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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
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 peer reviewed journal.

Data source

Reference
Reference Type:
publication
Title:
Fragrance raw materials monographs on Citral diethyl acetal
Author:
D. L. J. Opdyke
Year:
1983
Bibliographic source:
Food and Chemical Toxicology, Volume 21, Issue 5, October 1983, Page 667

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: As mentioned below
Principles of method if other than guideline:
To evaluate the skin sensitizing potential of 1,1-diethoxy-3,7-dimethylocta-2,6-diene in Human by Human maximization test.
GLP compliance:
not specified
Type of study:
other: Human maximization test.
Justification for non-LLNA method:
Not specified.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
1,1-diethoxy-3,7-dimethylocta-2,6-diene
Specific details on test material used for the study:
- Name of test material: 1,1-diethoxy-3,7-dimethylocta-2,6-diene
- Molecular formula: C14H26O2
- Molecular weight: 226.35 g/mol
- Smiles notation: O(C(OCC)C=C(CCC=C(C)C)C)CC
- Substance type: Liquid
- Physical state: Organic

In vivo test system

Test animals

Species:
other: Human
Strain:
other:
Remarks:
Not applicable.
Sex:
not specified
Details on test animals and environmental conditions:
No data available

Study design: in vivo (non-LLNA)

Induction
Route:
other: Topical application
Vehicle:
petrolatum
Concentration / amount:
4%
Challenge
Route:
other: Topical application
Vehicle:
petrolatum
Concentration / amount:
4%
No. of animals per dose:
25 human
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: No data available.
- Exposure period: No data available.
- Test groups: 25 human
- Control group: No data available.
- Site: No data available.
- Frequency of applications: No data available.
- Duration: No data available.
- Concentrations: 4%

B. CHALLENGE EXPOSURE
- No. of exposures: No data available.
- Day(s) of challenge: No data available.
- Exposure period: No data available.
- Test groups: 25 human
- Control group: No data available.
- Site: No data available.
- Concentrations: 4%
- Evaluation (hr after challenge): No data available.

Challenge controls:
No data available.
Positive control substance(s):
not specified

Study design: in vivo (LLNA)

Statistics:
No data available.

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Group:
test group
Dose level:
4%
No. with + reactions:
0
Total no. in group:
25
Clinical observations:
No skin sensitization effect were observed.
Remarks on result:
no indication of skin sensitisation

Any other information on results incl. tables

No indication of skin sensitization was observed.

Applicant's summary and conclusion

Interpretation of results:
other: Not sensitizing.
Conclusions:
1,1-diethoxy-3,7-dimethylocta-2,6-diene (7492-66-2) was observed for its skin sensitizing potential in human by human maximization test. 1,1-diethoxy-3,7-dimethylocta-2,6-diene was considered to be non sensitizing in human.
Executive summary:

Skin sensitization for1,1-diethoxy-3,7-dimethylocta-2,6-diene (7492-66-2)was assessed for its possible contact allergenic potential. For this purpose was Human maximization test was performed on 25 human. The test material was used at the concentration of 4% in petrolatum. No skin sensitization effect was observed in any human .Therefore1,1-diethoxy-3,7-dimethylocta-2,6-diene (7492-66-2) was considered to be non sensitizing in human.