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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
Eye irritation
Administrative data
- Endpoint:
- eye 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:
- From: 01/04/1986 To: 05/04/01986
- 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:
- 1 986
- Report date:
- 1986
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: FMC Preliminary Eye Irritation Protocol dated March 17, 1986
- Deviations:
- not specified
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- see deviations in any other 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 granules
- Physical state: Solid
- Analytical purity: >99%
- Lot/batch No.: 571G029B
- Stability: Stable indefinitely
- Storage condition of test material: Room temperature in dry area
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Products, Inc., Denver, Pennsylvania on February 26 and March 19, 1986
- Age at study initiation: Young rabbits.
- Weight at study initiation: 2.52kg - 3.26 kg
- Housing: The animals were individually housed in suspended stainless steel cages. DACB cageboard bedding was used in the litter pans.
- Diet (e.g. ad libitum): Purina High Fiber Rabbit Chow 5326, ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.9°C-25°C (reported as 66°F to 77°F)
- Humidity (%): 32%-55%
- Photoperiod (hrs dark / hrs light): 12 fluorescent light and 12 hour dark cycle.
IN-LIFE DATES: From: 26/02/1986 To: 05/04/1986
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated left eyes of the animal's served as controls
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100mg per eye - Duration of treatment / exposure:
- Two of the rabbits were exposed for 20-30 seconds before having their eye's rinsed.
Two of the rabbits did not have their eyes washed during the course of the study - 72 hours. - Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- Four animals, two did not have their eyes washed, the other two did.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
Two of the four exposed animals had their eyes was 20-30 seconds after exposure.
SCORING SYSTEM:
The eyes were scored for irritation potential using the method of Draize J.H., G. Woodard and H.O. calvery, J. Pharmacol. Exp. ther., 83, 387 (1944).
The Primary Eye Irritation Index was calculated according to Novermber, 1984, U.S. E.P.A. Pesticide Assessment Guidelines, Subdivision F, Hazard Evaluation: Human and Domestic Animals, Series 81-4.
TOOL USED TO ASSESS SCORE: After the 24 hour examination with a penlight type light, the eyes were examined with the aid of fluorescein dye.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- One hour after dosing, both of the unwashed eyes had severe discharge, one of which also had slight chemosis; both of the washed eyes exhibited slight discharge. At the 24-hour and 48-hour scorings, one of the unwashed eyes had a slight discharge. At the 72-hour scoring all irritation had resolved and the test was terminated.
- Other effects:
- No data.
Any other information on results incl. tables
Table 1 - eye examination, individual scores at one hour
Animal Number |
Cornea |
Iris |
Conjunctiva |
||
Opacity/Area |
Iritis |
Redness |
Chemosis |
Discharge |
|
Male 1 |
0/0 |
0 |
0 |
1 |
3 |
Male 2 |
0/0 |
0 |
0 |
0 |
3 |
Male 3 (w) |
0/0 |
0 |
0 |
0 |
1 |
Male 4 (w) |
0/0 |
0 |
0 |
0 |
1 |
(w) - denotes that the eyes of the animal were washed.
Table 1 continued – results at twenty-four hours
Animal Number |
Cornea |
Iris |
Conjunctiva |
Cornea |
||
Opacity/Area |
Iritis |
Redness |
Chemosis |
Discharge |
Stain/area |
|
Male 1 |
0/0 |
0 |
0 |
0 |
1 |
0/0 |
Male 2 |
0/0 |
0 |
0 |
0 |
0 |
0/0 |
Male 3 (w) |
0/0 |
0 |
0 |
0 |
0 |
0/0 |
Male 4 (w) |
0/0 |
0 |
0 |
0 |
0 |
0/0 |
(w) - denotes that the eyes of the animal were washed.
Table 1 continued – results at forty-eight hours
Animal Number |
Cornea |
Iris |
Conjunctiva |
Cornea |
||
Opacity/Area |
Iritis |
Redness |
Chemosis |
Discharge |
Stain/area |
|
Male 1 |
0/0 |
0 |
0 |
0 |
1 |
NA |
Male 2 |
0/0 |
0 |
0 |
0 |
0 |
NA |
Male 3 (w) |
0/0 |
0 |
0 |
0 |
0 |
NA |
Male 4 (w) |
0/0 |
0 |
0 |
0 |
0 |
NA |
(w) - denotes that the eyes of the animal were washed.
Table 1 continued – results at seventy-two hours
Animal Number |
Cornea |
Iris |
Conjunctiva |
Cornea |
||
Opacity/Area |
Iritis |
Redness |
Chemosis |
Discharge |
Stain/area |
|
Male 1 |
0/0 |
0 |
0 |
0 |
0 |
NA |
Male 2 |
0/0 |
0 |
0 |
0 |
0 |
NA |
Male 3 (w) |
0/0 |
0 |
0 |
0 |
0 |
NA |
Male 4 (w) |
0/0 |
0 |
0 |
0 |
0 |
NA |
(w) - denotes that the eyes of the animal were washed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the author concludes that the test material is temporarily approximated to be minimally irritating to unwashed eyes and non-irritating to washed eyes. Washing the eyes with tap water shortly after exposure decreased both the severity and duration of the irritation observed.
Although the study has only been conducted on two animals (unwashed eyes) it is considered to be sufficient for classification and labelling due to the minimal effects noted. This study is therefore submitted as a key study to provide the relevant classification according to Regulation (EC) No. 1272/2008 (EU CLP)
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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