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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. Also the predicted data for target chemical using the Danish QSAR database has also been compared with the experimental data. Based on the above summarized studies for target chemical 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:
calculation (if not (Q)SAR)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
accepted calculation method
Justification for type of information:
Data is from Danish QSAR.
Qualifier:
according to guideline
Guideline:
other: As mentioned below
Principles of method if other than guideline:
The data is predicted using Danish QSAR database.
GLP compliance:
not specified
Justification for non-LLNA method:
Allergic Contact Dermatitis in Guinea Pig and Human
Species:
other: Guinea Pig and Human
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data available.
Route:
other: No data available.
Route:
other: No data available.
No. of animals per dose:
No data available.
Details on study design:
No data available.
Challenge controls:
No data available.
Positive control substance(s):
not specified
Reading:
1st reading
Group:
test chemical
Clinical observations:
No sensitization observed
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
other: Not sensitizing
Conclusions:
According to Danish QSAR database, skin sensitization effects were estimated by using four different models i.e, Battery, Leadscope, SciQSAR and CASE Ultra for test chemical. Based on estimation, no Allergic Contact Dermatitis effects were observed when test chemical was exposed to human and guinea pig skin. Hence, the test chemical can be considered as not sensitizing to skin.
Executive summary:

According to Danish QSAR database, skin sensitization effects were estimated by using four different models i.e, Battery, Leadscope, SciQSAR and CASE Ultra for test chemical. Based on estimation, no Allergic Contact Dermatitis effects were observed when test chemical was exposed to human and guinea pig skin. Hence, the test chemical can be considered as not sensitizing to skin.

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. Also the predicted data for target chemical using the Danish QSAR database has also been compared with the experimental data and summarized as below:

 

According to Danish QSAR database, skin sensitization effects were estimated by using four different models i.e, Battery, Leadscope, SciQSAR and CASE Ultra for test chemical. Based on estimation, no Allergic Contact Dermatitis effects were observed when test chemical was exposed to human and guinea pig skin. Hence, the test chemical can be considered as not sensitizing to skin.

 

The above predicted data was supported by a Human maximization test of similar read across chemical was conducted on 24 volunteers to assess its skin sensitization potential. When the chemical was applied at a dose of 4% in petrolatum, none of the treated volunteers had developed any signs of skin sensitization. Hence the test chemical was considered to be not sensitizing to the skin of human volunteers.

 

Another Human maximization test of closely related chemical was conducted on 25 volunteers. None of the volunteers had developed any signs of skin sensitization when applied dermally at a dose of 5% in petrolatum. Hence the test chemical was considered to be not sensitizing to the skin of human volunteers.

 

The overall results were further supported by a maximization test carried out for another closely related chemical with 10% (6900 µg/cm2) test material in petrolatum on 26 male volunteers. Test material was applied under occlusion to the same site on the forearms of 26 male subjects for five alternate day, 48-h periods. Patch sites were pre-treated for 24 h with 5% aqueous sodium lauryl solution (SLS) under occlusion for the initial patch only. After 10–14 day rest period, a challenge patch was applied to a fresh site for 48 h under occlusion. Challenge applications were preceded by 30 minute applications of 5% aqueous SLS under occlusion on the left side whereas is test material was applied without SLS treatment on the right side. No sensitization reactions were observed. Hence, test material was considered to be not sensitizing to skin.

 Based on the above summarized studies for target chemical 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 and its 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.