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EC number: 231-163-8 | CAS number: 7440-55-3
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17/06/2019 - 11/07/2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Gallium trinitrate
- Cas Number:
- 69365-72-6
- Molecular formula:
- Ga(NO3)3 x H2O
- IUPAC Name:
- Gallium trinitrate
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Batch no MKCF5542
Ga content = 17.3%
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- 8-9 weeks; female animals were non-pregnant and nulliparous
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- The test item was administered in a single dose by gavage using a metal stomach tube. Animals were fasted 10-12 h prior to dosing (food but not water was withheld over-night). Following a period of fasting, animals were weighed, and the test item administered. After test item administration, food was withheld for further 3-4 hours.
The required amount of the test item (according to the body weight) was dissolved in vehicle (water for injection) shortly before administration. Dose was recalculated to concentration 100 % of Gallium (purity of test item was 17.3 %). - Doses:
- 2000 mg Ga/kg and 300 mg Ga/kg
- No. of animals per sex per dose:
- 3 animals at 2000 mg Ga/kg and 6 at 300 mg Ga/kg
- Control animals:
- no
- Details on study design:
- The starting dose could be selected from the fixed dose levels of 5, 50, 300, and 2000 mg/kg body weight. Available information indicated that the test item is likely to be non-toxic regarding acute toxicity. A limit dose of 2000 mg Ga/kg body weight was therefore used as a starting dose. In the first step, one group of 3 females was dosed. The test item in limit dose caused mortality of all three animals the first day after administration. In a second step, 3 females were treated at dose of 300 mg Ga/kg body weight. Test item-related mortality was not observed for 48 hours and therefore, in a third step, another 3 females were treated at the same dose level.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- 500 mg/kg bw
- Based on:
- element
- Remarks:
- Gallium
- Mortality:
- THe 3 females died at a dose of 2000 mg Ga/kg. Dose 300 mg/kg of body weight did not cause death in any animal.
- Clinical signs:
- other: The test item Gallium(III) nitrate hydrate administered to 3 females Wistar rats at a limit dose of 2000 mg Ga/kg caused immediate salivation and lethargy. Piloerection and sleep manifested starting ½ an hour after administration and persisted for 4 hours
- Gross pathology:
- All animals were necropsied. In animals No 1 and 2 dosed with 2000 mg Ga/kg body weight we observed necrosis of the stomach. No visible pathological findings were observed in animals dosed with 300 mg Ga/kg body weight.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The LD50 of the test item Gallium(III) nitrate hydrate is greater than 300 mg Ga/kg and lower than 2000 mg Ga/kg body weight after single oral administration to Wistar rats.
Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423 it can be concluded that the test item Gallium(III) nitrate hydrate is classified in GHS Category 4 with a LD50 cut off value 500 mg Ga/kg body weight, after single oral administration to Wistar rats. - Executive summary:
The purpose of the study was to evaluate the potential toxic effect of the test item “Gallium(III) nitrate hydrate” when administered as a single oral dose to Wistar rats.
The procedure according to OECD Guideline 423 Acute Toxic Class (ATC) method was used.
A limit dose of 2000 mg Ga/kg body weight was used as a starting dose. Available information indicated that the test item is likely to be non-toxic regarding acute toxicity, therefore, a limit dose of 2000 mg Ga/kg body weight was used as a starting dose. In the first step, one group of 3 females was dosed. The test item in limit dose caused mortality of all animals the first day after administration. In a second step, 3 females were treated with dose of 300 mg Ga/kg body weight. The test item in dose 300 mg Ga/kg did not cause death in the next 48 hours and therefore another 3 females were treated at the same dose level.
The test item Gallium(III) nitrate hydrate administered to 3 females Wistar rats at a limit dose of 2000 mg Ga/kg caused immediate salivation and lethargy. Piloerection and sleep manifested starting ½ an hour after administration and persisted for 4 hours. The first day all three animals died. During necropsy we observed necrosis of the stomach in animal No 1 and 2.
Dose 300 mg/kg of body weight did not cause death in any animal nor evident signs of toxicity in animals No 4 and 5. Animal No 6 manifested immediate piloerection and lethargy. Animals No 7, 8, 9 were lethargic right after test item administration. Salivation occurred in animal No 7 immediately after test item administration. During necropsy, no macroscopic findings were observed.
The LD50 of the test item Gallium(III) nitrate hydrate is greater than 300 mg Ga/kg and lower than 2000 mg Ga/kg body weight after single oral administration to Wistar rats.
Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423 it can be concluded that the test item Gallium(III) nitrate hydrate is classified in GHS Category 4 with a LD50 cut off value 500 mg Ga/kg body weight, after single oral administration to Wistar rats.
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