Tin tetrachloride

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

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:

guideline study

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

Test material information

Constituent 1

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 / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 102

Additional strain / cell type characteristics:

not applicable

Species / strain 2

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 results

Test results 1

Species / strain:

S. typhimurium TA 1535

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

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 1537

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

Positive controls validity:

valid

Test results 3

Species / strain:

S. typhimurium TA 98

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

Positive controls validity:

valid

Test results 4

Species / strain:

S. typhimurium 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

Test results 5

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

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.