Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Toxicity to reproduction
Administrative data
- Endpoint:
- fertility, other
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August 1989 - January 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: United States Food and Drug Administration, Title 21 code of federal regultions part 58, federal register, 22 december 1978, and subsequent amendments.
- Principles of method if other than guideline:
- The test was conducted accoding to Methods for Administrering agents and detecting malformations in experimental animals - in Teratology: Prinsiples and Techniques. J.G. Wilson and J. Warkany Eds. University of Chicago Press, p 262-277
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- female
Administration / exposure
- Route of administration:
- intravenous
- Vehicle:
- physiological saline
- Duration of treatment / exposure:
- Male: 9 weeks. pre mating + during mating Female : 2 weeks. pre mating + during mating + through day 7 gestation
- Frequency of treatment:
- Males were dosed 9 weeks prior to mating, and through mating to termination. Females were dosed from 2 weeks prior to mating until presumed day 7 of pregnancy. On day 20 of pregnancy, females were sacrificed, subjected to post mortem examination, during which kidney weights were recorded.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0.094 other: ml / 100 g (320 mgI/ml)
- Remarks:
- Treatment Iodixanol 0.3 gI/kg/day, Female: 25
- Dose / conc.:
- 0.312 other: ml / 100 g (320 mgI/ml)
- Remarks:
- Treatment Iodixanol 1.0 gI/kg/day, Female: 25
- Dose / conc.:
- 0.625 other: ml / 100 g (320 mgI/ml)
- Remarks:
- Treatment Iodixanol 2.0 gI/kg/day, Female: 25
- Control animals:
- yes
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- 0.3 other: g I/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: Maternal response
- Dose descriptor:
- NOEL
- Effect level:
- 1 other: g I/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: Maternal response
- Dose descriptor:
- NOEL
- Effect level:
- 2 other: g I/kgbw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: Maternal response
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
Effect levels (F1)
- Dose descriptor:
- NOEL
- Generation:
- F1
- Effect level:
- 2 other: gI/kg/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- viability
- body weight and weight gain
- organ weights and organ / body weight ratios
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Treatment with iodixanol had no apparent adverse effects on mating performance, pregnancy rate, copulation or fertility indices, litter parameters as assessed by pre- and post-implantation loss, litter size, sex ratio, or litter and mean foetal weight. Iodixanol did not produce any selective impairment of embryofoetal development or morphology as assessed by gross examination of foetuses on day 20 of pregnancy. The NOEL for maternal toxicity was determined to be 0.3 gI/kg/day, and >2 gI/kg/day for the developing conceptus.
- Executive summary:
The potential effects of intravenously administered iodixanol on fertility and general reproductive performance have been studied in 28 male and 24 female rats at dosages of 0 (saline control), 0.3, 1.0 and 2.0 gI/kg/day. Males were dosed 9 weeks prior to mating, and through mating to termination. Females were dosed from 2 weeks prior to mating until presumed day 7 of pregnancy. On day 20 of pregnancy, females were sacrificed, subjected to post mortem examination, during which kidney weights were recorded. Litter values were determined and the foetuses were subjected to gross examination prior to preservation. Males were also subjected to post mortem examination and the kidneys weighed.
Treatment with iodixanol was associated with toxic effects in the parent animals, similar to those observed in rat repeated dose toxicity studies with iodixanol. Doses of 2.0 gI/kg/day was associated with transient reddening of extremities, urinary excretion of a clear sticky fluid, and swollen face and/or paws among the males, and in females, increased water and decreased food consumption, accompanied by lower weekly body weight and reduced weight gain during pregnancy. Kidney weights increased in both sexes. Treatment with 1.0 gI/kg/day was associated with occasional reddening of the extremities and swollen paws and face, increased water consumption, slightly decreased food consumption in males, and slightly reduced weight gain in females from day 14 of pregnancy. Kidney weights increased in males. Treatment with 0.3 gI/kg/day was associated with an increase in water consumption, and in males a slight decrease in mean food consumption and weekly body weight. Treatment with iodixanol had no apparent adverse effects on mating performance, pregnancy rate, copulation or fertility indices, litter parameters as assessed by pre- and post-implantation loss, litter size, sex ratio, or litter and mean foetal weight. Iodixanol did not produce any selective impairment of embryofoetal development or morphology as assessed by gross examination of foetuses on day 20 of pregnancy. The NOEL for maternal toxicity was determined to be 0.3 gI/kg/day, and >2 gI/kg/day for the developing conceptus.
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.