Registration Dossier
Registration Dossier
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EC number: 233-116-7 | CAS number: 10038-98-9
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key 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:
- Studies of the metabolism of germanium
- Author:
- Rosenfeld G
- Year:
- 1 954
- Bibliographic source:
- Arch Biochem Biophys. 48(1):84-94
Materials and methods
- Objective of study:
- toxicokinetics
- Principles of method if other than guideline:
- Absorption, transport, distribution, storage and excretion of inorganic germanium in albino rats
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Germanium dioxide
- EC Number:
- 215-180-8
- EC Name:
- Germanium dioxide
- Cas Number:
- 1310-53-8
- Molecular formula:
- GeO2
- IUPAC Name:
- Germanium dioxide
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- rat
- Strain:
- other: albino
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no information
- Age at study initiation: no information
- Weight at study initiation: no information
- Fasting period before study: no information
- Housing: well ventilated cages
- Individual metabolism cages: no information
- Diet (e.g. ad libitum): no information
- Water (e.g. ad libitum): no information
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS : no information
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
Doses / concentrations
- Remarks:
- Doses / Concentrations:
10mg
- Control animals:
- not specified
Results and discussion
Main ADME resultsopen allclose all
- Type:
- absorption
- Results:
- rapid absorption after gavage (73.6% after 4h and 96.4% after 8h)
- Type:
- distribution
- Results:
- uniformly distributed between erythrocytes and plasma (2:3) and not bound to plasma proteins. Not deposited selectively but widely distributed among all the organs.
- Type:
- excretion
- Results:
- rapidly excreted via the urine and feces, kidney being the main excretory organ
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): low bioaccumulation potential based on study results
Germanium is relatively inert metabolically and are consonant with its remarkably low toxicity - Executive summary:
Metabolic studies have been conducted of the absorption, transport, distribution, storage and excretion of inorganic germanium (GeO2) in albino rats.
The analytical data demonstrate that germanium is rapidly absorbed after oral, subcutaneous, intramuscular or intraperitoneal administration.
When injected directly into the systemic circulation or absorbed following oral or parenteral administration, it is transported unbound by plasma proteins and is rapidly eliminated from the blood stream.
Germanium is not deposited selectively but is widely distributed among all the organs. It is not retained or stored by any tissue even after many weekly doses, but is rapidly excreted via the urine and feces, the kidney bein the main excretory organ.
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