2-ethylhexyl 12-ethyl-5,5-dioctyl-9-oxo-10-oxa-4,6-dithia-5-stannahexadecanoate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

other: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Justification for type of information:

Justification for Read Across is given in Section 13 of IUCLID.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

Missing TA102 strain and E.coli strains, Positive controls for strains TA98, TA100, and TA1537 were not included in the test with metabolic activation.

Principles of method if other than guideline:

Study performed in accordance to the publications of Ames.
- Ames, B.N., W.E. Durston, E. Yamasaki, and F.D. Lee. 1973. Carcinogens are mutagens: A simple test system combining liver homogenates for activation and bacteria for detection. Proc. Natl. Acad. Sci. USA. 70:2281-2285.
- Ames, B.N., F.D. Lee, and W.E. Durston. 1973b. An improved bacterial test system for the detection and classification of mutagens and carcinogens. Proc. Natl. Acad. Sci. USA. 70:782-786.
- Ames, B.N., J. McCann, and E. Yamasaki. 1975. Methods for detecting carcinogens and mutagens with the Salmonella/mammalian-microsome mutagenicity test. Mutation Res.31:347-364.

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate

EC Number:

239-622-4

EC Name:

2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate

Cas Number:

15571-58-1

Molecular formula:

C36H72O4S2Sn

IUPAC Name:

2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecan-1-oate

Method

Target gene:

his

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:

TiF:RAIF (SPF) rat liver induced with Aroclor 1254. One ml  of the activation mixture contained 0.3 ml S9 fraction and 0.7 ml of the co-factor solution.

Test concentrations with justification for top dose:

15, 45, 135, 405, and 1215 µg/0.1 ml

Vehicle / solvent:

Acetone

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

acetone

True negative controls:

no

Positive controls:

yes

Positive control substance:

4-nitroquinoline-N-oxide

other: Daunorubicin-HCl (5 and 10 μg/0.1 ml phosphate buffer) for TA98; n-Methyl-n'-nitro-n-nitrosoguanidine (3 and 5 μg/0.1 ml phosphate buffer) for TA1535; 9(S)aminoacridine hydrochloride monohydrate (50 and 100 μg/0.1 ml DMSO) for TA1537.

Remarks:

without metabolic activation

Controls 2

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

acetone

True negative controls:

no

Positive controls:

yes

Positive control substance:

cyclophosphamide

Remarks:

with metabolic activation

Details on test system and experimental conditions:

The test was conducted with triplicate replications. Positive and negative controls were tested concurrently.
The plates were incubated at 37 ± 1.5 °C in the absence of light for 48 hours.
The colonies were counted and the arithmetic mean was calculated.

Evaluation criteria:

The test substance was considered to be non-mutagenic if the colony count in relation to the negative control was not doubled in any concentration.

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

The test substance precipitated in the soft agar at 1215 μg/0.1 ml.
Solvent and positive controls produced the expected mutant colony counts.

Applicant's summary and conclusion

Conclusions:

negative with and without metabolic activation; under the experimental conditions, the substance displayed no mutagenic activity.

Executive summary:

The mutagenic potential of the substance was evaluated in the Ames test. Salmonella typhimurium strain TA98, TA100, TA1535 and TA1537 were exposed to the substance at 15, 45, 135, 405, and 1215 µg/0.1 ml with and without metabolic activation. The plates were incubated at 37 ± 1.5 °C in the absence of light for 48 hours. The colonies were counted and the arithmetic mean was calculated. Concurent negative and positive controls were tested. Positive controls for the strains TA98, TA1537, and TA100 were not included in the test with metabolic activation.

The test substance precipitated in the soft agar at 1215 μg/0.1 ml. Negative and positive controls produced the expected mutant colony counts.

Under the experimental conditions, the substance displayed no mutagenic activity.