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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
Acute Toxicity: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- Type of information:
- experimental study
- Adequacy of study:
- supporting 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:
- 1 986
- Report date:
- 1986
Materials and methods
- Principles of method if other than guideline:
- Five Wistar rats per sex per dose were exposed to the test substance via intraperitoneal injection. Animals were exposed to 121, 178, 261, 383, 562, 1000, 1470, 2000 mg/kg bw. After an observation period of 14 days animals were necropsied.
- GLP compliance:
- no
- Limit test:
- 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 the test material: PVP-JOD FC 1026
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Dr. K. Thomae GmbH, D-7950 Biberach, FRG- Weight at study initiation: mean males 160 – 210 g, mean females 149 – 190 g- Fasting period before study: 16 hours- Housing: 5 animals per cage, in stainless steel wire mesh cages, type DK-III (Becker & Co., Castrop-Rauxel, FRG)- Diet: Kliba-labordiaet, Fa. Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland, ad libitum- Water: tap water, ad libitum- Acclimation period: at least 1 week ENVIRONMENTAL CONDITIONS- Temperature (°C): 20 - 24- Humidity (%): 30 - 70- Air: fully air-conditioned- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- olive oil
- Details on exposure:
- - Administrative volume: 5 mL/kg bw- Justification for choice of vehicle: test substance is insoluble in water
- Doses:
- 121, 178, 261, 383, 562, 1000, 1470, 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days- Frequency of observations and weighing: recordings of signs and symptoms several times on the day of administration, at least once each workday, check for moribund and dead animals twice each workday and once on holidays- Necropsy of survivors performed: yes
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 309 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 247 - 390
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 275 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 186 - 402
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 370 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 180 - 580
- Mortality:
- - No mortality observed in all animals exposed to 121 mg/kg bw.- 1 out of 5 males, and 0 out of 5 females exposed to 178 mg/kg bw died.- 3 out of 5 males, and 2 out of 5 females exposed to 261 mg/kg bw died.- 4 out of 5 males, and 3 out of 5 females exposed to 383 mg/kg bw died.- 4 out of 5 males, and 4 out of 5 females exposed to 562 mg/kg bw died.- All animals exposed to 1000 or 1470 mg/kg bw died.- 5 out of 5 males, and 4 out of 5 females exposed to 2000 mg/kg bw died.
- Clinical signs:
- Clinical signs observed in males:- 121 mg/kg bw: piloerection; animals were symptom-free within 4 days after exposure- 178 mg/kg bw: dyspnea, apathy, staggering piloerection and a poor general state; animals that survived were symptom-free within 3 days after exposure- 261 mg/kg bw: dyspnea, apathy, staggering, piloerection, exsiccosis and a poor general state; animals that survived were symptom-free within 3 days after exposure- 383 mg/kg bw: dyspnea, apathy, staggering, spastic gate, piloerection, exsiccosis and a poor general state; animals that survived were symptom-free within 6 days after exposure- 562 mg/kg bw: dyspnea, apathy, staggering, tremors, twitching, piloerection, exsiccosis and a poor general state; animals that survived were symptom-free within 1 day after exposure- 1000 mg/kg bw: dyspnea, apathy, staggering, atonia, paresis, piloerection and a poor general state- 1470 mg/kg bw: dyspnea, apathy, staggering, paresis, piloerection and a poor general state- 2000 mg/kg bw: dyspnea, apathy, staggering and a poor general stateClinical signs observed in females:- 121 mg/kg bw: piloerection; animals were symptom-free within 1 day after exposure- 178 and 261 mg/kg bw: dyspnea, apathy, staggering, piloerection and a poor general state; animals that survived were symptom-free within 3 days of exposure- 383 mg/kg bw: dyspnea, apathy, staggering, tremors, spastic gait, piloerection, exsiccosis, blood in urine and a poor general state; animals that survived were symptom-free within 13 days after exposure- 562 mg/kg bw: dyspnea, apathy, abnormal position, staggering, tremors, twitching, piloerection, exsiccosis, salivation and a poor general state; animals that survived were symptom-free within 1 day- 1000 and 1470 mg/kg bw: dyspnea, apathy, staggering, paresis, piloerection and a poor general state- 2000 mg/kg bw: dyspnea, apathy, excitation, staggering and a poor general state
- Body weight:
- Mean body weight males on day 1 and 13 (surviving animals), respectively:- 121 mg/kg bw: 189 g and 270 g- 178 mg/kg bw: 161 g and 250 g- 261 mg/kg bw: 160 g and 213 g- 383 mg/kg bw: 198 g and 252 g- 562 mg/kg bw: 192 g and 278 g- 1000 mg/kg bw: 190 g and -- - 1470 mg/kg bw: 180 g and --- 2000 mg/kg bw: 210 g and --Mean body weight females on day 1 and 13 (surviving animals), respectively:- 121 mg/kg bw: 180 g and 223 g- 178 mg/kg bw: 149 g and 194 g- 261 mg/kg bw: 150 g and 190 g- 383 mg/kg bw: 190 g and 232 g- 562 mg/kg bw: 179 g and 207 g- 1000 mg/kg bw: 180 g and -- - 1470 mg/kg bw: 190 g and --- 2000 mg/kg bw: 189 g and 220 g
- Gross pathology:
- - Animals that died within the 1st day: liver serosa, acute enteritis, acute gastritis, thorax filled with fluid, lungs slightly inflated, abdominal fluid tinged with blood- Animals that died within the 2nd to the 9th day: intraabdominal fibrin coates and adhesions- Sacrificed animals: intraabdominal adhesions and intraabdominal white coats/fibrin (fibrinous peritonitis/deposits of test substance and thickened margins in the liver. Muddy fluid in the abdomen of two animals.
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.
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