Registration Dossier
Registration Dossier
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EC number: 604-569-1 | CAS number: 147126-62-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was performed according to the OECD guideline 406 and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
Test material
- Reference substance name:
- (1R,2S,5R)-2-isopropyl-5-methylcyclohexyl (2R,5R)-5-hydroxy-1,3-oxathiolane-2-carboxylate
- EC Number:
- 604-569-1
- Cas Number:
- 147126-62-3
- Molecular formula:
- C14H24O4S
- IUPAC Name:
- (1R,2S,5R)-2-isopropyl-5-methylcyclohexyl (2R,5R)-5-hydroxy-1,3-oxathiolane-2-carboxylate
- Test material form:
- other: White to light pink/yellow solid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: HA(BR)
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: males >300 g
- Housing: 5 animals/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 9 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18- 26°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: moistened with Water for Injection
- Concentration / amount:
- Induction: 25%, 50% , 75% and 100%
Challenge: 100%
The maximum non-irritant concentration was determined in a pre-test.
Challengeopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: moistened with Water for Injection
- Concentration / amount:
- Induction: 25%, 50% , 75% and 100%
Challenge: 100%
The maximum non-irritant concentration was determined in a pre-test.
- No. of animals per dose:
- Negative control: 10 male guinea pigs
Positive control: 5 male guinea pigs
Test item group: 20 male guinea pigs - Challenge controls:
- 15 days after the last induction application, the right flanks of all test and control animals were cleared of hair (closely clipped).
The test item was applied in the same marmer as during the induction phase, for a 6-hour exposure period on study Day 28, to the posterior right flanks of each test and negative control animal. - Positive control substance(s):
- yes
- Remarks:
- DNCB
Results and discussion
- Positive control results:
- 100% of the animals in the positive control group showed scores of 1.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1 % DNCB
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.1 % DNCB. No with. + reactions: 5.0. Total no. in groups: 5.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.1 % DNCB
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.1 % DNCB. No with. + reactions: 5.0. Total no. in groups: 5.0. Clinical observations: None.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- An evaluation of skin reaction was carried out and recorded at 24 and 48 hours after completion of each application. None of the guinea pigs treated with the test item had any signs of local skin irritation after the challenge period. Based on these findings, the test item was found to be non-sensitizing in a Buehler Skin Sensitization Study in guinea pigs.
- Executive summary:
Based on the results of this study the test item is considered to be non-sensitzing to the skin of guinea pigs.
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