Registration Dossier

Toxicological information

Eye irritation

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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

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1966

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Sulfolane

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:
Not reported.
Observation period (in vivo):
Not reported.
Number of animals or in vitro replicates:
Not reported.
Details on study design:
REMOVAL OF TEST SUBSTANCE
Not reported.

SCORING SYSTEM: U.S. Department of Health, Education and Welfare (Food and Drug Administration)

Results and discussion

In vivo

Results
Irritation parameter:
conjunctivae score
Basis:
other: Score according to US. Department of Health, Education and Welfare (FDA)
Time point:
other: Less than a few hours
Reversibility:
other: Yes
Remarks on result:
other: Mild

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:
other: Mild Irritant
Remarks:
Criteria used for interpretation of results: expert judgment
Conclusions:
Sulfolane is mildly irritating to the eyes of rabbits.
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.