Registration Dossier

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:
1977
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
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals 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:
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.