Registration Dossier

Administrative data

Description of key information

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:
1 (reliable without restriction)
Qualifier:
according to
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
Species:
human
Sex:
male/female
Details on test animals and environmental conditions:
ranging in age from 22 to 69 years
Route:
epicutaneous, semiocclusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
160 µl/patch (dilution : 10%)
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.
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
Reading:
1st reading
Group:
test group
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 group
Dose level:
160µl
No. with + reactions:
0
Total no. in group:
109

The test item can be considered as non sensitizer

Interpretation of results:
GHS criteria not met
Conclusions:
The test item can be considered as non sensitizer
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification