Registration Dossier

Administrative data

Description of key information

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the skin sensitization potential of the test chemical (2α,4aα,8β)-hexahydro-1,1,5,5-tetramethyl-2H-2,4a-methanonaphthalen-8(5H)-one (CAS No: 29461-13-0). The studies are as mentioned below:

 

A Human maximization test of test chemical was conducted by peer reviewed journal on 24 volunteers for similar read across chemical. None of the volunteers had developed any signs of skin sensitization. Hence the chemical was considered to be not sensitizing to the skin of human volunteers.

 

The above result was further supported by another maximization study carried out by peer reviewed journal in 25 volunteers for another similar read across chemical. During the test, each subject was treated with 4% of test chemical in petrolatum dermally and later observed for any signs of contact allergy. None of the volunteer showed any signs of contact sensitization. Hence the test chemical was considered to be not sensitizing to the skin of human volunteers.

 

Based on the above summarized studies for target chemical (2α,4aα,8β)-hexahydro-1,1,5,5-tetramethyl-2H-2,4a-methanonaphthalen-8(5H)-one (CAS No: 29461-13-0) and its structurally and functionally similar read across substances,it can be concluded that the testchemical 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”.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
experimental data of read across substances
Justification for type of information:
Data for the target chemical is summarized based on the structurally and functionally similar read across chemicals
Reason / purpose:
read-across source
Related information:
Composition 1
Reason / purpose:
read-across source
Related information:
Composition 1
Reference:
Composition 0
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
WoE report is based on 2 skin sensitization studies as- WoE-2 and WoE-3.
Skin sensitization of test chemical was determined by performing patch tests on humans.
GLP compliance:
not specified
Type of study:
other: Human maximization test
Justification for non-LLNA method:
not specified
Test material information:
Composition 1
Specific details on test material used for the study:
Name: (2α,4aα,8β)-hexahydro-1,1,5,5-tetramethyl-2H-2,4a-methanonaphthalen-8(5H)-one
InChI:1S/C15H24O/c1-13(2)7-6-11(16)12-14(3,4)10-5-8-15(12,13)9-10/h10,12H,5-9H2,1-4H3/t10-,12+,15-/m0/s1
Smiles:CC1(C)[C@H]2CC[C@]3(C2)[C@@H]1C(=O)CCC3(C)C
Molecular Formula: C15H24O
Molecular Weight: 220.3536 g/mole
Species:
other: Human
Strain:
other: Not specified
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:
1.24
2.25
Details on study design:
No data available
Reading:
1st reading
Group:
test group
Dose level:
4%
No. with + reactions:
0
Total no. in group:
24
Clinical observations:
No skin sensitization was observed.
Remarks on result:
no indication of skin sensitisation
Cellular proliferation data / Observations:
No skin sensitization was observed.
Interpretation of results:
other: not sensitizing
Conclusions:
The test material (2α,4aα,8β)-hexahydro-1,1,5,5-tetramethyl-2H-2,4a-methanonaphthalen-8(5H)-one (CAS No: 29461-13-0) was considered to be not sensitizing to the skin of human volunteers.
Executive summary:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the skin sensitization potential of the test chemical (2α,4aα,8β)-hexahydro-1,1,5,5-tetramethyl-2H-2,4a-methanonaphthalen-8(5H)-one (CAS No: 29461-13-0). The studies are as mentioned below:

 

A Human maximization test of test chemical was conducted by peer reviewed journal on 24 volunteers for similar read across chemical. None of the volunteers had developed any signs of skin sensitization. Hence the chemical was considered to be not sensitizing to the skin of human volunteers.

 

The above result was further supported by another maximization study carried out by peer reviewed journal in 25 volunteers for another similar read across chemical. During the test, each subject was treated with 4% of test chemical in petrolatum dermally and later observed for any signs of contact allergy. None of the volunteer showed any signs of contact sensitization. Hence the test chemical was considered to be not sensitizing to the skin of human volunteers.

 

Based on the above summarized studies for target chemical (2α,4aα,8β)-hexahydro-1,1,5,5-tetramethyl-2H-2,4a-methanonaphthalen-8(5H)-one (CAS No: 29461-13-0) and its structurally and functionally similar read across substances,it can be concluded that the testchemical 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”.

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

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the skin sensitization potential of the test chemical (2α,4aα,8β)-hexahydro-1,1,5,5-tetramethyl-2H-2,4a-methanonaphthalen-8(5H)-one (CAS No: 29461-13-0). The studies are as mentioned below:

 

A Human maximization test of test chemical was conducted by peer reviewed journal on 24 volunteers for similar read across chemical. None of the volunteers had developed any signs of skin sensitization. Hence the chemical was considered to be not sensitizing to the skin of human volunteers.

 

The above result was further supported by another maximization study carried out by peer reviewed journal in 25 volunteers for another similar read across chemical. During the test, each subject was treated with 4% of test chemical in petrolatum dermally and later observed for any signs of contact allergy. None of the volunteer showed any signs of contact sensitization. Hence the test chemical was considered to be not sensitizing to the skin of human volunteers.

 

Based on the above summarized studies for target chemical (2α,4aα,8β)-hexahydro-1,1,5,5-tetramethyl-2H-2,4a-methanonaphthalen-8(5H)-one (CAS No: 29461-13-0) and its structurally and functionally similar read across substances,it can be concluded that the testchemical 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 (2α,4aα,8β)-hexahydro-1,1,5,5-tetramethyl-2H-2,4a-methanonaphthalen-8(5H)-one (CAS No: 29461-13-0) and its structurally and functionally similar read across substanceswere observed in various studies. From the results obtained from these studies it is concluded that the chemical (2α,4aα,8β)-hexahydro-1,1,5,5-tetramethyl-2H-2,4a-methanonaphthalen-8(5H)-one (CAS No: 29461-13-0) is not likely to cause skin sensitization and hence can be classified as non-skin sensitizer.