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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

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.