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Toxicological information

Skin sensitisation

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Administrative data

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

Data source

Reference
Reference Type:
publication
Title:
Sensitization to patch test acrylates.
Author:
Kanerva, L., Estlander, T. & Jolanki R.
Year:
1988
Bibliographic source:
Contact Derm., 18, 10-15

Materials and methods

Test guideline
Qualifier:
according to
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.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
-Name of test material: N-tert-butylacrylamide
-Substance type:organic
-Physical state:Solid

In vivo test system

Test animals

Species:
human
Strain:
not specified
Sex:
not specified

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
1%
Day(s)/duration:
5 days
Adequacy of induction:
not specified
Challenge
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

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Group:
test group
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

Applicant's summary and conclusion

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.