Registration Dossier
Registration Dossier
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EC number: 232-191-3 | CAS number: 7789-80-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- publication
- Title:
- Sensitization to povidone-iodine.
- Author:
- Van Ketel WG, van den Berg WH.
- Year:
- 1 990
- Bibliographic source:
- Dermatologic Clinics, 1990 Jan;8(1):107-9.
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- Patch-Test
- GLP compliance:
- not specified
- Type of study:
- patch test
Test material
- Reference substance name:
- Potassium iodide
- EC Number:
- 231-659-4
- EC Name:
- Potassium iodide
- Cas Number:
- 7681-11-0
- IUPAC Name:
- potassium iodide
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): potassium iodide
- Substance type: Inorganic
- Physical state: Solid
Constituent 1
In vivo test system
Test animals
- Species:
- human
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: no data
- Vehicle:
- petrolatum
- Concentration / amount:
- Ranging from 5 to 20 per cent
Challengeopen allclose all
- Route:
- other: no data
- Vehicle:
- petrolatum
- Concentration / amount:
- Ranging from 5 to 20 per cent
- No. of animals per dose:
- Total 8 patients were tested
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- Concentrations ranging from 5 to 20 per cent in petrolatum
- No. with + reactions:
- 3
- Total no. in group:
- 8
- Clinical observations:
- In five of eight patients, the reactions were negative
- Remarks on result:
- other: Reading: 1st reading. Group: test group. Dose level: Concentrations ranging from 5 to 20 per cent in petrolatum. No with. + reactions: 3.0. Total no. in groups: 8.0. Clinical observations: In five of eight patients, the reactions were negative.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In five of eight patients, tested with potassium iodide in concentrations ranging from 5 to 20 per cent in petrolatum, the reactions were negative for skin sensitisation.
- Executive summary:
In five of eight patients, tested with potassium iodide in concentrations ranging from 5 to 20 per cent in petrolatum, the reactions were negative for skin sensitisation.
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