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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The solubility of the originally to be used test item - “gallium” – in test specific solvents was determined in pre-test. The test item is insoluble in all solvent indicated by the respective OECD guidelines at the required concentrations. Even after sonication, precipitates were clearly visible with the unaided eye. “Gallium(III) nitrate hydrate” is selected as alternative because of its higher solubility and the absence of sensitizing effects from the nitrate ions. In vitro skin sensitization testing in accordance with OECD 442C is not applicable to the testing of metals and metal compounds and therefore an in vivo approach has been selected.
A read-across approach between gallium (III) nitrate and gallium metal is followed assuming that the toxicity of gallium (III) nitrate hydrate is completely attributed to the gallium ion. Even if the nitrate ion would contribute partly to the toxicity of the substance, it is considered worst case to completely attribute the toxicity to the gallium ion. - Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Parameter:
- SI
- Value:
- 1.23
- Test group / Remarks:
- 25% Gallium(III) nitrate hydrate
- Parameter:
- SI
- Value:
- 1.11
- Test group / Remarks:
- 50% Gallium(III) nitrate hydrate
- Parameter:
- SI
- Value:
- 1.66
- Test group / Remarks:
- 100% Gallium(III) nitrate hydrate
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item Gallium (III) nitrate hydrate is not considered a skin sensitizer under the test conditions of this study (OECD 429). As gallium is part of the test substance, a read-across is performed and Gallium is also not considered a skin sensitizer.
- Executive summary:
The sensitization of Gallium (III) nitrate hydrate was evaluated using the Local Lymph Node Assay (LLNA). The LLNA has been developed to determine the allergic contact sensitization potential of chemicals.
Based on the recommendations of the OECD 429, the test item was suspended in DMSO (w/v). The positive control (alpha-Hexylcinnamic aldehyde) (25 %) was dissolved in the same vehicle. The Pre-screen test was performed using the dose of 5780 mg test item/mL (referred to as 100 %). Based on the observations recorded in the Pre-screen tests, the concentration of 100 % was selected as top dose for the main test.
Five female mice (CBA/Ca) per group were topically exposed (dorsum of both ears) to the test itemat concentrations of 25 %, 50 % and 100 % (corresponding to 1445, 2890 and 5780 mg/mL, respectively), to the positive control and to the vehicle only. Lymphocyte proliferation was measured using incorporation of radioactive 125I-iododeoxyuridine and 10-5M fluorodeoxyuridine in the draining lymph nodes. The radioactive incorporation was expressed as disintegrations per minute
(DPM)/pooled treatment group and compared with DPM value from the vehicle control group and expressed as the Stimulation Index (SI).
After application of the test item at three concentrations (25 %, 50 % and 100 % w/v) the animals did not show visible clinical symptoms of either local irritation or systemic toxicity. In this study the Stimulation Indices (SI) of 1.23, 1.11 and 1.66 were determined with the test item at concentrations of 25 %, 50 %, and 100 % in DMSO, respectively. The EC3 value could not be
calculated, since none of the tested concentrations induced a SI greater than the threshold value of 3.
The test item Gallium (III) nitrate hydrate is not considered a skin sensitizer under the test conditions of this study.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
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.