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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.