Registration Dossier
Registration Dossier
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EC number: 211-932-4 | CAS number: 713-95-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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 journals
Data source
Reference
- Reference Type:
- publication
- Title:
- delta–dodecalactone.
- Author:
- D.L.J.Opdyke
- Year:
- 1 979
- Bibliographic source:
- Food and Cosmetics Toxicology, Volume 17, Supplement, December 1979, Pages 773-774
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Maximization test
- Principles of method if other than guideline:
- A maximization test was performed to determine the sensitization potential of the test chemical
- GLP compliance:
- not specified
- Type of study:
- other: Maximization test
- Justification for non-LLNA method:
- Currently no LLNA study is available for assessment.
Test material
- Reference substance name:
- Dodecan-5-olide
- EC Number:
- 211-932-4
- EC Name:
- Dodecan-5-olide
- Cas Number:
- 713-95-1
- Molecular formula:
- C12H22O2
- IUPAC Name:
- 6-heptyloxan-2-one
- Test material form:
- liquid
- Details on test material:
- - Name of the test material : Dodecan 5- olide
- Molecular formula : C12H22O2
- Molecular weight : 198.31 g/mol
- Substance type : Organic
- Physical state : Liquid
Constituent 1
In vivo test system
Test animals
- Species:
- other: humans
- Strain:
- not specified
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 12% in petrolatum
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 12% in petrolatum
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 30
- Details on study design:
- no data available
- Challenge controls:
- no data available
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 12% in petrolatum
- No. with + reactions:
- 0
- Total no. in group:
- 30
- Clinical observations:
- No dermal reactions observed
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- The test chemical 12% in petrolatum did not induce any sensitization reactions on the skin of 30 human volunteers. Hence, the test chemical was considered to be not sensitizing to skin.
- Executive summary:
A human maximization test was carried out to assess the dermal sensitization potential of the test chemical. The test chemical 12% in petrolatum was applied to the skin of 30 human volunteers and observed for signs of dermal sensitization (duration of exposure, observation period not specified).
The test chemical 12% in petrolatum did not induce any sensitization reactions on the skin of 30 human volunteers. Hence, the test chemical was considered to be not sensitizing to skin.
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