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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 peerreviewed journal.

Data source

Reference
Reference Type:
publication
Title:
Fragrance raw materials monographs. Menthone Racemic
Author:
D. L. J. OPDYKE
Year:
1976
Bibliographic source:
Food and Cosm. Toxicology, Vol 14, Pp 475-476

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent
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
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 group
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.