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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

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:
1966
Reference Type:
publication
Title:
United States Federal Register: September 17, 1964: FR 13009 “Hazardous Substances”
Author:
United states
Year:
1964
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

Constituent 1
Chemical structure
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
Constituent 2
Reference substance name:
Sulfolane
IUPAC Name:
Sulfolane
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:
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.