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Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May 1- June 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Ames test 5 Salmonella strains and triplicate plates
Version / remarks:
oecd short term tox group - no Ecoli strain
Deviations:
no
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Bis[bis(3,5,5-trimethylhexyl)dithiocarbamate-S,S']zinc
EC Number:
283-381-8
EC Name:
Bis[bis(3,5,5-trimethylhexyl)dithiocarbamate-S,S']zinc
Cas Number:
84604-96-6
Molecular formula:
C38H76N2S4Zn
IUPAC Name:
bis({[bis(3,5,5-trimethylhexyl)carbamothioyl]sulfanyl})zinc
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
Purity 98%
BN 2152
stored at room temperature

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
with S-9 mix ( 2 aminoanthracene for strains TA1535, TA1537, TA1538, TA98 and TA100
Test concentrations with justification for top dose:
On each bacterial strain, four concentrations of test substance was assessed. he highest concentration will usually be 0.05g of test substnce dissolved in 1.0ml of solvent. Three 10 fld serial dilutions of the top concentrations will also be tested.
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
yes
Positive controls:
yes
Positive control substance:
9-aminoacridine
sodium azide
other: 2 aminoanthracene

Results and discussion

Test results
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not determined
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
Zinc Diisononyldithiocarbamate was non toxic towards the tester strains. Therefore the 5000 microgramme/plate was chosen as the top dose level in mutation tests.
The mean number of revertant colonies, together with the individual plate counts for Zinc Diisononyldithiocarbamate obtained in the first mutation test with tester strains TA 1535, TA1538, TA98 anmd TA100 are shown in tbale 2 and the sterility and positive controls in table 3.

No substantial increases int he revertant colony numbers of any of the five strains were observed following treatment with Zinc Diisononyldithiocarbamate at any dose level, either in presence or absence of liver microsomal fraction (S9 mix)

Applicant's summary and conclusion

Conclusions:
No evidence of mutagneic potential of test item was obtained in this bacterial test system.