Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Endpoint summary
Administrative data
Description of key information
Skin irritation: Five in vivo studies are available for skin irritation. The study reported by Freeman C (1988) is selected as the key study as it is conducted according to modern guidelines and performed in a GLP accredited facility. The results of this study are sufficient for classification and labelling in accordance with Regulation (EC) No. 1272/2008 (EU CLP). The additional studies are provided to support this conclusion.
Eye irritation: Two in vivo studies are available for eye irritation. The key study (Bradshaw, 2011) is conducted according to modern day guidelines and was performed in a GLP accredited facility. The results are deemed sufficient for classification and labelling in accordance with Regulation (EC) No. 1272/2008 (EU CLP).
The additional studies are provided to support this conclusion.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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
- 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:
- see additional information on materials and methods
- GLP compliance:
- yes
- 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: 2.37 - 2.50 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 - 17/06/1988 - 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 each with 2 test sites per animal.
2 females and 1 male. - Details on study design:
- TEST SITE
- Area of exposure: 2" by 2"
- % coverage: no data
- Type of wrap if used: The test material was moistened and applied to an 8-ply, 2x2" gauze pad. The entire trunk of the animal was wrapped with a semi-occlusive cheesecloth bandage. The animals were fitted with Elizabethan collars to prevent disturbance of the test sites.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test sites were wiped clean with a gauze moistened with methanol, then rinsed with tap water.
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize J. H.,G. Woodard and H. O. Calvery, J. Pharmacol. Exp. Ther., 83, 384 (1944). - 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:
- No erythema and no edema were recorded at 4.5, 24, 48 or 72 h. Zero scores were recorded at all timepoints for all animals.
- Other effects:
- All animals remained healthy during the study.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study and in accordance with Regulation (,EC) No. 1272/2008, tetrasodium pyrophosphate is non-irritating to intact skin when applied topically to New Zealand White rabbits.
This study is considered to be scientifically justified for use as a key study. - Executive summary:
no data
Reference
Three animals, each with two test sites did not display any sign of erythema formation or edema. Zero scores were recorded at all timepoints for all six test sites.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- 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 - 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).- 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. - 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).
Reference
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
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A data gap was identified for eye irritation in that the available data was not adequate in order to assess the classification of tetrasodium pyrophosphate. As such additional testing was performed. The justification for the additional in vivo testing is as follows:
A review of the existing data (four studies, reliability 3 or 4) gave contradictory results. As no data was sufficient for classification and labelling as stand-alone key data or as part of a weight of evidence and given that the results were contradictory (ranging from mild irritant to corrosive) it was necessary to further investigate the effects of tetrasodium pyrophosphate in the eye. In accordance with the testing strategy detailed in Annex VIII, section 8.2, column 2 of Regulation (EC) No. 1907/2006 (REACH) an ex-vivo BCOP assay (OECD Method 437) was first conducted to determine whether the substance is corrosive to the eyes (as no in vitro methods are validated for classification and labelling and given the data already available it was justified to first perform the BCOP) as this came back negative it was necessary to proceed to in vivo testing.
Justification for selection of skin irritation / corrosion
endpoint:
All studies except one conclude that tetrasodium pyrophosphate is
not a skin irritant. The one study that is not in agreement with this
(Younger F, 1962) is the oldest study available and assesses the skin
irritation in accordance with the "Federal hazardous substances
labelling act" which pools the results from abraded and unabraded skin.
This report lacks the raw data required to convert the results for use
under current classification systems and therefore cannot be used for
classification purposes. As there are great differences between the
criteria for classification under Regulation (EC) No. 1272/2008 and the
Federal hazardous substances labelling act this classification cannot be
considered to cast doubt on the conclusions made in the key study (and
supporting data). The key study is selected on the basis that this is
considered to be the most reliable for the purpose of classification and
labelling.
Justification for selection of eye irritation endpoint:
Five studies are available to assess the eye irritancy of
tetrasodium pyrophosphate. The available data was contradictory and as
such an intelligent testing approach was utilised to determine the eye
irritancy of tetrasodium pyrophosphate. In accordance with the testing
strategy detailed in Annex VIII, section 8.2, column 2 of Regulation
(EC) No. 1907/2006 (REACH) an ex-vivo BCOP assay (OECD Method 437) was
first conducted to determine whether the substance is corrosive to the
eyes (as no in vitro methods are validated for classification and
labelling and given the data already available it was justified to first
perform the BCOP) as this came back negative it was necessary to proceed
to in vivo testing. The key study (Bradshaw J, 2010) is a GLP, guideline
in vivo study and the results is considered to be appropriate and
adequate for classification and labelling.
Effects on eye irritation: corrosive
Justification for classification or non-classification
Skin Irritation: In accordance with Regulation (EC) No. 1272/2008 (EU CLP) tetrasodium pyrophosphate is not considered to be irritating to skin.
Eye Irritation: In accordance with Regulation (EC) No. 1272/2008 (EU CLP) tetrasodium pyrophosphate is considered to be corrosive to the eyes due to the severity of the effects noted in one animal at the 4 -hr observation point.
Respiratory irritation: No data (workplace or study) are available to suggest that tetrasodium pyrophosphate is a respiratory irritant.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.