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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
publication
Title:
Primary irritant dermatitis from topical clioquinol
Author:
Matti Kero1,*, Matti Hannuksekla1, Aslak Sothman2
Year:
1979
Bibliographic source:
Contact Dermatitis Volume 5, Issue 2, pages 115–117,

Materials and methods

Principles of method if other than guideline:
Primary irritation effets due to from topical clioquinol
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:
clioquinol

Test animals

Species:
human
Strain:
not specified

Test system

Type of coverage:
not specified
Amount / concentration applied:
3% large crystal
Duration of treatment / exposure:
2years
Number of animals:
seven patients

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Remarks on result:
other: irritant

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The clioquinol cause irritation to the human skin
Executive summary:

During the 2-year period seven patients were studied with primary irritant dermatitis from topical preparations containing clioquinol. During the same period contact hypersensitivity to the compound was recorded in 35 eczema patients. Six of the seven patients with clioquinol irritancy had used creams containing 3% large crystal clioquinol and fluorinated steroids.

One patient had used 6% small crystal clioquinol cream. Challenge tests with 3% small crystal and large crystal clioquinol creams showed that crystal size did not affect the appearance of the appearance of irritant dermatitis.