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:
2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant study conducted according to OECD Guidelines, with no or minor deviations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes (incl. certificate)
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: colorless to yelow liquid
Details on test material:
Batch No. 9000525487
Purity 99,1%
Expiration date February 08, 2004

Method

Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Test concentrations with justification for top dose:
Experiment I: 3, 10, 33, 100, 333, 1000, 2500 and 5000 micrograms/plate
Experiment II: 1, 3, 10, 33, 100, 333 and 1000 micrograms/plate
Controlsopen allclose all
Untreated negative controls:
yes
Remarks:
Concurrent untreated and solvent controls were performed
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
other: sodium azide, NaN3
Remarks:
TA1535 and TA100 without metabolic activation
Untreated negative controls:
yes
Remarks:
Concurrent untreated and solvent controls were performed
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
other: 4-nitro-o-phenylene-diamide
Remarks:
TA1537 and TA98 without metabolic activation
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
methylmethanesulfonate
Remarks:
TA102 without metabolic activation
Untreated negative controls:
yes
Remarks:
Concurrent untreated and solvent controls were performed
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene
Remarks:
TA 1535, TA 1537, TA 98, TA 100 and TA 102 with metabolic activation

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
Relevant toxic effects, evident asa reduction in the number of revertants, occurred in the test groups with and without metabolic activation at higher concentrations.
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

In conclusion it can be stated, that during the described mutagenicity test under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.
Therefore the Decenal-4-trans is considered to be non-mutagenic in this Salmonella Typhimurium reverse mutation assay.