N,N'-dimethyldiphenylthiuram disulphide

Genetic toxicity: in vitro

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study and GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

N,N'-dimethyldiphenylthiuram disulphide

EC Number:

234-196-6

EC Name:

N,N'-dimethyldiphenylthiuram disulphide

Cas Number:

10591-84-1

Molecular formula:

C16H16N2S4

IUPAC Name:

N-methyl-N-phenyl{[methyl(phenyl)carbamothioyl]disulfanyl}carbothioamide

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

content:: 98.1 %

Method

Target gene:

Salmonella typhimurium LT2 mutants

Species / strain

Species / strain / cell type:

S. typhimurium, other: Salmonella typhimurium TA98, TA100, TA102, TA1535, TA1537

Additional strain / cell type characteristics:

other: Salmonella typhimurium TA98, TA100, TA102, TA1535, TA1537

Metabolic activation:

with and without

Metabolic activation system:

S9-mix from livers of adult male Sprague-Dawley rats inducted by Aroclor 12534

Test concentrations with justification for top dose:

50, 158, 1581, 5000 µg/plate

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: sodium azide, nitrofurantoin, 4-nitro-1,2-phenylene diamine, cumene hydroperoxide, 2-aminoanthracene,

Details on test system and experimental conditions:

according to OECD TG 471: plate incorporation methodology and preincubation mthod

Evaluation criteria:

A reproducible and dose-related increase in mutant counts of at least one strain is considered to be a positive result

Results and discussion

Test results

Species / strain:

other: Salmonella typhimurium TA98, TA100, TA102, TA1535, TA1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: at 500 µg per plate the substance started to precipitate

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

Executive summary:

Vulkacit I was investigated for point mutation using the Ames test according to OECD TG 471(pate incorporation and preincubation method) and the strains Salmonella typhimurium TA98, TA100, TA102, TA1535, TA1537. Doses up to 5000 µg/plate in the presence and absence of a metabolicactivation system (S9 -mix) were applied. Substance precipitation occurred at the dose of 500 µg/plate and above. Evidence of mutagenic activity of Vulkacit I was not seen . No biololgical ly relevant increase in the mutant count in comparison with the negatife controls was observed. Therefore , Vulkacit I was considered to be non-mutagenic withour and with S9 -mix (Herbold 2001)