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EC number: 425-180-1 | CAS number: 66170-10-3
- 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
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vitro / ex vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: non Guideline, non GLP but good public available literature data
Data source
Reference
- Reference Type:
- publication
- Title:
- Skin Penetration and Retention of L-Ascorbic Acid 2-Phosphate Using Multilamellar Vesicles
- Author:
- Juno Yoo, Srinivasan Shanmugam, Chung-Kil Song, Dae-Duk Kim, Han-Gon Choi, Chul-Soon Yong, Jong-Soo Woo, and Bong Kyu Yoo
- Year:
- 2 008
- Bibliographic source:
- Arch Pharm Res Vol 31, No 12, 1652-1658, 2008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Animals care and procedures were conducted according to the guidelines for animal use in toxicology (Society of Toxicology USP 1989) and the study protocol was approved by the Animal Care and Use Committee, College of Pharmacy, Yeungnam University.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 113170-55-1
- EC Number:
- 601-239-9
- Cas Number:
- 113170-55-1
- IUPAC Name:
- 113170-55-1
- Reference substance name:
- Magnesium Ascorbyl Phosphate
- IUPAC Name:
- Magnesium Ascorbyl Phosphate
- Details on test material:
- chemical were of analytical grade and used without further purification.
Constituent 1
Constituent 2
- Radiolabelling:
- no
Test animals
- Species:
- other: mouse: skin penetration in vitro
- Strain:
- other: hairless
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Seven-week-old male hairless mice (weighing 35 ± 3.0 g) were obtained from Orient Bio (Seoul, Korea) and housed in groups not exceeding six per cage and maintained under standard conditions. The acclimation period was two weeks before the experimental procedure with a dark/light cycle of 12
h/12 h at the temperature of 23±2oC. Food and tap water were available ad libitum during the acclimation period.
Administration / exposure
- Type of coverage:
- open
- Vehicle:
- water
- Duration of exposure:
- 6h
- Doses:
- 0.4 mL was applied on the skin and allowed to spread over the skin.
- No. of animals per group:
- not indicated
- Control animals:
- no
- Details on study design:
- See details on in vitro system.
- Details on in vitro test system (if applicable):
- Seven-week-old male hairless mice (weighing 35 ± 3.0 g) were obtained from Orient Bio (Seoul, Korea) and housed in groups not exceeding six per cage and maintained under standard conditions. The acclimation period was two weeks before the experimental procedure with a dark/light cycle of 12 h/12 h at the temperature of 23±2°C. Food and tap water were available ad libitum during the acclimation period. Mice were sacrificed and full-thickness skin was taken, followed by removal of subcutaneous fat. Approximately 2 cm2 of the trimmed skin was placed into Keshary-Chien diffusion cell with 1.77 cm2 diffusion area.
0.4 mL were applied on the skin and allowed to spread over the skin. Donor compartment (epidermal layer of the skin) remained unoccluded, but covered with a lid, and the receptor compartment (dermal layer of the skin) was perfused with distilled water maintaining temperature at 37°C. Serial sampling of the receptor compartment was performed at predetermined intervals (0.25, 0.5, 1, 2, 3, 4, 5, and 6 h). Because L-ascorbic acid-2-phosphate magnesium salt (A2P) becomes metabolized to L-ascorbic acid (AA) by alkaline phosphatases in the skin, we measured both A2P and AA simultaneously. Penetrated amounts of A2P and AA were plotted as a function of time. The flux for both A2P and AA were calculated by the slope of the linear portion of the curve, which was achieved in about 1 h. We also performed the skin penetration study with A2P dissolved into distilled water as a control.
The skin was homogenized in 2 mL of distilled water under ice bath for 10 min followed by centrifugation at 12000 g for 5 min. Clear supernatant (500 μL) was taken and mixed with 500 μL of extraction solvent (10% metaphosphoric acid : 20% trichloroacetic acid : distilled water = 1:2:7) for protein precipitation, and was subjected to vortex for 30 sec and centrifugation at 16000 g for 3 min. The clear supernatant thus obtained was used for skin retention study by using HPLC assay.
For skin penetration study, the concentrations of A2P and AA were assayed simultaneously by HPLC system (Shimadzu, Japan) equipped with Class VP computer software, LC 10 AD VP pump, and SPD 10A UV-VIS detector at 240 nm. Column used was Inertsil ODS-3 (4.6 × 150 mm, GL Science Inc, Japan) and mobile phase consisted of a mixture of 0.02 M phosphate buffer and methanol (85:15, v/v) adjusted to pH 2.3 with phosphoric acid. Flow rate was 0.8 ml/min and the injection volume of the sample was 20 mL. The validation of the HPLC assay conditions was performed by repeating five times a day for five consecutive days.
Results and discussion
- Signs and symptoms of toxicity:
- not examined
- Dermal irritation:
- not examined
- Absorption in different matrices:
- The dermal penetration of L-ascorbic acid-2-phosphate magnesium salt (A2P) was determined to be 0.6926 nmole x cm2/h. With a molecular weight of 278.39 g/mole a dermal penetration of 192.89 ng x cm2/h is calculated. For the dermal penetration assay 0.4 ml were applied on a surface area of 2 cm2. As a worst case assumption 1 mg/cm2 was used for calculation. In conclusion 0.019%/h of L-ascorbic acid-2-phosphate magnesium salt (A2P) is resorbed via the skin. For a 8 h working day a dermal penetration of 0.16 % is calculated.
- Total recovery:
- not examined
Percutaneous absorption
- Dose:
- 0.4 ml
- Parameter:
- percentage
- Absorption:
- 0.2 %
- Remarks on result:
- other: 8 h
- Remarks:
- calculated for a 8 h working day (see above)
- Conversion factor human vs. animal skin:
- not applicable
Applicant's summary and conclusion
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.