Registration Dossier

Administrative data

Description of key information

Skin sensitisation

Based on the result obtained from the studies available for the structurally similar read across chemicals, it can be concluded that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.

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 from various test chemicals
Justification for type of information:
Data is summarized based on the available information from various test chemicals.
Reason / purpose:
read-across source
Reason / purpose:
read-across source
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
Species:
other: Human
Strain:
other: Not specified
Sex:
not specified
Details on test animals and environmental conditions:
not specified
Route:
intradermal and epicutaneous
Vehicle:
petrolatum
Remarks:
2 and 3
Concentration / amount:
4%
Day(s)/duration:
No data available
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Remarks:
2 and 3
Concentration / amount:
4%
Day(s)/duration:
No data available
Adequacy of challenge:
not specified
No. of animals per dose:
2. Total = 24
3. Total = 25
Details on study design:
not specified
Challenge controls:
not specified
Positive control substance(s):
not specified
Positive control results:
not specified
Reading:
1st reading
Group:
test group
Dose level:
4%
No. with + reactions:
0
Total no. in group:
24
Clinical observations:
No signs of sensitization were observed.
Remarks on result:
no indication of skin sensitisation
Remarks:
2
Reading:
1st reading
Group:
test group
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
Remarks:
3
Interpretation of results:
other: not sensitizing
Conclusions:
Based on the result obtained from the studies available for the structurally similar read across chemicals, it can be concluded that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.
Executive summary:

The skin sensitization potential was assessed based on the available results from the various test chemicals.These studies have been summarized as below -

 

A Human maximization test was conducted for the given test chemical on 24 volunteers to assess its skin sensitization potential. None of the volunteers had developed any signs of skin sensitization. Hence the test chemical was considered to be not sensitizing to the skin of human volunteers.

 

The above study was supported with another Human maximization test carried out in 25 volunteers to determine skin sensitization potential caused by the chemical. 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 result obtained from the studies available for the structurally similar read across chemicals, it can be considered that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.

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

Skin sensitization

The skin sensitization potential was assessed based on the available results from the various test chemicals.These studies have been summarized as below -

 

A Human maximization test was conducted for the given test chemical on 24 volunteers to assess its skin sensitization potential. None of the volunteers had developed any signs of skin sensitization. Hence the test chemical was considered to be not sensitizing to the skin of human volunteers.

 

The above study was supported with another Human maximization test carried out in 25 volunteers to determine skin sensitization potential caused by the chemical. 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 result obtained from the studies available for the structurally similar read across chemicals, it can be considered that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.

 

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the result obtained from the studies available for the structurally similar read across chemicals, it can be concluded that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.