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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from peer reviewed journals

Data source

Reference
Reference Type:
publication
Title:
Skin sensitization study of the test chemical
Author:
Van Ketel WG
Year:
1990
Bibliographic source:
Dermatologic Clinics

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Patch test
Principles of method if other than guideline:
Patch-Test were performed to assess the dermal sensitization potential of the test chemical
GLP compliance:
not specified
Type of study:
patch test
Justification for non-LLNA method:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Potassium iodide
EC Number:
231-659-4
EC Name:
Potassium iodide
Cas Number:
7681-11-0
Molecular formula:
IK
IUPAC Name:
potassium iodide
Details on test material:
- Name of test material : Potassium iodide
- Molecular formula : KI
- Molecular weight : 165.998g/mol
- Smiles notation : [K+].[I-]
- InChl : 1S/HI.K/h1H;/q;+1/p-1
- Substance type : Inorganic
- Physical state : Solid

In vivo test system

Test animals

Species:
other: humans
Strain:
not specified
Sex:
not specified

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
Ranging from 5 to 20 per cent
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, open
Vehicle:
petrolatum
Concentration / amount:
Ranging from 5 to 20 %
Adequacy of challenge:
not specified
No. of animals per dose:
Total 8 patients were tested
Details on study design:
no data available
Challenge controls:
no data available
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:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: not sensitizing
Conclusions:
In five of eight patients tested with the test chemical in concentrations ranging from 5 to 20 per cent in petrolatum, the reactions were negative for skin sensitisation. Hence the test chemical was considered to be not sensitizing to skin.
Executive summary:

Patch tests were conducted to determine the dermal sensitization potential of the test chemical in humans. 8 patients were tested with the test chemical in concentrations ranging from 5 to 20 per cent in petrolatum, and observed for signs of irritation. (duration not specified). In five of eight patients tested with the test chemical, the reactions were negative for skin sensitisation. Hence the test chemical was considered to be not sensitizing to skin.