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EC number: 204-783-1 | CAS number: 126-33-0
Skin sensitisation
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- other: Not GLP compliant, available as unpublished report.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:
- 1 982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- 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 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
- Reference substance name:
- sulfolane
- IUPAC Name:
- sulfolane
- Details on test material:
- - Name of test material (as cited in study report): sulfolane
Constituent 1
Constituent 2
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 chemical
- 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 chemical
- 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 chemical
- 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 chemical
- 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.
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