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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Not GLP compliant, available as unpublished report.
Justification for type of information:
.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: not specified
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
An LLNA study was not performed because there is an existing reliable study for skin sensitisation using the Guinea Pig Maximisation test method.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): sulfolane

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dutchland Laboratory Animals, Inc., USA
- Weight at study initiation: 300-500 g
- Housing: Individual animal per cage
- Diet: Purina Guinea Pig Chow ad libitum
- Water: Tap water ad libitum
- Acclimation period: minimum of one week

Study design: in vivo (non-LLNA)

Induction
Route:
other: epicutaneous
Vehicle:
other: acetone
Concentration / amount:
75% v/v for epicutaneous application
Challenge
Route:
epicutaneous, occlusive
Vehicle:
other: acetone
Concentration / amount:
75% v/v for epicutaneous application
No. of animals per dose:
5/sex (test and negative control groups)
Details on study design:
RANGE FINDING TESTS: A primary skin irritation screen was used to determine the concentration of test material used during the main study. The maximum practicable concentration of the test material in the chosen vehicle was taken as 75% v/v for topical applications.

MAIN STUDY
A. INDUCTION EXPOSURE
A topical application of 75% sulfolane solution was applied to the shaved backs of 5 male and 5 female guinea pigs and covered by an occlusive dressing for six hours. The same induction procedures were carried out on a control group of five male and five female animals, except that the test material was replaced by the vehicle acetone. The test material and control vehicle were reapplied once per week for three weeks.

B. CHALLENGE EXPOSURE
Fifteen days following the last induction application, all animals were challenged by occluded application of 75% sulfolane in acetone for 4 to 6 hours. The condition of the test sites was assessed approximately 24, 48 and 72 hours later.
Challenge controls:
The same induction procedures were carried out on a control group of five male and five female animals, except that the test material was replaced by vehicle in all doses. Challenge was identical as for test material, with application of a 75% sulfolane solution.

Positive control substance(s):
yes
Remarks:
Dinitrochlorobenzene (DNCB) at 0.15% and 0.1% was used for the induction and challenge phases, respectively.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
75%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
75 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test group
Dose level:
75 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
75%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
75%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test group
Dose level:
75%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
Dinitrochlorobenzene (DNCB) at 0.1% and 0.15%
Remarks on result:
other: See "Remarks"
Remarks:
Guinea pigs treated with 0.1% DNCB in acetone during the challenge phase only exhibited very slight erythema in 3/10 animals at 24 hours, which persisted in one animal at the 48-hr timepoint. Animals exposed to the same challenge concentration of DNCB, following the induction with 0.15% DNCB in acetone and a rest period, exhibited very slight to moderate to severe erythema at 24 hours, with persisted to some degree to the 48- and 72-hr timepoints in several animals. There was also slight edema in one animal at the 24-hr timepoint, and blanching in 4/10 animals at the 24-hr timepoint. It is concluded that the guinea pigs responded to hypersensitisation when a known sensitiser was used.

Any other information on results incl. tables

Guinea pigs receiving 75% sulfolane in acetone during the challenge phase only and those animals exposed to the same challenge dose following the induction with 75% sulfolane in acetone exhibited no dermal irritation at any timepoint.

Positive control: Guinea pigs treated with 0.1% DNCB in acetone during the challenge phase only exhibited very slight erythema in 3/10 animals at 24 hours, which persisted in one animal at the 48-hr timepoint. Animals exposed to the same challenge concentration of DNCB, following the induction with 0.15% DNCB in acetone and a rest period, exhibited very slight to moderate to severe erythema at 24 hours, with persisted to some degree to the 48- and 72-hr timepoints in several animals. There was also slight edema in one animal at the 24-hr timepoint, and blanching in 4/10 animals at the 24-hr timepoint. It is concluded that the guinea pigs responded to hypersensitisation when a known sensitiser was used.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study, repeated administration of sulfolane did not result in skin sensitisation to guinea-pigs.
Executive summary:

Under the conditions of this study, repeated administration of sulfolane did not result in skin sensitisation to guinea-pigs.