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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data is from peer reviewed publication
Justification for type of information:
Data is from publication.

Data source

Reference
Reference Type:
publication
Title:
Mutagenicity studies of p-substituted benzyl derivatives in the Ames Salmonella plate-incorporation assay
Author:
James C. Ball, Susan Foxall-VanAken and Trescott E. Jensen
Year:
1984
Bibliographic source:
Mutation Research, 138 (1984) 145-151

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: As mention below
Principles of method if other than guideline:
Gene mutation study was performed to evaluate the mutagenic nature of the test compound Benzyl alcohol
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: Benzyl alcohol
- Molecular formula: C7H8O
- Molecular weight: 108.1392 g/mol
- Substance type: Organic
- Physical state: No data available
- Purity: No data available
- Impurities (identity and concentrations): No data available
Specific details on test material used for the study:
- Name of test material: Benzyl alcohol
- Molecular formula: C7H8O
- Molecular weight: 108.1392 g/mol
- Substance type: Organic

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 specified
Metabolic activation:
not specified
Metabolic activation system:
No data
Test concentrations with justification for top dose:
100, 250, 500, 1000 µg/plate
Vehicle / solvent:
No data available
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
methylmethanesulfonate
Details on test system and experimental conditions:
Details on test system and conditions
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Preincubation period: No data available
- Exposure duration: No data available
- Expression time (cells in growth medium): No data available
- 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: Duplicate

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
Evaluation criteria:
A compound was considered to be mutagenic if the number of revertants/plate exceeded the 99.9% confidence limit and a concentration-dependent increase in the mutagenicity was observed. The 99.9% confidence limit was 99 revertants above spontaneous revertant levels for TA100 (spontaneous revertants = 196 ± 29 revertants/plate) and 40 revertants above spontaneous revertants for TA98 (spontaneous revertants = 40 ± 12 revertants/plate).
Statistics:
The 99.9% confidence limit was calculated by multiplying the standard deviation from 27 independent observations (duplicate determinations) by the appropriate t value of the Student's t distribution (one-sided) requiring 99.9% confidence (Skopek et al., 1978).

Results and discussion

Test results
Species / strain:
S. typhimurium, other: TA100 and TA98
Metabolic activation:
not specified
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Additional information on results:
No data available
Remarks on result:
other: No mutagenic effect were observed.

Applicant's summary and conclusion

Conclusions:
Benzyl alcohol (100-51-6) was failed to induce an increase in the number of revertants/plate and hence is not likely to be mutagenic in vitro.
Executive summary:

Gene mutation study was performed to evaluate the mutagenic nature of the test compound Benzyl alcohol. Ames Salmonella plate-incorporation assay was performed using Salmonella typhimurium strain TA100 and TA98. The test concentration were 0,100, 250, 500, 1000 µg/plateThe test compound benzyl alcohol failed to induce an increase in the number of revertants/plate and hence is not likely to be mutagenic in vitro.