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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro DNA damage and/or repair study
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1987
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

Reference
Reference Type:
publication
Title:
Prediction of Chemical Carcinogenicity in Rodents from in Vitro Genetic Toxicity Assays
Author:
Tennant R.W., Margolin B. H., Shelby M.D., et al.
Year:
1987
Bibliographic source:
Science 236 (1987) 933-941

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test:
The sister chromatid exchange assay using Chinese hamster ovary cells detects genotoxicity of a chemical and predicts rodent carcinogenicity.
- Short description of test conditions:
Not specified
- Parameters analysed / observed: Not specified
GLP compliance:
no
Type of assay:
sister chromatid exchange assay in mammalian cells

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Test concentrations with justification for top dose:
5.0 ug/ml
Vehicle:
Not specified
Details on test system and conditions:
Study references Galloway et al. 1985 for all details on test system and conditions
Evaluation criteria:
Study references Galloway et al. 1985 and Galloway (no date given)

Results and discussion

Test results
Species / strain:
Chinese hamster Ovary (CHO)
Metabolic activation:
with and without
Genotoxicity:
positive
Remarks:
with and without exogenous metabolic activation
Cytotoxicity:
not specified
Vehicle controls valid:
not specified
Negative controls valid:
not specified
Positive controls valid:
not specified

Applicant's summary and conclusion

Conclusions:
Based on the results of a sister chromatid exchange assay using Chinese hamster ovary cells, 5.0 ug/ml was the lowest positive dose and was positive with and without exogenous metabolic activation present.
Executive summary:

Based on the results of a sister chromatid exchange assay using Chinese hamster ovary cells, 5.0 ug/ml Propyl gallate was the lowest positive dose and was positive with and without exogenous metabolic activation present. Propyl gallate is considered to be genotoxic.