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 164 CRITERIA FOR POSITIVE RESULT: in general: dose-related increase in the mean revertants per plate of at least one tester strain with a minimum of two increasing concentrations of test article S.typh.TA1535 and TA1537: increase in mean revertants at the peak of the dose response is equal or greater than three times the mean vehicle control value S.typh.TA98 and TA100: increase in mean revertants at the peak of the dose response is equal or greater than two times the mean vehicle control value Result : 1) o-toluidine was negative in all tester strains without or with metabolic activation Positive controls were functional 2) o-toluidine did cause positive responses with strain TA98 in the presence of aroclor-induced rat liver-S9 and Norharman. Reliability : (2) valid with restrictions only 4 strains used Flag : Critical study for SIDS endpoint 24.05.2004 (164) Type : Ames test System of testing : Salmonella typhimurium TA 97, TA 98, TA 100, TA 1535 Test concentration : 0, 33, 100, 333, 500, 1000, 2000, 3333 µg/plate in DMSO Cycotoxic concentr. : > 3333 µg/plate Metabolic activation : with and without Result : negative Method : other: preincubation method according to Ames, Mutat. Res. 31,347(1975); Maron, Mutat. Res.113,173(1983), see also freetext TC Year : 1985 GLP : no data Test substance : other TS: o-toluidine, no data on purity Result : o-Toluidine was without significant activity without S9-mix with S9 mix of rats and hamsters with one exception: o-Toluidine induced a dose-related increase of revertants in TA100 only in the presence of 30% hamster liver S9-mix Test condition : Salmonella strains were used in a 20 min preincubation procedure without metabolic activation and with Aroclor-1554-induced S9 from male Sprague- Dawley rats(10%, 30%) and Syrian hamsters (10%, 30%). Dosing: Chemicals were tested under code at a minimum of five doses up to a toxic dose or the limit of solubility, to a maximum dose of 10 mg per plate. Evaluation: A positive response was defined as a dose-related increase over the controlregardless of its magnitude. In the first experiment the concentration of S9-mix was 10%. If all tests (non activation, rat S9 and hamster S9 were negative, they were repeated, with 30% S9-mix. If the repeat test was also negative, the chemical was declared nonmutagenic. If a positive result was seen, only the strain-activation combination giving the positive result, was repeated. If an equivocal or weak response was seen, only that strain-activation combination was repeated; Concurrent positive and negative controls were run. negative control: solvent = DMSO positive controls: without S9-mix: UNEP PUBLICATIONS
OECD SIDS o-TOLUIDINE 5. TOXICITY ID: 95-53-4 DATE: 07.01.2005 TA97 - 9-Aminoacridine TA98 - 4:Nitro-o-phenylene-diamine TA100 and TA1535 - Sodium azide with S9-mix all strains- - 2-Aminoanthracene Reliability : (2) valid with restrictions four strains only Flag : Critical study for SIDS endpoint 02.06.2004 (165) (166) (167) Type : Ames test System of testing : Salmonella typhimurium TA 98, TA100, TA1535, TA1537, TA102, TA104 Escherichia coli WP2urA, WP2urA/pKM101 Test concentration : +/-S9-mix: 1) 0.0763, 0.305, 1.22, 4.88, 19.5, 78.1, 313, 1250, 5000 µg/plate, 2) 78.1, 156, 313, 625, 1250, 2500, 5000 µg/plate, 3) -S9-mix,TA104: 4.88, 9.77 µg/plate, -S9-mix, TA102, TA104 and +S9mix,WP2uvrA/pKM101: 19.5, 39.1 µg/plate Cycotoxic concentr. : from 156 µg/ml Metabolic activation : with and without Result : negative Method : other: preincubation method according to Ames, Mutat. Res. 31,347 (1975); Maron, Mutat. Res.113, 173 (1983); highest doses used: cytotoxic, positive controls, solvent (DMSO) control (see also freetext ME) Year : 1997 GLP : no data Test substance : other TS: o-toluidine, purity : 99 % Method : -------positive controls: ---without S9-mix: 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide (Salmonella typhimurium TA100, TA98, Escherichia coli WP2uvrA, WP2uvrA/pKM101) Sodium azide (Salmonella typhimurium TA1535) 4-Nitroquinoline-N-oxide (Salmonella typhimurium TA1538) 9-Aminoacridine (Salmonella typhimurium TA1538) Bleomycin (Salmonella typhimurium TA102) Pyruvic aldehyde (Salmonella typhimurium TA104) ---with S9-mix 2-Aminoanthracene (for all strains) -------negative control: solvent: DMSO -------Preparation of S9 Fraction: Male Syrian Golden hamster were used for the preparation of liver fractions. Sodium phenobarbital and 5,6-benzofravone were used as an inducer of the hamster metabolic activation system. Sodium phenobarbital was injected intraperitoneally into the hamsters 4 days before killing and 1,2 and 3 days before killing 5,6 benzoflavone was injected intraperitonally. From these hamsters liver S9 fraction was prepared according to Ames et al. (1975),Methods for detecting carcinogens and mutagens in the Salmonella /mammalian microsome mutagenicity test, Mutat. Res. 31, 347- 364.S9 was dispensed into freezing ampules and stored at -80°C. Once the stock S9 had been thawed, remained S9 was not reused. Evaluation criteria: Twohold rule was used for data evaluation. the chemicals are considered to be mutagenic when dose-related increase in revertant colonycount isobserved and the number of revertant colonies per plate with the test substance is more than twice that of the negative control (solvent control) and when a reproducibility of test result is observed. UNEP PUBLICATIONS 165
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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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