Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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.