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EC number: 230-785-7 | CAS number: 7320-34-5
- 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
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:
- 13/06/1988 to 17/06/1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- , please see additional information on methods.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Tetrapotassium pyrophosphate
- EC Number:
- 230-785-7
- EC Name:
- Tetrapotassium pyrophosphate
- Cas Number:
- 7320-34-5
- Molecular formula:
- H4O7P2.4K
- IUPAC Name:
- tetrapotassium diphosphate
- Details on test material:
- - Name of test material (as cited in study report): Tetrapotassium pyrophosphate
- Substance type: White solid
- Physical state: solid
- Analytical purity: data on file with sponsor
- Reference No.: 600A5072X
- Stability under test conditions: data on file with sponsor
- Storage condition of test material: Room temperature
- Other:
FMC-T#: 636
Date received: 03/05/1988
Formulation: Technical
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 May 18, 1988
- Age at study initiation: Young
- Weight at study initiation: 2.3 - 2.69 kg
- Housing: individually housed in stainless steel cages. DAGB cageboard bedding was used in the litter pans.
- Diet (e.g. ad libitum): ad libitum; Purina High Fiber Rabbit Chow 5326
- Water (e.g. ad libitum): ad libitum; fresh tap water
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 67 - 73°F
- Humidity (%): 60 - 64 %
- Photoperiod (hrs dark / hrs light): 12 hour fluorescent light: 12 hour dark cycle.
IN-LIFE DATES: May 18, 1988 - 13/06/1988
Test system
- Type of coverage:
- occlusive
- 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
VEHICLE
no vehicle was used. - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2"x2"
- % coverage: no data
- Type of wrap if used: The test site was covered with an eight-ply, 2"x2" gauze pad which was secured with hypoallergenic tape. The entire trunk of the animal was wrapped in a semi-occlusive cheesecloth bandage. Elizabethan collars were also fitted to prevent disturbance of the test site.
- Other: Once unwrapped the test site was allowed to "rest" for 30 minutes to allow for regression of pressure and hydration effects.
- There were two test sites per animal, either side of the spinal chord served as a separate site.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test site was wiped clean with methanol then rinsed with tap water.
- Time after start of exposure:Four hours after application
SCORING SYSTEM: Draize, Woodard and Calvery. J. Pharm. Exp. Ther., 83, 384 (1944)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- other: all animals tested
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- other: all animals tested
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- See Table 1.
- 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, 0.5 hours after the wrapping was removed.
Animal / sex |
Left |
Right |
||||
ER |
ED |
other |
ER |
ED |
other |
|
1 / male |
1 |
0 |
0 |
1 |
0 |
0 |
2 / female |
0 |
0 |
0 |
0 |
0 |
0 |
3 / male |
0 |
0 |
0 |
0 |
0 |
0 |
Irritation score = 0.3/ 8.0 |
ER - erythema/ eschar
ED - edema
other - other comments
Zero scores were observed at all subsequent time points, i.e. 24h, 48h, and 72h.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study and based on the Primary Irritation Index, the test material is non-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. Tetrapotassium pyrophosphate 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).
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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