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Diss Factsheets

Toxicological information

Direct observations: clinical cases, poisoning incidents and other

Administrative data

direct observations: clinical cases, poisoning incidents and other
Type of information:
other: case report
Adequacy of study:
supporting study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference Type:
Chemical Burn Caused by Providone-iodine Alcohol Solution --A Case Report
Liu F-C., Liou J-T., Hui Y-L., Hsu J-C., Yang C-Y., Yu H-P., Lui P-W.
Bibliographic source:
Acta Anaesthesiol Sin. 2003 Jun;41(2):93-6.

Materials and methods

Study type:
clinical case study
Endpoint addressed:
skin irritation / corrosion
Principles of method if other than guideline:
A report of a 24-year-old female who was admitted for subtotal thyroidectomy. The skin over the anterior neck was sterilized with 10% Povidone-iodine (PI) alcohol solution. After a 3-hour surgery, the patient complained of burning pain over the back at the recovery room. Physical examination revealed a 9 x 11 cm area of skin lesion partially thickened amid on the middle of the back suggestive of chemical burn.
GLP compliance:

Test material

Constituent 1
Reference substance name:
Reaction mass of iodine and 2-Pyrrolidinone, 1-ethenyl-, homopolymer
EC Number:
Molecular formula:
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 the test substance: Providone-iodine (PI)


Type of population:
A 24-year-old female with thyroid tumor who underwent subtotal thyroidectomy.
Ethical approval:
not applicable
Route of exposure:
Reason of exposure:
Exposure assessment:
not specified
Details on exposure:
10% PI solution covered an area with its upper margin 2 cm above the jaw to lower margin 5 cm below two clavicles and with inclusion of the anterior aspect of neck and bilateral mastoids. This area was cleaned with normal saline prior to skin incision. The surgery lasted for about 3 h. During treatment and surgery the PI solution flowed down alongside the back and accumulated on the middle back.
Physical examination: Skin tests were carried out with 70% ethanol, 10% aqueous PI and 10% alcohol solution.
Medical treatment:
The patient was treated conservatively with 1% silver sulfadiazine after the surgery

Results and discussion

Clinical signs:
The surgery lasted for about 3 h. After endotracheal extubation, the patient was sent to the post-anesthesia recovery unit. A few hours later, the patient complained of pain around the incisional wound and felt a burning sensation on the back. Physical examination revealed an area of swelling, about 9 x 11 cm in size on the middle of the back where the PI solution had accumulated, suggesting partial thickness chemical burn. This area had two brownish lines extending from the neck as the original site of treatment to the site of burn where the PI solution had accumulated during surgery.
Results of examinations:
There was no allergic reaction on each test.
Effectivity of medical treatment:
The patient was discharged uneventfully 4 days later. Upon follow-up, the wound was seen to heal with minimal scarring within 3 weeks.
Outcome of incidence:
Prolonged skin contact with large amount of PI-solution may result in skin injury during surgery.

Applicant's summary and conclusion