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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:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Method of Marzulli-Maibach
GLP compliance:
yes
Type of study:
patch test
Justification for non-LLNA method:
LLNA method was not realized because another test was available

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Ref : 13L508D

In vivo test system

Test animals

Species:
human
Sex:
male/female
Details on test animals and environmental conditions:
ranging in age from 22 to 69 years

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
160 µl/patch (dilution : 10%)
Challengeopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
160 µl/patch (dilution : 10%)
No. of animals per dose:
109
Details on study design:
induction phase : 160 µl of test item covered the surface of the patch and was removed each wednesday, friday and monday then the site was scored by the investigator 20 minutes after patch removal. Dermal responses for this phase were scored.
Challenge phase : after a rest period of 2 weeks (no application of the test article), the challenge patch was applied to a previously unpatched and patched test site. The site was scored 20 minutes, 24 and 48 hours after removal.

Results and discussion

Positive control results:
During the induction phase : there were no responses to any subject
During the challenge phase : there were no responses to any subject

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Group:
test chemical
Dose level:
160µl
No. with + reactions:
0
Total no. in group:
109
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
160µl
No. with + reactions:
0
Total no. in group:
109

Any other information on results incl. tables

The test item can be considered as non sensitizer

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item can be considered as non sensitizer