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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from peer reviewed journal

Data source

Reference
Reference Type:
publication
Title:
Evaluation of Feasibility of Mutagenic Testing of Shale Oil Products and Effluents
Author:
J. L. Epler, T. K. Rao, and M. R. Guerin
Year:
1979
Bibliographic source:
Environmental Health Perspectives- Vol. 30, pp. 179-184, 1979

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Refer below principle
Principles of method if other than guideline:
Gene mutation toxiicty studywas performed to determine the mutagenic nature of 2, 3 Dimethylphenol usingin Salmonella typhimurium strains TA100 and TA98
GLP compliance:
not specified
Type of assay:
bacterial gene mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2, 3 Dimethylphenol
- Molecular formula (if other than submission substance): C8H10O
- Molecular weight (if other than submission substance): 122.166 g/mol
- Substance type: Organic
- Physical state: solid
Purity
- Impurities (identity and concentrations): No data available.
Specific details on test material used for the study:
- Name of test material: 2, 3 Dimethylphenol
- IUPAC name: 2,3-dimethylphenol
- Molecular formula: C8H10O
- Molecular weight: 122.166 g/mol
- Substance type: Organic
- Physical state: solid
- Purity: No data
- Impurities (identity and concentrations): No data available.

Method

Target gene:
Histidine
Species / strain
Species / strain / cell type:
S. typhimurium, other: TA100 and TA98
Details on mammalian cell type (if applicable):
Not applicable
Additional strain / cell type characteristics:
not applicable
Cytokinesis block (if used):
No data
Metabolic activation:
with and without
Metabolic activation system:
S9 metabolic activation system
Test concentrations with justification for top dose:
10-20 mg/ml (10000- 20000 µg/mL)
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The chemical is soluble in DMSO
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
not specified
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Preincubation period: No data available
- Exposure duration: 2 days
- Expression time (cells in growth medium): 2 days
- Selection time (if incubation with a selection agent): No data available
- Fixation time (start of exposure up to fixation or harvest of cells): No data available

SELECTION AGENT (mutation assays): No data available
SPINDLE INHIBITOR (cytogenetic assays): No data available
STAIN (for cytogenetic assays): No data available

NUMBER OF REPLICATIONS: No data available

NUMBER OF CELLS EVALUATED: No data available

DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data available

OTHER EXAMINATIONS:
- Determination of polyploidy: No data available
- Determination of endoreplication: No data available
- Other: No data available

OTHER: No data available
Rationale for test conditions:
No data
Evaluation criteria:
Reversion of histidine-requiring auxotrophs of Salmonella typhimurium
Statistics:
No data available

Results and discussion

Test results
Species / strain:
S. typhimurium, other: TA100 and TA98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
No data available

Applicant's summary and conclusion

Conclusions:
The test compound 2, 3 Dimethylphenol did not induce gene mutation in the Salmonella typhimurium strains TA100 and TA98 in the presence and absence of S9 metabolic activation system by the reversion assay and hence the test chemical is not likely to classify as a gene mutant in vitro.
Executive summary:

Gene toxicity in vitro study was conducted on the Salmonella typhimurium strains TA100 and TA98 for the test chemical 2, 3 Dimethylphenol. The study was performed by the plate incorporation assay to evaluate the toxic nature during the 2 days incubation period at a dose level of 10-20 mg/mL (10000- 20000 µg/mL) in the presence and absence of S9 metabolic activation system. The test compound 2, 3 Dimethylphenol did not induce gene mutation in the Salmonella typhimurium strains TA100 and TA98 in the presence and absence of S9 metabolic activation system by the reversion assay and hence the test chemical is not likely to classify as a gene mutant in vitro.