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Description of key information

The skin sensitization potential of target chemical Menthone (CAS no: 89-80-5)  was assessedin various experimental studies which were conducted on humans and guinea pigs for target chemicalMenthone (CAS no: 89-80-5) andits structurally similar read across substances.Based on the available data for the target and read across substances and applying the weight of evidence approach, it can be concluded that chemical Menthone (CAS no: 89-80-5)  is unable to cause skin sensitization and thus can be considered as not sensitizing. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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
Reference:
Composition 0
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 information:
Composition 1
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
Species:
other: human
Strain:
other: Not applicable
Sex:
not specified
Details on test animals and environmental conditions:
No data available
Route:
intradermal and epicutaneous
Vehicle:
petrolatum
Concentration / amount:
8%
Day(s)/duration:
No data available
Adequacy of induction:
not specified
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
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
Cellular proliferation data / Observations:
No signs of sensitization were observed.
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Skin sensitization:

Various studieshas been investigated for the test chemicalMenthone (CAS no: 89-80-5)to observe the potential for skin sensitization to a greater or lesser extent. The studies are based on in vivo experiments in guinea pigs and humans for target chemicalMenthone (CAS no: 89-80-5) and its structurally similar read across substances.The predicted data usingDanish QSAR databasehas also been compared with the experimental data and summarized as below;

The D. L. J. Opdyke (1979) conducted aHuman maximisation test in 25 volunteers to determine skin sensitization potential caused by the target 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.

 

 

According to Danish QSAR database , the skin sensitization effects were estimated by using four different models i.e, Battery, Leadscope, SciQSAR and CASE Ultra used within for menthone (CAS no: 89-80-5) . Based on estimation, no skin sensitization reactions were observed in guinea pigs and humans. Therefore, menthone (CAS no: 89-80-5) was considered to be not sensitizing.

 

 

The above results were supported by the experimental study carried out by peer reviewed journalfor structurally similar read across substancein whichHuman maximisation test was conducted on 24 volunteers to assess the skin sensitization potential of test chemical. Since the chemical did not induce any skin sensitizing effects in treated volunteers, the test chemical wasconsidered to be not sensitizing to theskin of 24 human volunteers.

 

In the last study, an open repetitive dermal test was reported by OECD HPV Chemicals Programme (2003) for anotherstructurally similar read across substanceon 20 guinea pigs which further supports the above mentioned results. In this test,the chemicalwas rubbed into shaved skin for 30 sec once daily for 3x5 days. After 5 days without application, the test substance was rubbed into an untreated part of the skin. Skin lesions were examined after 24 h, 2 and 3 days. No known signs of skin sensitization were observed in treated guinea pigs during the 3 days observation period. Hence the test chemical wasconsidered to be not sensitizing to theskin of guinea pigs.

 

Based on the available data for the target and read across substances and applying the weight of evidence approach,it can be concluded that thechemical Menthone (CAS no: 89-80-5) is unable to cause skin sensitization and considered as non-skin sensitizer.Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The skin sensitization potential of test substance Menthone (CAS no: 89-80-5) andits structurally similar read across substanceswere observed in various studies. From the results obtained from these studies it is concluded that the chemical Menthone (CAS no: 89-80-5) is not likely to cause skin sensitization and hence can be classified as non-skin sensitizer.