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EC number: 266-164-2 | CAS number: 66108-95-0
- 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:
- key study
- Study period:
- 06.03.1980-07.10.1980
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study was conducted scientifically and in accordance with Good Laboratory Practices.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Sexually mature proven breeder males (age of 4-5 months and body weight > 350 grams) and mature virgin females (age of 2.5 months and body weight range of 193-292 grams at Day 0) Charles River CD albino rats were used. Male stock breeders were house three per cage except during mating. Females were housed up to three per cage during acclimatization and then housed individually following insemination. Each male was house nightly with up to three females until mating was completed. Vaginal washings were made on the morning after each exposure to a male and the days of positive identification of spermatozoa in the washing was designed as Day 0 of pregnancy. Iohexol was administered intravenously into the tail veins as a bolus injection at 1.0; 2.0 and 4.0 gr I/kg to the three groups of 25 rats each. An additional group of 25 rats similarly received 10.8 ml/kg of sterile saline (0.9 % NaCl). The dams were medicated once daily from the sixth through the fifteenth day of pregnancy for a total of ten medications.The dams were observed daily for changes in appearance and behaviour and for any drug-related effects upon the course of pregnancy. They were weighed on Day 0, 6, 8, 0, 12, 15 and 20 of pregnancy. On the twentieth day of pregnancy, all surviving dams were sacrificed by cervical dislocation. The abdominal wall was opened and the ovaries and uterine horns were excised. The ovaries were examined and corpora lutea were counted. The uterine horns were opened longitudinally and fetuses displaced to one side to facilitate gross examination of the horns for resorption sites. The number of viable and non-viable fetuses, resorption, and implantation sites were determined. The remaining organs, thoracic, and abdominal were examined and any gross changes were noted. Fetuses of one-third of the litters were examined with the aid of a steroscope for abnormalities of the abdominal and thoracic viscera and of the cranial cravity and then discarded. Fetuses in the remaining two-thirds of the litters were individually identified and fixed in 70 % ethanol. These fetuses were later eviscerated and processed for skeletal examination using modification of the rapid clearing technique, KOH Alizarin Red-S method for fetal bone. Examination was made of the skull bones and sutura, vertebrae, ribs, pelvis, sternebrae, clavicle, scapule and appendages.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Iohexol
- EC Number:
- 266-164-2
- EC Name:
- Iohexol
- Cas Number:
- 66108-95-0
- Molecular formula:
- C19H26I3N3O9
- IUPAC Name:
- 5-[acetyl(2,3-dihydroxypropyl)amino]-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodoisophthalamide
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
Administration / exposure
- Route of administration:
- intravenous
- Frequency of treatment:
- The rats were dosed daily from the sixth through the fifteenth day of pregnancy for å total 10 injections.
- Duration of test:
- 15 days
Doses / concentrations
- Dose / conc.:
- 4 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 4
- Control animals:
- yes
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
Effect levels (maternal animals)
- Effect level:
- >= 1 - <= 4 mg/kg bw/day (nominal)
- Remarks on result:
- not determinable due to adverse toxic effects at highest dose / concentration tested
Results (fetuses)
Effect levels (fetuses)
open allclose all
- Dose descriptor:
- NOAEL
- Basis for effect level:
- other: embryotoxicity
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
- Dose descriptor:
- NOAEL
- Basis for effect level:
- other: teratogenicity
- 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:
- The compound was neither embryotoxic, nor teratogenic at the dosages tested.
- Executive summary:
In this study, a pregnant Sprague-Dawley rats received intravenous injections of 1, 2 and 4 g I/kg. A fourth group of rats was dosed with saline and acted as controls. The dosages had been decided from a preliminary study. The rats were dosed daily from the 6th trough the 15th day of pregnancy (total of 10 injections). On day 20 the dams were killed and the foetuses removed and evaluated. Iohexol had no effect on the behaviour of the dams, body weight, pregnancy rate, corpora lutea, number of implantations, litter size, number of resorptions, foetal weight and viability, sex ratio or pre and post implantation losses at any dossage level. There were no drug related effects in the foetuses derived from these dams. The compound was neither embryotoxic, nor teratogenic at the dosages tested.
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