Polysulfides, di-tert-dodecyl

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

not precised in the report

Deviations:

no

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Polysulfides, di-tert-dodecyl

EC Number:

270-335-7

EC Name:

Polysulfides, di-tert-dodecyl

Cas Number:

68425-15-0

Molecular formula:

not applicable

IUPAC Name:

di (alkyl C11-C13 Branched, C12 Rich), polysulfure S3-S5 rich

Method

Target gene:

Histidine operon

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA 98, TA 100, TA 1535, TA 1537, TA 1538

Metabolic activation:

with and without

Metabolic activation system:

S9 fraction from liver homogenates of rats induced with 500 mg/kg bw Aroclor 1254

Test concentrations with justification for top dose:

0, 5, 150, 500, 150, 5000 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: solubility

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: Without S9: 2-nitrofluorene (TA98 & TA1538), ENNG (TA100 & TA1535), 9-aminoacridine (TA1537). With S9: 2-aminoanthracene (all strains)

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

NUMBER OF REPLICATIONS: 2 (3 plates per concentration)

DETERMINATION OF CYTOTOXICITY
A preliminary toxicity test was performed to define the concentrations to be used for the mutagenicity study.

Evaluation criteria:

- negative and positive controls within the range of historical controls.
- positive: reproducible and significant dose related increase in revertants and/or reproducible doubling in the number of revertants compared with negative controls for one dose.

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

True negative controls validity:

not applicable

Positive controls validity:

valid

Test results 2

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

True negative controls validity:

not applicable

Positive controls validity:

valid

Test results 3

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

True negative controls validity:

not applicable

Positive controls validity:

valid

Test results 4

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

True negative controls validity:

not applicable

Positive controls validity:

valid

Test results 5

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

True negative controls validity:

not applicable

Positive controls validity:

valid

Additional information on results:

TPS-32 was not toxic towards the tester strains. Therefore 5000 µg/plate was chosen as the top dose level in the mutation tests. No substantial increases in revertant colony numbers of any of the five tester strains were observed following treatment with TPS-32 at any dose level, either in the presence or absence of metabolic activation (S-9 mix).

Applicant's summary and conclusion

Conclusions:

Not mutagenic

Executive summary:

In a study similar to OECD TG 471, a Salmonella typhimurium reverse mutation assay was performed with di-t-dodecyl polysulfides. S. typhimurium strains, TA98, TA100, TA1535, TA1537, and TA1538 were exposed to five concentrations of di-t-dodecyl polysulfides in the presence and absence of a metabolic activation system using plate incorporation at doses of 5 to 5,000 mg/plate. Exposure to five graded doses of di-t-dodecyl polysulfides in the presence and absence of metabolic activation, did not increase the reversion rates in any of the tester strains.