Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 1998-03-12 to 1998-05-06
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- adopted February 24, 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- 92/69/EEC
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 425-180-1
- EC Name:
- -
- Cas Number:
- 66170-10-3
- Molecular formula:
- C6 H9 O9 P . 3 Na (CAS) C6 H6 Na3 P O9 (Hill)
- IUPAC Name:
- trisodium mono-(5-(1,2-dihydroxyethyl)-4-oxido-2-oxo-2,5-dihydro-furan-3-yl)phosphate
- Details on test material:
- - Name of test material (as cited in study report): Sodium ascorbyl phosphate
- Physical state: Solid (powder), beige
- Analytical purity: 85.4 g/100 g
- Lot/batch No.: 28600/37-9
- Date of Manufacturing: 1997-05-02
- Storage condition of test material: Room temperature
- Stability under test conditions: The stability of the test substance in aqua bidest. for a time period of 96 hours was confirmed by analysis
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Boehringer Ingelheim Pharma KG
- Age at study initiation: Young adult animals
- Weight at study initiation: Animals of comparable weight (200g -300g); +/- 20% of the mean weight
- Housing: single housing, Stainless steel wire mesh cages, type DK-III (Becker & Co., Castrop-Rauxel, Germany); No bedding in the cages; wood shavings in the waste trays.
- Diet (e.g. ad libitum): Kliba-Labordiaet, Klingentalmuehle AG, Kaiseraugst, Switzerland, ad libitum.
- Water (e.g. ad libitum): Tap water ad libitum per day.
- Acclimation period: Acclimatization for at least 1 week.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12 hrs/12 hrs (6.00 a.m. - 6.00 p.m./ 6.00 p.m. - 6.00 a.m.)
IN-LIFE DATES: From: 1998-03-12 To: 1998-03-26
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal and dorsolateral parts of the trunk
- % coverage: About 50 cm2 (corresponds to at least 10 % of the body surface area).
- Type of wrap if used: the bandage consists of four layers absorbent gauze, Ph. Eur. Lohmann GmbH & Co. KG and Fixomull stretch (adhesive fleece), Beiersdorf AG
REMOVAL OF TEST SUBSTANCE
- Washing: Rinsing of the application site with warm water.
- Time after start of exposure: 24 hrs
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.22 mL/kg bw,
- Concentration (if solution): 90 g / 100 mL
- Constant volume or concentration used: yes (only one test group, limit test)
- For solids, paste formed: no (suspension applied to skin)
VEHICLE
- Amount(s) applied (volume or weight with unit): 2.22 mL/kg bw
- Concentration (suspension): 90g /100 mL
- Purity: aqua bidest. - Duration of exposure:
- 24 hrs
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 males, 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights shortly before application (day 0), weekly thereafter and at the end of the study (before fasting period). Recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals. Scoring of skin findings: Individual readings 30 - 60 minutes after removal of the semiocclusive dressing (day 1), weekly thereafter and at the end of the study (last day of the observation period). A check for any dead or moribund animal was made twice each workday and once on Saturdays, Sundays and on public holidays.
- Necropsy of survivors performed: yes Necropsy at the last day of the observation period. Withdrawal of food at least 16 hours before killing with CO2; then necropsy with grosspathology examination. Necropsy of all animals that died before as early as possible. - Statistics:
- The binomial test (Snedecor G.W., Cochran W.G. (1989), Statistical methods, 8th ed., Iowa State University Press Ames) was used for LD50 determination.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: 1 % significance level
- Mortality:
- No mortality observed after 14 days.
- Clinical signs:
- Male:
No abnormality.
Local effects: very slight erythema on day 1 (2 of 5 animals).
Female:
No abnormality.
Local effects: very slight erythema on day 1 (2 of 5 animals). - Body weight:
- Mean body weight of the male animals:
Before application (day 0): 275 g
after application (day 7): 311 g
after application (day 13): 336 g
Mean body weight of the female animals:
Before application (day 0): 242 g
after application (day 7): 249 g
after application (day 13): 258 g - Gross pathology:
- No particular findings.
- Other findings:
- No other findings.
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.