Registration Dossier
Registration Dossier
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EC number: 913-404-5 | CAS number: -
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
- Principles of method if other than guideline:
- Ten Sprague-Dawley rats per sex were exposed to 2500 mg/kg bw of the test substance for 24 hours. The substance was applied to the dorsal shaved skin. After an observation period of 14 days animals were necropsied.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
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 the test material: PVP-Jod CE 5041- Purity: 92%
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: WIGA, Sulzfeld- Weight at study initiation: mean males 137 g, mean females 126 g- Diet: ad libitum, Altromin R (Altromin GmbH, Lage/Lippe)- Water: ad libitum
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE - Area of exposure: 50 cm2 shaved dorsal skin TEST MATERIAL- Concentration (if solution): 50%
- Duration of exposure:
- 24 hours
- Doses:
- 2500 mg/kg as 50% aq. solution
- No. of animals per sex per dose:
- 10
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days - Necropsy of survivors performed: yes- Other examinations performed: clinical signs and local irritation
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed.
- Clinical signs:
- No clinical signs were observed.
- Gross pathology:
- The investigation revealed no pathological abnormalities.
- Other findings:
- No local signs of irritation were observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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.
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