Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: 204-783-1 | CAS number: 126-33-0
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 966
- Reference Type:
- publication
- Title:
- United States Federal Register: September 17, 1964: FR 13009 “Hazardous Substances”
- Author:
- United states
- Year:
- 1 964
- Bibliographic source:
- https://www.govinfo.gov/content/pkg/FR-1964-09-17/pdf/FR-1964-09-17.pdf
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: United States Federal Register: September 17, 1964: FR 13009 “Hazardous Substances”
- Principles of method if other than guideline:
- No further information available.
- GLP compliance:
- no
Test material
- Reference substance name:
- Tetrahydrothiophene 1,1-dioxide
- EC Number:
- 204-783-1
- EC Name:
- Tetrahydrothiophene 1,1-dioxide
- Cas Number:
- 126-33-0
- Molecular formula:
- C4H8O2S
- IUPAC Name:
- 1λ⁶-thiolane-1,1-dione
- Reference substance name:
- Sulfolane
- IUPAC Name:
- Sulfolane
- Details on test material:
- - Name of test material (as cited in study report): Sulfolane
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Tunstall Laboratory Breeding Unit
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.2 ml
- Duration of treatment / exposure:
- Single instillation of test substance, according to the method described in United States Federal Register: September 17, 1964: FR 13009 “Hazardous Substances”.
- Observation period (in vivo):
- 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- Six rabbits, according to the method described in United States Federal Register: September 17, 1964: FR 13009 “Hazardous Substances”
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
Not reported, removal not indicated according to the method described in United States Federal Register: September 17, 1964: FR 13009 “Hazardous Substances”.
SCORING SYSTEM: U.S. Department of Health, Education and Welfare (Food and Drug Administration)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: a few hours
- Remarks on result:
- no indication of irritation
- Remarks:
- All effects had resolved within a few hours, so it is considered by the reviewer that the score according to Draize would be 0 for each animal.
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: a few hours
- Remarks on result:
- no indication of irritation
- Remarks:
- All effects had resolved within a few hours, so it is considered by the reviewer that the score according to Draize would be 0 for each animal.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: a few hours
- Remarks on result:
- no indication of irritation
- Remarks:
- All effects had resolved within a few hours, so it is considered by the reviewer that the score according to Draize would be 0 for each animal.
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: a few hours
- Remarks on result:
- no indication of irritation
- Remarks:
- All effects had resolved within a few hours, so it is considered by the reviewer that the score according to Draize would be 0 for each animal.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: a few hours
- Remarks on result:
- no indication of irritation
- Remarks:
- All effects had resolved within a few hours, so it is considered by the reviewer that the score according to Draize would be 0 for each animal.
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: a few hours
- Remarks on result:
- no indication of irritation
- Remarks:
- All effects had resolved within a few hours, so it is considered that the score according to Draize would be 0 for each animal.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: a few hours
- Remarks on result:
- no indication of irritation
- Remarks:
- All effects had resolved within a few hours, so it is considered that the score according to Draize would be 0 for each animal.
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: a few hours
- Remarks on result:
- no indication of irritation
- Remarks:
- All effects had resolved within a few hours, so it is considered by the reviewer that the score according to Draize would be 0 for each animal.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: a few hours
- Remarks on result:
- no indication of irritation
- Remarks:
- All effects had resolved within a few hours, so it is considered by the reviewer that the score according to Draize would be 0 for each animal.
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within:
- Remarks on result:
- no indication of irritation
- Remarks:
- All effects had resolved within a few hours, so it is considered by the reviewer that the score according to Draize would be 0 for each animal.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: a few hours
- Remarks on result:
- no indication of irritation
- Remarks:
- All effects had resolved within a few hours, so it is considered by the reviewer that the score according to Draize would be 0 for each animal.
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: a few hours
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Sulfolane produced only mild conjunctivitis which cleared within a few hours.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: expert judgment, reported as a very mlld irritant
- Conclusions:
- Sulfolane was considered as mildly irritating to the eyes of rabbits, based on mild conjuctivitis which cleared within a few hours.
- Executive summary:
Sulfolane is a mild eye irritant to rabbits. When 0.2 ml sulfolane was instilled into the right eyes of rabbits, there was only mild conjunctivitis which cleared within a few hours.
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