Registration Dossier
Registration Dossier
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EC number: 231-302-2 | CAS number: 7488-55-3
Skin sensitisation
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:
- 2 006
- 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
- 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
Constituent 1
- 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
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