Registration Dossier
Registration Dossier
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EC number: 214-049-2 | CAS number: 1074-95-9
Skin sensitisation
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 peerreviewed journal.
Data source
Reference
- Reference Type:
- publication
- Title:
- Fragrance raw materials monographs. Menthone Racemic
- Author:
- D. L. J. OPDYKE
- Year:
- 1 976
- Bibliographic source:
- Food and Cosm. Toxicology, Vol 14, Pp 475-476
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- To evaluate the skin sensitizing potential of 2-isopropyl-5-methylcyclohexanone in human by Human maximization test.
- GLP compliance:
- not specified
- Type of study:
- other: Human maximization test
- Justification for non-LLNA method:
- Sufficient for classification .
Test material
- Reference substance name:
- (±)-menthone
- EC Number:
- 214-049-2
- EC Name:
- (±)-menthone
- Cas Number:
- 1074-95-9
- Molecular formula:
- C10H18O
- IUPAC Name:
- 2-isopropyl-5-methylcyclohexanone
- 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
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 2-isopropyl-5-methylcyclohexanone
- Molecular formula: C10H18O
- Molecular weight: 154.2512 g/mol
- Substance type: Organic
- Physical state: Liquid
In vivo test system
Test animals
- Species:
- other: Human
- Strain:
- other:
- Remarks:
- Not applicable
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data available.
Study design: in vivo (non-LLNA)
Induction
- Route:
- other:
- Vehicle:
- petrolatum
- Concentration / amount:
- 8%
- Day(s)/duration:
- No data available.
- No. of animals per dose:
- 25 human Volunteers
- 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:
- 8%
- No. with + reactions:
- 0
- Total no. in group:
- 25
- Clinical observations:
- No sensitization was observed.
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
No sensitization was observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Human Maximization test for was performed on 25 human volunteers using 2-isopropyl-5-methylcyclohexanone at 8% concentration in petrolatum.The test substance 2-isopropyl-5-methylcyclohexanone (1074-95-9) was considered to be non-sensitizing in human.
- Executive summary:
Human Maximization test for was performed on 25 human volunteers using 2-isopropyl-5-methylcyclohexanone at 8% concentration in petrolatum. After test no sensitization reaction was observed in any human volunteers. Therefore, 2-isopropyl-5-methylcyclohexanone (1074-95-9) was considered to be non-sensitizing in human.
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