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Toxicological information

Basic toxicokinetics

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Administrative data

Endpoint:
basic toxicokinetics in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)

Data source

Reference
Reference Type:
publication
Title:
No information
Author:
Ellenhorn, M.J. and D.G. Barceloux.
Year:
1988
Bibliographic source:
Medical Toxicology - Diagnosis and Treatment of Human Poisoning.New York, NY: Elsevier Science Publishing Co., Inc. 1988.p. 363

Materials and methods

Objective of study:
absorption
excretion
Test guideline
Qualifier:
according to guideline
Guideline:
other:
Principles of method if other than guideline:
Data is from Medical Toxicology
GLP compliance:
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:
5-chloro-7-iodoquinolin-8-ol
Details on test material:
- Name of test material (as cited in study report): clioquinol
- Substance type: Organic
- Physical state: Solid
Radiolabelling:
not specified

Test animals

Species:
human
Sex:
not specified

Administration / exposure

Route of administration:
other: oral and dermal
Vehicle:
not specified
Details on exposure:
Patients with widespread dermatitis were treated with 15-20 g of 3% clioquinol ointment to 40% of the body area twice daily.
Duration and frequency of treatment / exposure:
twice daily
Doses / concentrations
Remarks:
Doses / Concentrations:
15-20 g of 3% clioquinol ointment
No. of animals per sex per dose / concentration:
Details not available
Control animals:
not specified
Details on study design:
Patients with widespread dermatitis were treated with 15-20 g of 3% clioquinol ointment to 40% of the body area twice daily. This skin treatment resulted in a urinary excretion somewhat less than is obtained after a daily oral dose of 25 mg (one tablet) of clioquinol.

Results and discussion

Preliminary studies:
Patients with widespread dermatitis were treated with 15-20 g of 3% clioquinol ointment to 40% of the body area twice daily. The serum concentration increased to 0.8-1.2 ug/ml within 4 hr of application. In one patient, 15-20 mg was excreted in the urine daily mainly in the form of conjugated metabolites. This skin treatment resulted in a urinary excretion somewhat less than is obtained after a daily oral dose of 25 mg (one tablet) of clioquinol. Thus, 3-4% of the applied clioquinol was absorbed. 25% was excreted in the urine.
Main ADME resultsopen allclose all
Type:
absorption
Results:
3-4% of the applied clioquinol was absorbed
Type:
excretion
Results:
25% was excreted in the urine

Toxicokinetic / pharmacokinetic studies

Details on absorption:
3-4% of the applied clioquinol was absorbed.
Details on excretion:
In one patient, 15-20 mg was excreted in the urine daily mainly in the form of conjugated metabolites.This skin treatment resulted in a urinary excretion somewhat less than is obtained after a daily oral dose of 25 mg (one tablet) of clioquinol.

Metabolite characterisation studies

Metabolites identified:
yes
Details on metabolites:
In the form of conjugated metabolites.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): low bioaccumulation potential based on study results
3-4% of the applied clioquinol was absorbed, while 25% was excreted in the urine.
Executive summary:

15-20 mg of test substance Clioquinolwas excreted in the urine daily mainly in the form of conjugated metabolites. This skin treatment resulted in a urinary excretion somewhat less than is obtained after a daily oral dose of 25 mg (one tablet) of Clioquinol. Thus, 3-4% of the applied Clioquinol was absorbed and 25% was excreted in the urine.