Registration Dossier
Registration Dossier
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EC number: 204-783-1 | CAS number: 126-33-0
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- 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
Reference
- Reference Type:
- publication
- Title:
- The inhalation toxicity of sulfolane (tetrahydrothiophene -1,1-dioxide).
- Author:
- Andersen, M.E., Jones, R.A., Mehl, R.G., Hill, T.A., Kurlansik, L, Jenkins, Jr., L.J.
- Year:
- 1 977
- Bibliographic source:
- Toxicol. Appl. Pharmacol. 40: 463-472.
Materials and methods
Test guideline
- Guideline:
- other: Other: Andersen et al. (1977)
- Principles of method if other than guideline:
- No further information available.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
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 the study report): sulfolane
- Analytical purity: <97% (purity not reported; however 3% water was added to prevent freezing).
- Impurities: 3% water
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 260 – 480 g
- Diet: Commercial prepared dry chow ad libitum except during exposure
- Water: ad libitum except during exposure.
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Whole-body inhalation system: cylindrical glass battery jar supported in a Plexiglas frame.
- Exposure chamber volume: 30 Liter
- Method of holding animals in test chamber: The animals were kept singly in compartmentalized wire cages
- Aerosols were generated using a glass nebulizer and final chamber concentrations were varied by altering the drop rate of test material into the nebulizer. Particle size distribution analysis of the aerosol was between 1 and 4 um in mean particle size diameter. Exposures were made at various concentrations, all of which were below the aerosol concentration which caused wetting of the animals and chamber surfaces (Approximately 12,000 mg/m3).
TEST ATMOSPHERE
Atmospheric sulfolane concentrations were determined by drawing known volumes of chamber air first through an impinger and then through a bubbler containing distilled water. The aerosolized sulfolane trapped by the impinger was dissolved in distilled water. Sulfolane in these aqueous solutions was determined by gas-liquid chromatography with flame ionization detection. Samples were taken every 6 hours during the exposures. - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- Approximately 12,000 mg/m3
- No. of animals per sex per dose:
- Not reported.
- Control animals:
- not specified
- Details on study design:
- Duration of observation period following administration: 2 weeks
- Statistics:
- Not necessary.
Results and discussion
- Preliminary study:
- No information is available.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- 12 000 other: mg/m³ aerosol/vapor
- Exp. duration:
- 4 h
- Remarks on result:
- other: no mortality
- Mortality:
- No mortality.
- Clinical signs:
- other: Not reported.
- Body weight:
- Not reported.
- Gross pathology:
- Not reported.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LC50 of sulfolane aerosol/vapor was >12,000 mg/m3 in male and female rats.
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