Registration Dossier
Registration Dossier
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EC number: 205-232-8 | CAS number: 136-23-2
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
- Remarks:
- Guideline study, published in peer-reviewed literature, no restrictions, fully adequate for assessment.
Data source
Reference
- Reference Type:
- publication
- Title:
- Risk Assessments of Dithiocarbamate Accelerator Residues in Latex-based Medical Devices: Genotoxicity Considerations.
- Author:
- Tinkler J, Gott D and Bootman J
- Year:
- 1 998
- Bibliographic source:
- Food and Chemical Toxicology 36, 849-866
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- UKEMS Basic Mutagenicity Test Guidelines, 1990
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Zinc bis(dibutyldithiocarbamate)
- EC Number:
- 205-232-8
- EC Name:
- Zinc bis(dibutyldithiocarbamate)
- Cas Number:
- 136-23-2
- Molecular formula:
- C18H36N2S4Zn
- IUPAC Name:
- zinc bis(dibutyldithiocarbamate)
- Details on test material:
- - Name of test material (as cited in study report): zinc dibuthildithiocarbamate, ZDBC
- Physical state: fine white, aggregative powder
- Analytical purity: min. 98%
- Impurities (identity and concentrations): 28 ppm ZDMC, 17 pm ZDEC
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 1535, TA 1537, TA1538, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 homogenate from Aroclor 1254-induced adult male Sprague-Dawley rat livers
- Test concentrations with justification for top dose:
- 25, 79, 250, 790 and 2500 µg/plate; in additional experiment with TA100 2.5-250 µg/plate.
Controlsopen allclose all
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- Migrated to IUCLID6: 2 µg/plate, without S9
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- Migrated to IUCLID6: 5 µg/plate, with and without S9
- Details on test system and experimental conditions:
- The test design included a preliminary toxicity test and a mutation assay using the standard pour plate procedure, followed by an independent repeat experiment. An additional assay in TA 100 was performed at lower concentrations (2.5-250 µg/plate) in view of the toxicity seen in the first mutation experiment with this strain.
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium, other: TA98, TA100, TA1535, TA1537, TA1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 2500 µg/plate; at TA100 also at 250 and 790 µg/plate
- Additional information on results:
- Inhibition growth was seen in all strains at the highest dose tested (also at 250 and 790 µg/plate in TA100). There was no increase in the number of revertants observed in any strain, in either presence or absence of S9-mix.
Any other information on results incl. tables
Mean numbers of revertants observed in Salmonella typhimurium TA 100 cultures following exposure to ZDBC at various concentrations.
|
|
|
Mean revertants (+/- SD) |
|
Test substance |
Concentration (µg/plate) |
Activation system |
Experiment 1 |
Experiment 2 |
ZDBC |
2.5 |
- |
NT |
117 +/-5 |
7.9 |
- |
NT |
106 +/- 14 |
|
25 |
- |
149 +/- 12 |
100 +/- 5 |
|
79 |
- |
109 +/-7 |
97 +/- 8 |
|
250 |
- |
140 +/- 4* |
110 +/- 22* |
|
790 |
- |
90 +/- 57* |
64 +/- 4 |
|
2500 |
- |
21 +/- 22** |
18 +/-3* |
|
2.5 |
+ |
NT |
95 +/- 8 |
|
7.9 |
+ |
NT |
112 +/-6 |
|
25 |
+ |
147 +/-31 |
112 +/- 16 |
|
79 |
+ |
118 +/- 79 |
121 +/- 13 |
|
250 |
+ |
43 +/- 40* |
94 +/- 11* |
|
790 |
+ |
32 +/- 9* |
49 +/- 28* |
|
2500 |
+ |
30 +/- 8* |
16 +_/- 6* |
|
DMSO |
|
- |
135 +/- 9 |
127 +/- 7 |
DMSO |
|
+ |
120 +/-6 |
127 +/- 8 |
Sodium azide |
2 |
- |
683 +/-95 |
963 +/- 74 |
Benzo[α]pyrene |
5 |
- |
132 +/- 25 |
115 +/-10 |
Benzo[α]pyrene |
5 |
+ |
606 +/- 109 |
766 +/- 60 |
NT = not tested; *= toxic effect on tester strain was evident.
Applicant's summary and conclusion
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