Registration Dossier
Registration Dossier
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EC number: 264-731-9 | CAS number: 64216-15-5
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Information was taken from several review documents published by national and international agencies (e.g. German BGVV, EFSA, UN WHO) on human health aspects of minerals in human nutrition. This information represents the highest level of reliability and acceptance.
Data source
Referenceopen allclose all
- Reference Type:
- review article or handbook
- Title:
- Tolerable upper intake levels for vitamins and minerals
- Author:
- EFSA
- Year:
- 2 006
- Bibliographic source:
- http://www.efsa.eu.int (date: 25.08.2011)
- Reference Type:
- review article or handbook
- Title:
- Vitamin and mineral requirements in human nutrition
- Author:
- WHO
- Year:
- 2 004
- Bibliographic source:
- World Health Organization (WHO), 2nd Edition
- Reference Type:
- review article or handbook
- Title:
- Scientific Opinion on re-evaluation of calcium carbonate (E 170) as a food additive
- Author:
- EFSA
- Year:
- 2 011
- Bibliographic source:
- EFSA Journal 9 (7): 2318
- Reference Type:
- review article or handbook
- Title:
- Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and materials in Contact with Food on a request from the Commission related to Calcium Sulphate as a mineral substance in foods intended for the general population.
- Author:
- EFSA
- Year:
- 2 004
- Bibliographic source:
- EFSA Journal (2004) 112, 1-10
- Reference Type:
- review article or handbook
- Title:
- Toxikologische und ernährungsphysiologische Aspekte der Verwendung von Mineralstoffen und Vitaminen in Lebensmitteln: Teil I: Mineralstoffe (einschließlich Spurenelemente)
- Author:
- BgVV
- Year:
- 2 002
- Bibliographic source:
- http://www.bfr.bund.de/cm/343/verwendung_von_mineralstoffen_und_vitaminen_in_lebensmitteln.pdf (date: 28.11.2012)
Materials and methods
- Objective of study:
- absorption
- distribution
- excretion
- Principles of method if other than guideline:
- Review documents on human health aspects of mineral requirements in human nutrition. Information contained therein were collected and reviewed by national and international expert panels.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Calcium
- EC Number:
- 231-179-5
- EC Name:
- Calcium
- Cas Number:
- 7440-70-2
- Molecular formula:
- Ca
- IUPAC Name:
- calcium
- Test material form:
- other: via diet
Constituent 1
Test animals
- Species:
- human
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: diet
- Details on exposure:
- dietary intake
- Duration and frequency of treatment / exposure:
- daily
Results and discussion
Main ADME resultsopen allclose all
- Type:
- absorption
- Results:
- 10-40% of dietary Ca is absorbed
- Type:
- distribution
- Results:
- bone mineral serves as ultimate reservoir for the circulating Ca in the extracellular fluid
- Type:
- excretion
- Results:
- via skin 4-96mg/day
- Type:
- excretion
- Results:
- via faeces 80-224 mg/day
- Type:
- excretion
- Results:
- via urine 150-200mg/day (in adults)
Metabolite characterisation studies
- Metabolites identified:
- no
- Details on metabolites:
- calcium as inorganic cation is void of metabolism
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): other: bioaccumulation potential is not relevant since Ca is an essential element in human nutrition
Calcium absorption in humans is higly variable and occurs via active transport and passive diffusion. The calcium level in serum is hormonal controlled and inhealth individuals on a constant level. Excretion/loss is via urine, faeces, skin, hair and nails. The majority of absorbed calcium is stored in the skeleton.
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