Registration Dossier
Registration Dossier
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EC number: 203-012-6 | CAS number: 102-19-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- 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 journaks
Data source
Reference
- Reference Type:
- publication
- Title:
- Fragrance raw material monograph for the test chemical
- Author:
- D. L. J. Opdyke
- Year:
- 1 978
- Bibliographic source:
- Food and Cosmetics Toxicology,1978
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as per mentioned below
- Principles of method if other than guideline:
- To assess the dermal irritation potential of the test chemical in humans
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Isopentyl phenylacetate
- EC Number:
- 203-012-6
- EC Name:
- Isopentyl phenylacetate
- Cas Number:
- 102-19-2
- Molecular formula:
- C13H18O2
- IUPAC Name:
- isopentyl phenylacetate
- Test material form:
- not specified
- Details on test material:
- - Name of test material (IUPAC name): Isopentyl phenylacetate
- Common name: Isoamyl phenylacetate
- Molecular formula: C13H18O2
- Molecular weight: 206.283 g/mol
- Smiles notation: c1(CC(OCCC(C)C)=O)ccccc1
- InChl: 1S/C13H18O2/c1-11(2)8-9-15-13(14)10-12-6-4-3-5-7-12/h3-7,11H,8-10H2,1-2H3
- Substance type: Organic
Constituent 1
Test animals
- Species:
- other: humans
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- no data
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- other: Petrolatum
- Controls:
- not specified
- Amount / concentration applied:
- 2% in petrolatum
- Duration of treatment / exposure:
- 48 hours ,closed patch
- Observation period:
- 48 hours
- Number of animals:
- 29 human volunteers
- Details on study design:
- No data
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 48 h
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No signs of irritation observed
- Other effects:
- No data
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Conclusions:
- Since no signs of skin irritation were observed, the test chemical was considered to be not irritating to human skin after 48 hours exposure.
- Executive summary:
A skin irritation study was performed in humans to assess the irritation potential of test chemical 2% in petrolatum was tested on 29 human volunteers in a 48 hours closed patch test. The volunteers were observed for signs of irritation. Since no signs of skin irritation were observed, the test chemical was considered to be not irritating to human skin after 48 hours exposure.
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