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Toxicological information

Skin sensitisation

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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:
1990
Bibliographic source:
Dermatologic Clinics, 1990 Jan;8(1):107-9.

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other:
Principles of method if other than guideline:
Patch-Test
GLP compliance:
not specified
Type of study:
patch test

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

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 group
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.