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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Allergic contact dermatitis from povidone-iodine
Author:
Erdmann S., Hertl M., Merk H.F.
Year:
1999
Bibliographic source:
Contact Dermatitis 1999: 40: 331

Materials and methods

Type of sensitisation studied:
skin
Study type:
case report
Principles of method if other than guideline:
2 cases of post-operative dermatitis due to povidone iodine were presented. Patch tests with the test substance were performed.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Reaction mass of iodine and 2-Pyrrolidinone, 1-ethenyl-, homopolymer
EC Number:
913-404-5
Molecular formula:
Unspecified
IUPAC Name:
Reaction mass of iodine and 2-Pyrrolidinone, 1-ethenyl-, homopolymer
Details on test material:
- Purity: ≥ 92%- pH: ≥ 1 - ≤ 5 (aqueous preparation)
Specific details on test material used for the study:
- Name of test substance: povidone-iodine

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
Case 1: A 16-year-old boy
Case 2: A 62-year-old man
Clinical history:
Case 1: A 16-year-old boy presented with post-operative dermatitis on the distal right foot, after surgery on the right big toe nail, which had been treated with 10% PVP-I (Freka-cid cream). This treatment was stopped and, with oral prednisolone for 1 week, the dermatitis gradually resolved. Case 2: The 62-year-old man had been treated on the right flank with povidone-iodine (Betaisodona solution, also marketed as Betadine solution) prior to surgery on the left kidney. Within 24 h after the operation, he developed allergic contact dermatitis at the site where the antiseptic solution had been applied. With topical corticosteroids, the contact dermatitis gradually resolved.
Route of administration:
dermal
Details on study design:
Case 1 was patch tested with the following substances:Freka-cid cream (undiluted)- 5% Povidone-iodine (aqueous)- 10% Povidone-iodine (aqueous)- 5% Povidone-iodine (in petrolatum)- 10% Povidone-iodine (in petrolatum)- 0.5% Iodine (in petrolatum)- Povidone (undiluted)- All other constituents of Freka-acid cream
Case 2 was patch tested with the following substances:- Betaisodona solution (undiluted)- 10% Povidone-iodine (aqueous)- 0.5% Iodine (in petrolatum)- Povidone (undiluted)- all other constituents of Betaisodona solution

Results and discussion

Results of examinations:
Case 1: Patch testing with Freka-cid cream and all its constituents supplied by the manufacturer revealed positive reactions to Freka-cid and Povidone-iodine. Additional patch testing with a commercial series of common antiseptics showed a positive reaction to iodine. Case 2: Patch testing with Betaisodona solution and all its constituents supplied by the manufacturer revealed positive reactions to Betaisodona solution and Povidone-iodine. Additional patch testing with a commercial series of common antiseptics showed a positive reaction to iodine.

Applicant's summary and conclusion