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Toxicological information

Genetic toxicity: in vitro

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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:
2009-06-02 to 2009-08-03
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Followed OECD Protocol under GLP

Data source

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

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

Constituent 1
Chemical structure
Reference substance name:
Tin tetrachloride
EC Number:
231-588-9
EC Name:
Tin tetrachloride
Cas Number:
7646-78-8
Molecular formula:
Cl4Sn
IUPAC Name:
tin tetrachloride
Details on test material:
- Name of test material (as cited in study report): Tin tetrachloride
- Purity test date: 09-05-28
- Lot/batch No.: M028523759
- Storage condition of test material: 5+/-3°C, protected from light

Method

Target gene:
histidin gene
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 102
Additional strain / cell type characteristics:
not applicable
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 from Phenobarbital and Naphtoflavone induced rats
Test concentrations with justification for top dose:
31.6; 100; 316; 1000; 2500; 5000 µg/plate
Vehicle / solvent:
water
Controls
Untreated negative controls:
no
Remarks:
historical
Negative solvent / vehicle controls:
yes
True negative controls:
other: historical
Positive controls:
yes
Positive control substance:
other: Wiithout metabolic activation: TA100 and TA1535 Sodium Azide,TA 98and 1537 4-nitro-o-phenylene-diamine, TA102 2-aminoanthracene; With metabolic activation: all strains 2-aminoanthracene
Details on test system and experimental conditions:
METHOD OF APPLICATION: 2 Experiments: one directly in agar (plate incorporation) and one with preincubation

DURATION
- Preincubation period: 60 min
- Exposure duration: 48h


NUMBER OF REPLICATIONS: 3 plates per concentration, strain and experiment

DETERMINATION OF CYTOTOXICITY
- Method: background lawn, reduction in revertants
Evaluation criteria:
A test item is considered as mutagenic if:
-a clear and dose related increase in the nuber of revertants occurs and/or
-a biologically relevant positive response for at least one of the dose groups occurs
in at least one tester strain with and without metabolic activation.
A biologically relevant increase is described as follows:
- if in tester strains TA 100 and TA 102 the number of reversions is at least twice as high
-if in tester strains TA 98, TA 1535 and TA 1537 the number of reversions is at least three times higher
than the reversion rate of the solvent control.
Statistics:
-

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 102
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
At 5000 µg/plate with Metabolic activation. Accompanies with precipitation.
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
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 5000 µg/plate with Metabolic activation. Accompanies with precipitation.
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Remarks on result:
other: other: preincubation and plate incoporation
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Tin tetrachloride was not mutagenic in the Ames Test under the reported conditions. It did not induce base pair changes or frameshifts in the genome of the tester strains used.
Executive summary:

Tin tetrachloride was investigated according to OECD 471 for its potential to induce gene mutations in the plate incoproration test and the precincubation test with the tester strains TA 98, TA 100, TA 102, TA 1535 and TA1537 with and without metabolic activation by S9 mix. The substance did not show any mutagenic activity in either of the experiments. The positive and vehicle controls worked as expected. The highest tested dose (5000 µg/plate) showed toxicity and precipitation in all experiments with metabolic activation. Therefore Tin tetrachloride is considerd to be non mutagenic under the reported conditions.

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