Registration Dossier

Administrative data

Description of key information

The skin sensitization potential of test chemical was assessed in various experimental studies conducted on different subjects. Based on the available data for structurally and functionally similar read across substances, it can be concluded that the test chemical 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, other
Remarks:
(LLNA and 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
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 3 skin sensitization studies as- WoE-2, WoE-3 and WoE-4.
Skin sensitization of test chemical was determined by performing patch tests on humans.
GLP compliance:
not specified
Type of study:
other: 2.Buehler test 3.guinea pig maximisation test 4.guinea pig maximisation test
Justification for non-LLNA method:
Not specified
Species:
other: 2.guinea pig 3.guinea pig 4.guinea pig
Strain:
other: 2.not specified 3.not specified 4.not specified
Sex:
not specified
Details on test animals and environmental conditions:
2.No data available
3.No data available
4.No data available
Positive control results:
2.No data available
3.No data available
Reading:
other: 2.1st reading
Group:
test group
No. with + reactions:
0
Clinical observations:
No sensitization reaction observed after challenge application,
Remarks on result:
no indication of skin sensitisation
Reading:
other: 3.1st reading
Group:
test group
Dose level:
50 % active substance occlusive epicutaneous
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No sensitization reaction observed after challenge application,
Remarks on result:
no indication of skin sensitisation
Reading:
other: 4.1st reading
Group:
test group
Dose level:
No data available
No. with + reactions:
0
Clinical observations:
No skin allergic reactions were observed
Remarks on result:
no indication of skin sensitisation

2.No sensitization reaction observed after challenge application.

3.No sensitization reaction observed after challenge application.

4.No skin allergic reactions were observed.

Interpretation of results:
other: not sensitizing
Conclusions:
The test chemical was considered to be not sensitizing to the skin on the basis of summarized studies.
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. The studies are as mentioned below:

The skin sensitization study of test chemical was performed by Buehler test using OECD guideline 406 on guinea pig.No skin sensitization was observed after the challenge application.Hence,test chemical was considered as not skin sensitizing in guinea pig.

The skin sensitization study of test chemical was performed by guinea pig maximization method using OECD guideline 406 on guinea pig.The 30 animals were classified into two groups, test group 20 were as in control group 10 animals. In induction phase, first inductiongiven by intracutaneous route in concentration 5 % while in 2nd Induction 50 % active substance as occlusive epicutaneous applied .Challenge given using 50% concentration of active substance by epicutaneous route as occlusive patch. No skin sensitization was observed after the challenge application. Hence,test chemical was considered as not skin sensitizing to guinea pig.

Test chemical was used as a test material to evaluate skin sensitization potential according to OECD Guideline 406 "Skin Sensitization" on guinea pigs. No skin allergic reactions were observed. Hence, test chemical is considered to be not sensitizing to guinea pig skin.

Based on the above summarized studies for structurally and functionally similar read across substances,it can be concluded that the test chemical 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. The studies are as mentioned below:

The skin sensitization study of test chemical was performed by Buehler test using OECD guideline 406 on guinea pig.No skin sensitization was observed after the challenge application.Hence,test chemical was considered as not skin sensitizing in guinea pig.

The skin sensitization study of test chemical was performed by guinea pig maximization method using OECD guideline 406 on guinea pig.The 30 animals were classified into two groups, test group 20 were as in control group 10 animals. In induction phase, first inductiongiven by intracutaneous route in concentration 5 % while in 2nd Induction 50 % active substance as occlusive epicutaneous applied .Challenge given using 50% concentration of active substance by epicutaneous route as occlusive patch. No skin sensitization was observed after the challenge application. Hence,test chemical was considered as not skin sensitizing to guinea pig.

Test chemical was used as a test material to evaluate skin sensitization potential according to OECD Guideline 406 "Skin Sensitization" on guinea pigs. No skin allergic reactions were observed. Hence, test chemical is considered to be not sensitizing to guinea pig skin.

Based on the above summarized studies for structurally and functionally similar read across substances,it can be concluded that the test chemical 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 structurally and functionally similar read across substances were observed in various studies. From the results obtained from these studies it is concluded that the chemical is not likely to cause skin sensitization and hence can be classified as non-skin sensitizer.