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Diss Factsheets
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EC number: 209-677-9 | CAS number: 590-29-4
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics
- 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:
- Absorption and elimination of formate following oral administration of calcium formate in female human subjects
- Author:
- Hanzlik RP, Fowler SC, and Eells JT
- Year:
- 2 005
- Bibliographic source:
- Drug Metabolisn and Disposition 33, 282-286
Materials and methods
- Objective of study:
- toxicokinetics
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 417 (Toxicokinetics)
- Deviations:
- yes
- Remarks:
- ; absorption and excretion in human subjects following a single oral fixed dose
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Calcium diformate
- EC Number:
- 208-863-7
- EC Name:
- Calcium diformate
- Cas Number:
- 544-17-2
- Molecular formula:
- CH2O2.1/2Ca
- IUPAC Name:
- calcium diformate
- Details on test material:
- - Name of test material (as cited in study report): calcium formate
- Substance type: salt
- Physical state: solid
- Other:
Calcium formate (650 mg/capsule) and placebo capsules were custom formulated by Opti-Med inc., Seymour, IN, USA)
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): calcium formate
- Substance type: salt
- Physical state: solid
- Other:
Calcium formate (650 mg/capsule) and placebo capsules were custom formulated by Opti-Med inc., Seymour, IN, USA) - Radiolabelling:
- no
Test animals
- Species:
- human
- Strain:
- other: not applicable
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Human subjects attending the study:
- Status: normal, healthy adults
- Sex: female
- Number: 14
- Age: between 19 and 33 years of age
- Body weight: mean 64.5 +/-11.2 kg.; range 51-93 kg
- Pregnant or breastfeeding: none
- Fasting: 10 hours overnight
- Drinking: subjects were allowed water ad libitum during the 4.5 hours after dosing
Administration / exposure
- Route of administration:
- oral: capsule
- Vehicle:
- water
- Details on exposure:
- Dosing:
- Subjects ingested either placebo or calcium formate
- Doses: 0 (placebo) or 3900 mg CaFo (6 capsules, 350 mg each)
- Vehicle: 240 mL water was ingested along with the capsules - Duration and frequency of treatment / exposure:
- single oral dose
Doses / concentrations
- Dose / conc.:
- 3 900 other: mg
- Remarks:
- mean dose: 60 mg CaFo/kg bw.
- No. of animals per sex per dose / concentration:
- 14
- Control animals:
- yes, sham-exposed
- Details on study design:
- - Dose selection rationale: based on previous studies by Malorny (1969) and a preliminary study with 6 adult male volunteers (total 4550 mg/person)
- Details on dosing and sampling:
- PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled: blood
- Time and frequency of sampling: time 0, and at 30, 60, 90, 135, 180, 225, and 270 min after dosing - Statistics:
- Pharmacokinetic analyses were performed using Excel X. Elimination rate constants (kel) were calculated as minus the slope of a plot of lnC versus time, and half-lives (t1/2) from the relationship t1/2 = ln2/kel. AUC values were calculated by trapezual integration. Oral clearance and apparent volumes of distribution were calculated as (CL/F=dose/delta AUC) and (Vß/F=(CL/F) / kel, respectively, where delta AUC refers to the increment in formate AUC above the baseline area. Results are reported as mean +/- SD (report, table 1).
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Calcium formate was rapidly absorbed. Maximal formate plasma levels (mean: 0.50 +/- 0.04 mmolar) were seen at 60 min after dosing.
- Details on distribution in tissues:
- No other tissue examined. The mean apparent distribution volume of 2.36 L/kg body weight indicates that the distribution in tissues follows the water solubility.
- Details on excretion:
- A monoexponential decline of serum concentrations with an average half-life of 59+/-7 minutes was seen to occur after 60 minutes post dosing. Baseline levels were reached by 225 minutes post dosing. The AUC was 49.4 +/- 6.2 mM x min, of this, 8.7+/-2.0 mM x min were attributable to endogenous formate. Thus, the net AUC resulting from 3900 mg of calcium formate was 41.2 +/-5.8 mM x min. From this and the formate dose given (60 mmol/subject) the oral clearance was (CL/F=1.95 L/min), and from this and the apparent elimination rate constant, the distribution volume was 156+/-27 liters, or 2.36+/-0.38 L/kg body weight.
Toxicokinetic parametersopen allclose all
- Test no.:
- #1
- Toxicokinetic parameters:
- half-life 1st: 59 +/- 7 minutes
- Test no.:
- #1
- Toxicokinetic parameters:
- Cmax: 0.50 +/- 0.04 mM
- Test no.:
- #1
- Toxicokinetic parameters:
- Tmax: 60 minutes
- Test no.:
- #1
- Toxicokinetic parameters:
- AUC: 41.2 +/-5.8 mM x min (net)
- Test no.:
- #1
- Toxicokinetic parameters:
- AUC: 8.7+/-2.0 mM x min (endogenous formate)
- Test no.:
- #1
- Toxicokinetic parameters:
- other: distribution volume: 2.36+/-0.38 L/kg body weight
Metabolite characterisation studies
- Metabolites identified:
- no
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): no bioaccumulation potential based on study results
Calcium formate was rapidly absorbed, metabolised and eliminated in female human subjects ingesting 3900 mg calicum formate. - Executive summary:
Blood samples were withdrawn from 14 healthy female adult subjects (19 to 33 years of age; mean body weight 64.5 kg) following ingestion of placebo and a total of 3900 mg calcium formate at 0, and at 30, 60, 90, 135, 180, 225, and 270 min after dosing. Serum formate concentration was measured using a fluorometric assay.
The maximal serum levels (mean: 0.50 mM) was seen at 60 minutes after dosing, and a monoexponential decline of serum concentrations with an average half-life of 59+/-7 minutes thereafter. Baseline levels (placebo) were reached by 225 minutes post dosing. The AUC was 49.4 +/- 6.2 mM x min, of this, 8.7+/-2.0 mM x min were attributable to endogenous formate. Thus, the net AUC resulting from 3900 mg of calcium formate was 41.2 +/-5.8 mM x minute. From this and the formate dose given (60 mmol/subject) the oral clearance was (CL/F = 1.95 L/min), and from this and the apparent elimination rate constant, the distribution volume was 156+/-27 liters, or 2.36+/-0.38 L/kg body weight.
The results indicate that calcium formate was rapidly absorbed,metabolised and eliminated after oral ingestion by female human subjects, and that formate does not have an accumulation potential (Hanzlik; 2005)
The study was conducted similar to provisions of the OECD guideline No. 417, and is considered to be valid for assessment.
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