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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
secondary source
Title:
Unnamed
Year:
2000

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
434-600-2
EC Name:
-
Cas Number:
2628-16-2
Molecular formula:
CH3CO2C6H4CH=CH2
IUPAC Name:
4-ethenylphenyl acetate
Test material form:
liquid

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
Liver homogenate derived from Aroclor 1254 induced rats (S-9 mix)
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 50...5000 µg/plate
Concentration range in the main test (without metabolic activation): 50...5000 µg/plate
Vehicle / solvent:
Solvent: Dimethyl sulphoxide

Results and discussion

Test resultsopen allclose all
Key result
Species / strain:
other: as specified above
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(5000µg/plate)
Key result
Species / strain:
other: as specified above
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(5000 µg/plate)
Key result
Species / strain:
other: as specified above
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(5000 µg/plate)
Additional information on results:
Observations:
No increases in revertants were obtained with any of the four bacterial strains at the test substance levels tested, either with or without metabolic activation.

Positive controls produced marked increases in the revertant counts.
Remarks on result:
other:
Remarks:
result from preliminary test

Applicant's summary and conclusion

Conclusions:
negative with metabolic activation
negative without metabolic activation