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m-Cresol - ipcs inchem

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OECD SIDS<br />

m-CRESOL<br />

5. TOXICITY ID: 108-39-4<br />

DATE: 24.05.2004<br />

Solvent: DMSO<br />

CONTROL: DMSO and Mitomycin C, cyclophosphamide served as<br />

negative and positive control, respectively<br />

STATISTICAL ANALYSIS: Fisher's Exact Test with an adjustment for<br />

multiple comparisons<br />

Remark : The positive controls were functional<br />

Reliability : (1) valid without restriction<br />

Flag : Critical study for SIDS endpoint<br />

06.02.2004 (148)<br />

Type : Unscheduled DNA synthesis<br />

System of testing : other: Syrian Hamster Embryo (SHE) cells<br />

Test concentration : 1, 3, 10 uM, vehicle: medium<br />

Cycotoxic concentr. : not determined<br />

Metabolic activation : with and without<br />

Result : positive<br />

Method : other: according to OECD Guide-line 482: not tested up to cytotoxicity<br />

Year : 2000<br />

GLP : no data<br />

Test substance : other TS: m-cresol, purity: >=98 %<br />

Result : A dose-dependent positive result was only obtained when tested in the<br />

presence of a metabolic activation system. It was not tested up to<br />

cytotoxicity.<br />

Reliability : (2) valid with restrictions<br />

not tested up to cytotoxic concentration, no data on GLP, no positive or<br />

negative controls reported<br />

Flag : Critical study for SIDS endpoint<br />

06.02.2004 (149)<br />

5.6 GENETIC TOXICITY ‘IN VIVO‘<br />

146<br />

Type : Cytogenetic assay<br />

Species : other: mouse bone marrow cells<br />

Sex : male/female<br />

Strain : ICR<br />

Route of admin. : gavage<br />

Exposure period : once<br />

Doses : 0, 96, 320, 960 mg/kg bw in corn oil<br />

Result : negative<br />

Method : other: in accordance with OECD Guideline 475, 5 mice/sex/dose, bone<br />

marrow cells, sacrifice 6,24,48 hrs post treatment, negative and positive<br />

controls, stat. method: Kruskal-Wallis test<br />

Year : 1989<br />

GLP : yes<br />

Test substance : other TS: m-cresol, purity: 99.8 %<br />

Remark : dose finding study: see chapter 5.1.1<br />

CONTROL: corn oil and cyclophphamide served as negative and positive<br />

control<br />

EVALUATION CRITERIA: positive response is indicated by statistically<br />

significant dose-related increase in the number of structural aberrattions at<br />

3 dose levels<br />

Result : The treatment did not increase the frequency of chromosomal aberrations,<br />

indicating that m-cresol was not clastogenic under the conditions of this<br />

assay. The positive control was functional<br />

mortality: 3/5 male mice in the 960 mg-group<br />

signs of toxicity:<br />

960 mg-group: within 10 min after dosing: squinty eyes, scruffy coats, mild<br />

tonic convulsions and rapid breathing which ceased after 30 min.,<br />

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