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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

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
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

Constituent 1
Chemical structure
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
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.