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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian germ cell study: cytogenicity / chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Remarks:
- Study methodology is well documented and comparable to OECD guideline, however raw data is referred to but not present in the study report and therefore the conclusions of the report cannot be verified. READ ACROSS JUSTIFICATION: Read across between the following sodium and potassium pyrophosphates; - disodium dihydrogenpyrophosphate - trisodium hydrogen pyrophosphate - tertrasodium pyrophosphate - tetrapotassium pyrophosphate Can be justified on the following basis; All substance contain a pyrophosphate anion and either a sodium or a potassium cation. The pyrophosphate ion is the simplest form of a condensed phosphate group. A condensed phosphate anion has one or several P-O-P bonds. As the group contains only two phosphate groups, both of the phosphorus ions are classified as “terminal phosphorus”. The pyrophosphate can undergo ionisation with loss of H+ from each of the two –OH groups on each P and therefore can occur in the -1, -2 -3 or -4 state. The degree of ionisation is dependant upon the associated cations and the ambient pH (if in solution). Therefore the above substances have a pyrophosphate anion that is likely to behave in a similar way. In addition, the sodium and potassium cations are key elements in various cellular processes their import and export over cell membranes is regulated via pore systems and usually tightly regulated. As such, the presence of such cations is not expected to have an impact on the genotoxicity of the substances detailed above therefore as the pyrophosphate anion is common the results of genotoxicity studies can be reliably read-across within the group.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 478 (Genetic Toxicology: Rodent Dominant Lethal Test)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- Study predates GLP
- Type of assay:
- rodent dominant lethal assay
Test material
- Reference substance name:
- Disodium dihydrogenpyrophosphate
- EC Number:
- 231-835-0
- EC Name:
- Disodium dihydrogenpyrophosphate
- Cas Number:
- 7758-16-9
- Molecular formula:
- H2Na2O7P2
- IUPAC Name:
- disodium [hydroxy(oxido)phosphoryl] hydrogen phosphate
- Details on test material:
- - Name of test material (as cited in study report): sodium acid pyrophosphate
- Analytical purity: no data
- Lot/batch No.: no data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Simonsen Laboratories, Gilroy, California
no data on age/weight of animals.
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- - Vehicle(s)/solvent(s) used: water(administered as a suspension)
- Justification for choice of solvent/vehicle: Solubility of the compound was investigated with various solvents to determine the most appropriate vehicle for administration. Because of the low toxicity of the material and consuquent high dosage required the test material was administered as a suspension. - Duration of treatment / exposure:
- Acute study: single oral dose
Subacute study: 5 days - Frequency of treatment:
- Acute study: once
Subacute study: 1 dose per day, 24 hours apart for 5 days - Post exposure period:
- not applicable
Doses / concentrations
- Remarks:
- Doses / Concentrations:
720, 72, 7.2 mg/kg
Basis:
no data
- No. of animals per sex per dose:
- Acute study: 10 males
Subacute study: 10 males - Control animals:
- yes, concurrent vehicle
- Positive control(s):
- triethylenemelamine
- Justification for choice of positive control(s):substance is a known mutagen
- Route of administration: single i.p injection
- Dose: 0.2 mg/kg
Examinations
- Tissues and cell types examined:
- Procedure is designed to indicate possible mutagenic effects in male sperm. Effects are seen in fetal development.
- Details of tissue and slide preparation:
- No data
- Evaluation criteria:
- The following parameters indicate effects in dominant lethal studies:
- total implants (live fetuses plus early and late fetal deaths)
- total dead (early and late fetal deaths)
- dead implants per total implants
- pre-implantation loss (calculted as the difference between the total corpora lutea and total implant counts)
total corpora lutea was also evaluated because a significant change of this parameter could influence the significance of the pre-implantation loss. - Statistics:
- Total implants, total dead, total corpora lutea, and pre-implantation loss parameters were analysed for significance by the t-test (Federer WT, Experimental design (theory and application), The Macmillan Company, 1955).
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
Any other information on results incl. tables
The biological criteria used to evaluate mutagenic effects in the rat showed no consistant responses that could be attributed to treatment. Some occasional statistical differences between the control and test material groups were random and did not suggest a time or dose-response effect.
Tabulated data was not included in study report.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Review and statistical analysis of the data do not show sodium acid pyrophosphate (FDA No. 71-61) to b ea mutagen in the rat by the dominant lethal test.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)