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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Additional information
No data available. In accordance with column 2 of REACH Annex VIII, the toxicity to reproduction study (reproduction screening test, 8.7.1) does not need to be conducted as two studies on prenatal developmental toxicity (8.7.2) are available for ascorbic acid (read across).
Effects on developmental toxicity
Description of key information
No study is available for Sodium ascorbyl phosphate. A read across was performed to the parent compound Ascorbic acid to fill the data gap.
A developmental toxicity/teratogenicity study by Frohberg (1973) showed no maternally toxicity, fetotoxicicity, or teratogenic effects in rats and mice. Ascorbic Acid did also not affect embryonal, fetal, and postpartal development of rat pups.
In a further study in rats and hamsters no developmental toxicity was observed by Alleva (1976) .
Summarised, no developmental toxicity was observed in rats, mice and hamsters after oral administration during the gestation period up to the highest doses tested (1000 mg/kg /450 mg/kg. .
Thus, it can be concluded that Ascorbic acid and Sodium ascorbyl phosphate are not toxic to development and not teratogenic.
Effect on developmental toxicity: via oral route
- Dose descriptor:
- NOAEL
- 450 mg/kg bw/day
Additional information
Teratogenicity/Developmental toxicity Study Frohberg (1973) – Read across from Ascorbic acid:
In a developmental toxicity study Ascorbic acid was administered to
- 17-22 female Wistar rats/dose in water at dose levels of 0, 250, 500, 1000 mg/kg bw/day from days 6 through 15 of gestation (Teratogenicity test).
- 24-27 female Wistar rats/dose in water at dose levels of 0, 250, 500, 1000 mg/kg bw/day from days 0 of gestation through 21 post partum (peri- and postnatal test).
- 21-23 female NMRI mice/dose in water at dose levels of 0, 250, 500, 1000 mg/kg bw/day from days 6 through 15 of gestation (Teratogenicity test).
Teratogenicity test (rats and mice):
The treatment did not produce maternally toxic, fetotoxic, or teratogenic effects. There was no effect on gestation or on maternal body weight gain. The number of abortions and resorptions, the mean number of live fetuses per dam, the mean fetal body weight, and the incidence of runts or malformed fetuses were not affected by treatment with the test substance.
Peri- and postnatal test (rats):
The test substance did not affect embryonal, fetal, and postpartal development of the pups. There was no substance-related effect on gestation, delivery, maternal raising instinct or lactation. In the high dose group, the mean number of implantations per dam and the mean number of live pups per dam was decreased when compared with vehicle controls and with basic controls. According to the authors, although these changes were not statistically significant, an effect of this "extremely high dose level" of the test substance on nidation could not be fully excluded.
No LOAELs can be evaluated as no adverse effects occurred. The maternal NOAEL is > 1000mg/kg bw/day. The developmental NOAEL is > 1000 mg/kg bw/day.
The developmental toxicity study in the rat is classified acceptable and meets generally accepted scientific standards, well documented and acceptable for assessment
Teratogenicity/developmental toxicity Study Alleva (1976) – Read across from Ascorbic acid:
In a developmental study Ascorbic acid was administered to
- 11 female Holtzman rats/dose orally at dose levels of 0, 50, 150, 450 mg/kg bw/day from day 1 to 19 of pregnancy.
- 10-14 female hamsters/dose orally at dose levels of 0, 50, 150, 450 mg/kg bw/day from day 1 to 15 of gestation.
Abortion, mortality of offspring, and live pup weights were determined. No other parameters were investigated. No increase in abortion or mortality of offspring was observed in all species. A slight increase in pup weight was observed in one group of hamsters. This is considered as no adverse effect.
No LOAEL can be evaluated as no adverse effects occurred. The NOAEL is > 450 mg/kg bw/day in female rats and hamsters.
Justification for classification or non-classification
Based on the results (no developmental tocicity, no teratogenicity - read across from Ascorbic Acid) Sodium ascorbyl phosphate is not classified reprotoxic according to EU Directive 67/548/EC amended and repealed by EU Regulation No.1272/2008 and CLP.
Additional information
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.