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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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 journal.

Data source

Reference
Reference Type:
publication
Title:
Fragrance raw materials monographs: 4-(p-methoxyphenyl) butan-2-one
Author:
D. L. J. Opdyke
Year:
1974
Bibliographic source:
Food and Cosmetics Toxicology. 12, 929, 1974

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-(p-methoxyphenyl) butan-2-one on human.
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-(4-methoxyphenyl)butan-2-one
Cas Number:
104-20-1
Molecular formula:
C11H14O2
IUPAC Name:
4-(4-methoxyphenyl)butan-2-one
Details on test material:
IUPAC: 4-(p-methoxyphenyl)butan-2-one
commen name: anisyl acetone
Molecular formula:C11H14O2
Molecular weight : 178.23 g/mole
Substance type: Organic
InChI :1S/C11H14O2/c1-9(12)3-4-10-5-7-11(13-2)8-6-10/h5-8H,3-4H2,1-2H3
Smiles :c1(ccc(OC)cc1)CCC(C)=O
physical property: colourless oily liquid
Specific details on test material used for the study:
IUPAC: 4-(p-methoxyphenyl)butan-2-one
commen name: anisyl acetone
Molecular formula:C11H14O2
Molecular weight : 178.23 g/mole
Substance type: Organic
InChI :1S/C11H14O2/c1-9(12)3-4-10-5-7-11(13-2)8-6-10/h5-8H,3-4H2,1-2H3
Smiles :c1(ccc(OC)cc1)CCC(C)=O
physical property: colourless oily liquid

In vivo test system

Test animals

Species:
other: Human
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
25 human volunteers were used

Study design: in vivo (non-LLNA)

Induction
Route:
other: not specified
Vehicle:
petrolatum
Concentration / amount:
5% in petrolatum
Day(s)/duration:
no data available
Adequacy of induction:
not specified
Challenge
Route:
other: not specified
Vehicle:
petrolatum
Concentration / amount:
5% in petrolatum
Day(s)/duration:
No data available
Adequacy of challenge:
not specified
No. of animals per dose:
25 human volunteers were used
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:
5% in petrolatum
Total no. in group:
25
Clinical observations:
no skin reaction 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:
The substance 4-(p-methoxyphenyl) butan-2-one produced no skin reactions on 25 human volunteers 4-(p-methoxyphenyl) butan-2-one is considered to be non-sensitizing to human skin.
Executive summary:

Maximization test was done to evaluate sensitization effect produce by 4-(p-methoxyphenyl) butan-2-one in human subjects.Test was carried out on 25 human volunteers. The material was tested at a concentration of 5% in petrolatum and produced no sensitization reactions. Therefore, the substance 4-(p-methoxyphenyl) butan-2-one is considered to be non-sensitizing to human skin.