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EC number: 231-767-1 | CAS number: 7722-88-5
- 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:
- In vivo. 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:
- 16 June 2010 - 5 Ocotober 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Tetrasodium pyrophosphate
- EC Number:
- 231-767-1
- EC Name:
- Tetrasodium pyrophosphate
- Cas Number:
- 7722-88-5
- Molecular formula:
- H4O7P2.4Na
- IUPAC Name:
- tetrasodium (phosphonatooxy)phosphonate
- Details on test material:
- - Name of test material (as cited in study report): tetrasodium pyrophosphate
- Physical state: solid
- Analytical purity: 98%
- Purity test date: 08/2011
- Lot/batch No.: 449/09
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories U.K. Ltd., Loughborough, UK
- Weight at study initiation: 2.02 kg
- Housing:Suspended cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 95 mg (as measured by gently compacting the required volume into an adapted syringe) - Duration of treatment / exposure:
- Once
- Observation period (in vivo):
- 4 hours - after which the animal was euthanized.
- Number of animals or in vitro replicates:
- 1
- Details on study design:
SCORING SYSTEM:
Assessment of ocular damage/irritation was made approximately 1 hour following treatment, according to the numerical evaluation (from Draize J H (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p.48 to 49).
Any other ocular effects were also noted.
TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.
Any clinical signs of toxicity, if present, were also recorded.
The animal’s bodyweight was recorded on Day 0 (the day of dosing).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 1 hr
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: Exposure to the test material for 1 hour only due to severe reactions
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 1 hr
- Score:
- 1
- Max. score:
- 2
- Remarks on result:
- other: Exposure to the test material for 1 hour only due to severe reactions
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- other: 1 hr
- Score:
- 3
- Max. score:
- 3
- Remarks on result:
- other: Haemorrhage of the nictitating membrane and upper and lower conjunctival membrane observed. Exposure to the test material for 1 hour only due to severe reactions
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 1hr
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- other: Exposure to the test material for 1 hour only due to severe reactions
- Irritant / corrosive response data:
- Scattered or diffuse corneal opacity, iridial inflammation and moderate conjunctival irritation were noted in the treated eye one hour after treatment. Haemorrhage of the nictitating membrane and upper and lower conjunctival membrane were also noted in the treated eye at this observation. Blood stained discharge was also observed on the day of dosing.
Due to severe bleeding of the eye the animal was killed for humane reasons, on the day of dosing, in accordance with Company policy and current UK Home Office guidelines.
Any other information on results incl. tables
Individual and Total Scoresfor Ocular Irritation
Rabbit Number and Sex |
69566Male K* |
IPR= 3 |
|
Time After Treatment |
1 Hour |
CORNEA |
|
E = Degree of Opacity |
1 |
F = Area of Cornea Involved |
4 |
Score (E x F) x 5 |
20 |
IRIS |
|
D |
1 |
Score (D x 5) |
5 |
CONJUNCTIVA |
|
A = Redness |
3H |
B = Chemosis |
2 |
C = Discharge |
2 |
Score (A + B + C) x 2 |
14 |
Total Score |
39 |
IPR= Initial pain reaction
H = Haemorrhage of the nictitating membrane and upper and lower conjunctival membrane
K = Animal killed for humane reasons in accordance with Company policy and current UK Home Office guidelines due to severe bleeding of the eye
*= Blood stained discharge observed prior to death
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Substance was considered to cause irreversible effects on the eye of 1 rabbit. The reaction was so severe that the test animal had to be euthanized 4 hours post-administration. Therefore in accordance with Regulation (EC) No. 1272/2008 (EU CLP) tetrasodium pyrophosphate is considered to cause serious and irreversible effects on the eye.
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 in accordance with 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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