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Diss Factsheets
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EC number: 204-024-4 | CAS number: 113-24-6
- 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 somatic cell study: cytogenicity / bone marrow chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Hyperpolarized Pyruvate (13C) Injection, INVESTIGATOR’S BROCHURE
- Author:
- not stated
- Year:
- 2 020
- Bibliographic source:
- IB Edition Number: 4.0
Release Date: 23 March 2020
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- no guideline available, but well documented study.
- GLP compliance:
- not specified
- Type of assay:
- mammalian bone marrow chromosome aberration test
Test material
- Reference substance name:
- Pyruvic acid
- EC Number:
- 204-824-3
- EC Name:
- Pyruvic acid
- Cas Number:
- 127-17-3
- Molecular formula:
- C3H4O3
- IUPAC Name:
- 2-oxopropanoic acid
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Parapyruvate/lactone in TRIS solution was formulated according to the user instruction,
assuming the stock solution comprised concentrations of 10 mg/ml for each of the main
components, parapyruvate and lactone. However, the certificate of analysis showed that the
stock solution contained 8.6 mg/ml parapyruvate and 8.19 mg/ml lactone. The difference
between the target assay value and the observed assay value was attributed to increased water
content in the dry dispensed substance. Accordingly, the actual concentrations for parapyruvate
and lactone were approximately 14-18% less than expected.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- From a range finding experiment, the nominal dose of 200 mg/kg was considered a suitable maximum dose for
the Micronucleus Experiment. Two lower nominal doses of 60 and 20 mg/kg were also
administered. No substantial difference was observed between males and females in the Range-
Finder, therefore male animals only were used in the Micronucleus Experiment.
Administration / exposure
- Route of administration:
- infusion
- No. of animals per sex per dose:
- 6 per group
- Positive control(s):
- cyclophosphamide 20 mg/kg
Results and discussion
Test results
- Key result
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Positive controls validity:
- not specified
Applicant's summary and conclusion
- Conclusions:
- It is concluded that Parapyruvate/lactone in TRIS solution did not induce micronuclei in the
polychromatic erythrocytes of the bone marrow of male rats treated up to the nominal dose of 200 mg/kg (the maximum practicable dose) following both 24 and 48 h sampling under the conditions of this assay. - Executive summary:
No clinical signs were observed in the Micronucleus Experiment. Bone marrow smears were prepared from sacrificed animals approximately 24 and 48 h post-treatment.
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