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Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
in vivo mammalian cell study: DNA damage and/or repair
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:
Tobacco library
Author:
Tobacco library
Year:
2004

Materials and methods

Test guideline
Qualifier:
no guideline available
Type of assay:
unscheduled DNA synthesis

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
other: no data
Doses / concentrations
Remarks:
Doses / Concentrations:
25.0 to 1000.0 µg/mL
Basis:
no data
Control animals:
not specified

Results and discussion

Test results
Sex:
not specified
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls validity:
not specified
Negative controls validity:
valid
Positive controls validity:
not specified

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
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. This material was therefore considered negative in this assay, suggesting DNA alterations were not produced.