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Diss Factsheets
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EC number: 209-683-1 | CAS number: 590-46-5
- 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 in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- In the assessment of betaine hydrochloride (C5H12NO2.Cl, CAS 590-46-5), a read-across approach is followed based on the information available for betaine (C5H11NO2, CAS 107-43-7). This read-across strategy is based on the hypothesis that the betaine moiety is the driver for the ecotoxicological and toxicological effects of both substances.
The read-across hypothesis is justified by the immediate dissociation of betaine hydrochloride to betaine and hydrogen and chloride ions upon dissolution in aqueous media. Both betaine and betaine hydrochloride are highly soluble (>400 g/L). Exposure to the non-common cations (H+ and Cl-) does not influence the prediction of the (eco)-toxicity at relevant concentrations because both elements are abundantly present in natural environments and the human body and emissions from this substance do not significantly increase their overall exposure concentration.
Further information is included as attachment in section 13 of IUCLID. - Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across: supporting information
- Objective of study:
- metabolism
- Type:
- metabolism
- Results:
- Completely metabolized by liver and kidney cells by methylation to dimethylglycine and ultimately to serine.
- Metabolites identified:
- yes
- Details on metabolites:
- Dimethylglycine
- Conclusions:
- Betaine is completely metabolized by liver and kidney cells, a very small amount is passed in urine.
According to a read-across approach based on the rapid dissociation of betaine hydrochloride to betaine and hydrogen and chloride ions upon dissolution in aqueous media, it is concluded that the results for betaine are also applicable to betaine hydrochloride. After passage through the stomache, betaine hydrochloride will be completely dissociated and betaine will be further completely metabolized by liver and kidney cells.
There is no bioaccumulation potential based on these study results.
Reference
Description of key information
No bioaccumulation potential
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
Based on several pharmacokinetic and metabolism studies on betaine and the fact that betaine hydrochloride is complete dissociated into betaine, protons and chloride ions after passage through the stomach, it can be concluded that betaine hydrochloride is mainly metabolized by liver hepatocytes and kidney cortex cells, and only a fraction is secreted in urea. Betaine has not shown any adverse effects on human health or any effects that might raise concern regarding the safety of this substance. The longer half-lifes and lower elimination times with lower doses reflect the balance between the body's own betaine synthesis, exogenous betaine and elimination. Betaine, as well as its main metabolite dimethylglycine, are homeostatically controlled by the body.
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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