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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17/07/2019 - 30/07/2019
- 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 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
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%
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- 29 females
8-9 weeks, non-pregnant and nulliparous female animals were used. The health condition of animals was examined by a veterinarian
before initiation of the study. Animals were healthy, without visible signs of disease.
The animals were acclimated in identical conditions as during the experiment for 5 days prior to the start of treatment. The acclimation
was according to standard operation procedures.
The animals were housed in IVC polycarbonate cages (5 animals per cage) suspended on stainless steel racks, in a room equipped with
central air-conditioning. The room temperature was within the range of 22 ± 3 °C, relative humidity was at least of 30 % and did not exceed
70 %, the aim was 50-60 %. The light regime was set to a 12-hour light / 12-hour dark cycle. The sanitation was performed according to
standard operation procedures.
A laboratory food ssniff (ssniff Spezialdiäten GmbH, Germany) was served ad libitum. The certificate of analysis is included in the raw data.
The animals received tap water for human consumption. Supply of drinking water was unlimited. The quality of drinking water is periodically monitored (including microbiological control) and recorded; certificate of analysis is included in raw data.
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- 25%, 50%, 100% w/v
- No. of animals per dose:
- 5 per dose
- Details on study design:
- Five female mice (CBA/Ca) per group were topically exposed (dorsum of both ears) to the test item at 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).
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- SI = 4.51
In vivo (LLNA)
Resultsopen allclose all
- 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
- Cellular proliferation data / Observations:
- In comparison with the control group, no significant increase of the pooled lymph node weights was observed.
Applicant's summary and conclusion
- 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).
- 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.
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