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EC number: 241-253-9 | CAS number: 17211-15-3
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 987
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- single oral administration
- GLP compliance:
- no
- Remarks:
- Study conducted in 1987, before 1 June 2008 (refering to REACH Article 13(4))
Test material
- Reference substance name:
- Myo-Inositol, hexakis(dihydrogen phosphate), dodecasodium salt
- EC Number:
- 241-253-9
- EC Name:
- Myo-Inositol, hexakis(dihydrogen phosphate), dodecasodium salt
- Cas Number:
- 17211-15-3
- IUPAC Name:
- Esters of sodium phosphate with myo-Inositol, plant-derived (old IUPAC name: dodecasodium;(2,3,4,5,6-pentaphosphonatooxycyclohexyl) phosphate)
- Test material form:
- solid: bulk
- Details on test material:
- According to the authors of the study the water content of the test item was 11%.
Constituent 1
- Specific details on test material used for the study:
- The study was performed on dodecasodium phyate (C6H6(PO3Na2)6 x H2O with a water content of 11%) which is equivalent to the substance "Esters of sodium phosphate with myo-Inositol, plant-derived (old name: Myo-Inositol, hexakis(dihydrogen phosphate), dodecasodium salt, CAS 17211 -15 -3).
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:: Sodium Phytate from NAKARAI CHEMICALS, LTD. (Reagent first grade, Lot No. M6H 2435, C6H6(PO3Na2)6 x H2O, Water content 11%)
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Sample was diluted or dissolved with purified water. For details on volumes (ml/kg bw) & doses (g/kg bw) refer to Table in section "Any other information on materials and methods incl. tables".
Test animals
- Species:
- rat
- Strain:
- Fischer 344/DuCrj
- Sex:
- male/female
Administration / exposure
- Vehicle:
- water
- Doses:
- Experiment 3: 0.61 / 0.91 / 1.35 / 2.03 / 3.04 g/kg bw (Volume 0.8 ml/kg bw)
Experiment 4: 0.94 / 1.03 / 1.14 / 1.25 / 1.38 / 1.51 g/kg bw (Volume 0.5 ml/kg bw) - No. of animals per sex per dose:
- 5
- Control animals:
- no
- Statistics:
- Experiment 3: Moving Avergae method
Experiment 4: Lichtfield-Wilcoxon
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1.13 other: g/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 0.935 - <= 1.365
- Remarks on result:
- other: Experiment 3
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1.672 other: g/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Experiment 3
- Remarks:
- by Moving Avergae method
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1.03 other: g/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 0.95 - <= 1.117
- Remarks on result:
- other: Experiment 4
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1.2 other: g/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 0.668 - <= 2.156
- Remarks on result:
- other: Experiment 4
- Mortality:
- Experiment 4:
- Most of deaths occurred ≤24 h after administration
- male: onset after 3h / peak after 7h / last after 24h
- female: onset after 3h / peak after 5h / last after 46h - Clinical signs:
- other: Marked expansion of the stomach and bleeding of the glandular portion of the stomach were seen. The color of liver and spleen was turned dark red. The color of the duodenum, ileum and jejunum was turned dark or black due to bleeding or bodily fluid contai
Any other information on results incl. tables
Table: LD50 of sodium phytate in rats
Material | Exp. No. | Sex | Death Time (hr.) | Slope Function (Confidence Interval at p = 0.05) | LD50 (g/kg) (Confidence Interval at p = 0.05) |
Sodium phytate (C6H6(PO3Na2)6* xH2O) |
3 |
M |
1.241 (0.874 ~ 1.763) | 1.13 (0.935 ~ 1.365) | |
F |
1.672 (-) | ||||
4 |
M |
3 (onset) 7 (peak) 24 (last) |
1.119 (1.018 ~ 1.230) | 1.03 (0.950 ~ 1.117) | |
F | 3 (onset) 5 (peak) 46 (last) | 1.180 (0.594 ~ 2.346) | 1.20 (0.668 ~ 2.156) |
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The LD50 values for acute toxicity (oral) in rats (Fischer 344/DuCrj) of the test item were reported to be 1200 mg/kg bw (female) and 1030 mg/kg bw (male). [Exp. 4]
- Executive summary:
A single oral administration to rats (Fischer 344/DuCrj) was followed by a 7 -day observation period. Rats were dosed between 940 - 1510 mg/kg body weight with in total 6 different doses (Experiment 4). Most of the deaths in male and female rats occured ≤ 24 h after administration in the treated animals. For male rats the onset was after 3 h, the peak of deaths was reached after 7 h and the last death occured after 24 h. For female rats the onset was also after 3h, the peak of deaths was already reached after 5 h and the last death occured after 46 h. Observed clinical signs of treated animals comprised marked expansion of the stomach and bleeding of the glandular portion of the stomach.
The oral LD50 values of the test item in rats were reported to be 1030 (males) and 1200 (females) mg/kg body weight.
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