Registration Dossier

Administrative data

Description of key information

Sulfolane was not irritating to rabbit skin when applied under occlusive conditions for 6 hr/day on three consecutive days.  When instilled into rabbit eyes, sulfolane produced mild conjunctivitis which cleared within a few hours.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin 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
Qualifier:
according to
Guideline:
other: Brown et al. (1966)
Principles of method if other than guideline:
No further information available.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Tunstall Laboratory Breeding Unit
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
1 ml
Duration of treatment / exposure:
6 hours, once per day for three applications
Observation period:
7 days after first application
Number of animals:
4 males and 4 females
Details on study design:
TEST SITE
Two 2 cm x 2 cm patches with 1 ml of test material were applied to the backs of rabbits and covered with a sheet of thin polythene. These were then bandaged into position by means of a 5 cm. open-weave bandage.

REMOVAL OF TEST SUBSTANCE
- Not reported.

SCORING SYSTEM: According to Brown et al. (1966).
Irritation parameter:
erythema score
Basis:
other: Score according to Brown et al. (1966)
Time point:
other: 7 days
Score:
< 10
Remarks on result:
other: Non-irritating
Irritant / corrosive response data:
No information is available.
Other effects:
No information is available.

There was no sign of skin irritation in any of the rabbits. The use of sulphan blue showed the skin to be unchanged, and histopathological examination of skins taken from the rabbits post mortem revealed no evidence of skin damage.

Interpretation of results:
GHS criteria not met
Conclusions:
Sulfolane is a non-irritant to rabbit skin.
Executive summary:

Sulfolane is a non-irritant to rabbit skin when applied under occlusive conditions for 6 hours a day on three consecutive days.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
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
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
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Tunstall Laboratory Breeding Unit
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)
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

Sulfolane produced only mild conjunctivitis which cleared within a few hours.

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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation

Brown et al.(1966) reported that sulfolane was a non-irritant to rabbit skin when applied under occlusive conditions for 6 hours per day on three consecutive days. There was no sign of skin irritation in any of the rabbits. The use of sulphan blue also showed the skin to be unchanged, and histopathological examination of skins taken from the rabbits post mortem revealed no evidence of skin damage.

Eye Irritation

Brown et al. (1966) reported that sulfolane was 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.


Justification for classification or non-classification

Skin Irritation

Classification proposal regarding skin irritation: GHS/CLP: None.

Eye Irritation

Classification proposal regarding eye irritation: GHS/CLP: None.