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:
25.11.-18.12.1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
S. typhimurium TA 1538
Species / strain / cell type:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254(R) induced rat liver S9-mix
Test concentrations with justification for top dose:
Experiment I: 0, 4 to 10 000 µg/plate (6 doses)
Experiment II: 0, 0.16, 0.8, 4, 20, 50, 100, 250 µg/plate (6 doses)
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Remarks:
without metabolic activation; no further specifications were given
Details on test system and experimental conditions:
Two independent experiments were performed

Evaluation criteria:
negative result: no significant and no dose dependant increase in the number of revertant colonies
Statistics:
Arithmetic means of the counted colonies were calculated.

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
at 50 or 100 µg/plate
Vehicle controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
at 50 or 100 µg/plate
Vehicle controls validity:
valid
Positive controls validity:
valid
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
at 50 or 100 µg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
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

The test item did not exert mutagenic activity in the Salmonella typhimurium and Escherichia coli reverse mutation assay with and without metabolic activation.
Executive summary:

Mutagenic activity of the test item was investigated in Salmonella typhymurium strains TA1535, TA1537, TA98, TA100 and TA1538 as well as Escherichia coli WP2 uvrA with and without metabolic activation (induced rat liver S9-mix) at concentrations of 0 to 10 000 µg/plate in the first experiment and up to 2500 µg/plate in the second experiment.

Under the conditions tested the test compound did not cause a significant increase in the number of revertant colonies in any strain and no dose dependent effect was observed with or without metabolic activation.

The test substance proved to be toxic at doses at 50 or 100 µg/plate.

Therefore the test item is not considered mutagenic under the conditions of test in this bacterial reverse mutation assay.