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EC number: 205-238-0 | CAS number: 136-30-1
- 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian cell study: DNA damage and/or repair
- Remarks:
- Type of genotoxicity: DNA damage and/or repair
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 486 (Unscheduled DNA Synthesis (UDS) Test with Mammalian Liver Cells in vivo)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- unscheduled DNA synthesis
Test material
- Reference substance name:
- Sodium dimethyldithiocarbamate
- EC Number:
- 204-876-7
- EC Name:
- Sodium dimethyldithiocarbamate
- Cas Number:
- 128-04-1
- Molecular formula:
- C3H7NS2.Na
- IUPAC Name:
- sodium dimethyldithiocarbamate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Ltd, Margate, Kent, UK
- Age at study initiation: 6-7 weeks
- Weight at study initiation: 161-198 g
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- purified water
- Duration of treatment / exposure:
- one application of 10 mL/kg bw
- Frequency of treatment:
- n.a.
- Post exposure period:
- 2-4 h, 12-14 h
Doses / concentrations
- Remarks:
- Doses / Concentrations:
400, 1000 mg/kg bw
Basis:
other: concentration in vehicle: 40, 100 mg /mL
- No. of animals per sex per dose:
- 4
- Control animals:
- yes
- Positive control(s):
- 2-4 h preparation interval: 2-Acetylaminofluorene (2-AAF), 75 mg/kg bw, in corn oil,
12-14 h preparation interval: Dimethylnitrosamine (DMN), 10 mg/kg bw, in water
Examinations
- Tissues and cell types examined:
- - Tissue: Liver
- Type of cells: Hepatocytes - Details of tissue and slide preparation:
- - Number of animals: 4 per dose (hepatocytes were prepared from 3)
- Number of cells: 4.5×105 cells per slide - Evaluation criteria:
- - Parameters: 3H-incorporation (silver grain formation)
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- One animal (2-4h, 400 mg/kg SDDC) had a cell viability of 44%. Because of slide analysis that was considered to have no effect on the test system.
Any other information on results incl. tables
Table 7.6.2-B1: Net nuclear grain values and percentage of cells in repair
NNG = net nuclear grains
|
Applicant's summary and conclusion
- Conclusions:
- It was concluded that SDMC does not induce UDS detectable to the liver of rats under the experimental conditions employed in the present test.
- Executive summary:
In the present in vivo genotoxicity study, SDMC (41.4% w/w aqueous solution) was tested for its ability to induce unscheduled DNA synthesis (UDS) in the livers of orally dosed male rats. The test was performed according to OECD 476 and under GLP. To determine if there were any substantial inter-sex differences in toxicity both male and female animals were tested in an initial toxicity range-finder experiment. Groups of four male rats (Han Wistar (Crl:WI (GlxIBRL/Han) BR) were treated once with the vehicle (purified water), SDDC (at 400 mg/kg or 1000 mg/kg) or the required positive control, by oral gavage, at a dose volume of 10 mL/kg. The positive controls used were 75 mg/kg 2-acetamidofluorene (2-AAF) suspended in com oil (Experiment 2) and 10 mg/kg dimethylnitrosamine (DMN) dissolved in purified water (Experiment 1). No clinical signs of toxicity were observed in Experiment 1 (2-4 hours) or Experiment 2 (12-14 hours). Approximately 2-4 hours (Experiment 1) or 12-14 hours (Experiment 2) after dosing, animals were sacrificed and their livers perfused with collagenase to provide a primary culture of hepatocytes. Cultures were made from three animals in each dose group and were treated with [3H] thymidine. Six slides from each animal were prepared with fixed hepatocytes and of these, three were dipped in photographic emulsion to prepare autoradiograms. Slides were examined microscopically after development of the emulsion and staining, and the net grain count (NNG), the number of grains present in the nucleus minus the mean number of grains in three equivalent areas of cytoplasm, was determined for each of two of the three slides, each animal and dose group. Negative (vehicle) control animals gave a group mean NNG value of less than zero with only 1% cells in repair. Group mean NNG values were increased by 2-AAF and DMN treatment to more than 10.9 and more than 50% cells found to be in repair. In this study the vehicle control NNG value was consistent with both published and historical control data, and the system was shown to be sensitive to two known DNA damaging agents requiring metabolism for their action. The assay was therefore accepted as valid. Treatment with 400 or 1000 mg/kg SDMC did not produce a group mean NNG value greater than -0.6 nor were any more than 4% cells found in repair at either dose. It was concluded that SDMC did not induce UDS detectable under the experimental conditions employed.
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