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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: Comparable to OECD 471 guideline, however missing the E.coli WP2 strains

Data source

Reference
Reference Type:
publication
Title:
An evaluation of food flavoring ingredients in a genetic toxicity screening battery.
Author:
Heck JD, Vollmuth TA, Cifone MA, Jagannath DR, Myhr B & Curren RD
Year:
1989
Bibliographic source:
The Toxicologist.9(1):257

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
.No E.coli WP2 strain
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No data

Method

Target gene:
Histidine synthesis in the Salmonella typhimurium strains.
Species / strainopen allclose all
Species / strain:
S. typhimurium TA 1538
Details on mammalian cell lines (if applicable):
No data
Additional strain characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254- induced adult male Sprague Dawley rat liver and necessary cofactors as described in Ames et al(1973).
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Details on mammalian cell lines (if applicable):
No Data
Additional strain characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254- induced adult male Sprague Dawley rat liver and necessary cofactors as described in Ames et al(1973).
Test concentrations with justification for top dose:
1000 µg or nl/plate

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not specified
Vehicle controls valid:
not specified
Negative controls valid:
not specified
Positive controls valid:
not specified
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not specified
Vehicle controls valid:
not specified
Negative controls valid:
not specified
Positive controls valid:
not specified
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

The test material has been found to be non-mutagenic under the test conditions reported.