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EC number: - | CAS number: -
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting 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:
- Effects of Nano Calcium Carbonate and Nano Calcium Citrate on Toxicity in ICR Mice and on Bone Mineral Density in an Ovariectomised Mice Model
- Author:
- Huang S, Ching Chen J, Wei Hsu C and Chang WH
- Bibliographic source:
- Nanotechnology 20:375102 (7pp)
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The study examined whether the bioavailability of calcium carbonate and calcium citrate could be improved by reducing the particle size. Because nanoscale supplements are novel formulas in health foods, the acute toxicity, sub-chronic toxicity (see separate IUCLID entry) and bioavailability (see separate IUCLID entry) needs to be determined in both sexes of mice in advance.
Standard acute toxicological evaluations of the ICR mice were performed in the initial assessment of the effects of nanoscale calcium carbonate internalisation. Micro calcium carbonate and nano calcium carbonate were administered in a single dose by gavage using a gastric intubation tube. The animals were then observed for a period of 7 days. - GLP compliance:
- no
Test material
- Reference substance name:
- Calcium carbonate
- EC Number:
- 207-439-9
- EC Name:
- Calcium carbonate
- Cas Number:
- 471-34-1
- Molecular formula:
- CH2O3.Ca
- IUPAC Name:
- calcium carbonate
- Test material form:
- solid: nanoform, no surface treatment
- Details on test material:
- Calcium carbonate was nanoscaled with the aid of a pulsed air-flow pulveriser.
The morphology of nano calcium carbonate was characterised by:
1). Dynamic laser-light scattering (DLS): The diameters of the micro and nano calcium carbonate particles were 3773 ± 759 nm and 151 ± 19 nm, respectively.
2). Field emission scanning electron microscopy (FE-SEM): The images revealed the smooth surface morphology of nano calcium carbonate. The diameter of the particles ranged from 100 to 200 nm and were spherical in shape. Aggregates were also seen in the images.
3). Transmission electron microscopy (TEM): The particles have a spherical-to-oval morphology with a diameter of 100 to 200 nm.
The measurements made using DLS, FE-SEM and TEM were comparable.
Constituent 1
- Specific details on test material used for the study:
- Uncoated nano calcium carbonate
Test animals
- Species:
- mouse
- Strain:
- ICR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: National Taiwan University Hospital, Taipei, Taiwan
- Age at study initiation: 8-10 weeks
- Fasting period before study: Animals were fasted overnight
- Diet: Pelleted mouse feed available ad libitum
- Water: Reverse osmosis water available ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-25 °C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12 h/12 h day/night cycle
Sham surgery (n = 6, SHAM) or bilateral ovariectomy (n = 30, OVX) was performed from a dorsal approach at 6 to 8 week old mice. Surgical removal of the ovaries is a well-represented approach to mimic the postmenopausal condition in mice. In the sham operation, ovaries were exteriorised and then replaced.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- The test materials were administered in a single dose by gavage using a gastric intubation tube.
- Doses:
- Vitamin D3 (261 U/ kg bw) plus micro calcium carbonate: 1.3 g/kg bw
Vitamin D3 (261 U/ kg bw) plus nano calcium carbonate: 1.3 g/kg bw - No. of animals per sex per dose:
- 8 animals/sex/dose
- Control animals:
- yes
- Details on study design:
- On day seven, all the animals were weighed and any signs of toxicity were noted.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- other: NOAEL
- Effect level:
- 1 300 mg/kg bw
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: Throughout the study, no unusual behaviour or differences between groups were observed (i.e. no laboured breathing, difficulty moving, hunching or unusual interactions with cage mates were observed).
Any other information on results incl. tables
Table 1: Body weight and mortality during the 7-day acute toxicity test
Dose |
Sex (n) |
Initial body weight (g) |
Final body weight (g) |
Mortality dead/treated |
Control |
Male (8) Female (8) |
33.2 ± 3.3 32.5 ± 3.7 |
35.3 ± 3.9 34.2 ± 3.8 |
0/8 0/8 |
Micro calcium carbonate (1.3 g/kg bw) |
Male (8) Female (8) |
33.4 ± 3.2 32.7 ± 3.4 |
34.9 ± 3.2 34.3 ± 3.6 |
0/8 0/8 |
Nano calcium carbonate (1.3 g/kg bw) |
Male (8) Female (8) |
32.5 ± 3.6 33.1 ± 2.9 |
33.7 ± 4.1 34.9 ±3.8 |
0/8 0/8 |
Data are mean ± SE values
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No mortality or unusual behaviour were observed during the course of the study. The NOAEL for both micro calcium carbonate and nano calcium carbonate were reported to be 1.3 g/kg bw.
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