Registration Dossier
Registration Dossier
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EC number: 204-578-7 | CAS number: 122-84-9
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:
- Fragrance Raw Material Monographs - p-methoxyphenylacetone
- Author:
- Edited by D.L.J. Opdyke
- Year:
- 1 979
- Bibliographic source:
- Food and Cosmetics Toxicology, Volume 17, Supplement, December 1979, Page 857
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- To evaluate skin sensitization potential of 4-methoxyphenylacetone on 25 human volunteers.
- GLP compliance:
- not specified
- Type of study:
- other: Human maximization test
- Justification for non-LLNA method:
- Not specified
Test material
- Reference substance name:
- 4-methoxyphenylacetone
- EC Number:
- 204-578-7
- EC Name:
- 4-methoxyphenylacetone
- Cas Number:
- 122-84-9
- Molecular formula:
- C10H12O2
- IUPAC Name:
- 1-(4-methoxyphenyl)propan-2-one
- Details on test material:
- IUPAC name: p- methoxyphenylacetone
commen name:1-(p-Methoxyphenyl)-2-propanone
Molecular formula:C10H12O2
physical property: liquid
Molecular weight :164.203 g/mol
Substance type:organic
InChI:1S/C10H12O2/c1-8(11)7-9-3-5-10(12-2)6-4-9/h3-6H,7H2,1-2H3
Smiles: c1(ccc(OC)cc1)CC(C)=O
Constituent 1
- Specific details on test material used for the study:
- IUPAC name: p- methoxyphenylacetone
commen name:1-(p-Methoxyphenyl)-2-propanone
Molecular formula:C10H12O2
Molecular weight :164.203 g/mol
Substance type:organic
InChI:1S/C10H12O2/c1-8(11)7-9-3-5-10(12-2)6-4-9/h3-6H,7H2,1-2H3
Smiles: c1(ccc(OC)cc1)CC(C)=O
physical property: liquid
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:
- 4% in petroletum
- Day(s)/duration:
- 48 hours
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 4% in petrolatum
- Day(s)/duration:
- 48 hours
- 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:
- 4% in petrolatum
- Total no. in group:
- 25
- Clinical observations:
- No skin reaction were observed
- Remarks on result:
- no indication of skin sensitisation
In vivo (LLNA)
- Cellular proliferation data / Observations:
- No skin reaction observed
Applicant's summary and conclusion
- Interpretation of results:
- other: not skin sensitizing
- Conclusions:
- No sensitization reactions were observed in any of the volunteers. Hence, 4-methoxyphenylacetone 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 4-methoxyphenylacetone in humans.
4-methoxyphenylacetone was applied in concentration 4% in petrolatum to the skin of 25 human volunteers and observed till 48 hours.
No sensitization reactions were observed in any of the volunteers. Hence, 4-methoxyphenylacetone can be considered to be not sensitizing to human skin.
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