Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
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
Species:
human
Sex:
male/female
Route:
epicutaneous, open
Vehicle:
petrolatum
Concentration / amount:
5%
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.
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.
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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

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.

Migrated from Short description of key information:

Clioquinol was found to be sensitising to human skin by patch test test.

Justification for selection of skin sensitisation endpoint:

Clioquinol was found to be sensitising to human skin by patch test test.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The test substance clioquinol is considered as non-sensitising for the purpose of classification.