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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Data is from experimental reports following standard procedures

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1962
Report date:
1962

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Evaluation of the irritating and sensitizing potentials of the test chemical in humans.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one
EC Number:
204-846-3
EC Name:
3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one
Cas Number:
127-51-5
Molecular formula:
C14H22O
IUPAC Name:
3-methyl-4-(2,6,6-trimethylcyclohex-2-en-1-yl)but-3-en-2-one
Test material form:
liquid
Details on test material:
- Name of test material : 3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one
- Common name : alpha-isomethyl ionone
- Molecular formula : C14H22O
- Molecular weight : 206.327 g/mol
- Smiles notation : C1([C@@H](\C=C(\C(C)=O)C)C(=CCC1)C)(C)C
- InChl : 1S/C14H22O/c1-10-7-6-8-14(4,5)13(10)9-11(2)12(3)15/h7,9,13H,6,8H2,1-5H3/b11-9+
- Substance type : Organic
- Physical state : Liquid

Test animals

Species:
human
Strain:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: the age of the volunteers lies between 24 - 56
A total of 28 volunteers were randomly selected for the study. Of these 28 human subjects, 15 were male and 13 were female.

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
other: 10% w/v alcohol
Controls:
not specified
Amount / concentration applied:
0.5 ml (the test sample was made up as a 10% (w/v) solution in alcohol)
Duration of treatment / exposure:
24 hours
Observation period:
24 hours
Number of animals:
Pilot study: 5 volunteers
Main study: 23 volunteers
Details on study design:
All applications were made as closed patches which were subsequently secured by overlying strips of firmly secured adhesive tape. These closed patches covered 0.5 ml of diluted test sample.The patches were applied on the arms of the human subjects.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The pilot study group of 5 volunteers and remaining 23 volunteers completed the assay without any reaction
Other effects:
No data available

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
The pilot study group of 5 volunteers and remaining 23 volunteers completed the assay without any reactions. Therefore, it was reported that the test chemical was not a primary skin irritant.
Executive summary:

The objective of the assay was to study the irritating and sensitizing potentials of the test sample when applied to humans as a 10% solution in alcohol.

A total of 28 volunteers were randomly selected for the study. Of these 28 human subjects, 15 were male and 12 were female. The test sample was made up as a 10% (w/v) solution in alcohol. Immediately upon receiving the test sample, patches were applied to five of the volunteers as a preliminary check for primary irritation. Since no reactions were found in the 5 volunteers after 24 hours. The remaining individuals also had their arms patched. All applications were made as closed patches which were subsequently secured by overlying strips of firmly secured adhesive tape. These closed patches covered 0.5 of diluted test sample. The patches were applied on the arms of the human subjects. The pilot study group of 5 volunteers and remaining 23 volunteers completed the assay without any reactions. Therefore, it was reported that the test chemical was not a primary skin irritant.