS: o-toluidine, no data on purity Result : o-Toluidin was tested positive with and without metabolic activation The positive controls were functional. Test condition : Incubation time: without metabolic activation: The total incubation time was 26 hours: 2 hours with TS alone, adding BRdU for 24 hours, adding colcemid the last 2-3 hours with metabolic activation: Cells were incubated for 2 hours in the presence of TS, then cells were wasched and BRdU was added for 26 hourswith colcimid the last 2-3 hours METABOLIC ACTIVATION: S9-mix was prepared from liver homogenates from Aroclor 1254 injected male Sprague-Dawley rats CONCENTRATIONS: Chemicals were tested up to a maximum concentration of 5 mg/ml unless limited by solubility or toxicity. Controls: a) negative controls : cells received no treatment UNEP PUBLICATIONS
OECD SIDS o-TOLUIDINE 5. TOXICITY ID: 95-53-4 DATE: 07.01.2005 b) solvent controls treatment with DMSO c) positive controls +S9-mix: cyclophosphamide -S9-mix: mitomycin C statistical analysis: group means were statistically analyzed by a one-was analysis of variance F-test Reliability : (2) valid with restrictions no data on GLP and no data on purity of TS Flag : Critical study for SIDS endpoint 21.05.2004 (178) (179) (180) Type : Unscheduled DNA synthesis System of testing : primary rat hepatocytes Test concentration : 0, 25, 50, 100, 300, 600 µg/ml in Ethanol Cycotoxic concentr. : preliminary test; 76% toxicity at 1000 µg/ml; 45% at 667 µg/ml Metabolic activation : without Result : negative Method : other: OECD Guide-line 482, see also freetext TC Year : 1997 GLP : yes Test substance : other TS: o-toluidine purity: 99.95% Result : o-toluidine did not cause a significant increase in UDS as measured by an increase in net nuclear grain counts. Positive controls were functional. Test condition : Preliminary cytotoxicity assay: 12 doses ranged from 1 to 5000 µg/ml and parallel 12 doses ranged from 10 to 2000 µg/ml determined by LDH activity relative to the solvent control UDS-test: Cells were incubated 18 to 20h with test-substance. Medium: WME (Williams Media E) negative controls: untreated and solvent control (ethanol) positive controls: dimethylbenz(a)anthracene 300 and 100 µg/ml Net nuclear counts were performed, per treatment 100 cell were counted. The proportion of cells in repair in the untreated and solvent control must be less than 15% and the nuclear grain count must be less than one. The positive control compound must induce at least a 5 count increase in the mean net nuclear grains over that of the solvent control. Reliability : (1) valid without restriction Flag : Critical study for SIDS endpoint 17.05.2004 (182) Type : Micronucleus test in vitro System of testing : lymphocytes (human) Test concentration : 0 - 8 mM Cycotoxic concentr. : > 8 mM Metabolic activation : with and without Result : positive Method : other: according Fenech and Morley, 1985 Year : 1993 GLP : no data Test substance : other TS: o-toluidine, no data on purity Result : o-toluidine was found to be a marked direct genotoxic agent when tested according to: s UNEP PUBLICATIONS 173
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OECD SIDS o-TOLUIDINE FOREWORD INTR
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OECD SIDS o-TOLUIDINE 6 REFERENCES
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o-TOLUIDINE CAS N°: 95-53-4 - UNEP Chemicals

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