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:
2009-06-30 to 2009-07-10
Reliability:
1 (reliable without restriction)
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Deviations:
no
Principles of method if other than guideline:
not applicable
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction products of 3-(trimethoxysilyl)propane-1-thiol and 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane (1:1).
EC Number:
700-534-0
Cas Number:
117172-56-2
Molecular formula:
Not applicable: UVCB substance, see section 1.2 and 1.4. The UVCB substance consits of differnt products consiting of differnt isomers: Product I and Product II cannot analytically be distinguished and moreover, Product I-III are expected to consist of isomers that can neither analytically be identified nor quantified.
IUPAC Name:
Reaction products of 3-(trimethoxysilyl)propane-1-thiol and 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane (1:1).
Constituent 2
Reference substance name:
Reaction products of 3- (trimethoxysilyl)propane-1-thiol and 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane (1:1)
IUPAC Name:
Reaction products of 3- (trimethoxysilyl)propane-1-thiol and 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane (1:1)
Details on test material:
- Name of test material: Intermediate 36
- Colour: light yellow
- Physical state: liquid
- Analytical purity: >99%

Method

Target gene:
The Salmonella typhimurium histidine (his) reversion system measures his- => his+ reversions. The Salmonella typhimurium strains are constructed to differentiate between base pair (TA 1535, TA 100) and frameshift (TA 1537, TA 98) mutations. The Escherichia coli WP2 uvrA (trp) reversion system measures trp– => trp+ reversions. The Escherichia coli WP2 uvrA detect mutagens that cause other base-pair substitutions (AT to GC).
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
E. coli WP2 uvr A
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
2-Aminoanthracene, 2AA
Test concentrations with justification for top dose:
The test concentrations were 5000; 2500; 1000; 316.2, 100, 31.62 and 10 µg/plate.
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
yes
Positive controls:
yes
Positive control substance:
other: different positive controls (see section "Any other information on materials and methods incl. tables" below)

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
Vehicle controls validity:
valid
Untreated negative 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
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

no remarks

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

The reported data of this mutagenicity assay show, that under the experi-mental conditions reported, the test item did not induce gene mutations by frameshift or base-pair substitution in the genome of the strains used. Therefore, Intermediate 36 is considered non-mutagenic in this bacterial reverse mutation assay.
Executive summary:

The reported data of this mutagenicity assay according to OECD Guideline 471 (Bacterial Reverse Mutation Assay) shows, that under the experimental conditions reported, the test item did not induce gene mutations by frameshift or base-pair substitution in the genome of the strains used. Therefore, Intermediate 36 is considered non-mutagenic in this bacterial reverse mutation assay.