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Diss Factsheets
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EC number: 205-126-1 | CAS number: 134-03-2
- 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
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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:
- For justification please refer to read across justification in IUCLID section 13.
- Reason / purpose for cross-reference:
- read-across source
- Specific details on test material used for the study:
- CAS number: 134-03-2
- Details on absorption:
- Results from source substance:
Ascorbic acid is rapidly absorbed from the intestine by a sodium-dependent active transport process. The absorption efficiency is up to 98% at low doses and 2 % are excreted into faeces. The tranporter is saturable, the absorption efficiency therefore gradually decreases at higher intakes to 80-90% at up to 180 mg, 75 mg at 1g and 16% at 12g (Hornig and Moser, 1981). - Details on distribution in tissues:
- Results from source substance:
Ascorbic acid is readily oxidised to dehydroascorbic acid which can be reduced back to ascorbic acid or hydrolysed (irreversibly) to diketogulonic acid. The latter is partly excreted with urine and partly oxidised to mainly oxalic acid and threonic acid (and to a lesser extent to xylose, xylonic acid and lyxonic acid). Oxidation to carbon dioxide is not a major route but may occur at high doses, possibly as a result of metabolism of unabsorbed ascorbate by the intestinal microflora. To some extent, ascorbic acid may also form a conjugate with sulphate which is excreted in the urine as is unchanged ascorbic acid. The percentage that is excreted depends on the dose. Only 3% of a 60 mg dose is excreted in the faeces, while the majority is excreted in the faeces at very high doses, e.g. 1 g or more. At total daily intakes above 80-100 mg, most of the ascorbic acid above this dose range is excreted unchanged in the urine, indicating that tissues reserves are saturated. - Details on excretion:
- Results from source substance:
cf. sections above
Reference
Results from source substance:
The pharmacokinetics of ascorbic acid and calcium ascorbate were investigated in 20 dogs. The animals received single oral doses at two dose levels, 15 and 50 mg/kg bw. A rapid increase of the ascorbic acid plasma level was seen. The obtained Cmax and area under the curve values increased in a non-linear fashion with the increased dose.
There was no significant difference in pharmacokinetic parameters between ascorbic acid and calcium ascorbate. (Wang et al., 2001).
The EFSA ANS Panel considered that sodium and calcium ascorbate are fully dissociated in the stomach, and that the bioavailability would be expected to be similar to that of ascorbic acid in the gastrointestinal tract (EFSA ANS Panel, 2015).
Description of key information
The absorption rate is high at low and moderate doses up to 80 -100 mg/day. Most of excess dose is excreted with the urine and faeces.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
- Absorption rate - oral (%):
- 100
Additional information
Ascorbic acid is rapidly absorbed, metabolised and excreted following oral intake. The absorption is complete at low doses whereas most of ascorbic acid above this dose range is excreted unchanged in the urine because the transporter from the gut is saturated.
Data for ascorbic acid can be adopted for sodium ascorbate because following oral intake either substance will dissociate and be protonated at the low pH value in the stomach which results in a similar absorption from the gut.
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.
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