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Toxicological information

Skin sensitisation

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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:
2008
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

Constituent 1
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

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.