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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: other: procedure described in paper by Ames
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Summary study report
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
review article or handbook
Title:
I U C L I D D a t a s e t Substance ID: 68334–30–5
Author:
EUROPEAN COMMISSI – European Chemicals Bureau
Year:
2000
Bibliographic source:
I U C L I D D a t a s e t Substance ID: 68334–30–5 pag 671-672

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 98
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with
Test concentrations with justification for top dose:
1 to 60 ul/ml of DMSO extract
Controls
Remarks:
No data

Results and discussion

Test results
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with
Genotoxicity:
not specified
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified

Any other information on results incl. tables

A weak mutagenic response was found, but did not vary in a dose–dependent manner. The mutagenicity index was 1.0. The authors advise that a mutagenicity index above 1.0 should be regarded as a positive response, the mutagenicity index being the slope of the dose–response curve at zero concentration.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
ambiguous