Registration Dossier
Registration Dossier
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EC number: 204-984-4 | CAS number: 130-26-7
Skin sensitisation
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:
- 1 980
- 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
- Reference substance name:
- Clioquinol
- EC Number:
- 204-984-4
- EC Name:
- Clioquinol
- Cas Number:
- 130-26-7
- Molecular formula:
- C9H5ClINO
- IUPAC Name:
- 5-chloro-7-iodoquinolin-8-ol
Constituent 1
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.
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