Registration Dossier
Registration Dossier
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EC number: 249-648-8 | CAS number: 29461-13-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from publication.
Data source
Reference
- Reference Type:
- publication
- Title:
- Fragrance report of test substance
- Author:
- D.L.J. Opdyke
- Year:
- 1 979
- Bibliographic source:
- Food and Cosmetics Toxicology 1979
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- A Human maximization test of test chemical was conducted on 24 volunteers to assess its skin sensitization potential.
- GLP compliance:
- not specified
- Type of study:
- other: Human maximization test
- Justification for non-LLNA method:
- not specified
Test material
- Reference substance name:
- (1S-endo)-1,3,3-trimethylbicyclo[2.2.1]heptan-2-ol
- Cas Number:
- 2-tert-butylcyclohexyl acetate
- Molecular formula:
- C10H18O
- IUPAC Name:
- (1S-endo)-1,3,3-trimethylbicyclo[2.2.1]heptan-2-ol
- Test material form:
- liquid
- Details on test material:
- - IUPAC Name: (1S-endo)-1,3,3-trimethylbicyclo[2.2.1]heptan-2-ol
- InChI: 1S/C10H18O/c1-9(2)7-4-5-10(3,6-7)8(9)11/h7-8,11H,4-6H2,1-3H3/t7-,8-,10+/m1/s1
- Smiles: C[C@]12CC[C@H](C1)C(C)(C)[C@H]2O
- Molecular formula: C10H18O
- Molecular weight: 154.253 g/mol
- Substance type: Organic
- Physical state: liquid
Constituent 1
In vivo test system
Test animals
- Species:
- other: Human
- Strain:
- other: Not applicable
- Sex:
- not specified
- Details on test animals and environmental conditions:
- not specified
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- petrolatum
- Concentration / amount:
- 4%
- Day(s)/duration:
- No data available
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 4%
- Day(s)/duration:
- No data available
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- Total = 24
- Details on study design:
- not specified
- Challenge controls:
- not specified
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- not specified
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 4%
- No. with + reactions:
- 0
- Total no. in group:
- 24
- Clinical observations:
- No signs of sensitization were observed.
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- The test chemical was considered to be not sensitizing to the skin of human volunteers.
- Executive summary:
A Human maximization test was conducted for the given test chemical on 24 volunteers to assess its skin sensitization potential. None of the volunteers had developed any signs of skin sensitization. Hence the test chemical was considered to be not sensitizing to the skin of human volunteers.
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