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Toxicological information

Skin sensitisation

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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 peer reviewed journal

Data source

Reference
Reference Type:
publication
Title:
Monographs on Fragrance Raw Materials-Menthone racemic
Author:
D. L. J. Opdyke
Year:
1979
Bibliographic source:
Food and Cosmetics Toxicology 1979, Pages 522–523

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
A Human maximisation test was carried out in 25 volunteers to determine skin sensitization potential caused by the test chemical .
GLP compliance:
not specified
Type of study:
other: Human maximisation test
Justification for non-LLNA method:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- IUPAC Name: (2R,5S)-5-methyl-2-(propan-2-yl)cyclohexan-1-one- Common Name: Menthone/ trans-menthone- InChI: 1S/C10H18O/c1-7(2)9-5-4-8(3)6-10(9)11/h7-9H,4-6H2,1-3H3- Smiles:C1([C@@H](CC[C@@H](C1)C)C (C)C)=O- Molecular formula:C10H18O - Molecular weight :154.2512 g/mole- Substance type: Organic- Physical state: Clear liquid (colourless to yellowish)- Purity: 98% (by GC)
Specific details on test material used for the study:
- Name of test material: (2R,5S)-5-methyl-2-(propan-2-yl)cyclohexan-1-one- Common name : Menthone- Molecular formula: C10H18O- Molecular weight: 154.2512 g/mol- Substance type: Organic- Physical state: liquid -Smiles: C1([C@@H](CC[C@@H](C1)C)C(C)C)=O-InChI: 1S/C10H18O/c1-7(2)9-5-4-8(3)6-10(9)11/h7-9H,4-6H2,1-3H3

In vivo test system

Test animals

Species:
other: human
Strain:
other: Not applicable
Sex:
not specified
Details on test animals and environmental conditions:
No data available

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
petrolatum
Concentration / amount:
8%
Day(s)/duration:
No data available
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
8%
Day(s)/duration:
No data available
Adequacy of challenge:
not specified
No. of animals per dose:
25
Details on study design:
No data available
Challenge controls:
No data available

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Group:
test group
Dose level:
8%
No. with + reactions:
0
Total no. in group:
25
Clinical observations:
No signs of sensitization was observed.
Remarks on result:
no indication of skin sensitisation

In vivo (LLNA)

Cellular proliferation data / Observations:
No signs of sensitization were observed.

Applicant's summary and conclusion

Interpretation of results:
other: not sensitizing
Conclusions:
The test material Menthone (CAS no: 89-80-5) was considered to be not sensitizing to the skin of human volunteers .
Executive summary:

A Human maximisation test was carried out in 25 volunteers to determine skin sensitization potential caused by the chemicalMenthone (CAS no: 89-80-5).

 

Each subject was treated with 8% of Menthone in petrolatum dermally and later observed for any signs of contact allergy.

None of the volunteer showed any signs of contact sensitization. Hence the chemical Menthone (CAS no: 89-80-5) wasconsidered to be not sensitizing to theskin of human volunteers.