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EC number: 233-343-1 | CAS number: 10124-56-8
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Remarks:
- Study was performed prior to the update of the REACH Regulation and prior to the validation of in vitro test methods.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: FMC Non-Definitive Primary Skin Irritation Protocol (Number 10)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Please see additional information on materials and methods.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Sodium metaphosphate
- EC Number:
- 233-343-1
- EC Name:
- Sodium metaphosphate
- Cas Number:
- 10124-56-8
- Molecular formula:
- H6O18P6.6Na
- IUPAC Name:
- Sodium metaphosphate
- Details on test material:
- - Name of test material (as cited in study report): Sodium Hexametaphosphate
- Substance type: White powder
- Physical state: solid
- Analytical purity: not determined
- Reference No.: B578AB101
- Stability under test conditions: Not determined
- Storage condition of test material: Room temperature
- Other:
FMC-T#: 861
Date received: May 9, 1990
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Animals, Inc., Denver, Pennsylvania on June 6, 1990.
- Age at study initiation: Young
- Weight at study initiation: 2.06 - 2.35 kg
- Housing: individually housed in stainless steel cages. DACB cageboard bedding was used in the litter pans.
- Diet (e.g. ad libitum): Purina High Fiber Rabbit Chow 5326 was provided
- Water (e.g. ad libitum): fresh tap water was provided
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 68-72°F
- Humidity (%): 51-66 %
- Photoperiod (hrs dark / hrs light): 12 hour fluorescent light: 12 hour dark cycle.
IN-LIFE DATES: June 6, 1990 to termination ca. mid June 1990
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: the test material was moistened with physiological saline
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 gram - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3 animals, 1 female and 2 males, were used in this study, per animal two test sites were dosed either side of the spinal column.
- Details on study design:
- TEST SITE
- Area of exposure: 2" by 2"
- % coverage:
- administration of the test material: The test material was weighed onto an 8-ply, 2"x2" gauze pad and moistened. The pad was secured with hypoallergenic tape. The entire trunk of the animal was wrapped with a semi-occlusive cheesecloth bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, a gauze pad moistened with methanol was used to wipe the test site, the test site was then rinsed with tap water.
- Time after start of exposure: 4 h
SCORING SYSTEM: Approximately 30 minutes after unwrapping, the test sites of each rabbit were scored for irritation using the method of:
Draize J. H., G. Woodard and H. O. Calvery, J. Pharmacol. Exp. Ther., 83, 384 (1944). The 30 minute delay was instituted to allow for regression of pressure and hydration effects.
RATING SYSTEM:
- Non Irritating: No irritation observed in any animal at any scoring interval.
- Slightly irritating: Any animal exhibiting scores of 1 or less at any scoring interval and irritation clearing within 72 hours.
- Mildly irritating: Any animal exhibiting scores of 2 or less at any scoring interval and irritationg clearing within 7 days.
- Moderately irritating: Any animal exhibiting scores of 3 or less at any scoring interval and irritation clearing within 7 days.
- Severely irritating: Any animal exhibiting scores of 4 or less at any scoring interval
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- The only irritation noted was slight erythema in one rabbit 4.5 h after dosing. All irritation resolved within 24h, and the test was terminated following the 72 h scoring.
- Other effects:
- All animals remained healthy throughout the study.
Any other information on results incl. tables
Table 1 - Individual skin scores at 4.5 hours
Animal # / sex |
Left |
Right |
||||
ER |
ED |
O |
ER |
ED |
O |
|
1 / female |
1 |
0 |
0 |
1 |
0 |
0 |
2 / male |
0 |
0 |
0 |
0 |
0 |
0 |
3 / female |
0 |
0 |
0 |
0 |
0 |
0 |
Irritation score = 0.3/ 8.0 |
ER - erythema and eschar scores
ED - edema
O - Other comments
At all subsequent time points, i.e. at 24 h, 48 h and 72 h, zero scores were recorded for all test sites.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study and based on the FMC rating system, the test material is temporarily approximated to be slightly irritating to intact skin when applied topically to New Zealand White rabbits.
This study has been selected as the key study because the results are sufficient in order to derive a reliable conclusion on classification and labelling. Sodium metaphosphate is not considered to be classified according to Regulation (EC) No. 1272/2008 (EU CLP) as no effects were noted for the relevant parameters (erythema/eschar or oedema) at 24, 48 and 72 hours after exposure.
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