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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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 from human reported by WHO

Test material

Constituent 1
Chemical structure
Reference substance name:
Tin sulphate
EC Number:
231-302-2
EC Name:
Tin sulphate
Cas Number:
7488-55-3
Molecular formula:
O4S.Sn
IUPAC Name:
λ²-tin(2+) sulfate
Specific details on test material used for the study:
-

In vivo test system

Test animals

Species:
other: 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: challenge no relevant based on test protocol
Vehicle:
other: not relevant based on test protocol
Concentration / amount:
no data
Day(s)/duration:
not relevant based on test protocol
Adequacy of challenge:
other: challenge not relevant based on test protocol
No. of animals per dose:
no data
Positive control substance(s):
not required

Results and discussion

In vivo (non-LLNA)

Results
Key result
Reading:
other: not relevant based on test protocol, human
Hours after challenge:
1
Group:
other: not relevant based on test protocol
Dose level:
not relevant based on test protocol
No. with + reactions:
1
Total no. in group:
1
Clinical observations:
positive result reported in human
Remarks on result:
other: positive in human
Remarks:
the value "1" is entered to "hours after challenge", "No. with + reactions" and "Total No. in group" for completeness reasons only. There is no value given in literature, only positive result in human is reported

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Remarks:
based on EU GHS criteria
Conclusions:
Sn°2+ -salts are reported to produce sensitisation in human