Registration Dossier
Registration Dossier
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EC number: 204-052-7 | CAS number: 114-70-5
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 from secondary source
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Fragrance raw materials monographs for CAS no: 103-82-2
- Author:
- D.L.J. Opdyke
- Year:
- 1 975
- Bibliographic source:
- Food and Cosmetics Toxicology Volume 13, Issue 6, 1975, Pages 901-902
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- Skin sensitization study of Phenylacetic acid was performed by human Maximization test in human
- GLP compliance:
- not specified
- Type of study:
- patch test
- Justification for non-LLNA method:
- No data available
Test material
- Reference substance name:
- Phenylacetic acid
- EC Number:
- 203-148-6
- EC Name:
- Phenylacetic acid
- Cas Number:
- 103-82-2
- Molecular formula:
- C8H8O2
- IUPAC Name:
- phenylacetic acid
- Details on test material:
- - Name of test material (as cited in study report): Phenylacetic acid
- Molecular formula : C8H8O2
- Molecular weight : 136.149 g/mol
- Substance type: Organic
- Physical state: Solid
- Purity: No data available
- Impurities (identity and concentrations): No data available
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Phenylacetic acid
- Molecular formula : C8H8O2
- Molecular weight : 136.149 g/mol
- Substance type: Organic
- Physical state: Solid
- Purity: No data available
- Impurities (identity and concentrations): No data available
In vivo test system
Test animals
- Species:
- other: Human
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data available
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 2%
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 2%
- 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
Study design: in vivo (LLNA)
- Statistics:
- No data available
Results and discussion
- Positive control results:
- No data available
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 2%
- No. with + reactions:
- 0
- Total no. in group:
- 25
- Clinical observations:
- No skin sensitization reaction was noted
- Remarks on result:
- no indication of skin sensitisation
In vivo (LLNA)
- Cellular proliferation data / Observations:
- no skin sensitization reaction was noted
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- The skin sensitization test for phenylacetic acid (103-82-2) was considered to be non- sensitizing to humans.
- Executive summary:
Skin sensitization test was performed on 25 human volunteers by maximization test at 2% concentration in petrolatum. After observation no skin sensitization reaction was noted. Hence phenylacetic acid (103-82-2) was considered to be non- sensitizing to humans.
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