Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: no guideline followed, study in human
Data waiving:
other justification
Justification for data waiving:
other:

Data source

Reference
Reference Type:
review article or handbook
Title:
Safety evaluation of certain contaminants in food - Part: Inorganic Tin (addendum)
Author:
WHO, Kroes
Year:
2006
Bibliographic source:
WHO Food addivies series: 55

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
patch test in human
GLP compliance:
not specified
Type of study:
patch test

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
human

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, open
Concentration / amount:
no data
Challenge
Concentration / amount:
no data
No. of animals per dose:
no data

Study design: in vivo (LLNA)

Concentration:
no data
No. of animals per dose:
no data

Results and discussion

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
Sn°2+ -salts are sensitising for human