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Diss Factsheets

Administrative data

Description of key information

The skin sensitization potential of target chemical3,3-Dimethyl-8,9-dinorbornan-2-one (CAS No: 1195-79-5) was assessedin various experimental studies which were conducted on guinea pigs and humans for target chemical 3,3-Dimethyl-8,9-dinorbornan-2-one (CAS No: 1195-79-5) andits structurally similar read across substancesFenchyl acetate (CAS No: 13851-11-1) and alpha-Fenchyl alcohol (CAS No: 512-13-0). The predicted data usingQSAR toolbox and Danish QSAR databasehas also been compared with the experimental data.Based on the available data for the target and read across substances and applying the weight of evidence approach, it can be concluded that chemical3,3-Dimethyl-8,9-dinorbornan-2-one (CAS No: 1195-79-5) 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
Qualifier:
according to guideline
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 chemical .
GLP compliance:
not specified
Type of study:
other: Human maximisation test
Justification for non-LLNA method:
No data available
Specific details on test material used for the study:
- Name of test material : 3, 3-Dimethyl-8, 9-dinorbornan-2-one
- Common name : 1,3,3-trimethylbicyclo[2.2.1]heptan-2-one
- Molecular formula : C10H16O
- Molecular weight : 152.2354 g/mol
- Smiles notation : C[C@@]12CC[C@@H](C1)C(C)(C)C2=O
- InChl : 1S/C10H16O/c1-9(2)7-4-5-10(3,6-7)8(9)11/h7H,4-6H2,1-3H3/t7-,10+/m0/s1
- Substance type: Organic
- Physical state: Liquid
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:
4%
Day(s)/duration:
No data available
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
4%
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 chemical
Dose level:
4%
No. with + reactions:
0
Total no. in group:
25
Clinical observations:
No signs of sensitization were 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 Fenchone (CAS No: 1195-79-5) 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 chemicalFenchone (CAS No: 1195-79-5).

 

Each subject was treated with 4% of Fenchone (CAS No: 1195-79-5) 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 Fenchone (CAS No: 1195-79-5) wasconsidered to be not sensitizing to theskin of human volunteers.

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

Various studieshas been investigated for the test chemical3,3-Dimethyl-8,9-dinorbornan-2-one (CAS No: 1195-79-5) 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 chemical3,3-Dimethyl-8,9-dinorbornan-2-one / Fenchone (CAS No: 1195-79-5) and its structurally similar read across substanceFenchyl acetate (CAS No: 13851-11-1) and alpha-Fenchyl alcohol (CAS No: 512-13-0).The predicted data usingDanish QSAR databasethe has also been compared with the experimental data and summarized as below;

The D.L.J. Opdyke {Food and Cosmetics Toxicology 1979, Pages 380–382}carried outaHuman maximisation test in 25 volunteers to determine skin sensitization potential caused by the target chemical3,3-Dimethyl-8,9-dinorbornan-2-one (CAS No: 1195-79-5). Each subject was treated with 4% of Fenchone (CAS No: 1195-79-5) 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 Fenchone (CAS No: 1195-79-5) 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 for 3,3-Dimethyl-8,9-dinorbornan-2-one (CAS No: 1195-79-5) . Based on estimation, no skin sensitization reactions were observed in guinea Pig and Human. Therefore, 3,3-Dimethyl-8,9-dinorbornan-2-one (CAS No: 1195-79-5) was considered to be not sensitizing.

 

The above results were further supported by anotherHuman maximization tests conducted byD.L.J. Opdyke for read across chemicals Fenchyl acetate (CAS No: 13851-11-1) and alpha-Fenchyl alcohol (CAS No: 512-13-0) as below;

In case of Fenchyl acetate (CAS No: 13851-11-1) {Food and Cosmetics Toxicology 1979, Pages 383},maximization testwas conducted on 25 volunteers.Under the test conditions, none of the volunteers had developed any signs of skin sensitization when applied dermally at a dose of 5% in petrolatum. Hence the chemical Fenchyl acetate (CAS No: 13851-11-1) wasconsidered to be not sensitizing to theskin of human volunteers.

 In maximization test of alpha-Fenchyl alcohol (CAS No: 512-13-0) {Food and Cosmetics Toxicology 1979, Pages 384–385}, the test chemical was applied on 24 volunteers at a concentration of 4% in petrolatum.

 None of the volunteers had developed any signs of skin sensitization. Hence the chemical alpha-Fenchyl alcohol (CAS No: 512-13-0) was considered to benot sensitizing to theskin of volunteers.

 

Based on the available data for the target chemical, supporting studies and read across substance,it can be concluded thatchemical 3,3-Dimethyl-8,9-dinorbornan-2-one (CAS No: 1195-79-5) is unable to cause skin sensitization and considered as not sensitizing . 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 substance3,3-Dimethyl-8,9-dinorbornan-2-one (CAS No: 1195-79-5) and its structurally similar read across substanceFenchyl acetate (CAS No: 13851-11-1) and alpha-Fenchyl alcohol (CAS No: 512-13-0) were observed in various studies. From the results obtained from these studies it is concluded that the chemical3,3-Dimethyl-8,9-dinorbornan-2-one (CAS No: 1195-79-5) is not likely to cause skin sensitization and hence can be classified as non-skin sensitizer.