Registration Dossier
Registration Dossier
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EC number: 227-231-1 | CAS number: 5726-19-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Fragrance material review on d-cyclocitronellene acetate
- Author:
- Bhatia SP et al.
- Year:
- 2 008
- Bibliographic source:
- Food Chem Toxicol. 2008 Dec;46 Suppl 12:S48-51. Epub 2008 Sep 23.
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- (1981)
- Deviations:
- yes
- Remarks:
- (no data on controls)
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Existing study, performed before OECD guidelines were available for LLNA method. The study is appropiate to assess the sensitising characteristics of the test item.
Test material
- Reference substance name:
- α,3,3-trimethylcyclohexylmethyl acetate
- EC Number:
- 246-737-3
- EC Name:
- α,3,3-trimethylcyclohexylmethyl acetate
- Cas Number:
- 25225-10-9
- IUPAC Name:
- 1-(3,3-dimethylcyclohexyl)ethyl acetate
- Details on test material:
- - Name of test material (as cited in study report): d-cyclocitronellene acetate
- Molecular formula (if other than submission substance): C12H22O2
- Molecular weight (if other than submission substance): 198.31
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: liquid paraffin
- Concentration / amount:
- 10% (intradermal) and 100% (epicutaneous)
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: liquid paraffin
- Concentration / amount:
- 10% and 20%.
- No. of animals per dose:
- Total: 30 animals
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE: Induction consisted of two stages, intradermal injection followed one week later by occluded patch application.
INTRADERMAL:
- No. of exposures: 6 injections (2 per test groups)
- Test groups: Freund's complete adjuvant (FCA), test material in liquid paraffin and test material in FCA.
- Duration: 1 weeks
- Concentrations: 0 % (only FCA), 10% in vehicle (liquid paraffin) and 10% in FCA. 0.1 ml each.
EPICUTANEOUS:
- No. of exposures: 1
- Exposure period: 48 h
- Test groups: Test material
- Concentrations: 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days after topical induction (day 21).
- Test groups: test material
- Concentrations: 10% and 20%
- Evaluation (hr after challenge): 24h, 48h and 72h after patch removal
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 30
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 30
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 30
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 30
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 30
- Reading:
- other: 3rd
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 30
Any other information on results incl. tables
No sensitization reactions were observed either in control groups.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- EU Criteria
- Conclusions:
- Under the experimental conditions applied, d-cyclocitronellene acetate was considered not sensitizer.
- Executive summary:
A guinea pig maximization test was conducted with thirty male Hartley Dunkin albino guinea pigs. Induction consisted of two stages, intradermal injection followed one week later by a 48 h occluded patch application. A total of 6 intradermal injections were administered. They comprised: 2 injections of 0.1 ml of 50% Freund’s complete adjuvant (FCA), 2 injections of 0.1 ml of a 10% solution of the test material in liquid paraffin; 2 injections of 0.1 ml of a 10% suspension of the test material in FCA (1:1). The topical induction concentration was 100%. Fourteen days after topical induction animals were challenged with 10 and 20% test material in liquid paraffin. The treatment sites were examined for evidence of sensitization 24, 48 and 72 h after patch removal. No sensitization reactions were observed.
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