Registration Dossier

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:
other: no guideline followed, study in human

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
Justification for non-LLNA method:
historical data form human reported by who

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
-

In vitro test system

Details on study design:
-

In chemico test system

Details on study design:
-

In vivo test system

Test animals

Species:
human

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, open
Vehicle:
not specified
Concentration / amount:
no data
Day(s)/duration:
no data
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
other: no relevant based on test protocol
Vehicle:
other: no relevant based on test protocol
Concentration / amount:
no data
Day(s)/duration:
no relevant based on test protocol
Adequacy of challenge:
other: no relevant based on test protocol
No. of animals per dose:
no data
Positive control substance(s):
not required

Study design: in vivo (LLNA)

Vehicle:
not specified
Concentration:
no data
No. of animals per dose:
no data
Positive control substance(s):
other: no relevant based on test protocol

Results and discussion

In vivo (non-LLNA)

Results
Key result
Reading:
other: no relevant based on test protocol, human
Hours after challenge:
1
Group:
other: no relevant based on test protocol
Dose level:
no relevant based on test protocol
No. with + reactions:
-1
Total no. in group:
1
Clinical observations:
positive result in human
Remarks on result:
other: positive in human
Remarks:
the value in filed hours, no with reaction and total based 1 is for TCC. There is no value given in literature, only positive result in human is reported

Applicant's summary and conclusion

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