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Diss Factsheets

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:
1996-12-10 until 1997-02-11
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD test under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Silane CP 2
- Physical state: liquid
- Analytical purity: 96.3% (GC)
- Impurities (identity and concentrations): as stated in substance data
- Composition of test material, percentage of components: as stated in substance data
- Lot/batch No.: 10466 QB
- Expiration date of the lot/batch: 1997-12-01
- Stability under test conditions: 2 hours in DMSO (water-free)
- Storage condition of test material: in original container, at room temperature, in the dark

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
S9 Mix
Test concentrations with justification for top dose:
Experiment 1 (plate incorporation test): 33.3; 100, 333.3, 1000, 2500 and 5000 µg/plate
Experiment 2 (pre-incubation test): 10, 33.3, 100, 333.3, 1000, and 5000 µg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: the solvent was chosen becuase of irts solubility properties nad its relative nontoxicity to the bacteria. The test substance is stable in the solvnet for 2 hours.
Controlsopen allclose all
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
yes
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
positive control for TA 1535, TA 100 without S9 Mix
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
yes
Positive controls:
yes
Positive control substance:
other: 4-nitro-o-phenylene-diamine
Remarks:
positive control for TA 1537, TA 98 without S9 Mix
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
yes
Positive controls:
yes
Positive control substance:
other: 2-aminoanthrancene
Remarks:
positive control for all strains with S9 Mix
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation); preincubation

DURATION
- Preincubation period: 60 minutes
- Exposure duration: 48 hours

DETERMINATION OF CYTOTOXICITY
- Method: reduction in the number of revertants, bachground growth
Evaluation criteria:
in accordance with the Guideline

Results and discussion

Test results
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
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 substance is not mutagenic in the Salmonella typhimurium Reverse Mutation Assay.
Executive summary:

The Ames Test did not produce any positive results for Tester Strains TA 1535, TA 1537, TA 98 and TA 100 both with and without metabolic activation. The negative, solvent and positive controls worked as expected.

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