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EC number: 618-837-0 | CAS number: 92339-11-2
- 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
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 19.05.1989-11.07.1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study meets the requirements of the Principles of Good Laboratory Practice
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- This study describes the preliminary experiment performed to assess the effect of intravenous administration on pregnancy of the rabbit and in utero development of the offspring in order to select the highest dose level for subsequent teratology study in rabbit. A preliminary teratology study was conducted in Chbb:HM rabbits (16). Five groups of three mated female rabbits were administered 0 (saline control), 0.3, 1.0, 2.0 or 3.0 gI/kg/day iodixanol by daily intravenous injections from day 6 up to and including day 18 of gestation. Day 0 was defined as the day of mating. Maternal clinical signs, body weight and food consumption were recorded. On day 29 of pregnancy the rabbits were sacrificed and the uterus and ovaries examined for the following: number of implantation sites; number of early and late resorption sites; distribution and number of live and dead foetuses and resorptions in the uterine horns; number of corpora lutea; sex and weight of each foetus, weight of placenta, weight of uterus. External abnormalities of each foetus were also recorded. The mean values of all maternal and foetal parameters in the dosed groups were comparable to those of the control group.Control animals received sterile saline (0.9% NaCl solution).
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
Administration / exposure
- Route of administration:
- intravenous
- Details on mating procedure:
- Fifteen pregnant rabbits weighing between 1.7 and 2.7 kg and approximately 4 months of age (SPF albino female rabbits of the Chbb:HM, C.H.Boehringer/Biberach:Himalaya strain) were delivered on the day of mating.Mating took place in the facilities of the breeder with males of proven fertility.Mated females were allocated to dose group and cage in the rack in the order of mating, i.e. females mated each day were evenly distributed between dose groups.
- Duration of treatment / exposure:
- Daily intravenous injections on days 6 up to and including day 18 of gestation
- Frequency of treatment:
- Daily
- No. of animals per sex per dose:
- Five groups of three mated female rabbits were administered 0 (saline control), 0.3, 1.0, 2.0 or 3.0 gI/kg/day iodixanol.
- Control animals:
- yes
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Basis for effect level:
- other: maternal toxicity
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Basis for effect level:
- other: fetotoxicity
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- It was concluded that iodixanol did not cause maternal or foetal toxicity in the rabbit at intravenous dosages up to 3.0 gI/kg/day
- Executive summary:
A preliminary teratology study was conducted in Chbb:HM rabbits (16). Five groups of three mated female rabbits were administered 0 (saline control), 0.3, 1.0, 2.0 or 3.0 gI/kg/day iodixanol by daily intravenous injections from day 6 up to and including day 18 of gestation. Day 0 was defined as the day of mating. Maternal clinical signs, body weight and food consumption were recorded. On day 29 of pregnancy the rabbits were sacrificed and the uterus and ovaries examined for the following: number of implantation sites; number of early and late resorption sites; distribution and number of live and dead foetuses and resorptions in the uterine horns; number of corpora lutea; sex and weight of each foetus, weight of placenta, weight of uterus. External abnormalities of each foetus were also recorded. The mean values of all maternal and foetal parameters in the dosed groups were comparable to those of the control group. It was therefore concluded that iodixanol did not cause maternal or foetal toxicity in the rabbit at intravenous dosages up to 3.0 gI/kg/day.
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