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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:
other: Non-GLP, near guideline methodology, published in peer reviewed literature, adequate for assessment

Data source

Reference
Reference Type:
publication
Title:
Detection of carcinogens as mutagens in the Salmonella/microsome test: Assay of 300 chemicals
Author:
McCann J, Choi E, Yamaski E & Ames BN
Year:
1975
Bibliographic source:
Proc. Nat. Acad. Sci USA, Vol 72, No. 12, pp5135-5139

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): vinyl acetate
- Source: Aldrich
- Purity: highest available

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
Aroclor induced rat liver S9 mix
Test concentrations with justification for top dose:
No data
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
not specified
Positive control substance:
not specified
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation);
- Homogenates of rat (or human) liver (S9 mix) were added directly to petri plates to evaluate the need for metabolic activation.

Method described in detail in Ames B N , McCann J & Yamasaki E (1975). Mutation Research.



Evaluation criteria:
Number of revertants per plate (histidine revertants on a petri plate/number of micrograms tested).

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
not applicable
Untreated negative controls validity:
not applicable
Positive controls validity:
not applicable
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation

Vinyl acetate was negative in bacterial gene mutation assays using Salmonella typhimurium TA98, TA100, TA1535 and TA1537, with and without rat liver S-9 activation.
Executive summary:

Approximately 300 carcinogens and non-carcinogens of a variety of chemical types were tested for mutagenicity in the Salmonella/microsome test. Bacteria were used as sensitive indicators for DNA damage and mammalian liver extracts for metabolic conversion of carcinogens to their active metabolic forms. Vinyl acetate was shown to be negative in bacterial gene mutation assays using Salmonella typhimurium TA98, TA100, TA1535 and TA1537, with and without rat liver S-9 activation.