p-tolyl acetate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

Data is from peer-reviewed journal

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

Principles of method if other than guideline:

The bacterial reverse mutation assay was performed to evaluate the mutagenic potential of the test material p-Acetoxybenzyl alcohol.

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Reference substance 001

Cas Number:

6309-46-2

Molecular formula:

C9H10O3

Specific details on test material used for the study:

- Name of test material: p-Acetoxybenzyl alcohol
- Molecular formula: C9H10O3
- Molecular weight: 166.175 g/mol
- Substance type: Organic
- Physical state: No data
- Purity: No data
- Impurities (identity and concentrations): No data

Method

Target gene:

Histidine

Species / strain

Species / strain / cell type:

S. typhimurium TA 100

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

not specified

Cytokinesis block (if used):

No data

Metabolic activation:

not specified

Metabolic activation system:

Not specified

Test concentrations with justification for top dose:

50, 100, 250, 500 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: Dry DMSO (molecular
seives, 3A)
- Justification for choice of solvent/vehicle: No data

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:

METHOD OF APPLICATION: in agar (plate incorporation)

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

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

NUMBER OF REPLICATIONS: No data

NUMBER OF CELLS EVALUATED: No data

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

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

OTHER: No data

Rationale for test conditions:

No data

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 5:12 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.

Results and discussion

Test results

Species / strain:

S. typhimurium TA 100

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

Remarks on result:

other: no mutagenic potential

Applicant's summary and conclusion

Conclusions:

p-Acetoxybenzyl alcohol failed to induce mutation in Salmonella typhimurium strain TA100 and hence does not classify as a gene mutant in vitro.

Executive summary:

The bacterial reverse mutation assay was performed to evaluate the mutagenic potential of the test material p-Acetoxybenzyl alcohol. The study was performed on Salmonella typhimurium strain TA100 as per the plate incorporation assay. p -Acetoxybenzyl alcohol failed to induce mutation in Salmonella typhimurium strain TA100 and hence does not classify as a gene mutant in vitro.