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EC number: 208-863-7 | CAS number: 544-17-2
- 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
There was no systemic toxicity noted at the highest tested dose in oral rat studies with calcium diformate (28-day study; NOAEL 1000 mg/kg bw/day) or potassium diformate (90-day study; NOAEL 3000 mg/kg bw/day; corresponds to 3000 mg calcium diformate/kg bw/day). Dermal and inhalation studies are not available; these routes of exposure are not regarded to be relevant. There was no target organ except the stomach which showed local irritation.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 3 000 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Additional information
Available experimental data on calcium diformate are available but insufficient to fulfill the data requirements for the proper tonnage band. For this end, repeated dose studies with a supporting chemical liberating formate can be used for cross reading.
Experimental data:
Calcium diformate; subacute rat study
The repeated dose toxicity of calcium diformate (0, 200, 400, 1000 mg/kg bw/day, oral gavage, frequency 7/week) was examined in a 28-day study using male and female Wistar rats (5/sex and dose) and conducted according OECD guideline No. 407 and under GLP conditions.
There were no clinical signs of toxicity or mortalities during the entire study period. The body weight of all treated male groups, and of the females at 400 mg/kg bw/day, was increased compared to the controls over the entire study period. Clinical observations, food and water intake, enzyme activities, substrates and electrolytes in peripheral blood, gross pathology, organ weights (brain, adrenals, thymus, heart, liver, spleen, kidneys, testes and epididymes examined), and histopathology did not show any toxicological relevant changes up to and including 1000 mg/kg bw/day in both sexes.
As to neurobehavior, open field observations revealed lower numbers of rearing in high dose males compared to controls, and a slightly reduced body temperature in high dose females. There were no other findings in the Open Field Observation, the Functional Observational Battery, or the Motor and Locomotor Activity tests.
Of the hematology parameters examined, statistically significant reductions of the erythrocyte count, hemoglobin concentration, and hematocrit were seen in high dose males compared to the controls. In females, a trend to lower values was seen for the same parameters without gaining a level of statistical significance. The authors derived a NOAEL of 400 mg/kg bw/day, based on the hematological effects.
However, the above red blood cell effects are within the historical control range (mean±2 s) of this laboratory for the same strain of male and female rats. It is therefore concluded that the observed effects on red blood cells are statistically significant compared to the concurrent controls, but that the effects are not of biological or toxicological relevance. The increased body weight gain of the treated males compared to controls supports this view.
Therefore, it is concluded that the NOAEL was 1000 mg calcium diformate/kg bw/day in the rat for both sexes under the conditions of this study, i.e. the highest tested dose in this study (Bayer, 2005). The study is considered to be valid and suitable for assessment.
Calcium diformate; longterm study
Calcium diformate was repeatedly administered in a pre-guideline study to male and female rats with drinking water (0.2 and 0.4% in water; 7 days/week) in multigenerational experiments that lasted for 36 and 24 months (first to 5thand 3ndgeneration, respectively). Examinations comprised clinical signs and mortality, growth and body weight development, ophthalmological examinations, unspecified organ functions, and reproduction.
Reportedly calcium diformate had no effects on the male or female body weight development and had no adverse effects on the eyes or neurofunctions in this study. The subchronic NOAEL was therefore 150-200 and 200 mg calcium diformate/kg bw/day under the conditions of this study (Malorny, 1969).
This early study is not comparable with current study protocols, but the review is well-documented and meets basic scientific principles. It is therefore acceptable for assessment and provides supporting information.
Data from supporting chemicals
Dietary administration of potassium diformate (1:2) to rats at 600, 1200, and 3000 mg/kg bw and day for 13 weeks did not produce any overt systemic toxicity. Minor local irritation had occurred in the forestomach of both sexes, with effects being seen in the males at all dose levels. Recovery was not complete in all animals after the 4-week treatment-free period (Covance, 1998). The authors did not derive NOAEL values, but they may be considered as follows:
Local irritation: NOAEL below 600 mg/kg bw/day, based on the irritation of the forestomach and the squamous cell hyperplasia seen at 600 mg/kg bw and day in both sexes.
Systemic toxicity: NOAEL(rat, 90 day study) 3000 mg Formi LHS/kg bw/day, as no adverse effect was seen at the highest dose tested. Taking stoichiometry and formula weights into consideration, this is equivalent to 3000 mg calcium diformate/kg bw/day.
This subchronic toxicity study in the rat is acceptable and satisfies the guideline requirement for a subchronic oral study (OECD 408).
Justification for classification or non-classification
No classification required. Criteria of regulations 67/548/EC and 1272 /2008/EC not met. No target organ identiified.
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