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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
Repeated dose toxicity: other routes
Administrative data
- Endpoint:
- chronic toxicity: other route
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28.05.1980
- 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:
- 1 980
Materials and methods
- 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:
- monkey
- Strain:
- Macaca fascicularis
- Sex:
- male/female
Administration / exposure
- Route of administration:
- intravenous
- Duration of treatment / exposure:
- 28 consecutive days
- Frequency of treatment:
- Once a day
Doses / concentrations
- Remarks:
- Doses / Concentrations:0.33 g I/kg/day; 1.0 g I/kg/day; 3.0 g I/kg/day
- No. of animals per sex per dose:
- 3 male and 3 female
- Control animals:
- yes
Results and discussion
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- There were no overt clinical signs of toxicity; body weight and food consumption were unaffected. No effects on the heart rate, respiratory rate and body temperature were recorded and the ECG studies showed no abnormalities. There were no significant ophtalmoscopic findings. Haematological parameteres were within the normal range and the only significant biochemical finding was a slight elevation of serum leucine arylamide values, indicating some minor liver disturbance at high dose level ( 3 g I/kg/day). Postmorten examination showed some bruising at the injection site. There was an increase in kidney weights at the high dose level. Histopathological examination showed minor vacuolation of the hepatocytes at 3 g I/kg and the vacuolation of the tubular epithelial cells in some animals receiving 1 and 3 g I/kg/day. 0.33 g I/kg/day was shown to be a no effect dose.
- Executive summary:
In this study iohexol was administered to groups of 3 male and female cynomolgus monkeys at dosage levels equivalent to 0.33, 1 and 3 g I/kg/day. Control animals were dosed with the appropriate volume of physiological saline. The preparation of iohexol administered contained 370 mg I/ml and was given for 28 consecutive days. There were no overt clinical signs of toxicity; body weight and food consumption were unaffected. No effects on the heart rate, respiratory rate and body temperature were recorded and the ECG studies showed no abnormalities. There were no significant ophtalmoscopic findings. Haematological parameteres were within the normal range and the only significant biochemical finding was a slight elevation of serum leucine arylamide values, indicating some minor liver disturbance at high dose level ( 3 g I/kg/day). Postmorten examination showed some bruising at the injection site. There was an increase in kidney weights at the high dose level. Histopathological examination showed minor vacuolation of the hepatocytes at 3 g I/kg and the vacuolation of the tubular epithelial cells in some animals receiving 1 and 3 g I/kg/day. 0.33 g I/kg/day was shown to be a no effect dose.
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