1,6-bis((dibenzylthiocarbamoyl)disulfanyl)hexane

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: GLP and OECD Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: 92/69/EWG, B.14 (Ames-Test)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

429-280-6

EC Name:

-

Cas Number:

151900-44-6

Molecular formula:

Hill formula: C36H40N2S6 CAS formula: C36H40N2S6

IUPAC Name:

N,N-dibenzyl({6-[(dibenzylcarbamothioyl)disulfanyl]hexyl}disulfanyl)carbothioamide

Details on test material:

purity: 99.66%

Method

Target gene:

Ames assay

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Metabolic activation system:

S9-Mix mit 10 % S9 Fraktion von Aroclor induzierten männlichen Sprague Dawley Ratten "ENGLISH" S9 mix with 10 % S9 fraction of Aroclor 1254 induced male Sprague Dawley rats.

Test concentrations with justification for top dose:

Concentration range in the main test (with metabolic activation): 50, 158, 500, 1581, 5000 µg/plate
Concentration range in the main test (without metabolic activation): 50, 158, 500, 1581, 5000 µg/plate

Vehicle / solvent:

Solvent: DMSO

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Positive controls:

yes

Positive control substance:

other: Na-azide, NF, 4-NPDA, Cumene, 2-AA

Details on test system and experimental conditions:

Concentration of the test substance resulting in precipitation: 1581 µg/plate and higher

Evaluation criteria:

postive controls: sodium azide, nitrofurantoin, 4-nitro-1,2-phenylene diamine, cumene hydroperoxide, 2-aminoanthracene increased mutant counts to well over those of the negative control, and thus demonstrated the system's sensitivity and the activity of the S9 mix

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

Observations:
Keine

"ENGLISH"

none

Remarks on result:

other: strain/cell type: TA 98, 100, 102, 1535, 1537

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Vulcuren VP KA 9188 was considered to be non-mutagenic with and without metabolic activation in the plate incorporation as well as in the preincubation modification of the Salmonella/microsome test.

Precipitation of the test substance: 1581 µg/plate and higher

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative with and without metabolic activation

Executive summary:

Vulcuren VP KA 9188 was considered to be non-mutagenic with and without metabolic activation in the plate incorporation as well as in the preincubation modification of the Salmonella/microsome test. No bacteriotoxic effects were seen in any of the dose groups evaluated (Bayer 2000a).