Reaction mass of iodine and 2-Pyrrolidinone, 1-ethenyl-, homopolymer

Sensitisation data (human)

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

Test material information

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.