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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 946-329-1 | 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics, other
- Remarks:
- expert satement
- Type of information:
- other: expert satement
- Adequacy of study:
- key study
- Study period:
- 2017
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: An extended assessment of the toxicokinetic behaviour of zinc glucoheptonate was performed, taking into account the chemical structure, the available physico-chemical-data and the available toxicity data of the structural analogues.
Data source
Reference
- Reference Type:
- other: Expert statement
- Title:
- Toxicokinetic assessment of ZnGHA
- Author:
- Chemservice S.A.
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
- Objective of study:
- absorption
- distribution
- excretion
- metabolism
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: TGD, Part I, Annex IV, 2003; ECHA guidance R7c., 2012
- Principles of method if other than guideline:
- Physical chemical properties of zinc glucoheptonate were integrated with the published toxicological data and data on ADME parameters of the structurally related substance zinc gluconate to create a prediction of its toxicokinetic behaviour. Additionally, well investigated ADME data on zinc from different sources (food, medications and other inorganic and organic compounds) have been taken into account, because the systemic toxicity of zinc glucoheptonate is considered to be driven by released zinc from the zinc glucoheptonate complex.
Test material
- Reference substance name:
- Reaction products of sodium glucoheptonate with zinc sulfate and sodium hydroxide
- EC Number:
- 946-329-1
- Molecular formula:
- Not specified (UVCB substance).Molecular formula of the main substance:C14H30O22SZn2
- IUPAC Name:
- Reaction products of sodium glucoheptonate with zinc sulfate and sodium hydroxide
- Test material form:
- solid: granular
- Remarks:
- microgranulated
Constituent 1
- Radiolabelling:
- no
Results and discussion
Main ADME resultsopen allclose all
- Type:
- absorption
- Results:
- Due to the MW of 619.2 g/mol and logPow -16.9, it is readily absorbed via the GI tract. Low absorption potential via dermal route and inhalation is expected due to its high water solubility (500-550 g/L) and low vapour pressure (1.55 x 10E-4 Pa).
- Type:
- distribution
- Results:
- Zinc, if released from glucoheptonate, is distributed to all organs and tissues and will be bound with organic ligands rather than existing free in solution as a cation
- Type:
- metabolism
- Results:
- The enzyme 6-phosphogluconolactonase (catalysing the second step of pentose phosphate pathway (PPP)) was shown to possess a broad substrate specificity hydrolysing gluconolactone moieties including glucoheptonate.
- Type:
- excretion
- Results:
- Glucoheptonate is mainly excreted via the kidneys. About 70-80% of the ingested amount of zinc is excreted via faeces (5 to 10 mg/day depending upon the dietary zinc concentration).
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Zinc glucoheptonate is expected to be moderately absorbed after oral exposure, based on its high water solubility and molecular weight suggestive for favoured absorption through gastrointestinal tract. As worst-case, 100 % oral absorption is considered appropriate. Concerning absorption after exposure via inhalation, as the chemical has a low vapour pressure, is highly hydrophilic, has a negative LogPow, and has 13.9 % of particles less than 100 µm, it is clear, that the substance is poorly available for inhalation and will not be absorbed significantly via lungs. However, an absorption by aspiration cannot be fully ruled out. Therefore, 100% inhalation absorption is considered. Zinc glucoheptonate is not expected to be absorbed following dermal exposure into the stratum corneum and into the epidermis, due to its very high water solubility and considering low absorption potential of zinc and glucoheptonate moieties. 10 % absorption is therefore considered for dermal route of exposure.
- Details on distribution in tissues:
- Glucoheptonate moieties, are expected to be distributed predominantly to kidneys and organs with higher expression of glucose transporters. The substance does not indicate a significant potential for accumulation. Zinc, if released from glucoheptonate, is distributed to all organs and tissues and will be bound with organic ligands rather than existing free in solution as a cation
- Details on excretion:
- Glucoheptonate is involved into intermediary carbohydrate metabolism and eliminated unchanged primarily via the urine and to a lesser extent via the bile. About 70-80% of the ingested amount of zinc is excreted via faeces (5 to 10 mg/day depending upon the dietary zinc concentration).
Metabolite characterisation studies
- Details on metabolites:
- Metabolism of glucoheptonate in mammalian tissues is described in several publications dealing with investigations of substrate specificity of a various number of aldonic acids and its isomeric analogues lactones. The enzyme 6-phosphogluconolactonase (catalysing the second step of pentose phosphate pathway (PPP)) was shown to possess a broad substrate specificity hydrolysing gluconolactone moieties including glucoheptonate. The enzyme is present in almost all mammalian tissues including humans. Further investigations revealed that glucoheptonate moiety undergoes a series of biochemical transformations similar to those of PPP.
Applicant's summary and conclusion
- Executive summary:
Zinc glucoheptonate is expected to be moderately absorbed after oral exposure, based on its high water solubility and molecular weight suggestive for favoured absorption through gastrointestinal tract. As worst-case, 100 % oral absorption is considered appropriate. Concerning absorption after exposure via inhalation, as the chemical has a low vapour pressure, is highly hydrophilic, has a negative LogPow, and has 13.9 % of particles less than 100 µm, it is clear, that the substance is poorly available for inhalation and will not be absorbed significantly via lungs. However, an absorption by aspiration cannot be fully ruled out. Therefore, 100% inhalation absorption is considered. Zinc glucoheptonate is not expected to be absorbed following dermal exposure into the stratum corneum and into the epidermis, due to its very high water solubility and considering low absorption potential of zinc and glucoheptonate moieties. 10 % absorption is therefore considered for dermal route of exposure. Glucoheptonate moieties, are expected to be distributed predominantly to kidneys and organs with higher expression of glucose transporters. The substance does not indicate a significant potential for accumulation. Zinc homeostasis is regulated in mammals by gastrointestinal absorption, excretion via faeces and via the urine as well as by the release from tissues. The total body zinc is maintained constant at the physiologically required levels of zinc in the various tissues at low and high dietary zinc intakes. Zinc, if released from glucoheptonate, is distributed to all organs and tissues and will be bound with organic ligands rather than existing free in solution as a cation. Glucoheptonate is involved into intermediary carbohydrate metabolism and eliminated unchanged primarily via the urine and to a lesser extent via the 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.
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.