Registration Dossier

Administrative data

Description of key information

The results from the studies lead to a possibility of the test chemical being not sensitizing to skin. By applying the weight of evidence approach, the test chemical can be considered to 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”.

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
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 2,3,4 are referred as study 1,2,3
GLP compliance:
not specified
Type of study:
other: Weight of evidence based on structurally similar substances
Justification for non-LLNA method:
Currently no LLNA Study is available for assessment.
Species:
other: guinea pigs and humans
Strain:
not specified
Sex:
not specified
Route:
epicutaneous, occlusive
Vehicle:
not specified
Concentration / amount:
12%
Day(s)/duration:
5 alternate-day 48-hour periods
Adequacy of induction:
other: for 24 hours with 2.5% aqueous sodium lauryl sulfate under occlusion
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
The first injection consisted of 0.05 ml of the test material, whereas the subsequent 9 injections consisted of 0.1 ml each
Day(s)/duration:
every other day or 3 times weekly
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
not specified
Concentration / amount:
12%
Day(s)/duration:
48 hours
Adequacy of challenge:
other: Sodium lauryl sulfate (5%-15%) was applied to the test site for 1 hour before the application of the challenge.
No.:
#1
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
0.05 ml of a freshly prepared 0.1% test chemical
Day(s)/duration:
24 hours
Adequacy of challenge:
not specified
No. of animals per dose:
1. not specified
2. 25 human volunteers
3. 2 male guinea pigs
Details on study design:
The study is based on weight of evidence approach from the read across values
Challenge controls:
no data available
Positive control substance(s):
not specified
Reading:
1st reading
Group:
test group
Clinical observations:
no dermal reactions observed
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
other: not sensitizing
Conclusions:
The results from these studies lead to a possibility of the test chemical being not sensitizing to skin. By applying the weight of evidence approach, the test chemical can be considered to 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:

The dermal sensitization potential of the test chemical is being estimated based on the experimental data for the various test chemicals.  

Skin sensitization effects were estimated by four different models i.e, Battery, Leadscope, SciQSAR and CASE Ultra used within Danish QSAR database for the test chemical. Based on estimation, no skin sensitization reactions were observed in guinea pigs and humans. Therefore, the test chemical was considered to be not sensitizing.

This estimated result is supported by a human maximization assay performed to determine the degree of dermal sensitivity caused by the test chemical. 12% of the test chemical was applied for 5 alternate-day 48-hour periods on the volar side of the arm of 25 participants after pretreatment for 24 hours with 2.5% aqueous sodium lauryl sulfate under occlusion. Sodium lauryl sulfate (5%-15%) was applied to the test site for 1 hour before the application of the challenge. There were no signs of sensitization for either the 48- or 72-hour challenge. Hence, the test chemical was considered to be not sensitizing to the skin of humans.

The above results are supported by the study conducted on 2 male white guinea pigs to determine the degree of dermal sensitivity caused by the test chemical. 0.1% Test material was dissolved in physiological saline. The test material was injected “intracutaneously” every other day or 3 times weekly until a total of 10 injections had been made. The first injection consisted of 0.05 ml of the test material, whereas the subsequent 9 injections consisted of 0.1 ml each. Two weeks following the tenth injection, a challenge injection was made using 0.05 ml of a freshly prepared 0.1% test chemical in physiological saline. Twenty-four hours after each injection, evaluations were made of the diameter, height, and color of skin reactions. No skin reactions were observed. Therefore, the test chemical was considered to be non-sensitizing to skin of guinea pigs.

The results from these studies lead to a possibility of the test chemical being not sensitizing to skin. By applying the weight of evidence approach, the test chemical can be considered to 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”.

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

The dermal sensitization potential of the test chemical is being estimated based on the experimental data for the various test chemicals.

 

Skin sensitization effects were estimated by four different models i.e, Battery, Leadscope, SciQSAR and CASE Ultra used within Danish QSAR database for the test chemical. Based on estimation, no skin sensitization reactions were observed in guinea pigs and humans. Therefore, the test chemical was considered to be not sensitizing.

 

This estimated result is supported by a human maximization assay performed to determine the degree of dermal sensitivity caused by the test chemical.

12% of the test chemical was applied for 5 alternate-day 48-hour periods on the volar side of the arm of 25 participants after pretreatment for 24 hours with 2.5% aqueous sodium lauryl sulfate under occlusion. Sodium lauryl sulfate (5%-15%) was applied to the test site for 1 hour before the application of the challenge. There were no signs of sensitization for either the 48- or 72-hour challenge.

Hence, the test chemical was considered to be not sensitizing to the skin of humans.

The above results are supported by the study conducted on 2 male white guinea pigs to determine the degree of dermal sensitivity caused by the test chemical. 0.1% Test material was dissolved in physiological saline. The test material was injected “intracutaneously” every other day or 3 times weekly until a total of 10 injections had been made. The first injection consisted of 0.05 ml of the test material, whereas the subsequent 9 injections consisted of 0.1 ml each. Two weeks following the tenth injection, a challenge injection was made using 0.05 ml of a freshly prepared 0.1% test chemical in physiological saline. Twenty-four hours after each injection, evaluations were made of the diameter, height, and color of skin reactions.

No skin reactions were observed. Therefore, the test chemical was considered to be non-sensitizing to skin of guinea pigs.

The results from these studies lead to a possibility of the test chemical being not sensitizing to skin. By applying the weight of evidence approach, the test chemical can be considered to 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”.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The results of the experimental studies indicate a possibility that the test chemical can be not sensitizing to skin.

Hence by applying the weight of evidence approach, the test chemical can be considered to be not sensitizing to skin. It can be classified under the category “Not Classified” as per CLP regulation.