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EC number: 214-014-1 | CAS number: 1072-71-5
- 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
Skin sensitization in vivo: Bühler assay, albino guinea pig m/f (5/sex), similar to OECD 406, occlusive: non-sensitizing
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- In vivo study performed prior (1980) to REACH implementation and adoption of LLNA test guideline.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1980-10-06 - 1980-11-12 (experimental phase)
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not applicable
- GLP compliance:
- not specified
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- In vivo guinea pig study was performed prior (1980) to REACH implementation and adoption of LLNA test guideline.
- Species:
- guinea pig
- Strain:
- other: Albino
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 300 - 400 g
- Housing: The animals were housed and maintained in compliance with the Animal Welfare Act (Pub. L-94-279) 9 CFR Part 3.
- Indication of any skin lesions: none stated - Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5 g
- Day(s)/duration:
- 10 application, every second day
- Adequacy of induction:
- other: highest possible concentration (undiluted material), non-irritant
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5 g
- Day(s)/duration:
- 24 h
- Adequacy of challenge:
- other: highest possible concentration (undiluted)
- No. of animals per dose:
- 5 males & 5 females
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: 24h exposure
- Test groups: group of ten (five male and five female rats)
- Control group: none stated
- Site: intact skin test sites
- Frequency of applications: every second day
- Duration: 19 days
- Concentrations: undiluted
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: At the termination of the 2 week rest period a challenge application was put on skin sites differing from the original test sites. The challenge application remained on for 24 hours.
- Exposure period: 24h
- Test groups: group of ten (five male and five female rats)
- Site: skin sites differing from the original test sites
- Concentrations: undiluted
- Evaluation (hr after challenge): 24h & 48h - Challenge controls:
- none stated
- Positive control substance(s):
- not required
- Positive control results:
- n/a
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no effects stated
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no effects stated
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: 1st & 2nd reading
- Group:
- negative control
- Remarks on result:
- other: information not given
- Reading:
- other: 1st & 2nd reading
- Group:
- positive control
- Remarks on result:
- other: information not given
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Study was performed scientifically reasonable similar OECD TG 406 on 1,3,4-Thiadiazole-2,5-dithiole, is sufficiently documented, and taking into account the obtained results with acceptable restrictions. Hence, the results can be considered as reliable to assess the sensitizing potential of 1,3,4-Thiadiazole-2,5-dithiole in guinea pigs.
The undiluted test material was tested on 5 male and 5 female guinea pigs. According to OECD TG 406 regarding the Bühler test, “a minimum of 20 animals is used in the treatment group“. As the test item did not produce any sign of irritation, neither during induction nor challenge, in all the tested animals, the result can be nevertheless considered as unambiguous. Hence, the test item does not need to be classified as a skin sensitizer. - Executive summary:
In a dermal sensitization study (performed scientifically reasonable similar OECD TG 406) with unchanged 1,3,4-Thiadiazole-2,5-dithiole in 300-400 g albino guinea pigs (5/sex) were tested using the method of Bühler, irritation scoring according to Draize.
A 0.5 gm portion of material was applied to the intact skin test sites on the guinea pigs. After a 24 hour contact period (occlusive) the patch was removed and the animals were allowed to rest for one day. Exposure was repeated 10 times. After the tenth application the animals were rested for a two week period. At the termination of the rest period a challenge application was put on skin sites differing from the original test sites. The challenge application remained on for 24 hours. Twenty-four hours after each induction stage application and twenty-four and forty-eight hours after the challenge (re-test) application, the sites were examined for irritation, if any.
In none of the animals any sign of systemic toxicity, irritation or sensitization was noted after any application.
In this study, 1,3,4-Thiadiazole-2,5-dithiole is not a dermal sensitizer, no classification is required.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
According to Regulation 1272/2008, "For a non-adjuvant guinea pig test method a response of at least 15 % of the animals is considered positive. Test methods for skin sensitisation described in Regulation (EC) No 440/2008 adopted in accordance with Article 13(3) of Regulation (EC) No 1907/2006 (‘Test Method Regulation’) shall be used, or other methods provided that they are well-validated and scientific justification is given." The undiluted test material was tested on 5 male and 5 female guinea pigs. According to OECD TG 406 regarding the Bühler test, “a minimum of 20 animals is used in the treatment group“. As the test item did not produce any sign of irritation, neither during induction nor challenge, in all the tested animals, i.e. <15%, the result can be nevertheless considered as unambiguous. Hence, the test item does not need to be classified as a skin sensitizer. Further testing is not considered necessary.
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