Registration Dossier
Registration Dossier
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EC number: 240-505-5 | CAS number: 16455-61-1
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics, other
- Remarks:
- expert statement based on physico-chemical properties and toxicological data of structurally related substances.
- Type of information:
- other: expert statement
- Adequacy of study:
- key study
- Study period:
- 2017
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: expert statement based on physico-chemical properties and toxicological data of structurally related substances.
Data source
Reference
- Reference Type:
- other: expert statement
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
- Objective of study:
- absorption
- distribution
- excretion
- metabolism
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: ECHA guidance on Toxicokinetics (Chapter R. 7C, section R.7.12, 2014)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- dark red to black powder
Constituent 1
Results and discussion
Main ADME resultsopen allclose all
- Type:
- absorption
- Results:
- A moderate absorption potential is considered for oral route of exposure. A limited absorption potential is predicted for dermal and inhalation routes of exposure.
- Type:
- distribution
- Results:
- If absorbed, the substance is expected to be distributed into intravasal compartment.
- Type:
- metabolism
- Results:
- No extensive metabolism is expected for the chelating agents and polycondensation products.
- Type:
- excretion
- Results:
- The target substance is expected to be excreted via the urine or via the bile.
Metabolite characterisation studies
- Metabolites identified:
- not measured
Applicant's summary and conclusion
- Conclusions:
- O,o-Fe(Na)EDDHA has low absorption potential via all exposure routes. If absorbed, it is expected to be distributed predominantly in intravasal compartment. The substance is not expected to be metabolised and will be excreted mainly unchanged via the faeces or via the urine.
- Executive summary:
O,o-Fe(Na)EDDHA is expected to be moderately absorbed after oral exposure, based on its high water solubility and its insolubility in n-octanol. Concerning the absorption after exposure via inhalation, as the chemical is considered to have a low vapour pressure, is highly hydrophilic, insoluble in n-octanol, and has a rather high molecular weight, it is clear, that the substance is poorly available for inhalation and will not be absorbed significantly. The substance is also not expected to be absorbed following dermal exposure into the stratum corneum and into the epidermis, due to its molecular weight and its high water solubility. Concerning its distribution in the body the substance is expected to be distributed mainly in the intravasal compartment, due to its high water solubility. The substance does not indicate a significant potential for accumulation. O,o-Fe(Na)EDDHA is expected not to be significantly metabolised but to be eliminated unchanged via urine and bile.
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.
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