Registration Dossier

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:
supporting study
Study period:
1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: meets generally accepted scientific standards, well documented and acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
The genotoxicity of a variety of aniline derivates in a DNA repair test with primary cultured rat hepatocytes
Author:
Yoshimi N., Sugie S., Iwata H., Niwa K., Mori H., Hashida Ch., Shimizu H.,
Year:
1987
Bibliographic source:
Mutation Research, vol. 206, p. 183-191, 1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Williams G.M., Laspia M.F., Dumkel V.C., Reliability of the hepatocyte primary culture/DNA repair test in testing of coded carcinogens and noncarcinogens, Mutation Research, vol. 97, p. 359-370, 1982.
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

Method

Species / strain
Species / strain:
hepatocytes:
Additional strain characteristics:
not specified
Metabolic activation:
not specified
Test concentrations with justification for top dose:
doses 1, 0.1, 0.01 and 0.001 mmol of the test substance
Vehicle:
- Vehicle(s)/solvent(s) used: DMSO
Controls
Negative controls:
not specified
Solvent controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
2-acetylaminofluorene

Results and discussion

Test results
Species / strain:
hepatocytes:
Metabolic activation:
not specified
Genotoxicity:
negative
Cytotoxicity:
yes
Vehicle controls valid:
yes
Negative controls valid:
not specified
Positive controls valid:
yes
Remarks on result:
other: strain/cell type: rat hepatocytes
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative