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Diss Factsheets
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EC number: 238-242-6 | CAS number: 14306-25-3
- 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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- This endpoint study record is part of a Weight of Evidence approach comprising two published studies. The test item of this study was a sodium phytate (grade of neutralisation not specified) and the test item of the second published study (RL1) was an analogue substance ("Myo-Inositol, hexakis(dihydrogen phosphate), dodecasodium salt" (CAS 17211 -15 -3; EC 241 -253 -9)) with a similar structure and similar intrinsic properties (Read-across approach). For the justification of the Read-across approach, please refer to the analogue justification attached to IUCLID section 13.
Both data sources are in accordance with generally accepted scientific standards and were performed on different test animal species (mouse and rat). The derived results from the studies are comparable and are sufficient to fulfil the information requirements of this endpoint as further explained in the provided endpoint summary.
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 carried out in 1987, before 1 June 2008 (refering to REACH Article 13(4))
Test material
- Reference substance name:
- Myo-Inositol, hexakis(dihydrogen phosphate), sodium salt
- EC Number:
- 238-242-6
- EC Name:
- Myo-Inositol, hexakis(dihydrogen phosphate), sodium salt
- Cas Number:
- 14306-25-3
- Molecular formula:
- C6H18O24P6.xNa
- IUPAC Name:
- Esters of sodium hydrogen phosphate with myo-Inositol, plant-derived (old name: myo-Inositol, hexakis(dihydrogen phosphate), sodium salt)
- Test material form:
- solid - liquid: aqueous solution
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sodium Phytate from NAKARAI CHEMICALS, LTD. (unknown grade of neutralisation)
- Expiration date of the lot/batch: no data
- Purity test date: no data
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Sample was water solution. For information on the applied doses (mg/kg B.W.) refer to Table 3 in section "Illustration (picture/graph)".
Test animals
- Species:
- mouse
- Strain:
- ICL-ICR
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: unspecified
- Doses:
- 590 / 880 / 1320 / 1980 / 2970 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 48 hr
- Frequency of observations and weighing: 7 (no weighing)
- Other examinations performed: clinical signs - Statistics:
- Lichtfield Wilcoxon
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 2 750 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 1 990 - <= 3 800
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 030 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 560 - <= 1 910
- Mortality:
- Male: At 2970 mg/kg bw two animals died in the first hour, one animal in the third and another animal in the fourth hour after dosing. At 1980 mg/kg bw 3 animals died in the first hour and one animal between 24 to 48h. At 1320 mg/kg bw 3 animals died in the first hour.No mortalities occurred at 880 mg/kg bw and lower.
Female: At 2970 mg/kg bw two animals died in the fiirst hour and one animal after 5 hours after dosing. At 1980 mg/kg bw one animal died in the first hour. No mortalities occurred at 1320 mg/kg bw and lower. - Clinical signs:
- other: In the substance-treated animals the following clinical signs were observed: - Erosion of the stomach wall - bleeding of the glandular portion of the stomach - hypertrophy of the gallbladder - thinning of the small intestinal wall
Any other information on results incl. tables
Lichtfield-Wilcoxon |
|||
Dose Range (mg/kg bw) |
LD50 (mg/kg bw) |
Confidence limit (p = 0.05) |
|
Male | 590 - 2970 | 1030 | 560 - 1910 |
Female | 590 - 2970 | 2750 | 1990 - 3800 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The LD50 values for acute toxicity (oral) in mice (ICL-ICR) of the test item were reported to be 2750 mg/kg bw (female) and 1030 mg/kg bw (male).
- Executive summary:
A single oral administration to mice (ICL-ICR)with5 different doses between 590 - 2970 mg/kg body weight were conducted. Most of the deaths in male and female mice occured within 1h after administration.In male animals dosed at 2970 mg/kg body weight mortality occurred in 4 of 5 males in the first 4 hours after administration. At a dose of 1980 mg/kg bw 3 of 5 male mice died in the first hour and one animal between 24 to 48h after administration. At a dose of 1320 mg/kg bw 3 of 5 male animals died in the first hour. No mortalities occurred at a dose of 880 mg/kg bw and lower. In female mice at 2970 mg/kg bw mortality occured for 2 of 5 animals in the first hour and for one animal after 5 hours. At a dose of 1980 mg/kg bw 1 of 5 female mice died in the first hour. No mortalities among female mice occurred at a dose of 1320 mg/kg bw and lower. In the substance-treated animals erosion of the stomach wall, bleeding of the glandular portion of the stomach, hypertrophy of the gallbladder, and thinning of the intestinal wall were reported.
The oral LD50 values of this test item in mice (ICL-ICR) were reported to be 1030 (males) and 2750 (females) mg/kg body weight.
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.
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