Registration Dossier
Registration Dossier
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EC number: 232-102-8 | CAS number: 7786-67-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Isopulegol
- EC Number:
- 201-940-6
- EC Name:
- Isopulegol
- Cas Number:
- 89-79-2
- IUPAC Name:
- 2-isopropenyl-5-methylcyclohexanol
- Reference substance name:
- 5-methyl-2-(1-methylvinyl)cyclohexan-1-ol
- EC Number:
- 232-102-8
- EC Name:
- 5-methyl-2-(1-methylvinyl)cyclohexan-1-ol
- Cas Number:
- 7786-67-6
- Molecular formula:
- C10H18O
- IUPAC Name:
- 5-methyl-2-(prop-1-en-2-yl)cyclohexan-1-ol
- Details on test material:
- Name of test material: Isopulegol
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- The 1st injection consisted of 10% w/v in Complete Adjuvant (CA), 2nd injection consisted of 10% w/v in a mixture of Freund’s and 3rd
injection consisted of complete adjuvant plus physiological saline(1:1).
A topical induction consisted of isopulegol at 10% concentration w/v in CA.
Then the topical challenge application was made to the clipped left anterior flank with 0.1 ml aliquot of isopulegol at 5%, 10%, 20% or 40% w/v
in a mixture of propyleneglycol plus acetone (1:1).
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- The 1st injection consisted of 10% w/v in Complete Adjuvant (CA), 2nd injection consisted of 10% w/v in a mixture of Freund’s and 3rd
injection consisted of complete adjuvant plus physiological saline(1:1).
A topical induction consisted of isopulegol at 10% concentration w/v in CA.
Then the topical challenge application was made to the clipped left anterior flank with 0.1 ml aliquot of isopulegol at 5%, 10%, 20% or 40% w/v
in a mixture of propyleneglycol plus acetone (1:1).
- No. of animals per dose:
- Five animals were assigned to the test group and five animals to the control
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. No with. + reactions: 0.0. Total no. in groups: 5.0.
Any other information on results incl. tables
Any animals experimented skin sensitizing reactions under these conditions of study.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- No sensitization observed in guinea pig maximization test (GPMT)
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