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EC number: 234-196-6 | CAS number: 10591-84-1
- 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
Endpoint summary
Administrative data
Description of key information
Single oral application of the test item to rats yielded LD50 > 5000 mg/kg bw.
Single inhalation exposure against the test item for 4 hours yielded LC50 > 5000 mg/m³
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: reporting in brief but relevant information is available
- Principles of method if other than guideline:
- Single oral application by gavage of 5000 mg/kg bw dissolved in lutrol to 10 male Wistar rats; observation time: 14 days
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 160-180 g
- Housing: 5 /cage - Route of administration:
- oral: gavage
- Vehicle:
- other: lutrol
- Details on oral exposure:
- single oral application by gavage
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 10
- Control animals:
- not specified
- Details on study design:
- Single oral application by gavage of 5000 mg/kg bw dissolved in lutrol to 10 male Wistar rats; observation time: 14 days LD 50 calcuation according to Fink and Hund Arneim.-forsch. 15, 624 (1965)
- Statistics:
- no further data
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Remarks on result:
- other: no mortality no clinical findings
- Mortality:
- 0/10
- Clinical signs:
- other: no clinical findings
- Gross pathology:
- not examined
- Other findings:
- no further data
- Executive summary:
Single oral application by gavage of 5000 mg/kg bw to 10 male rats caused no death and no clinical findings were observed during the 14 day-observation period. Thus, the LD50 was considered to be >5000 mg/kg bw (Loeser 1976)
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- The only available reliable study on rats
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: according to OECD TG and GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 2 month
- Weight at study initiation: 180-200 g
- Fasting period before study:
- Housing: before test : singly and during test in groups
- Diet ad libitum
- Water ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 40-60
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- inhalation
- Type of inhalation exposure:
- nose only
- Vehicle:
- clean air
- Details on inhalation exposure:
- generation and characterization of chamber atmosphere - mean vaöues
target concentration 5000 mg/m³
gravimetric concentration 5064 mg/m³
inlet air flow 28 l/min (concurrent control : air. 15 l/min)
exhaust air flow: 23.8 l/min (concurrent control: 12.8 l/min)
mean temperature 23.0°C (concurrent control: 23.7°C
mean rel humidity 8.4 % (concurrent control: 5 %)
Mass Median Aerodynamic Diameter(MMAD) 4.10 µm
Aerosol Mass < 3 µm: 38 %
- Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- ca. 4 h
- Concentrations:
- 0 or 5000 µg/m³
- No. of animals per sex per dose:
- 5 rats /sex and concentration
- Control animals:
- yes
- Details on study design:
- according to the respective guideline , 2 weeks pot exposure observation
To identify exposure related effects, comparisons with an appropriate vehicle control were performed. This control was exposed to an atmosphere using essentially similar exposure conditions as were used for the test substance.
body weight determination on dayys 1,3,7 and weekly thereafter
deaths were recorded
cöonical signs andappearannnce and behavior of each rat were recordedNecropsy was performed
andgross pathological changes were notet (if available) - Statistics:
- yes
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5 064 mg/m³ air (analytical)
- Exp. duration:
- 4 h
- Mortality:
- no rat died
- Clinical signs:
- other: no specific clinical signs were observed
- Body weight:
- Comparisons between the control and the exposure group revealed transient changes in body weights of no toxicological significance
- Gross pathology:
- -Animals sacrificed at the end of the observation period:
The macroscopic findings of extrapulmonary organs were essentially indistinguishable amongst expossusre and control groups.
The focal discoloration observed in 2 of 6 rats of the test groups are not considered to be pathodiagnostic of any adverse effects of the lung. - Other findings:
- no further data
- Executive summary:
A study on acute inhalation toxicity of N,N'-dimethyldiphenylthiuram disulfide on rats has been conducted in accordance with OECD TG 403. A group of male and female rats was nose-only exposed to the dry powder aerosol of the test article at an actual concentration of 5064 mg/m³ The respirability of the aerosol was adequate to achieve the objective of the study, i.e. the average mass median aerodynamic diameter (MMAD) was 4.1 µm. The animals were obsreved post exposure for 14 days. Mortality did not occur. Apart from a minimal and transient decrease in body weights, which was considered to be of no toxicological significance, the exposure was tolerated without any pathodiagnostic effects suggestive of portal entry or systemic toxicity. The results can be summarized as follows: LC50 (rat) >5064 mg/m³ (Pauluhn 2012)
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating conc.
- Value:
- 5 064 mg/m³ air
- Quality of whole database:
- The only available study is performed according to OECD Guidline and GLP and has Klimisch Score 1
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
oral exposure
Single oral application by gavage of 5000 mg/kg bw to 10 male rats caused no death and no clinical findings were observed during the 14 day-observation period. Thus, the LD50 was considered to be >5000 mg/kg bw (Loeser 1976)
inhalation exposure
A study on acute inhalation toxicity of N,N'-dimethyldiphenylthiuram disulfide on rats has been conducted in accordance with OECD TG 403. A group of male and female rats was nose-only exposed for 4 hours to the dry powder aerosol of the test article at an actual concentration of 5064 mg/m³ .The respirability of the aerosol was adequate to achieve the objective of the study, i.e. the average mass median aerodynamic diameter (MMAD) was 4.1 µm. The animals were observed post exposure for 14 days. Mortality did not occur. Apart from a minimal and transient decrease in body weights, which was considered to be of no toxicological significance, the exposure was tolerated without any pathodiagnostic effects suggestive of portal entry or systemic toxicity.
Thus, the results can be summarized as follows: LC50 (rat) >5064 mg/m³/4h (Pauluhn 2012)
dermal exposure
According to Regulation (EC) No 1907/2006 (REACh) ANNEX VIII column 2, in addition to the acute toxicty using the oral route , for substances other than gases, at least the acute toxicity data for one other route should be provided. This recommendation is fulfilled because there is an acute inhalation study available which was performed according to the respective guideline and GLP. Thus, there is no need to conduct an acute toxicity study using the dermal route..
Justification for selection of acute toxicity – oral endpoint
The only available reliable study on rats
Justification for selection of acute toxicity – inhalation endpoint
guideline study and GLP
Justification for selection of acute toxicity – dermal endpoint
According to Regulation (EC) No 1907/2006 (REACh) ANNEX VIII column 2, in addition to the acute toxicty using the oral route , for substances other than gases, at least the acute toxicity data for one other route should be provided. This recommendation is fulfilled because there is an acute inhalation study available which was performed according to the respective guideline and GLP. Thus, there is no need to conduct an acute toxicity study using the dermal route..
Justification for classification or non-classification
Based on the available data no classification or labelling is required.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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