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EC number: 262-872-0 | CAS number: 61617-00-3
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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
- Study period:
- September - October 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Conducted to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1,3-dihydro-4(or 5)-methyl-2H-benzimidazole-2-thione, zinc salt
- EC Number:
- 262-872-0
- EC Name:
- 1,3-dihydro-4(or 5)-methyl-2H-benzimidazole-2-thione, zinc salt
- Cas Number:
- 61617-00-3
- Molecular formula:
- C8H8N2S.1/2Zn
- IUPAC Name:
- Zinc bis[4(or 5)-methyl-2-thioxo-2,3-dihydrobenzimidazol-1-ide]
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Description: off-white powder
Date received: 14 August 2002
Storage conditions: room temperature in the dark
Constituent 1
Method
- Target gene:
- Histidine locus
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbitone/Beta-naphthoflavone induced rat liver S9.
- Test concentrations with justification for top dose:
- Preliminary Toxicity Study:
The concentrations tested were 0, 0.15, 0.5, 1.5, 5, 15, 50, 500, 1500 and 5000 microg/plate.
Mutation Study 1 and 2:
Five concentrations of the test material (50, 150, 500, 1500 and 5000 migrog/plate) were assayed. - Vehicle / solvent:
- Dimethyl sulphoxide was selected as the vehicle of choice because it formed a good partial solution/suspension with the test material at 50mg/ml.
Controlsopen allclose all
- Negative solvent / vehicle controls:
- yes
- Remarks:
- A solvent treatment group was used as vehicle control
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- Migrated to IUCLID6: 3 microg/plate for TA100 and 5 microg/plate for TA1535
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Migrated to IUCLID6: 80 microg/plate for TA1537
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- Migrated to IUCLID6: 0.5 microg/plate for TA102
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- Migrated to IUCLID6: 0.2 microg/plate for TA98
- Positive control substance:
- other: 2-Aminoanthracene 1 microg/plate for TA100 and 2 microg/plate for TA 1535 and TA 1537
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- Used in the S9 series of plates
Migrated to IUCLID6: 5 microg/plate for TA98
- Positive control substance:
- other: 1,8-Dihydroxyanthraquinone 10 microg/plarte for TA102
- Remarks:
- Used in the S9 series of plates
- Details on test system and experimental conditions:
- Preliminary Toxicity Study:
In order to select appropriate dose levels for use in the main study, a preliminary test was carried out to determine the toxicity of the test material. The concentrations tested were 0, 0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1500 and 5000 microg/plate. The test was performed by mixing 0.1ml of bacterial culture (TA100), 2ml of molten, trace histidine supplemented, top agar, 0.1ml of test material fomulation, 0.5ml of S9-mix or phosphate buffer and overlaying onto sterile plates of Volgel-Bonner Minimal agar (30 ml/plate). Ten doses of the test material and a vehicle control (dimethyl suplhoxide) were tested. In addition, 0.1ml of the maximum concentration of the test material and 2ml of molten, trace histidine supplemented, top agar was overlaid onto a sterile Nutrient agar plate in order to assess the sterility of the test material. After approximately 48 hours incubation at 37 deg C the plates were assessed for numbers of revertant colonies using a Domino colony counter and examined for effects on the growth of the bacterial background lawn.
Mutation Study - Experiment 1:
Five concentrations of the test material 50, 150, 500, 1500 and 5000 microg/plate were assayed in triplicate against each tester strain, using the direct plate incorporation method.
Measured aliquots (0.1 ml) of one of the bacterial cultures were dispensed into sets of test tubes followed by 2.0 ml of molten trace histidine supplemented, top agar, 0.1 ml of the test material formulation, vehicle or positive control and either 0.5 ml of S9-mix or phosphate buffer. The contents of each test tube were mixed and equally distributed onto the surface of Vogel-Bonner Minimal agar plates (one tube per plate). This procedure was repeated, in triplicate, for each bacterial strain and for each concentration of test material both with and without S9-mix.
All the plates were incubated at 37 degC for approximately 48 hours and the frequency of revertant colonies assessed using a Domino colony counter.
Mutation Study - Experiment 2:
The second experiment was performed using methodology as described in Experiment 1, using fresh bacterial cultures, test material and control solutions. The test material dose range was the same as Experiment 1. - Evaluation criteria:
- The reverse mutation assay may be considered valid if the following criteria are met:
All tester strain cultures exhibit a characteristic number of spontaneous revertants per plate in the vehicle and untreated controls.
The appropriate characteristics for each tester strain have been confirmed, e.g. rfa cell-wall mutation and pkM101 plasmid R-factor etc.
All tester strain cultures should be in the approximate range of 1 to 9.9E9 bacteria per ml.
Each mean positive control value should be at least two times the respective vehicle control value for each strain, thus demonstrating both the intrinsic sensitivity of the tester strain to mutagenic exposure and the integrity of the S9-mix.
The test material may be considered positive in this test system if the following criteria are met:
The test material should have induced a reproducible, dose-related and statistically significant increase in the revertant count in at least one strain of bacteria.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- The test material caused no visible reduction in the growth of the bacterial background lawn at any dose level, although a decrease in the frequency of revertant colonies was noted at 5000 microg/plate. The test material was, therefore, tested up to the maximum recommended dose level of 5000 microg/plate. No test material precipitate was observed on the plates at any of the doses tested in either the presence of absence of S9-mix.
No significant increases in the frequency of revertant colonies were recorded for any of the strains of Salmonella, at any dose level either with or without metabolic activation. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
ZMB2 is considered to be non-mutagenic under the conditions of this test.
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