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Description of key information

The sensitization potential of test chemical was assessed in 22 patients by patch testing.

None of the patients experienced sensitization to test chemical although one patient showed slight to moderate irritation from this compound. Hence the test chemical can be considered as not sensitizing to the skin.

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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from publication
Qualifier:
according to guideline
Guideline:
other: Patch-Test
Principles of method if other than guideline:
Patch-Test was conducted to determine the skin sensitisation effects of test chemical on humans.
GLP compliance:
not specified
Type of study:
patch test
Justification for non-LLNA method:
Currently no LLNA study is available for assessment. The patch test has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD.
Species:
other: humans
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
Source: Department of Dermatology, Institute of Occupational Health, Finland
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
1%
Day(s)/duration:
5 days
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
1%
Day(s)/duration:
5 days
Adequacy of challenge:
not specified
No. of animals per dose:
22
Details on study design:
- No. of exposures: 1
- Exposure period: 24 hours
- Test groups: 22 patients
- Control group: not specified
- Site: on the back
- Frequency of applications: 1
- Duration: 5 days
- Concentrations: 1%
- Evaluation: the test site was read on patch removal and after 24, 48, 72 and 96-120 hours.
OTHER: the test chemical was applied on the back with a non-occlusive porous tape (Scanpor Surgical Tape) or when the back is full of patch test, thighs were used.
Challenge controls:
not specified
Positive control substance(s):
not specified
Reading:
1st reading
Group:
test chemical
Dose level:
1%
No. with + reactions:
0
Total no. in group:
22
Clinical observations:
one patient showed slight to moderate irritation from this compound
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
other: not sensitising
Conclusions:
None of the patients experienced sensitization to test chemical although one patient showed slight to moderate irritation from this compound. Hence the test chemical can be considered as not sensitizing to the skin.
Executive summary:

The sensitization potential of test chemical was assessed in 22 patients by patch testing. The patients were treated with 1% of test chemical in petrolatum for 24 hours under occlusive condition.

The test chemical was applied on the back with a non-occlusive porous tape (Scanpor Surgical Tape) or when the back is full of patch test, thighs were used. The test site was read on patch removal and after 24, 48, 72 and 96-120 hours.

None of the patients experienced sensitization to test chemical although one patient showed slight to moderate irritation from this compound. Hence the test chemical can be considered as not sensitizing to the skin.

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

Various studies have been reviewed to determine the allergic potential of the test chemical in living organisms. These include in vivo experimental studies performed on humans, guinea pigs for the various test chemicals. The results are mentioned as follows:

The sensitization potential of test chemical was assessed in 22 patients by patch testing. The patients were treated with 1% of test chemical in petrolatum for 24 hours under occlusive condition.

The test chemical was applied on the back with a non-occlusive porous tape (Scanpor Surgical Tape) or when the back is full of patch test, thighs were used. The test site was read on patch removal and after 24, 48, 72 and 96-120 hours.

None of the patients experienced sensitization to test chemical although one patient showed slight to moderate irritation from this compound. Hence the test chemical can be considered as not sensitizing to the skin.

This is supported by the results of another Patch test performed with the various acrylic monomers to identify their cross sensitization patterns.

The patch tests(AI test, IMECO, Stockholm, Sweden) were applied to the back of 5 patients for 48 hours and reactions were read after 72 hours and 120 hours. The test chemical was tested at 1% and 5% in petrolatum. The second testing with 5% in petrolatum after 1% in petrolatum was carried out to reinforce the conclusion that the first negative response was not due to the inadequate concentration tested.

The test chemical gave a negative response when tested at 1% and 5% in petrolatum in all the patients tested. Hence, the test chemical can be considered to be not sensitizing to skin.

The above patch test results are supported by a Guinea pig maximization test conducted to assess the skin sensitization potential of test chemical.

In the maximization test, 15 Hartley strain guinea-pigs were each given intradermal injections of test chemical together with an adjuvant, followed 7 days later with a 48-h covered patch. A challenge patch (24-h covered contact) was applied 7 days after this induction regimen.

None of the treated guinea pigs showed any signs of skin sensitizing effects. Hence the test material was considered as not sensitizing to the skin of guinea pigs.

These results are further supported by another Guinea pig Maximization test performed according to OECD 406to assess the skin sensitization potential of test chemical in guinea pigs. 

During induction phase, animals were initially induced intradermally on day zero with 0.1 % of the chemical and topically with 100 % of the chemical on day seven. The treated guinea pigs were challenged on day 21 at 100% concentration.

The test chemical did not cause skin sensitization in treated guinea pigs. Hence the test material was considered as not sensitizing to the skin of guinea pigs.

Based on the available results for the test chemicals, it can be considered that the test chemical certainly lacks the potential to cause any allergic reactions to the skin. Hence, it can be considered to be not sensitizing to skin.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available results for the test chemicals, it can be considered that the test chemical certainly lacks the potential to cause any allergic reactions to the skin. Hence, it can be considered to be not sensitizing to skin.