Registration Dossier
Registration Dossier
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EC number: 229-352-5 | CAS number: 6485-40-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
Data source
Reference
- Reference Type:
- publication
- Title:
- Monographs on Fragrance Raw Materials: l-Carvone.
- Author:
- Opdyke D. L. J.
- Year:
- 1 973
- Bibliographic source:
- Food and Cosmetics Toxicology, Volume 11, Issue 6, December 1973, Pages 1057-1058.
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Evaluation of the dermal irritation potential of l-carvone in humans.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- L-p-mentha-1(6),8-dien-2-one
- EC Number:
- 229-352-5
- EC Name:
- L-p-mentha-1(6),8-dien-2-one
- Cas Number:
- 6485-40-1
- Molecular formula:
- C10H14O
- IUPAC Name:
- (5R)-2-methyl-5-(prop-1-en-2-yl)cyclohex-2-en-1-one
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- other: humans
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- n.a
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- other: petrolatum
- Controls:
- not specified
- Amount / concentration applied:
- 1% in petrolatum
- Duration of treatment / exposure:
- 48 hours
- Observation period:
- 48 hours
- Number of animals:
- 25 human subjects
- Details on study design:
- n.a
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
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Conclusions:
- In conclusion, in this 48-hour closed-patch test in humans, L-carvone is considered to be non-irritating to the skin.
- Executive summary:
A 48-hrs closed-patch dermal irritation study was performed in humans to assess the irritation potential of l-carvone. 25 human subjects were topically exposed to l-carvone (concentration of 1% in petrolatum) for 48 hours. L-carvone was considered to be non-irritating to the human skin after 48 hours exposure.
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