Registration Dossier

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
Study period:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable well-documented study report which meets basic scientific principles. Quadruplicate plating was applied but negative results were not confirmed by a follow up experiment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: company guideline referencing to Ames (1973) and Green (1976), and similar to OECD 471
Deviations:
no
Principles of method if other than guideline:
Acceptable well-documented study report which meets basic scientific principles with reference to Ames and coworkers .
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strainopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
rat liver S9-mix
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Metabolic activation system:
rat liver S9-mix
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
rat liver S9-mix
Test concentrations with justification for top dose:
4 - 10000 µg/plate
Vehicle:
DMSO
Controls
Negative controls:
no
Solvent controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
9-aminoacridine
other: 2-Aminoanthracene, Methylhydrazone Derivative, Streptocctocine, ENNG
Details on test system and conditions:
plate incorporation
Evaluation criteria:
not specified
Statistics:
none

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity:
other: yes, except TA 1537
Vehicle controls valid:
yes
Negative controls valid:
not examined
Positive controls valid:
yes
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity:
yes
Vehicle controls valid:
yes
Negative controls valid:
not examined
Positive controls valid:
yes
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity:
yes
Vehicle controls valid:
yes
Negative controls valid:
not examined
Positive controls valid:
yes
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 without metabolic activation
negative with metabolic activation

The test substance was not mutagenic in the presence and absence of a metabolizing system in this Bacterial Reverse Mutation Test
Executive summary:

The test substance was tested for mutagenicity with the tester strains TA 100, TA1535, TA 1537, TA 98, TA 1538 of Salmonella typhimurium and WP2 uvrA of Echerichia coli.

The mutagenicity studies were conducted in the absence and in the presence of a metabolizing system derived from induced rat liver homogenate (S-9 Mix). A dose range of 7 different doses from 4 to 10000 µg/plate was tested.

Toxicity: The tested compound showed toxicity to the bacterial strains except of TA 1537.

Mutagenicity: In the absence and in the presence of the metabolic activation system the test compound did not show a dose dependent increase in the number of revertants in any of the bacterial strains.

It can be stated that the tested sample is not mutagenic in these bacterial test systems without and with exogenous metabolic activation at the dose levels investigated.