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 210 Preliminary cytotoxicity test : inhibition of cell growth Incubation time: 1 hour METABOLIC ACTIVATION: S9-mix: liver homogenates from Aroclor 1254 induced Sprague-Dawley rats Controls: negative control: solvent(DMSO) positive control : methyl methane sulfonate (MMS), Dimethylnitrosamin (DMN) Result : (1) ASD: o-Toluidine caused low levels of DNA damage at high concentrations in the presence and in the absence of a metabolic activation system. (2) Micronuclious assay in vitro: o-toluidine was reported to cause no chromosome breakage neither in the presence nor in the absence of a metabolic activation system (data not shown). (3) SCE-assay: o-toluidine did not induce an increased rate of sister chromatid exchanges when compared with the concurrent control. The data of the positive controls in each assay are not shown or reported. Reliability : (4) not assignable no data on purity of TS, no information on GLP, data of positive controls are not reported, (1) unusual test method, (2) data are not shown 15.07.2004 (178) (279) (280) Type : Chromosomal aberration test System of testing : Chinese Hamster Lung (CHL) cells Test concentration : (1) direct method: 0, 0.13, 0.27, 0.54 (treatment time: 24 or 48 hours) (2) Pulse treatrment method: 0, 0.13, 0.27, 0.54, 1.10 mg/ml in DMSO(treatment time: 6 hours) Cycotoxic concentr. : no data Metabolic activation : with and without Result : Method : other: according to Ishidate (1985Progress in Mutatio Res. 5, pp,427: see freetext TC Year : 1994 GLP : no data Test substance : other TS: o-toluidine, no data on purity Result : (1) Direct method Chromosome aberrations were not induced by the direct method (24 or 48H) at any concentration. (2) Puls treatment Aberrations were induced by pulse treatments (6h), with or without S9 mix, at the highest concentration (1.1 mg/ml). Furthermore, polyploid cells were increased dose-dependently by both the direct method (48h) and by pulse treatment (6h) with or without S9 mix. The positive controls were functional in bothe trials- Test condition : (1) Direct method: 1-day-old culture: cells were treated for 24 or 48 hours with test substance without an additional metabolic activation system negative control: solvent: DMSO positive control: Mitomycin C (MMC) (2) Pulse treatment: UNEP PUBLICATIONS
OECD SIDS o-TOLUIDINE 5. TOXICITY ID: 95-53-4 DATE: 07.01.2005 cells were treated for 6 hours with or without 5% S9-mix METABOLIC ACTIVATION: S9 mix liver homogenates from phenobarbital and 5,6-benzoflavone induced rats Controls: negative controls: untreated cultures; vehicle (DMSO) treated cultures; positive control: Dimethylnitrosamine (DMN) Reliability : (4) not assignable no data on cytoxicity 15.07.2004 (215) (216) Type : Chromosomal aberration test System of testing : RL4 cells Test concentration : 0, 87.5, 175, 350, 700 µg/ml DMSO Cycotoxic concentr. : 500 - 750 µg/ml DMSO Metabolic activation : without Result : positive Method : other: chromosomal aberration test ( see freetext TC) Year : 1985 GLP : no data Test substance : other TS: o-toluidine, no data on purity Result : Over the dose-range 87.5-700µg/ml o-toluidine induced a dose related increase in chromatid gaps that was significant at 700 µg/ml. In the absence of other chromatid or chromosome aberrations the increase in gaps alone is regarded as indicative of weak clastogenic activity. Test condition : ---Test system RL4 cells (epithelial-like cell isolated from liver of 10-day-old male Wistar rat, cycle time: 13 h) ---Preliminary cytotoxicity test Cytotoxicity was measurement as plating efficiency Cytotoxicity reduced by 50% between 500 and 750 µg/ml and 700 µg/ml was used as the highest dose level. ---Incubation time: 22 hoursadditional 2 hrs after addition of colcemid solution ---Controls positive controls: 7,12-dimethylbenzanthracene 1µg/ml negative controls: solvent (DMSO) Reliability : (4) not assignable Method evaluation, unsuitable cell system 15.07.2004 (180) (281) (282) Type : Chromosomal aberration test System of testing : CH1-L (fibroblasts from the liver of Chinese hamster) Test concentration : 0, 12, 30, 60, 120 µg/ml DMSO Cycotoxic concentr. : preliminary test, tests carried out with dose up to 50% growth inhibition Metabolic activation : without Result : positive Method : other: chromosome aberrations and aneuploidy Year : 1985 GLP : no data Test substance : other TS: o-toluidine, no data on purity Result : All concentrations tested, both excluding and including gaps, caused significant increase in the level of chromosome aberrations. Although doseresponse was observed, this was not statistically significant. A similar situation was found with regard to aneuploidy levels. The higher 2 doses had significant greater levels of hyperdiploidy, but dose-response was non-significant. UNEP PUBLICATIONS 211
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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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