Registration Dossier

Administrative data

Description of key information

The skin sensitization potential of target chemical was assessedin various Non- LLNA experimental studies for target and its structurally and functionally similar read across substances.Based on the available key data and supporting studies,it can be concluded thatchemical is unable to cause skin sensitization and considered as not sensitizing. 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:
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: as mentioned below
Principles of method if other than guideline:
Patch-Test 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:
human
Strain:
not specified
Sex:
not specified
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 studieshas been investigated for the test chemical to observe the potential for skin sensitization to a greater or lesser extent. The studies are based on in vivo experiments for target chemicaland its structurally and functionally similar read across substance which have summarized as below;

 

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.

 

The above result was supported by the 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 showedany signs ofskin sensitizing effects.Hence the test material was considered as not sensitizing to the skin of guinea pigs.

 

The overall results were supported by another maximization test conducted in guinea pigs according to OECD Test Guideline (TG) 406.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 data for the target chemical, supporting studies and read across substance,it can be concluded thatchemical is unable to cause skin sensitization and considered as not sensitizing. 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 similar read across substance 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.