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EC number: 225-625-8 | CAS number: 4979-32-2
- 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 somatic cell study: cytogenicity / bone marrow chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- unsuitable test system
- Remarks:
- Only 50 cells analysed for each animal, limit test with 1000 mg/kg bw
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- Deviations:
- yes
- Remarks:
- number of cells analysed per dose group (50)
- GLP compliance:
- yes
- Type of assay:
- chromosome aberration assay
Test material
- Reference substance name:
- N,N-dicyclohexylbenzothiazole-2-sulphenamide
- EC Number:
- 225-625-8
- EC Name:
- N,N-dicyclohexylbenzothiazole-2-sulphenamide
- Cas Number:
- 4979-32-2
- Molecular formula:
- C19H26N2S2
- IUPAC Name:
- N-(1,3-benzothiazol-2-ylsulfanyl)-N-cyclohexylcyclohexanamine
- Test material form:
- solid: particulate/powder
- Remarks:
- white
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Duration of treatment / exposure:
- single administration
- Frequency of treatment:
- once
- Post exposure period:
- 6 h, 24 h, 48 h
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1000 mg/kg bw
Basis:
- No. of animals per sex per dose:
- 15/sex and dose DCBS treatment group and vehicle control (5 males and 5 females each at 6 h, 24 h and 48 h),
positive control: 5 males and 5 females - Control animals:
- yes, concurrent vehicle
Examinations
- Tissues and cell types examined:
- bone marrow cells
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Clinical observations:
Clinical signs were observed for all 1000 mg/kg treated animals at 24 and 48 hours after application. The clinical signs observed were depression, red stains on nose/eyes, soft faeces, slight depression, urine stains, and rough coat. No animal died during the study
Body weight: A significant changes in body weight was seen for the 48 hours (1000 mg/kg bw) treatment group.
Mitotic index: No statistically significant differences between the mean mitotic indices of the test groups and the vehicle control were seen.
Chromosome aberrations: positive control group (cyclophosphamide)signifcant increase in aberrant cells
1000 mg/kg treatment (6 h and 24 h groups): no statistically significant increase in the frequency of chromosome aberrations compared to control values
1000 mg/kg treatment (48 h): No statistically significant increase in aberrant cells was noted for the 48 hour treatment group (1 % aberrant cells) compared to historical control data (0.27% aberrant cells), whereas comparison to the current negative control (0% aberrant cells) revealed a statistically relevant difference using the non-parametric analysis. Further statistical analysis was performed on the 48-hours results and comparisons were made with historical control data and data from the current solvent control. The author concluded that the statistical significant increase in aberrations seen at 48 hours is based upon comparison with control value of zero. Based on these findings, the authors concluded that the test substance DCBS is not clastogenic.
Average chromosome number(normal diploid chromosome number rat: 42 chromosome: No statistically significant differences between the mean chromosome numbers of the test group and the vehicle control were noted
Santocure DCBS did not produce chromosome damage as measured by significant increases in chromosome aberrations or chromosome number as compared to concurrent controls in the rat bone marrow assay.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
- Executive summary:
The genotoxic potential of DCBS was evaluated in an in vivo bone marrow chromosome aberration assay. Male and female Sprague-Dawley CD® rats were administered with 1000 mg/kg bw test substance once via gavage. Groups of 5 males and 5 females (treatment group and vehicle control each) were sacrificed at 6, 24 and 48 hours following test substance administration. The body weight and clinical observations were recorded during the study. The bone marrow cells were prepared and at least 50 mitotic cells per animal were analysed for cytogenetic aberrations. Clinical signs were observed for all 1000 mg/kg treated animals at 24 and 48 hours after application. The clinical signs observed were depression, red stains on nose/eyes, soft faeces, slight depression, urine stains, and rough coat. No animal died during the study. A significant changes in body weight was seen for the 48 hours (1000 mg/kg bw) treatment group. No statistically significant differences between the mean mitotic indices of the test groups and the vehicle control were seen. A statistically significant increase in percent aberrant cells and the mean number of aberrations per cell was seen in the positive control group (cyclophosphamide). Results from the 6- and 24 hours sacrifice data show that no statistically significant increase in the frequency of chromosome aberrations compared to control values was seen in the groups treated with DCBS. No statistically significant increase in aberrant cells was noted for the 48 hour treatment group (1 % aberrant cells) compared to historical control data (0.27% aberrant cells), whereas comparison to the current negative control (0% aberrant cells) revealed a statistically relevant difference using the non-parametric analysis. Further statistical analysis was performed on the 48-hours results and comparisons were made with historical control data and data from the current solvent control. The author concluded that the statistical significant increase in aberrations seen at 48 hours is based upon comparison with control value of zero. Based on these findings, the authors concluded that the test substance DCBS is not clastogenic. Moreover, the average number of chromosomes in the examined metaphases was determined for each animal and all treatment groups were statistically compared to the control group. Rats have a normal diploid chromosome number of 42. No statistically significant differences between the mean chromosome numbers of the test group and the vehicle control were noted (Monsanto Co 1985).
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