Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 913-404-5 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

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:
- 1 999
- 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
- 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)
Constituent 1
- 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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.

EU Privacy Disclaimer
This website uses cookies to ensure you get the best experience on our websites.