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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Reaction mass of ammonium;potassium;sodium;2-[2-[bis(carboxymethyl)amino]ethyl-(carboxymethyl)amino]acetate;magnesium, ammonium;potassium;sodium;2-[bis[2-[bis(carboxymethyl)amino]ethyl]amino]acetate;magnesium and ammonium;potassium;sodium;2-[2-[bis(carboxymethyl)amino]ethyl-(2-hydroxyethyl)amino]acetate;magnesium
EC number: 902-533-2 | CAS number: -
- 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
Endpoint summary
Administrative data
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics, other
- Remarks:
- general toxicokinetic assessment
- Type of information:
- other: summary of available information
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Review of toxicokinetics based on available information (Reliability 2)
- Justification for type of information:
- All available information on the test substance was used to assess the potential toxicokinetics, based on the REACH Guidance on Toxicokinetics (Reach Guidance 7c).
- Objective of study:
- toxicokinetics
- Qualifier:
- according to guideline
- Guideline:
- other:
- Version / remarks:
- R.7.12 Guidance on Toxicokinetics
- Details on distribution in tissues:
- A toxicant can enter the body via the gastrointestinal tract, the lungs and the skin. In general, a compound needs to be dissolved before it can be taken up from the gastrointestinal tract after oral administration.1
The substance is a reaction mixture of MgEDTA, MgDTPA and MgHEEDTA. As the test substance is used as a fertilizer, it is expected that it will be highly water soluble, in order to have the magnesium available for plant uptake; each chelate is expected to have a water solubility of > 1 g/mL. It will therefore readily dissolve into the gastrointestinal fluids and make contact with the mucosal surface. The molecular weight of each chelate in the reaction mixture (<500) is favorable for absorption. As the pKa is high, the test substance is a weak acid, and not expected to dissociate into ions in aqueous solution, and will therefore not hamper the absorption. However, the log Kow (≤ -10.4) will severely limit the uptake through the lipid membranes. For risk assessment purposes the oral absorption of the reaction mixture of MgEDTA, MgDTPA and MgHEEDTA is set at 10%.2 The oral toxicity data do not provide reason to deviate from the proposed oral absorption factor.
The low vapour pressure (≤ 2.44E-19 mm Hg at 25°C) and the absence of a boiling point (reaction and/or decomposition of the test substance starts at 150°C) indicate that the reaction mixture of MgEDTA, MgDTPA and MgHEEDTA is a substance with low volatility. Therefore it is not likely that the reaction mixture of MgEDTA, MgDTPA and MgHEEDTA will reach the nasopharyncheal region or subsequently the tracheo/bronchial/pulmonary region via inhalation of vapour.
In humans, particles with aerodynamic diameters below 100 μm have the potential to be inhaled. Particles with aerodynamic diameters below 50 μm may reach the thoracic region and those below 15 μm the alveolar region of the respiratory tract. The reaction mixture of MgEDTA, MgDTPA and MgHEEDTA is a solid, with unknown mean particle size. It cannot be excluded that at least part of the substance will reach the nasopharyncheal region and subsequently the tracheo/bronchial/pulmonary region via inhalation. If the reaction mixture of MgEDTA, MgDTPA and MgHEEDTA reaches the tracheobronchial region, it is likely to diffuse/dissolve into the mucus lining of the respiratory tract due to its water solubility. However, further uptake through the lipid membranes will be hampered due to the low log Kow of the components (≤ -10.4). For risk assessment purposes the inhalation absorption of the reaction mixture of MgEDTA, MgDTPA and MgHEEDTA is set at 10%.2 The inhalation toxicity data do not provide reason to deviate from the proposed oral absorption factor.
The reaction mixture of MgEDTA, MgDTPA and MgHEEDTA is a powder, however, the substance is used/marketed as a liquid. Due to the high water solubility, it will dissolve easily into the surface moisture of the skin to allow uptake. The moderate size of each components (approximately 300-400 Da) is not expected to hamper uptake, however the low log Kow of the components (≤ -10.4) will severely limit penetrance of the first skin layer, the stratum corneum (non-viable layer of corneocytes forming a complex lipid membrane).
According to the criteria given in the REACH Guidance2, a default value of 100% dermal absorption should be used unless MW >500 and log Kow <-1 or >4, in which case a value of 10% skin absorption should be chosen. Although the MW (300-400) of the reaction mixture of MgEDTA, MgDTPA and MgHEEDTA indicate that the criteria for 10% absorption are not met, the extremely low log Kow will severely limit absorption.
Taken together, based on molecular weight, some dermal absorption might be expected, but the extremely low log Kow will severely limit absorption. The oral absorption of the reaction mixture of MgEDTA, MgDTPA and MgHEEDTA is set at 10%. Based on these considerations, for risk assessment purposes the dermal absorption of the reaction mixture of MgEDTA, MgDTPA and MgHEEDTA is set at 10%.2
Once absorbed, distribution of the test substance throughout the body is expected based on its water solubility and moderate molecular weight. No metabolism is expected and the absorbed reaction mixture of MgEDTA, MgDTPA and MgHEEDTA is expected to be excreted mainly via urine3. Based on its low partition coefficient, water solubility and moderate molecular size the reaction mixture of MgEDTA, MgDTPA and MgHEEDTA is not expected to accumulate significantly in adipose tissue.
- Conclusions:
- A toxicokinetic assessment was performed based on the available data of the substance. Based on the physical/chemical properties of the reaction mixture of MgEDTA, MgDTPA and MgHEEDTA, absorption factors for this substance are derived to be 10% (oral), 10% (inhalation) and 10% (dermal) for risk assessment purposes. No significant bioaccumulation potential is expected.
Reference
Description of key information
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
- Absorption rate - oral (%):
- 10
- Absorption rate - dermal (%):
- 10
- Absorption rate - inhalation (%):
- 10
Additional information
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.