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EC number: 231-164-3 | CAS number: 7440-56-4
- 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
Endpoint summary
Administrative data
Description of key information
For assessing the acute oral toxicity of Ge, reference has been made to toxicity data obtained by standard acute oral toxicity testing on GeO2. Bio-elution data in artificial gastric body fluids demonstrate that the solubility of Ge in Ge metal powder is lower than the solubility of Ge from GeO2.
Assessment of the acute oral toxicity of germanium dioxide in Arulnesan et al 2012:
An Acute Oral Toxicity Study of Germanium Dioxide, was carried out according to OECD 425. The test item was suspended in 1% methyl cellulose at a concentration of 200 mg/mL. The first animal was dosed at 2000 mg/kg at a dose volume of 10.0 mL/kg. Since this first animal survived, four additional animals were dosed at 2-day intervals. A total of 5 female CD (Sprague-Dawley) rats were dosed. All animals received the test item by oral gavage using a feeding cannula inserted into the stomach of the animals. The animals were observed for a 14-day period after dosing. Body weights were recorded prior to test item administration (i.e., Day 0), on Day 7 and prior to necropsy on Day 14. No mortalities were observed post dosing and during the 14-day observation period in any of the animals. All rats gained body weight by Day 7 and at the end of the study. At the end of the 14-day observation period, each animal was sacrificed and submitted for gross necropsy. No gross pathological findings were observed in any of the rats at necropsy. Based on the foregoing results, the acute oral LD50 in rats of the test item, Germanium Dioxide, was found to be in excess of 2000 mg/kg. Therefore, the test item is considered not to present a significant acute toxic risk if swallowed.
Assessment of the acute inhalation toxicity of germanium in Arts et al 1990:
The acute (4 -hour) inhalation toxicity of germanium powder was studied by exposing total-body group of rats, consisting of five male and five female rats, to a test atmosphere containing germanium powder at a concentration of 3.86 or 5.34 g/m3 in air respectively for one single time for a period of 4 hours. It was concluded that the 4 hours LC50 value of germanium powder was higher than 5.34 g/m3
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- 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
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: SPF-reared, Wistar derived rats (strain code Bor:WISW) delivered by Winkelmann, Versuchstierzucht GmbH & Co KG, Borchen, FRG
- Age at study initiation: no information
- Weight at study initiation: mean body weight: M: 272g, F: 198g
- Housing: individually in wire-mesh stainless steel cages
- Diet : cereal based Institute's stock diet ad libitum
- Water : bottled tap water ad libitum
- Acclimation period: acclimatized for at least 16 days in a cleaned and desinfected animal room in the inhalation facilities
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.3 ± 0.90C
- Humidity (%): between 29 and 46 (average 37)
- Air changes (per hr): 30 to 44
- Photoperiod (hrs dark / hrs light): 12/12
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- whole body
- Vehicle:
- not specified
- Mass median aerodynamic diameter (MMAD):
- ca. 2.3 - ca. 2.5 µm
- Geometric standard deviation (GSD):
- ca. 1.4 - ca. 1.5
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION:
Before the generation of the test atmosphere, the test material was dried in an oven (settings 2.5 hours, 15O0C). Thereafter the test material was ground using a blender. An aerosol was generated by delivering appropriate quantities of the test material to an atomizer. Next the aerosol was passed through a cyclone placed close to the bottom of the chamber for separating the larger particles from the aerosol. The aerosol was subsequently diluted with clean air before entering the inhalation chamber.
TEST ATMOSPHERE
The actual mass concentration of germanium powder in the test atmosphere was determined at least two times each hour by gravimetry. Measured test atmosphere samples were drawn through fiber glass filters (Sartorius). The weights of the deposits on the filters were obtained by weighing the filters before and after sampling using a micro balance. The nominal concentration was determined by dividing the total amount of test material used by the total volume of air passed through the inhalation chamber. The particle size distribution of the test material in the test atmosphere was determined once in a sample taken from the test atmosphere in the chamber using an 11-stage cascade impactor. - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 3.86 g/m3: first group exposed
5.34 g/m3: second group exposed - No. of animals per sex per dose:
- per exposed group : 5 rats per sex
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 3 times (prior to exposure, at days 7 and days 14)
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight,histopathology - Statistics:
- no statistics reported
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5 340 mg/m³ air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- One male animal died shortly after exposure to 3.86 g/m3, one female animal died shortly after exposure to 5.34 g/m3.
- Clinical signs:
- other: During the first hour of exposure the animals were restless. One male animal exposed to 3.86 g/m3 showed mouth breathing. During the rest of the exposure period observations were impossible due to very high dust concentrations which did not allow any view
- Body weight:
- One male animal exposed to 5.34 g/m3 showed a slight weight loss seven days after exposure, whereas weight gain was observed at the end of the
14-day observation period. Body weights of the other animals were not affected by exposure. - Gross pathology:
- Gross examination at autopsy revealed red spotted lungs in most animals exposed to 3.86 g/m3
In most animals autopsied after exposure to 5.34 g/m3, lungs showed grey-white, occasionally red, coloured spots or were palely discoloured with dark coloured spots. - Other findings:
- none
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- 4 hours LC50 value of germanium powder was higher than 5.34 g/m3
- Executive summary:
The acute (4 -hour) inhalation toxicity of germanium powder was studied by exposing total-body group of rats, consisting of five male and five female rats , to a test atmosphere containing germanium powder at a concentration of 3.86 or 5.34 g/m3 in air respectively for one single time for a period of 4 hours.
It was concluded that the 4 hours LC50 value of germanium powder was higher than 5.34 g/m3
Reference
none
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 5 340 mg/m³ air
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the physicochemical and toxicological properties suggest no potential for a significant rate of absorption through the skin
- the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on read across from the results of the available and reliable acute oral rat study with germanium dioxide, germanium does not require classification for acute oral toxicity according to EU CLP criteria (EC 1272/2008).
Based on the results of the available acute inhalation rat study, germanium does not require classification for acute inhalation toxicity according to EU CLP criteria (EC 1272/2008).
There are no available data on which to evaluate acute dermal toxicity. However, acute dermal toxicity can be considered to be low in view of the poor absorption by this route and the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route. Therefore, germanium does not require classification for acute dermal toxicity according to EU CLP criteria (EC 1272/2008)
No clear evidence of specific target organ toxicity was noted. As such, classification for STOT-SE is not considered appropriate.
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