Registration Dossier
Registration Dossier
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EC number: 203-013-1 | CAS number: 102-20-5
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 journals
Data source
Reference
- Reference Type:
- publication
- Title:
- Monograph on fragrance raw materials
- Author:
- D.L.J Opdyke
- Year:
- 1 975
- Bibliographic source:
- Food and Cosmetics Toxicology ,1975
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- To assess the dermal sensitization potential of the test chemical in humans
- GLP compliance:
- not specified
- Type of study:
- other: Human Maximization test
- Justification for non-LLNA method:
- Not specified
Test material
- Reference substance name:
- Phenethyl phenylacetate
- EC Number:
- 203-013-1
- EC Name:
- Phenethyl phenylacetate
- Cas Number:
- 102-20-5
- Molecular formula:
- C16H16O2
- IUPAC Name:
- 2-phenylethyl phenylacetate
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): Phenethyl phenylacetate
- Molecular Formula: C16H16O2
- Molecular Weight: 240.3 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
- Details on test animals and environmental conditions:
- no data available
Study design: in vivo (non-LLNA)
Induction
- Route:
- other: no data
- Vehicle:
- petrolatum
- Concentration / amount:
- 2% in petrolatum
- Day(s)/duration:
- no data available
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- other: no data
- Vehicle:
- petrolatum
- Concentration / amount:
- 2% in petrolatum
- Day(s)/duration:
- no data available
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 25 human volunteers
- 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
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 2% in petrolatum
- No. with + reactions:
- 0
- Total no. in group:
- 25
- Clinical observations:
- No sensitization reactions observed
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- No sensitization reactions were observed in any of the volunteers. Hence, the test chemical can be considered to be not sensitizing to human skin.
- Executive summary:
A maximization test was carried out to assess the dermal sensitization potential of the test chemical in humans. The test chemical was applied in concentration 2% in petrolatum to the skin of 25 human volunteers and observed for signs of dermal irritation or sensitization. No sensitization reactions were observed in any of the volunteers. Hence, the test chemical can be considered to be not sensitizing to human skin.
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