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EC number: 238-735-6 | CAS number: 14691-80-6
- 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
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:
- experimental study
- 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. This study is considered to be acceptable for use as supporting data to underpin the conclusion that sodium and potassium pyrophosphates are not considered to be genotoxic.
- Justification for type of information:
- Study submitted on analogous substance as supporting data only.
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
- Test material form:
- not specified
- 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.
This study is considered to be acceptable for use as supporting data to underpin the conclusion that sodium and potassium pyrophosphates are not considered to be genotoxic.
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