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Diss Factsheets
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EC number: 215-137-3 | CAS number: 1305-62-0
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- no data available
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Well-documented study on the consequences of hypercalcaemia on systemic and renal haemodynamics. Under physiological conditions, the hydroxyl-ions released from lime following oral adminstration have been neutralised in the GI tract and are therefore not relevant for consideration of toxicokinetics. Therefore for assessment of the metabolic fate of the systemically relevant species of lime following administration via the oral route, the calcium ion Ca2+ is the chemical species of interest. In the current study, calcium was administered in the form of calcium gluconate. Gluconate is an integral component of mammalian energy metabolism and therefore toxicologically not relevant. The objective of the study was the evaluation of any effects of calcium, including its retention and fate in the human body. In view of the the limited relevance of the anionic counter-ions discussed here, calcium released both from lime and calcium gluconate can be considered as structurally equivalent (analogue), and the results of the study can be used by read-across.
Data source
Reference
- Reference Type:
- publication
- Title:
- Systemic and renal vascular responses to dietary calcium and vitamin D
- Author:
- Zawada, E.T.; et al.
- Year:
- 1 986
- Bibliographic source:
- Hypertension, 8, 975-982
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The consequences of hypercalcemia on systemic and renal haemodynamics, vasoactive hormones and excretion of water and electrolytes were studied in 10 female mongrel dogs received daily oral doses of 100 mg Ca gluconate and 10000 U of vitamin D per kg bw for two weeks. 10 other dogs who did not receive Ca and vitamin D served as control animals.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Calcium gluconate
- EC Number:
- 206-075-8
- EC Name:
- Calcium gluconate
- Cas Number:
- 299-28-5
- IUPAC Name:
- calcium bis(2,3,4,5,6-pentahydroxyhexanoate) (non-preferred name)
- Details on test material:
- - Name of test material (as cited in study report): Calcium gluconate
No further details are given.
Constituent 1
Test animals
- Species:
- dog
- Strain:
- other: mongrel dogs
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 14 and 25 kg
- Diet: ad libitum; commercial dog chow (Purina, St. Louis, MO, USA)
- water: ad libitum
No further details are given.
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- DIET PREPARATION
exposure group: doses of 100 mg Ca gluconate and 10000 U of vitamin D per kg bw .
control animals: did not receive Ca and vitamin D - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- no data
- Duration of treatment / exposure:
- 2 weeks
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100 mg/kg bw calcium gluconate
Basis:
nominal in diet
- No. of animals per sex per dose:
- 10 dogs
- Control animals:
- yes, plain diet
- Details on study design:
- no data
- Positive control:
- No positive control substance was tested.
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: No data
FOOD CONSUMPTION AND COMPOUND INTAKE : No data
FOOD EFFICIENCY: No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
OPHTHALMOSCOPIC EXAMINATION: No data
HAEMATOLOGY: No data
CLINICAL CHEMISTRY: Yes. (for methodological details see below "Any other information on materials and methods incl. tables")
- Parameters checked: plasma renin activity, plasma aldosterone concentration, whole blood ionized calcium (iCa), ionized potassium, ionized sodium, total serum calcium, and serum magnesium (sMg).
URINALYSIS: Yes
- urinary excretion of Na and K were determined using ion-selective electrodes
- the urinary PGE2 concentration was measured
NEUROBEHAVIOURAL EXAMINATION: No data
OTHER:
- Systolic and diastolic blood pressures and mean arterial pressure in the femoral artery were determined.
- Cardiac output and cardiac index were measured.
- Total peripheral resistance and renal resistance were calculated.
- Inulin and p-aminohippuric acid (PAH) clearances were measured by standard methods. - Sacrifice and pathology:
- GROSS PATHOLOGY: No data
HISTOPATHOLOGY: No data - Other examinations:
- no data
- Statistics:
- The values reported for each dog are the average of the baseline and 3 ensuing recording periods. In the case of the urine parameters the values reported are the average of the 3 results from the separate urine collections. Statistical analysis was by the Mann-Whitney U test. Parameters designated significant in the text are those in which the Mann-Whitney test showed significance with 95 % or greater confidence. Coefficients of correlation were calculated by regression analysis. Significant results are again set at 95 % or greater confidence limits.
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- effects observed, treatment-related
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- CLINICAL CHEMISTRY
- Serum Mg levels were significantly lowered.
- Aldosterone levels and plasma renin activity were not significantly affected.
URINALYSIS & OTHER FINDINGS
- Hypercalcemia induced by dietary supplementation with Ca and vitamin D resulted in significantly lower glomerular filtration rate, effective renal plasma flow, renal blood flow, and osmolarity.
- The renal resistance was increased in hypercalcemic dogs.
- Hypercalcemia also resulted in an increased fractional excretion of water, Na, Ca, and Mg.
- Systolic blood pressure and stroke volume were decreased in hypercalcemic dogs, while total peripheral resistance was increased.
- Urinary prostaglandin excretion were not significantly affected.
Effect levels
- Dose descriptor:
- NOAEL
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- These results suggest that hypercalcemia induced by chronic dietary supplementation increases total peripheral resistance and renal vascular resistance. The study is not appropriate for derivation of a NOAEL.
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