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EC number: 404-310-0 | CAS number: 10591-85-2 PERKACIT TBZTD; PERKACIT TBZTD PDR; PERKACIT TBZTD PDR-D; TBZD
- 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 vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- Adopted on 26 May 1983
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Tetrakis(phenylmethyl)thioperoxydi(carbothioamide)
- EC Number:
- 404-310-0
- EC Name:
- Tetrakis(phenylmethyl)thioperoxydi(carbothioamide)
- Cas Number:
- 10591-85-2
- Molecular formula:
- C30-H28-N2-S4
- IUPAC Name:
- N,N-dibenzyl[(dibenzylcarbamothioyl)disulfanyl]carbothioamide
- Test material form:
- solid: particulate/powder
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- mammalian cell line, other: Human lymphocytes
- Cytokinesis block (if used):
- Fixation time: 24 hours including a 2 hr treatment with colcemid
- Metabolic activation:
- with and without
- Metabolic activation system:
- Arochlor-induced rat liver
- Test concentrations with justification for top dose:
- prelim study : with and without metabolic activation: 4 to 100 µg/mL
main study : 3.7 to 100 µg/ml - Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- mitomycin C
- Details on test system and experimental conditions:
- Exposure period (with metabolic activation) 2 hours ; Exposure period (without metabolic activation) 24 hours
Duplicates were used rather than an independent repeat (the study was independently repeated later).
Chromosome aberrations were counted on four slides of each culture.
Fixation time:
24 hours including a 2 hr treatment with colcemid
200 metaphases were scored per concentration - Rationale for test conditions:
- In accordance with the OECD Testing Guideline 473 adopted on 26 May 1983.
- Evaluation criteria:
- The major criterion to designate the results of a chromosome aberration test as positive is a dose-related, statistically significant increase in the number of cells with structural chromosome aberrations. However, a clear dose-response relationship can be absent because the yield of chromosome aberrations can vary markedly with post-treatment sampling time of an asynchronous population and because increasing doses of clastogens can induce increasing degrees of mitotic delay. A test substance producing neither a dose-related, statistically significant increase in the number of cells with structural chromosome aberrations, nor a statistically significant and reproducible positive response at any of the doses is considered non-clastogenic in this system.
- Statistics:
- Different types of aberrations (chromatid-type and chromosome-type) have been listed with their numbers and frequencies for all test and control cultures. As gaps are usually considered as unreliable end points for induced chromosome damage, this type of aberration was recorded separately and was not included in the final assessment of clastogenic activity. Data were analysed, when appropriate, by Fisher's exact probability test using the number of cells with aberrations to determine significant differences between test and control cultures.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: human lymphocytes
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (>= 100 µg/mL)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- other: human lymphocytes
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (>= 33.3 µg/mL)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- The highest dose level was determined to by the limit of solubility of the test substances in the solvent DMSO.
The positive control substances, mitomycin C (in the absence of the S-9 mix) and cyclophosphamid (in the prensense of the S-9 mix) showed the expected statistically significant increase in structural chromosomal abberations.
Applicant's summary and conclusion
- Conclusions:
- The test substance did not induce a significant increase in the number of cells with structural chromosome aberrations at any of the concentrations used, either in the absence or in the presence of the S-9 mix.
- Executive summary:
Tetrabenzylthiuram disulfide (TBzTD) was examined for its potential to induce chromosome aberrations in human lymphocytes, both in the absence and in the presence of a metabolic activation system (S-9 mix), in compliance with OECD guideline 473. The dose levels used in the chromosome aberration assay were established on the basis of the results of a preliminary toxicity test carried out with 6 concentrations of the test substance (ranging from 0.41 to 100.0 µg/ml), both in the absence and in the presence of the metabolic activation system (S-9 mix). The highest dose level for the toxicity test was determined by the limit of solubility of the test substance in the chosen solvent (DMSO). For the chromosome aberration assay in the absence of the S-9 mix, the cells were exposed to 4 concentrations of the test substance (3.70, 11.11, 33.33 and 100.0 µg/ml) for 24 hours. In the presence of the S-9 mix, the cells were exposed for only 2 hours (because of the toxicity of the S-9 mix for the cells) to the same concentrations. As positive controls, mitomycin C (in the absence of the S-9 mix) and cyclophosphamide (in the presence of the S-9 mix) were used, while the vehicle (DMSO) was used as negative control. The test substance did not induce a significant increase in the number of cells with structural chromosome aberrations at any of the concentrations used, either in the absence or in the presence of the S-9 mix.
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