Registration Dossier
Registration Dossier
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Diss Factsheets
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EC number: 208-288-1 | CAS number: 520-26-3
- 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)
Description of key information
Overall, following analysis of an extensive range of data in the open peer reviewed literature we conclude that the metabolism of the structurally related, naturally occurring flavonoids, flavanones, flavones and dihydrochalcone glycosides results in significant hydrolysis of the glycosides yielding the corresponding aglycones. These aglycones are readily absorbed, metabolised, conjugated and excreted via the bile and urine, and partly undergo flavone ring cleavage and subsequently cleavage of the three carbon-bridge of dihydrochalcones by the gut flora. A series of polar metabolites are formed that are excreted directly in the feces or absorbed and excreted via the bile and urine, either as such or as their conjugates.
It is concluded that the toxicokinetic profiles of these six flavonoids follows a common pattern and are considered to be very similar. The use of methyl hesperidin, glucosyl hesperidin, naringin, diosmin and neohesperidin dihydrochalcone as structural surrogates for hesperidin for toxicity and ecotoxicity studies is therefore a valid and justified approach. The flavonone hesperidin is readily absorbed orally and dermally and subsequently metabolized and excreted. No indications for bioaccumulation were noted. A detailed toxicokinetic assessment is attached.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
- Absorption rate - oral (%):
- 100
- Absorption rate - dermal (%):
- 100
Additional information
An assessment of the Absorption, Distribution, Metabolism, and Excretion of "hesperidin and related flavonoids" was performed to the extent that can be derived from the relevant available information according to the requirements of Annex VIII of the Regulation (EC) 1907/2006. From the analysis of an extensive range of data in the open peer reviewed literature, it was demonstrated that parent flavonoids were not well absorbed. However the ingestion of the flavanones, flavones and dihydrochalcone glycosides (parent flavonoids) can result in significant hydrolysis of the glycosides, yielding the corresponding aglycones. These aglycones are readily absorbed, metabolised, conjugated and excreted via the bile and urine, and partly undergo flavone ring cleavage and subsequently cleavage of the three carbon-bridge of dihydrochalcones by the gut flora. A series of polar metabolites are formed that are excreted directly in the feces or absorbed and excreted via the bile and urine, either as such or as their conjugates. It is concluded that the toxicokinetic profile of these six flavonoids follows a common pattern and is considered to be very similar. The use of methyl hesperidin, glucosyl hesperidin, naringin, diosmin and neohesperidin dihydrochalcone as structural surrogates for hesperidin for toxicity and ecotoxicity studies is therefore a valid and well justified approach.
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.