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Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study

Data source

Reference
Reference Type:
publication
Title:
Mutagenicity test data of existing chemical substances
Author:
Japan Chemical Industry Ecology-Toxicology& Information Centre (JETOC)
Year:
1997
Bibliographic source:
Supplement

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
m-cresol
EC Number:
203-577-9
EC Name:
m-cresol
Cas Number:
108-39-4
Molecular formula:
C7H8O
IUPAC Name:
m-cresol
Details on test material:
Purity: >= 98 %

Method

Species / strain
Species / strain / cell type:
other: Salmonella typhimurium TA98, TA100, TA102, TA104, TA1535, TA1537 and Escherichia coli WP2uvrA and WP2uvrA/pKM101
Metabolic activation:
with and without
Metabolic activation system:
liver S9-fraction from male Sprague-Dawley rats pretreated with pheno- barbital and 5,6-benzoflavone
Test concentrations with justification for top dose:
(1) + (2) S. typh. TA98, TA100, TA1353, TA1537 and E.coli WP2uvrA:
(1) 0.0763, 0.305, 1.22, 4.88, 19.5, 78.1, 313, 1250, 5000 µg/plate
(2) 19.5, 39.1, 78.1, 156, 313, 625, 1250, 2500, 5000 µg/plate
(3) + (4) S.typh. TA102, TA104, E.coli WP2uvrA/pKM101:
(3) 0.0763, 0.305, 1.22, 4.88, 19.55, 78.1, 313, 1250, 5000 µg/plate
(4) 19.5, 39.1, 78.1, 156, 313, 625, 1250, 2500, 5000 µg/plate
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide, sodium acide, 9-aminoacridine, 2-nitrofluorene, 4-nitroquinoline-N-oxide, bleomycin, pyruvic aldehyde, 2-amino anthracene
Details on test system and experimental conditions:
METHOD OF APPLICATION: preincubation;

Evaluation criteria:
The chemical were considered to be mutagenic when a dose-related increase of revertant colony
count was observed and the number of revertant colonies per plate with the test substance was more han twice that of the negative control and
when a reproducibility of test result was observed.
Statistics:
yes: Two-hold criteria was used for data evaluation.

Results and discussion

Test results
Species / strain:
other: Salmonella typhimurium TA98, TA100, TA102, TA104, TA1535, TA1537 and Escherichia coli WP2uvrA and WP2uvrA/pKM101
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
from 1250 µg/plate onwards
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
the positive controls were functional.

Applicant's summary and conclusion