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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Remarks:
- In vivo study performed prior (1980) to REACH implementation.
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1980-09-29 - 1980-10-20 (experimental phase)
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Given information allows the conclusion the study was well performed according to adopted guidelines, given data allows also conclusions on classification according to Regulation 1272/2008.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 16 CFR Section 1500.42
- Version / remarks:
- The methods employed in the testing, evaluation and in the grading of the test material are similar to those described in Section 1500.42 - Federal Hazardous Substances Act Regulation CFR 16 P. 125.
- Deviations:
- not specified
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 1,3,4-thiadiazole-2,5-dithiol
- EC Number:
- 214-014-1
- EC Name:
- 1,3,4-thiadiazole-2,5-dithiol
- Cas Number:
- 1072-71-5
- Molecular formula:
- C2H2N2S3
- IUPAC Name:
- 1,3,4-thiadiazole-2,5-dithiol
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Albino
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: young adult
- Housing: The animals were housed and maintained in compliance with the Animal Welfare Act (Pub. L-94--279) 9 CFR Part 3.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- The first six rabbits did not have their eyes washed subsequent to instillation. The remaining three rabbits had the treated eyes washed after 30 seconds for 1 minute with tepid water (rate of flow approximately 1000 ml/minute).
- Observation period (in vivo):
- The treated eyes were examined at one, two, three, five, seven, fourteen and twenty-one days following instillation and washout of the test material into the eyes.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The first six rabbits did not have their eyes washed subsequent to instillation. The remaining three rabbits had the treated eyes washed after 30 seconds for 1 minute with tepid water (rate of flow approximately 1000 ml/minute).
SCORING SYSTEM: Interpretation of the results was made in accordance with the Draize Scale of Scoring Ocular Lesions.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3.55
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.89
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.45
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3.22
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- probability of severe irritation
- Irritant / corrosive response data:
- Based on the accompanying tables, the subject material is a primary ocular irritant within the definition of the Act-Reference: Section 1500.42 (b)(1)(2) and requires cautionary labelling with respect to that section.
The material is a severe ocular irritant in the unwashed eye. Washing reduces the degree and duration of the irritation substantially.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Study was performed scientifically reasonable similar to that described in Section 1500.42 ― Federal Hazardous Substances Act Regulations ― 16 CFR - P. 125 on 1,3,4-Thiadiazole-2,5-dithiole, and is sufficiently documented. Hence, the results can be considered as reliable to assess the irritating potential of 1,3,4-Thiadiazole-2,5-dithiole on the rabbit eye in vivo.
According to Regulation 1272/2008, classification as Irreversible effects on the eye/serious damage to eyes (Category 1), If, when applied to the eye of an animal, a substance produces:
— at least in one animal effects on the cornea, iris or conjunctiva that are not expected to reverse or have not fully reversed within an observation period of normally 21 days; and/or
— at least in 2 of 3 tested animals, a positive response of:
— corneal opacity ≥ 3 and/or
— iritis > 1,5
calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material.
Further, these observations include animals with grade 4 cornea lesions and other severe reactions (e.g., destruction of cornea) observed at any time during the test, and lesions are not fully reversible within a 21-day observation period.
An OECD 405 guideline study suffices for classification, and according to the guideline, a substance shall not be removed for 24h, solids not until 1 hour after application unless corrosion effects are noted. Hence, the results gained with animals No 7-9 cannot be used for classification, as the substance was washed out after 30 seconds. So classification must be based on the results obtained from animals No 1-6 as here the substance was not washed out. In all six animals a corneal opacity score of 4 was observed in at least one time point, all observed effects were not fully reversible after 21 days, mean corneal opacity was ≥ 3 in 5/6 animals, and iritis was also > 1,5 in 5/6 animals. Hence, the substance must be classified as Eye dam. Cat. 1. - Executive summary:
In a primary eye irritation study (16 CFR Section 1500.41), 0.1 g unchanged 1,3,4-Thiadiazole-2,5-dithiole was instilled into the conjunctival sac of the right eye of young albino rabbits. In six rabbits, the eye was not washed out, in 3 the eye was rinsed after 30 seconds. Animals then were observed for 21days. Irritation was scored by the method of Draize.
In all six animals a corneal opacity score of 4 was observed in at least one time point, all observed effects were not fully reversible after 21 days, mean corneal opacity was ≥ 3 in 5/6 animals, and iritis was also > 1,5 in 5/6 animals. The material is a severe ocular irritant in the unwashed eye. Washing reduces the degree and duration of the irritation substantially.
In this study, 1,3,4-Thiadiazole-2,5-dithiole is severely irritating to the eye, and must be classified as Eye Dam. Cat. 1 based on the criteria of Regulation 1272/2008.
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