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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)

Data source

Reference
Reference Type:
publication
Title:
Persistence of patch test reactions to clioquinol (Vioform) and cross-sensitization
Author:
Soesman-van Waadenoijen Kernekamp A, van Ketel WG.
Year:
1980
Bibliographic source:
Contact Dermatitis. 1980 Dec;6(7):455-60.

Materials and methods

Principles of method if other than guideline:
Patch Test
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:
Clioquinol
EC Number:
204-984-4
EC Name:
Clioquinol
Cas Number:
130-26-7
Molecular formula:
C9H5ClINO
IUPAC Name:
clioquinol

In vivo test system

Test animals

Species:
human
Sex:
male/female

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, open
Vehicle:
petrolatum
Concentration / amount:
5%
Challenge
Concentration / amount:
5%
No. of animals per dose:
Ten patients
Details on study design:
Patch tests were performed on the back according to the criteria of the ICDRG (Fregert & Bandmann 1975) and were read after 48 h. In patients 4 and 8 (Table 2), positive reactions to clioquinol were found after 96 and 72 h, respectively, in the tests performed previously. Altogether in each patient 15 patch tests were applied.

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
72
Group:
test chemical
Dose level:
5%
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
Sensitizing
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 72.0. Group: test group. Dose level: 5%. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: Sensitizing.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Clioquinol was found to be sensitising to human skin by patch test test.
Executive summary:

Clioquinol was found to be sensitising to human skin bypatch test test..Ten patients with positive patch test reactions to clioquinol were retested in 1979 after an average interval of 6 years. On subsequent testing we also examined test reactions to other quinoline derivatives (including antimalarial drugs) and potassium iodide. All patients showed a positive reaction to clioquinol at retesting.