Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
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 materials monographs: Menthone Racemic
Author:
D. L. J. OPDYKE
Year:
1976
Bibliographic source:
Food and Cosm. Toxicology Vol 14, 1976, Pp 475-476,1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
A Closed-patch test was performed on human volunteers to assess the irritation potential of 2-isopropyl-5-methylcyclohexanone
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Name of test material: 2-isopropyl-5-methylcyclohexanone
- Molecular formula: C10H18O
- Molecular weight: 154.2512g/mol
- Smiles notation: C1([C@@H](CC[C@@H](C1)C)C(C)C)=O
- InChl: 1S/C10H18O/c1-7(2)9-5-4-8(3)6-10(9)11/h7-9H,4-6H2,1-3H3
- Substance type: Organic
- Physical state: liquid
Specific details on test material used for the study:
- Name of test material: 2-isopropyl-5-methylcyclohexanone [(±)-menthone]
- Molecular formula: C10H18O
- Molecular weight: 154.2512g/mol
- Smiles notation: C1([C@@H](CC[C@@H](C1)C)C(C)C)=O
- InChl: 1S/C10H18O/c1-7(2)9-5-4-8(3)6-10(9)11/h7-9H,4-6H2,1-3H3
- Substance type: Organic
- Physical state: liquid

Test animals

Species:
other: humans
Strain:
not specified
Details on test animals and environmental conditions:
no data available

Test system

Type of coverage:
occlusive
Preparation of test site:
other: closed patch
Vehicle:
other: petrolatum
Controls:
not specified
Amount / concentration applied:
8% in petrolatum
Duration of treatment / exposure:
48 hours
Observation period:
48 hours
Number of animals:
no data available

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
48 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No irritation observed

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
2-isopropyl-5-methylcyclohexanone was considered to be not irritating to human skin.
Executive summary:

A Closed-patch test was performed on human volunteers to assess the irritation potential of 2-isopropyl-5-methylcyclohexanone. 2-isopropyl-5-methylcyclohexanone was applied at 8% in petrolatum for 48 hrs. After 48 hrs 2-isopropyl-5-methylcyclohexanone was observed to cause no irritation in humans.

 

Therefore, 2-isopropyl-5-methylcyclohexanone was considered to be not irritating to human skin.