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Description of key information

Skin sensitization study was conducted on 5 Guinea Pigs for the test chemical. The test chemical was not sensitizing to the skin of any of the 5 Guinea Pigs. Therefore the test chemical was considered to be not sensitizing in Guinea Pigs.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
data is from NTRL reports
Qualifier:
according to guideline
Guideline:
other: As mentioned below
Principles of method if other than guideline:
Skin Sensitization potential of the test chemical was assessed on guinea pigs
GLP compliance:
not specified
Type of study:
other: standardized test
Justification for non-LLNA method:
not specified
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data available.
Route:
other: no data available
Vehicle:
not specified
Adequacy of induction:
not specified
No.:
#1
Route:
other: No data available.
Vehicle:
not specified
Adequacy of challenge:
not specified
No. of animals per dose:
5 guinea pigs
Details on study design:
No data available.
Challenge controls:
No data available.
Positive control substance(s):
not specified
Statistics:
No data available.
Key result
Reading:
1st reading
Group:
test chemical
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No sensitization was observed
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
other: Not sensitizing
Conclusions:
The test chemical was not sensitizing to the skin of any of the 5 Guinea Pigs. Therefore the test chemical was considered to be not sensitizing inGuinea Pigs.
Executive summary:

Skin sensitization study was conducted on 5 Guinea Pigs for the test chemical. The test chemical was not sensitizing to the skin of any of the 5 Guinea Pigs. Therefore the test chemical was considered to be not sensitizing inGuinea Pigs.

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

Various studies have been investigated to determine the allergenic potential of the test chemical in living organisms. The results include in vivo experimental studies in guinea pigs as well as humans for the test chemicals. The results are summarized as follows:

Skin sensitization study was conducted on 5 Guinea Pigs for the test chemical. The test chemical was not sensitizing to the skin of any of the 5 Guinea Pigs. Therefore the test chemical was considered to be not sensitizing in Guinea Pigs.

This is supported by the results of Human maximization test performed to evaluate skin sensitization potential of the test chemical.

The test chemical was applied in concentration 2% in petrolatum on the skin of 25 human volunteers.

No skin reactions were observed. Hence, the test chemical can be considered as not skin sensitizer for human skin.

The above results are further supported by an Open Epicutaneous Test (OET) performed on guinea pigs to assess the skin sensitization potential of test chemical. The Pretest was performed to establish the primary irritating threshold concentration of test substance. For this, a single application of 0.025 ml of each test concentration (e.g, 100, 30, 10 and 3%) is simultaneously performed on one of the areas measuring 2 cm2 of the flank skin previously clipped and marked with a circular stamp. Reactions are read 24 h after the application of the test material. On the basis of preliminary study, the maximal non-irritating concentration selected was 4%. Thus the sensitization test was conducted at a dose of 4% of test chemical. On day 1 during induction, 0.1 ml of test chemical was applied at concentrations of 4% in vehicle to an area measuring 8 cm2 on the clipped flank skin of the guinea pigs. The applications are repeated daily for 3 weeks or done 5 times weekly during 4 weeks, usually on the same skin sites. The application sites were left uncovered and the reactions, if continuous daily applications were performed, can be read 24 h after each application, or at the end of each week. To determine whether or not contact sensitization was induced, all groups of guinea pigs previously treated for 21 days, as well as 10 untreated, or only pretreated with the vehicle, controls are tested on days 21 and 35 on the contralateral flank with the test material. This test was performed by applying with a pipette 0.025 ml of each concentration to skin areas measuring 2 cm2. The reactions were read after 24, 48 and/or 72h. It was observed that none of the guinea pigs induced contact sensitization at challenge concentration of 4%.Thus, the test chemical was considered to be not sensitizing on skin of guinea pigs at concentration of 4% in an Open Epicutaneous Test (OET).

These results are also supported by a similar Open Epicutaneous Test (OET) performed on guinea pigs to assess the skin sensitization potential of the test chemical. The pretest was performed to determine the primary irritating threshold concentration of test substances at various concentrations (e.g, 100, 30, 10 and 3%). In this test, a single application of 0.025 ml of each test concentration was simultaneously performed on one of the areas measuring 2 cm2 of the flank skin previously clipped and marked with a circular stamp. Reactions are read 24 h after the application of the test material. On the basis of pretest, the concentration selected for sensitization test was 8 %.

On day 1 during induction, 0.1 ml of 8% test chemical was applied to an area measuring 8 cm2 on the clipped flank skin of the guinea pigs. The applications are repeated daily for 3 weeks or done 5 times weekly during 4 weeks, usually on the same skin sites. The application sites were left uncovered and the reactions, if continuous daily applications were performed, can be read 24 h after each application, or at the end of each week. To determine whether or not contact sensitization was induced, all groups of guinea pigs previously treated for 21 days, as well as 10 untreated, or only pretreated with the vehicle, controls are tested on days 21 and 35 on the contralateral flank with the test material. This test was performed by applying with a pipette 0.025 ml of chemical to skin areas measuring 2 cm2. The reactions were read after 24, 48 and/or 72h.

It was observed that none of the guinea pigs induced contact sensitization at challenge concentration of 2%. Thus, the test chemical was considered to be not sensitizing on skin of guinea pigs when tested via an Open Epicutaneous Test (OET).

Based on the available results and 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

Based on the available results and 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” .