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Diss Factsheets
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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
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
An extended read-across statement is attached under section 13.
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Skin sensitisation potential of glucoheptonates is believed to be driven by metal cation bonded to the organic part of the molecule and not by the organic part itself. Glucohepotonates can dissociate on the skin releasing their metals that can further interact with skin proteins, while no skin sensitisation potential can be attributed to the organic part of the molecule. Glucoheptonates are not known to bind to proteins, producing a hapten eliciting a skin sensitisation response.
Therefore, data on skin sensitisation potential of several organic and inorganic compounds have been taken into account to address skin sensitisation potential of zinc cation which could be released from the zinc glucoheptonate in contact with skin.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Information on purity of the registered substance is provided in the target record under "Test material" as confidential. The content of zinc glucoheptonate in the registered product is 75 %. Another component is Na2SO4. Sodium is a macroelement occuring in surface waters and in living organisms in considerable amounts. Sulfur species are also found in living organisms. Thus, these cations and anions are considered not to impact the sensitisation of zinc to mammals.
There is limited information on purity of the source substance zinc gluconate.
3. ANALOGUE APPROACH JUSTIFICATION
Zinc gluconate (source) and Sodium Zinc glucoheptonate complex (HGA:Zn-1:1) (target) are structurally very similar. Both - the source and the target substance - contain the same types of hydrocarbon constituents (sugar residues), which are only variable in carbon chain length. In case of zinc gluconate two gluconic acid-chains (C6H11O7-) are involved and in case of zinc glucoheptonate it is two glucoheptonic acid chains (C7H10O8).
It has generally been shown by a substantial body of evidence, that the toxicity profiles of chelate compounds in general depend mainly on metal ion, its affinity to this metal, and their ability to supply or to sequester it from the body. In the OECD SIDS report is mentioned “Evidence from the reviewed literature suggests that the eventual toxicity of the gluconate salts would be attributable to the cation rather than to the gluconate moiety of these substances.”
4. DATA MATRIX
please refer to the detailed data matrix attached in section 13.
Data source
Materials and methods
- Study type:
- other: review article
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
Results and discussion
Any other information on results incl. tables
Zinc gluconate, also called zincum gluconicum, is the zinc salt of gluconic acid. It has been shown to be efficient to treat inflammatory skin diseases such as acne vulgaris. Recent studies revealed that its antiinflammatory
effects may target at peroxisome proliferator-activated receptors-α (PPARs-α), human β-defensin-2, and psoriasin.
Applicant's summary and conclusion
- Executive summary:
Zinc gluconate, also called zincum gluconicum, is the zinc salt of gluconic acid. It has been shown to be efficient to treat inflammatory skin diseases such as acne vulgaris. Recent studies revealed that its antiinflammatory effects may target at peroxisome proliferator-activated receptors-α (PPARs-α), human β-defensin-2, and psoriasin. This anti-inflammatory activity of Zinc gluconate may prevent the initiation of skin sensitisation. This is of high relevance for the target substance zinc glucoheptonate, because it is very similar to zinc gluconate. Therefore, an identical effect can be expected for zinc glucoheptonate.
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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