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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 232-197-6 | CAS number: 7790-28-5
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 3 July 2012 to 24 August 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- A GLP study conducted to sound scientific principles with a sufficient level of detail to assess the quality of the submitted data. Some of the analytical techniques employed were not conclusive.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
- Objective of study:
- other: Gastric hydrolysis
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Guideline 111 (Hydrolysis as a Function of pH)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
- Principles of method if other than guideline:
- Gastric hydrolysis of the test material was investigated using a procedure based on EU Method C.7 and OECD 111. During the study, the test material was dissolved in either Fasted State Simulated Gastric Fluid (FaSSGF), or Fed State Simulated Gastric Fluid (FeSSGF), in the dark at body temperature. The concentration of the test material was determined as a function of time. Furthermore, the quantities, and nature of the decomposition products, was investigated.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Sodium periodate
- EC Number:
- 232-197-6
- EC Name:
- Sodium periodate
- Cas Number:
- 7790-28-5
- Molecular formula:
- HIO4.Na
- IUPAC Name:
- sodium periodate
- Test material form:
- solid: crystalline
- Details on test material:
- - Physical state: Solid, white
- Storage conditions of test material: Room temperature in the dark
Constituent 1
- Radiolabelling:
- no
Administration / exposure
- Details on exposure:
- PREPARATION OF SOLUTIONS
Sample solutions were prepared in stoppered glass flasks at a nominal concentration of 5.0 g/L in the two test media (pre-warmed to 38 °C). The test solutions were split into individual vessels for each data point. The solutions were shielded from light whilst maintained at the test temperature. The sample solutions were maintained at 38.0 ± 0.5 °C for a period of at least 0.75 hours.
Doses / concentrations
- Dose / conc.:
- 5 other: g/L (nominal conc.)
Results and discussion
Main ADME results
- Type:
- other: Gastric hydrolysis
- Results:
- the test material quickly degraded in both the fasted and fed state simulated gastric simulations solutions. The half-life of the test material in fasted and fed state simulated gastric fluids was significantly less than 1 hour 38.0 ± 0.5 °C
Toxicokinetic / pharmacokinetic studies
Toxicokinetic parameters
- Key result
- Test no.:
- #1
- Toxicokinetic parameters:
- half-life 1st: < 1 hour at 28 ± 0.5 °C
Metabolite characterisation studies
- Metabolites identified:
- no
Any other information on results incl. tables
- Definitive Test
The test material concentrations at the given time points are given in the following table:
Fasted state |
||||
Time (hours) |
conc (g/L) NaIO4 |
% NaIO4 of "weighed-out" conc. |
||
A |
B |
A |
B |
|
0 |
0.075 |
0.153 |
1.5 |
3.1 |
0.75 |
<0.005 |
0.014 |
<0.1 |
0.3 |
Fed state |
||||
Time (hours) |
conc (g/L) NaIO4 |
% NaIO4 of "weighed-out" conc. |
||
A |
B |
A |
B |
|
0 |
<0.005 |
<0.005 |
<0.1 |
<0.1 |
0.75 |
<0.005 |
<0.005 |
<0.1 |
<0.1 |
The above results indicate that the test material was quickly degraded in both the fasted and fed state simulated gastric fluids.
Furthermore, a scientific review of the titration method used indicated that it measures the potential of the (remaining) oxidising species in the solution to convert potassium iodide into iodine, which is then titrated to the end point with the arsenate titrant. The problem with this is that the oxidising potential includes periodate (oxidation state: +7) and its degradation (reduction) product iodate (oxidation state: +5), as both species will oxidise iodide to iodine. Thus, all of the periodate will have been reduced to iodate when the oxidation potential had diminished by (7 - 5) / 7, i.e. 29 %. Consequently, as the initial and 0.75 to 1.5 hours time point samples indicated essentially no oxidising potential remaining, it is clear that all of the periodate had been reduced to (at least) iodate almost instantaneously on contact with the two test media.
Consequently, it was concluded that the half-life of the test material in both fasted and fed state simulated gastric fluids was significantly less than 1 hour at 38 °C.
- Additional Tests
Part A): On addition of the hydrochloric acid, the solution became yellow in colour. After addition of at least 15 mL of 0.05M potassium iodate titrant, the solution was still yellow in color. More importantly, the chloroform layer remained colourless throughout. An aliquot of each gastric fluid treated as the samples gave similar results, i.e. the chloroform layer remained colourless throughout the titrations. However, on adding the hydrochloric acid, the solutions did not become yellow in colour. This test was undertaken to assess whether iodine or an iodide salt had formed in the test solutions. The observations indicated a negative result.
Part B): On addition of the potassium iodide, the fasted state sample became brown in colour, whereas, the fed state supernatant turned yellow/brown in colour. This test was undertaken to assess whether there was an oxidising component in the test solutions to oxidise iodide to iodine, e.g. iodate or periodate. The result indicated there may be such a component although further test work would be required.
Part C): After addition of the silver nitrate solution, the fasted state sample became white in colour; however, after a few minutes, a precipitate formed at the bottom of the beaker and the sample had turned grey in colour with a few grey specks present. A 5 g/L potassium iodide solution treated similarly turned from a clear solution to a milky white/yellow solution. Furthermore, after approximately 30 minutes standing, the fasted state sample had become a purple coloured solution with a precipitate at the bottom of the beaker; the fed state sample had become a brown solution with large amounts of a silver coloured precipitate present; and the potassium iodide control sample had become a lime green coloured, milky opaque solution. This test was undertaken to assess whether iodide could be identified in the solutions by the presence of a yellow silver iodide precipitate, with silver (grey deposits) also being a common component. It was clear the test results were ambiguous and no clear conclusion could be drawn.
Validation
Definitive Test: The linearity of the detector response with respect to concentration was assessed over the concentration range of 1.01 x 10³ to 7.58 x 10³ mg/L. This was satisfactory with a correlation coefficient (r) of 1.000 being obtained.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: Periodate rapidly transforms to iodate in the stomach
Under the conditions of the study, the test material quickly degraded in both the fasted and fed state simulated gastric simulations solutions. The half-life of the test material in fasted and fed state simulated gastric fluids was determined to be significantly less than 1 hour at 38.0 ± 0.5 °C.
The definitive analytical technique used to determine the test material concentration of the initial and final reaction solutions was satisfactory in confirming the reduction of the periodate ion in both solutions.
Additional analytical techniques employed were not conclusive in proving the presence of iodate, iodide or iodine in the reacted test solutions. However, as there was essentially zero oxidising potential remaining in the degraded solutions, as well as no visible evidence of purple coloured elemental iodine in these solutions, it was considered that the periodate had been reduced all of the way down to iodide. This, however, could not be proved by the analytical techniques on hand. - Executive summary:
Gastric hydrolysis of the test material was investigated using a procedure based on EU Method C.7 and OECD 111. During the study, the test material was dissolved in either Fasted State Simulated Gastric Fluid (FaSSGF), or Fed State Simulated Gastric Fluid (FeSSGF), in the dark at body temperature. The concentration of the test material was determined as a function of time. Furthermore, the quantities, and nature of the decomposition products, was investigated.
Under the conditions of the study, the test material quickly degraded in both the fasted and fed state simulated gastric simulations solutions. The half-life of the test material in fasted and fed state simulated gastric fluids was determined to be significantly less than 1 hour at 38.0 ± 0.5 °C.
The definitive analytical technique used to determine the test material concentration of the initial and final reaction solutions was satisfactory in confirming the reduction of the periodate ion in both solutions.
Additional analytical techniques employed were not conclusive in proving the presence of iodate, iodide or iodine in the reacted test solutions. However, as there was essentially zero oxidising potential remaining in the degraded solutions, as well as no visible evidence of purple coloured elemental iodine in these solutions, it was considered that the periodate had been reduced all of the way down to iodide. This, however, could not be proved by the analytical techniques on hand.
Alternative analytical techniques would therefore be required to analyse the nature of the complex solutions. However, this was outside of the scope of the current study.
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.