Registration Dossier
Registration Dossier
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EC number: 205-413-1 | CAS number: 140-39-6
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 journal .
Data source
Reference
- Reference Type:
- publication
- Title:
- Fragrance material monograph for p-cresylacetate
- Author:
- D. L.J Opdyke
- Year:
- 1 974
- Bibliographic source:
- Food and Cosmetics Toxicology, Volume 12, Issue 3, June 1974, Page 391
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- A maximization test was carried out with p-tolyl acetate on 25 human subjects.
- GLP compliance:
- not specified
- Type of study:
- other: Maximization test
- Justification for non-LLNA method:
- not specified
Test material
- Reference substance name:
- p-tolyl acetate
- EC Number:
- 205-413-1
- EC Name:
- p-tolyl acetate
- Cas Number:
- 140-39-6
- Molecular formula:
- C9H10O2
- IUPAC Name:
- 4-methylphenyl acetate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 4-methylphenyl acetate
- Molecular formula: C9H10O2
- Molecular weight: 150.176 g/mol
- Substance type: Organic
- Physical state: Liquid
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: No data available.
- Vehicle:
- petrolatum
- Concentration / amount:
- 4%
- Day(s)/duration:
- No data available
Challenge
- Route:
- other: No data available.
- Vehicle:
- petrolatum
- Concentration / amount:
- 4%
- Day(s)/duration:
- No data available.
- 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
- Key result
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 4%
- No. with + reactions:
- 0
- Total no. in group:
- 25
- Clinical observations:
- No sensitization was observed
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitizing
- Conclusions:
- The p-tolyl acetate (CAS No. 140-39-6) was tested at 4% concentration in petrolatum and produced no sensitisation reactions.
- Executive summary:
A maximization test was carried out on 25 volunteers. The p-tolyl acetate (CAS No. 140-39-6) was tested at 4% concentration in petrolatum and produced no sensitisation reactions. Thus, it is not classified as skin snsitizer as per CLP regulation.
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