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Diss Factsheets
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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- GLP compliance:
- 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: JODOSEPT L- Description: brown liquid- Batch no.: ZK 1055/175-2- Storage: at room temperature away from direct sunlight
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS - Source: Elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne - Age at study initiation: 15 weeks - Weight at study initiation: male 2771 g, females 2858 and 2671 g - Housing: individually in stainless steel cages with an automatic cleaning system with feed hoppers, drinking water bowls, with haysticks and wood for gnawing - Diet: pelleted standard Kliba 3410 rabbit maintenance diet (Provimi Kliba AG, 4303 Kaiseraugst, Switzerland), ad libitum - Water: community tap water from Itingen, ad libitum ENVIRONMENTAL CONDITIONS - Temperature (°C): 20 ± 3 - Humidity (%): 40 - 70 - Air changes (per hr): 10 - 15 - Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE - Area of exposure: 6 cm2 dorsal skin- Type of wrap if used: 2.5 cm x 2.5 cm patch of surgical gauze covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape. REMOVAL OF TEST SUBSTANCE - Washing: after the dressing was removed the skin was washed with lukewarm tap water - Time after start of exposure: 4 hoursOBSERVATION TIME POINTS1, 24, 48 and 72 hours after removal of the dressing, gauze patch and test article.SCORING SYSTEM: - Method of calculation: a numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992OBSERVATIONS- Viability/mortality: daily- Clinical signs: daily during the observation period- Body weights: At start of acclimatization, on the first day of application and at termination of observation.- Pathology: No necropsy was performed.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Other effects:
- No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred . The body weight of all rabbits were considered to be within the normal range of variability. Brown staining by the test article of the treated skin was 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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