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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
Remarks:
Type of genotoxicity: DNA damage and/or repair
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study has been assessed for the use in a category approach. According to the methodology and to the extent of available details, the study has been judged as reliable with restrictions.

Data source

Reference
Reference Type:
secondary source
Title:
Unnamed
Year:
2004

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 482 (Genetic Toxicology: DNA Damage and Repair, Unscheduled DNA Synthesis in Mammalian Cells In Vitro)
Deviations:
not specified
GLP compliance:
not specified
Type of assay:
DNA damage and repair assay, unscheduled DNA synthesis in mammalian cells in vitro

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
no data.

Method

Species / strain
Species / strain:
hepatocytes: rat primary hepatocytes
Additional strain characteristics:
not specified
Metabolic activation:
not specified
Test concentrations with justification for top dose:
Five treatments ranging from 25.0 to 1000.0 µg/mL
Vehicle:
no data
Controls
Negative controls:
yes
Remarks:
untreated control hepatocytes
Solvent controls:
not specified
True negative controls:
not specified
Positive controls:
not specified
Evaluation criteria:
UDS was assessed measuring the possible increase in autoradiographic nuclear grain counts in the treated cells compared to untreated control hepatocytes.

Results and discussion

Test results
Species / strain:
hepatocytes: rat primary hepatocytes
Metabolic activation:
not specified
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'.
Additional information on results:
L-tartaric acid did not cause a significant increase in UDS as measured by an increase in autoradiographic nuclear grain counts compared to untreated control hepatocytes

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

L-tartaric acid was considered negative in this assay, suggesting DNA alterations were not produced.