Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 215-180-8 | CAS number: 1310-53-8
- 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
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption 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:
- Dermal absorption of inorganic germanium in rats
- Author:
- Yokoi K, Kawaai T, Konomi A and Uchida Y
- Year:
- 2 008
- Bibliographic source:
- Regulatory Toxicology and Pharmacology, 52: 169-173
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- - Principle of test: Three groups of rats were treated with a 3-h topical application of hydrophilic ointment containing graded level of neutralized GeO2 (pH 7.4): 0,
0.21 and 0.42 mg GeO2/g. Germanium concentration in blood and tissues sampled from rats after topical application of inorganic germanium was measured by inductively coupled plasma-mass spectrometry - GLP compliance:
- yes
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
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Japan SLC Inc., Shizuoka, Japan.
- Age at study initiation: 4-week-old
- Weight at study initiation: 50–70 g (mean 56.8 g, standard deviation 3.5 g
- Fasting period before study: no
- Housing: kept individually in stainless steel cages with raised wire bottoms
- Individual metabolism cages: yes
- Diet: free access to AIN-93G diet
- Water: free access to deionized water
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS: no information
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- other:
- Duration of exposure:
- 3h
- Doses:
- 0, 0.21 mg/g and 0.42 mg/g
- No. of animals per group:
- 6
- Control animals:
- yes
- Details on study design:
- DOSE PREPARATION
- Method for preparation of dose suspensions:
Preparation of inorganic germanium ointment:
Hydrophilic ointment containing neutralized GeO2 (inorganic germanium ointment) was prepared as follows. GeO2 of 2.5 g was stirred with excess amount of sodium hydroxide in deionized water (MilliQ, Millipore Co.) for hydrolysis. The alkaline solution
containing hydrolyzed GeO2 was neutralized with hydrochloric acid to give a solution with pH 7.4. Purified water was added to obtain 2.5 g/L neutralized GeO2 solution (1.735 g of elemental germanium/L). To prepare inorganic germanium ointment containing 0.42 mg GeO2/g, 3 mL of 2.5 g/L neutralized GeO2 solution was added to 15 g of hydrophilic ointment (Yoshida Pharmaceutical Co., Saitama, Japan) concordant to Japan Pharmacopoeia that contains 250 g white petrolatum, 200 g stearylalcohol, 120 g propyleneglycol, 40 g polyoxyethylene (60) hydrogenated castor oil, 10 g monostearylglycerine, 1 g methyl p-hydroxybenzoate, 1 g propyl p-hydroxybenzoate, and 378 g purified water per 1000 g. They were thoroughly mixed with a Teflon-coated ointment spatula on a 30 cm x 30 cm square polyvinyl chloride board. Similarly, 1.5 mL of 2.5 g/L neutralized GeO2 solution, 1.5 mL purified water, and 15 g hydrophilic ointment was mixed to obtain inorganic germanium ointment containing 0.21 mg GeO2/g.
APPLICATION OF DOSE: topical; Polyvinylidene chloride food wrap (Saran Wrap, Asahi Kasei Home Products Co., Tokyo, Japan) was cut into 2 cm x 2 cm square sheets and attached on cotton gauze by adhesives (Alonalpha, Toa Gosei Chemical Industry, Tokyo, Japan). 2 g of inorganic germanium ointment or blank ointment were spread on the polyvinylidene chloride sheet attached on cotton gauze for applying to the hair-removed skin.
VEHICLE
negative control: 3 mL purified water was mixed with 15 g hydrophilic ointment to prepare blank ointment.
TEST SITE:
A patch of hair approximately 3 x 4 cm from the dorsal abdominal surface along the spinal axis was clipped with an animal hair clipper. The remaining hair was removed with a depilatory cream (Epilat, Kanebo, Tokyo, Japan). The animals were
washed by warm tap water, and their fur was wiped by a towel and dried by a hair dryer. After overnight withdrawal of diets, the hydrophilic ointment containing neutralized GeO2 (inorganic germanium ointment) spread on the polyvinylidene chloride
sheet attached on cotton gauze was applied to the rat skin re-covered with short hair (approximately 1 mm length) after hair removal.
ANALYSIS
- Method type(s) for identification : Germanium concentration in the sample solution was measured by inductively coupled argon plasma-mass spectrometry (ICPM-8500, Shimadzu, Co., Kyoto, Japan).
Results and discussion
- Signs and symptoms of toxicity:
- not examined
- Dermal irritation:
- not examined
Percutaneous absorptionopen allclose all
- Time point:
- 3 h
- Dose:
- 0.21 mg/g
- Parameter:
- amount
- Remarks:
- in plasma
- Absorption:
- ca. 5.5 other: ng/g
- Remarks on result:
- other: average value in plasma based on reported graphs
- Time point:
- 3 h
- Dose:
- 0.21 mg/g
- Parameter:
- amount
- Remarks:
- in liver
- Absorption:
- ca. 6.4 other: ng/g
- Remarks on result:
- other: average value in liver based on reported graphs
- Time point:
- 3 h
- Dose:
- 0.21 mg/g
- Parameter:
- amount
- Remarks:
- in blood
- Absorption:
- ca. 3.8 other: ng/g
- Remarks on result:
- other: average value in blood based on reported graphs
- Time point:
- 3 h
- Dose:
- 0.21 mg/g
- Parameter:
- amount
- Remarks:
- in kidney
- Absorption:
- ca. 18 other: ng/g
- Remarks on result:
- other: average value in kidney based on reported graphs
- Time point:
- 3 h
- Dose:
- 0.42 mg/g
- Parameter:
- amount
- Remarks:
- in plasma
- Absorption:
- ca. 8.8 other: ng/g
- Remarks on result:
- other: average value in plasma based on reported graphs
- Time point:
- 3 h
- Dose:
- 0.42 mg/g
- Parameter:
- amount
- Remarks:
- in liver
- Absorption:
- ca. 15 other: ng/g
- Remarks on result:
- other: average value in liver based on reported graphs
- Time point:
- 3 h
- Dose:
- 0.42 mg/g
- Parameter:
- amount
- Remarks:
- in blood
- Absorption:
- ca. 5.3 other: ng/g
- Remarks on result:
- other: average value in blood based on reported graphs
- Time point:
- 3 h
- Dose:
- 0.42 mg/g
- Parameter:
- amount
- Remarks:
- in kidney
- Absorption:
- ca. 37 other: ng/g
- Remarks on result:
- other: average value in kidney based on reported graphs
Applicant's summary and conclusion
- Conclusions:
- After 3-hour dermal exposure (depilated dorsal skin) of male F344 / N rats to a neutralized solution of sodium germanate (GeO2 dissolved in NaOH) in a hydrophilic ointment base (2 g ointment containing 0, 0.21 or 0.42 mg GeO2 / g ), the germanium content in whole blood, plasma, liver and kidney increased in a dose-dependent manner. The kidney content was about three times higher than that in the liver
- Executive summary:
In this study the dermal absorption of neutralized GeO2 or germanate using male F344/N rats was investigated. Three groups of rats were treated with a 3-h topical application of hydrophilic ointment containing graded level of neutralized GeO2 (pH 7.4): 0, 0.21 and 0.42 mg GeO2/g. Germanium concentration in blood and tissues sampled from rats after topical application of inorganic germanium was measured by inductively coupled plasma-mass spectrometry. Animals topically applied 0.42 mg GeO2/g ointment had significantly higher germanium concentrations in plasma, liver, and kidney than those of rats that received no topical germanium. The results indicate that skin is permeable to inorganic germanium ion or germanate and recurrent exposure of germanium compounds may pose a potential health hazard.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.