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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- 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:
- Teratologische Untersuchungen eines niedermolekularen Polyvinylpyrrolidon-Jod-Komplexes an Kaninchen
- Author:
- Siegemund B., Weyers W.,
- Year:
- 1 987
- Bibliographic source:
- Arzneim.-Forsch./Drug Res., Vol. 37(3), 340-341, 1987
Materials and methods
- Principles of method if other than guideline:
- The test substance was tested for its developmental effects after intramuscular application in rabbits.
- GLP compliance:
- not specified
- 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 substance: polyvinylpyrrolidone-iodine complex (PVP-Jod-Komplexe)
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS - Age at study initiation: 3.5 to 4 month - Housing: Full wired cages, individual - Diet: Altromin ® Standard Diät. Nr. 3110; Altromin, Lage/Lippe ad libitum - Water: ad libitum ENVIRONMENTAL CONDITIONS - Temperature (°C): 20 - 23 - Humidity (%): 65 - Air changes (per hr): 10 - Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- intramuscular
- Vehicle:
- water
- Details on mating procedure:
- Each female animal was bred successively with 3 different males of the same breeding and origin. After visual determination of at least 2 copulations, the animals were selected for testing with the test substance.
- Duration of treatment / exposure:
- day 6 to day 18 of gestation
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 16 mg/kg bw/day
- Dose / conc.:
- 35 mg/kg bw/day
- Dose / conc.:
- 75 mg/kg bw/day
- No. of animals per sex per dose:
- 12 control animals, 15 low dose group animals, 15 middle dose group animals, and 15 high dose group animals
- Control animals:
- yes
- Details on study design:
- Day "0" of gestation was the day of copulations. The administration of the substance was carried out from day 6 to day 18 of gestation via percutaneous injection into the lumbar muscles. This application form was chosen to investigate the worst case (after local application complete absorption takes place). The administration volume was 0.5 mL/kg body weight. The control group received physiological saline. The middle dosage chosen in this study, is about the amount that is needed for wiping a 20 x 20 cm large treatment field. For the treatment area a person of ca 70 kg was assumed. At day 29 pups were born via C-Section.
Examinations
- Maternal examinations:
- - General examinations - Body weight development- Number of pregnant animals- Number of aborted pregnancies and number of aborted pregnancies with resorptions or malformations.
- Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes- Number of resorptions- Mean placenta weight- Number of corpora lutea- Number of implantations
- Fetal examinations:
- The following examinations were recorded:- Mean fetal weight- The number of living and dead fetussus- Number of Runts - Malformations
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No influence on the general state of the females was observed. In one animal the middle dose group was in week two of gestation a complete paralysis of both hind limbs observed. The animal was euthanized at day 24 of pregnancy.
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- A clear dose-related effect on the body weight gain was observed. Weight gain was about 13.4% (16 mg/kg) to 9.5% (75 mg/kg) in treated animals, versus 16.7% in controls. Only the hig high dose was significantly different from control.
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not specified
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- not specified
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- not examined
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): no effects observed - Changes in number of pregnant:
- not examined
- Other effects:
- no effects observed
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 35 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): not examined - Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- no effects observed
- External malformations:
- no effects observed
- Skeletal malformations:
- not specified
- Visceral malformations:
- not specified
- Other effects:
- no effects observed
- Details on embryotoxic / teratogenic effects:
- Malformations were observed in both control as well as test groups. In one fetus in the control group perirenal bleeding was observed. Three fetuses from the lower dose group had ectopic kidneys. In an animal of the same group, the kidneys were fused, and a misshapen liver was found in another animal. Another ectopic kidney was observed in one animal of the medium dose. In the high dose group an animal was observed with only one kidney. In another, a malformation of the diaphragm was present. A dose response relationship was not observed for these malformations.
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 75 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Fetal abnormalities
- Key result
- Abnormalities:
- effects observed, non-treatment-related
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
Any other information on results incl. tables
Table 1. Results of examinations
| Control | Low dose | Middle dose | High dose |
Number of animals used | 12 | 14 | 15 | 15 |
Pregnant animals | 10 | 9 | 10 | 9 |
Aborted pregnancies | 0 | 0 | 0 | 0 |
- With resorptions | 5 | 5 | 7 | 4 |
- With malformations | 0 | 0 | 0 | 0 |
Number of living fetuses | 70 | 67 | 66 | 71 |
Number of dead fetuses | 1 | 0 | 2 | 0 |
Number of Runts | 1 | 2 | 1 | 1 |
Number of resorptions | 7 | 9 | 13 | 8 |
Number of malformations | 1 | 5 | 1 | 2 |
Numbers per pregnancy (average ± SD) | ||||
Living fetuses | 7.0 ± 2.16 | 7.4 ± 2.87 | 7.4 ± 1.87 | 8.8 ± 1.80 |
Dead fetuses | 0.1 ± 0.32 | 0.0 | 0.22 ± 0.44 | 0.0 |
Resorptions | 0.7 ± 0.95 | 1.0 ± 1.12 | 1.44 ± 1.13 | 1.0 ± 1.41 |
Implantations | 7.8 ±2.39 | 8.44 ± 2.60 | 9.11 ± 1.83 | 9.88 ± 1.96 |
Corpus luteum | 9.3 ± 1.83 | 10.67 ± 1.58 | 9.89 ± 1.90 | 11.00 ± 4.09 |
Resorption of implantations (%) | 8.04 ± 9.96 | 12.58 ± 15.29 | 15.13 ± 10.93 | 9.19 ± 12.2 |
preimplantation losses (%) | 18.2 ± 20.4 | 27.5 ± 20.4 | 10.4 ± 17.6 | 11.6 ± 16.9 |
Postimplantation losses (%) | 9.13 ± 9.57 | 12.58 ± 15.27 | 18.08 ± 14.15 | 9.18 ± 12.2 |
Malformations | 1.43 | 7.46 | 1.52 | 2.82 |
Mean fetal weight | 42.6 ± 5.56 | 39.8 ± 7.47 | 36.3 ± 4.14 | 37.3 ± 2.41 |
Mean placenta weight | 4.23 ± 0.76 | 4.07 ± 0.77 | 3.79 ± 0.79 | 3.74 ± 0.24 |
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.