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Administrative data

Description of key information

Short description of key information:
sensitising in human

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: no guideline followed, study in human
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
Specific details on test material used for the study:
-
Species:
other: human
Route:
epicutaneous, open
Vehicle:
not specified
Concentration / amount:
no data
Day(s)/duration:
no data
Adequacy of induction:
not specified
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
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
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
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

In a WHO (2006) report Sn2+ -salts are reported to produce sensitisation in human. So the substance is classified as skin sensitising (H317) according to Regulation (EC) No 1272/2008.

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