Registration Dossier

Administrative data

Description of key information

Based on the available data and applying the weight of evidence approach, it can be estimated that the test chemical can be not sensitizing to skin.Comparing the above annotations with the criteria of CLP regulation,the test chemicalcan 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:
Weight of evidence approach based on various test chemicals
Justification for type of information:
Weight of evidence approach based on various test chemicals
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
other: Weight of evidence approach based on various test chemicals
Principles of method if other than guideline:
Weight of evidence approach based on various test chemicals. The study 2,3 are referred as study 1,2
GLP compliance:
not specified
Type of study:
other: Weight of evidence approach based on various test chemicals
Species:
other: humans
Strain:
not specified
Sex:
male/female
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
5% aqueous test chemical
Adequacy of induction:
not specified
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
1% aqueous test chemical
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
5% aqueous test chemical
Adequacy of challenge:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
1% aqueous test chemical
Adequacy of challenge:
not specified
No. of animals per dose:
1. 14 patients
2. 14 patients
Positive control substance(s):
not specified
Reading:
1st reading
Group:
test group
No. with + reactions:
0
Clinical observations:
no dermal reactions observed
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
other: not sensitizing
Conclusions:
Based on the available data and applying the weight of evidence approach, it can be estimated that the test chemical can be not sensitizing to skin. Comparing the above annotations with the criteria of CLP regulation, the test chemical can be classified under the category “Not Classified”.
Executive summary:

Various studies have been summarized to ascertain the level of dermal sensitization caused by test chemical in living organisms. These results include in vivo experimental studies performed on humans, for the test chemicals.

Patch tests were performed with aqueous solution of test chemical to determine the degree of allergenic reactions.

Patch tests were carried out with European Standard series except for primin(TRUE TEST) with 5% aqueous test chemical were tested. The patches were applied to the backs of 14 volunteers (10male and 5 female) and were read at 2 and 3 days according to the recommendations of the ICDRG.

Positive patch test reactions were further assessed as irritant or allergic.

Positive reactions were observed in only 1 volunteer. The test chemical was considered to be an insensitive test agent, mostly due to its poor solubility.

Hence, the test chemical can be considered to be not sensitizing to skin.

This is supported by the results of a patch test conducted to determine the degree of contact sensitization caused by the chemical.

The patches were applied to the backs of 14 volunteers (10male and 5 female) at concentration of 1% of aqueous solution of test chemical and were read at 2 and 3 days according to the recommendations of the ICDRG. Positive patch test reactions were further assessed as irritant or allergic.

Since only one volunteer had positive reaction out of 14 patients, the test material was considered as not sensitizing to the skin at tested concentration.

Based on the available data and applying the weight of evidence approach, it can be estimated that the test chemical can be not sensitizing to skin.Comparing the above annotations with the criteria of CLP regulation,the test chemicalcan be classified under the category “Not Classified”.

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

Various studies have been summarized to ascertain the level of dermal sensitization caused by test chemical in living organisms. These results include in vivo experimental studies performed on humans, for the test chemicals.

Patch tests were performed with aqueous solution of test chemical to determine the degree of allergenic reactions.

Patch tests were carried out with European Standard series except for primin(TRUE TEST) with 5% aqueous test chemical were tested. The patches were applied to the backs of 14 volunteers (10male and 5 female) and were read at 2 and 3 days according to the recommendations of the ICDRG.

Positive patch test reactions were further assessed as irritant or allergic.

Positive reactions were observed in only 1 volunteer. The test chemical was considered to be an insensitive test agent, mostly due to its poor solubility.

Hence, the test chemical can be considered to be not sensitizing to skin.

This is supported by the results of a patch test conducted to determine the degree of contact sensitization caused by the chemical.

The patches were applied to the backs of 14 volunteers (10male and 5 female) at concentration of 1% of aqueous solution of test chemical and were read at 2 and 3 days according to the recommendations of the ICDRG. Positive patch test reactions were further assessed as irritant or allergic.

Since only one volunteer had positive reaction out of 14 patients, the test material was considered as not sensitizing to the skin at tested concentration.

Based on the available data and applying the weight of evidence approach, it can be estimated that the test chemical can be not sensitizing to skin.Comparing the above annotations with the criteria of CLP regulation,the test chemicalcan be classified under the category “Not Classified”.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available data and applying the weight of evidence approach, it can be estimated that the test chemical can be not sensitizing to skin.Comparing the above annotations with the criteria of CLP regulation,the test chemical can be classified under the category “Not Classified”.