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

Referenceopen allclose all

Reference Type:
publication
Title:
Fragrance Raw Material Monograph: d-Carvone
Author:
Edited by:D. L. J. Opdyke
Year:
1978
Bibliographic source:
Food and Cosmetics Toxicology, Volume 16, Supplement 1, 1978, Pages 673-674
Reference Type:
review article or handbook
Title:
Toxicology and Carcinogenesis Studies of d-Carvone (CAS No. 2244-16-8) in B6C3F1 Mice (Gavage Studies)
Author:
U.S. National Toxicology Program (NTP)
Year:
1990
Bibliographic source:
Toxicology and Carcinogenesis Studies of d-Carvone (CAS No. 2244-16-8) in B6C3F1 Mice (Gavage Studies),NTP TR 381, (Report Date: 1990)

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
To assess the dermal irritation potential of d-carvone in humans
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Name of test material: d-Carvone- IUPAC name: (5S)-2-methyl-5-(prop-1-en-2-yl)cyclohex-2-en-1-one- Molecular formula: C10H14O- Molecular weight: 150.22 g/mole- Smiles :C1[C@H](CC=C(C1=O)C)C(C)=C- Inchl: 1S/C10H14O/c1-7(2)9-5-4-8(3)10(11)6-9/h4,9H,1,5-6H2,2-3H3/t9-/m0/s1- Substance type: Organic- Physical state: Colorless
Specific details on test material used for the study:
- Name of test material: d-Carvone- IUPAC name: (5S)-2-methyl-5-(prop-1-en-2-yl)cyclohex-2-en-1-one- Molecular formula: C10H14O- Molecular Weight: 150.22 g/mole- Smiles Notation: C1[C@H](CC=C(C1=O)C)C(C)=C- Inchl: 1S/C10H14O/c1-7(2)9-5-4-8(3)10(11)6-9/h4,9H,1,5-6H2,2-3H3/t9-/m0/s1- Substance type: Organic- Physical state: Colorless to pale-yellow 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:
not specified
Vehicle:
other: petrolatum
Controls:
not specified
Amount / concentration applied:
2% in petrolatum
Duration of treatment / exposure:
48 hours
Observation period:
48 hours
Number of animals:
No data available
Details on study design:
No data available

Results and discussion

In vivo

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

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
d-carvone was not irritating to humans after 48 hours exposure.
Executive summary:

A skin irritation study was performed in humans to assess the irritation potential of d-carvone. d-carvone was tested 2% in petrolatum human volunteers in a 48 hours closed patch test. d-carvone was not irritating to humans after 48 hours exposure.