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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 8 November, 1988 to 12 May 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Guideline study performed in compliance with GLP, available as unpublished report, no restrictions, fully adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- Version / remarks:
- Directive 84/449/EEC, Part B, B.7
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- (1981)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
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:
- C30H28N2S4
- IUPAC Name:
- N,N-dibenzyl[(dibenzylcarbamothioyl)disulfanyl]carbothioamide
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Sprague-Dawley CD rat, outbred, SPF quality
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Analysis of formulations
Samples of formulations prepared during weeks 1, 2, 3 and 4 were analysed to check the accuracy of preparation.
Concentration of the test article in vehicle was determined weekly on days 6, 13, 20 and 27.
TBzTD was determined to be stable for at least 4 hours in propylene glycol at all concentrations tested. TBzTD formed a homogeneous suspension in propylene gl ycol at all concentrations tested. - Duration of treatment / exposure:
- Test duration: 28 days
- Frequency of treatment:
- Dosing regime: 7 days/week
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 50 mg/kg bw/day (nominal)
- Dose / conc.:
- 200 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 50 mg/kg bw/day
Male: 5 animals at 200 mg/kg bw/day
Male: 5 animals at 1000 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 50 mg/kg bw/day
Female: 5 animals at 200 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/day
Examinations
- Statistics:
- The following statistical methods were used to analyse the body weight, food consumption, organ weights and clinical laboratory data:
Univariate one-way analysis of variance was used to assess the significance of intergroup differences.
If the variables could be assumed to follow a normal distribution, the Dunnett-test (many to one t-test) based on a pooled variance estimate was applied for the comparison of the treated groups and the control groups.
The Steel-test (many-one rank test) was applied when the data could not be assumed to follow a normal distribution.
A11 tests we re two-s i ded and in all cases p < 0.05 was accepted as the lowest level of significance.
Group means were calculated for continuous data and medians were calculated for discrete data (scores) in the summary tables.
Individual values, means, standard deviations and statistics were rounded off before printing. For example, test statistics were calculated on the basis of exact values for means and pooled variances and then rounded off to two decimal places. Therefore, two groups may display the same printed means for a given parameter, yet display different test statistics values References:
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- One male of the control and one female receiving 200 mg/kg/day showed slight diarrhoea on days 8 and 2, respectively.
No clinical signs were noted in treated males and in females receiving 50 or 1000 mg/kg/day.
One control male (animal 5) showed a broken left upper incisor on day 12 and a broken right upper incisor on day 14. One male receiving 50 mg/kg/day (animal 7) showed a broken left upper incisor on day 12. - Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- One female (animal 39) died on day 11 of dosing. This early death was in the absence of any signs of toxicity, not considered to be treatment related.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Body weight and body weight gain of treated animals remained similar to those of control rats over the study period.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- There were no differences in appetite between treated and control animals during the 29 day observation period.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Changes in red blood cell parameters between treated and control animals, included a statistically significant increase in red blood cell counts and hemoglobin in females receiving 1000 mg/kg/day and a statistically significant decrease in red cell distribution width in females receiving 50, 200 or 1000 mg/kg/day.
However, these values were within the range normally seen in rats of this age and strain and therefore not considered to be of toxicological significance.
Total white blood cell counts achieved a level of statistical significance in their difference from controls for females receiving 50 or 200 mg/kg/day, but in the absence of any corresponding effect in females receiving 1000 mg/kg/day and in treated males, these increases were considered to have arisen by chance and to be of no biological significance.
Eosinophils were noted as statistically significant high in comparison with control levels for females receiving 1000 mg/kg/day. However, of the 4 values measured, only 2 values fell outside the normal expected range. Therefore, in the absence of consistent response, a treatment related distribution or similar response in males this finding is considered to be the result of extreme biological variation and not directly related to the treatment.
Other differential white blood cell counts did not differ significantly from control values. - Clinical biochemistry findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- There were no toxicologically significant differences in blood chemistry parameters between control and treated animals of both sexes.
Statistically significant differences arising between Calcium of males receiving 50 mg/kg/day, Sodium of males receiving 200 mg/kg/day, GOT of females receiving 1000 mg/kg/day and Albumin of females receiving 200 or 1000 mg/kg/day in comparison with controls were within biologically normal limits and considered to have occurred fortuitously. - Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- Spleen weights of treated females were slightly, but statistically significantly decreased in comparison with control weights. However, after correction for body weight, these decreases attained a level of statistical significance only for females receiving 200 mg/kg/day.
However, all values were within the range normally seen for rats of this age and strain. - Gross pathological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Pelvic dilatation of the kidneys was noted in 2 females receiving 50 mg/kg/day. This finding is known to occur spontaneously in rats of this age and strain and not considered of toxicological significance.
- Histopathological findings: non-neoplastic:
- effects observed, non-treatment-related
- Description (incidence and severity):
- A small number of microscopic findings were noted in the rats examined. These microscopic findings did not distinguish treated rats from controls and were findings commonly noted in rats of this age and strain.
- Histopathological findings: neoplastic:
- no effects observed
Effect levels
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects observed at the highest dose tested
- Remarks on result:
- other: original NCD unit is mg/kg/day.
- Dose descriptor:
- NOEL
- Effect level:
- ca. 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No treatment related effects observed at this dose level
- Remarks on result:
- other: original NCD unit is mg/kg/day. The accuracy of preparat on testing revealed that the concentrations analyzed were in agreement with the concentrations prepared
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- No treatment-related changes were noted in any dose group up to 1000 mg/kg bw per day. From the results presented in this study a no effect level (NOEL) was established at 1000 mg/kg/day.
- Executive summary:
The sub-acute toxicity of tetrakis(phenylmethyl)thioperoxydi(carbothioamide) (TBzTD) was investgated according to OECD 407: Repeated Dose 28-day Oral Toxicity Study in Rodents. TBzTD was administered daily by gavage to SPF-bred Sprague-Dawley rats. The study comprised of four groups.
5 male and 5 female rats were assigned to each of the following dose levels:
0 mg/kg bw per day (control)
50 mg/kg bw per day
200 mg/kg bw per day
1000 mg/kg bw per day
No treatment-related changes were noted in any dose group. From the results presented in this study a no effect level (NOEL) was established at 1000 mg/kg/day.
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