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Toxicological information

Skin sensitisation

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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:
1979
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

Constituent 1
Chemical structure
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)acetone
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
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.