Registration Dossier
Registration Dossier
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EC number: 231-323-7 | CAS number: 7492-66-2
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 peer reviewed journal.
Data source
Reference
- Reference Type:
- publication
- Title:
- Fragrance raw materials monographs on Citral diethyl acetal
- Author:
- D. L. J. Opdyke
- Year:
- 1 983
- Bibliographic source:
- Food and Chemical Toxicology, Volume 21, Issue 5, October 1983, Page 667
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- 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 substance name:
- 1,1-diethoxy-3,7-dimethylocta-2,6-diene
- EC Number:
- 231-323-7
- EC Name:
- 1,1-diethoxy-3,7-dimethylocta-2,6-diene
- Cas Number:
- 7492-66-2
- Molecular formula:
- C14H26O2
- IUPAC Name:
- 1,1-diethoxy-3,7-dimethylocta-2,6-diene
- Details on test material:
- 1,1-diethoxy-3,7-dimethylocta-2,6-diene
Constituent 1
- 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 chemical
- 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.
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