Registration Dossier
Registration Dossier
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EC number: 200-848-3 | CAS number: 75-20-7
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1999
- 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:
- Bioavailability, biodistribution and toxicity of biocal a new calcium source. Comparative studies in rats
- Author:
- Sarabia, MI, et al.
- Year:
- 1 999
- Bibliographic source:
- Nutr Res 19: 1223–1231
Materials and methods
- Objective of study:
- absorption
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Application of 30 mg Ca/kg bw/d (45Ca-Gluconate) by gavage, for 12 days
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Calcium gluconate
- EC Number:
- 206-075-8
- EC Name:
- Calcium gluconate
- Cas Number:
- 299-28-5
- Molecular formula:
- C6H12O7.1/2Ca
- IUPAC Name:
- calcium bis(2,3,4,5,6-pentahydroxyhexanoate) (non-preferred name)
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- 45 Ca
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Duration and frequency of treatment / exposure:
- 12 days; daily
Doses / concentrations
- Dose / conc.:
- 30 mg/kg bw/day (nominal)
- No. of animals per sex per dose / concentration:
- no data
- Control animals:
- not specified
Results and discussion
Main ADME results
- Type:
- absorption
- Results:
- 99%
Toxicokinetic / pharmacokinetic studies
Transfer into organs
- Key result
- Test no.:
- #1
- Transfer type:
- other: transfer to bones
- Observation:
- distinct transfer
- Remarks:
- bones
- Details on excretion:
- 1.2 % Ca was excreted in urin
Applicant's summary and conclusion
- Conclusions:
- Ca2+ applied by gavage is almost completely resorbed and built into the bones. 1.2 % of the dose was excreted in urine
- Executive summary:
In a metabolism study, 45-Calcium bis(2,3,4,5,6)-pentahydroxyhexanoate was administered to rats daily by oral gavage at a dose level of 30 mg/kg bw/day for 12 days.
The test material was almost completely resorbed and built into the bones. 1.2 % of the dose was excreted in urine.
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