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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 235-552-3 | CAS number: 12284-76-3
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Trialuminium bismuth hexaoxide
- EC Number:
- 235-552-3
- EC Name:
- Trialuminium bismuth hexaoxide
- Cas Number:
- 12284-76-3
- Molecular formula:
- Al3BiO6
- IUPAC Name:
- bismuth;oxido(oxo)alumane
- Test material form:
- solid
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Remarks:
- CBA/Ca (CBA/CaOlaHsd)
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS B.V., Inc., Horst, The Netherlands
- Females (if applicable) nulliparous and non-pregnant: yes
- Microbiological status of animals, when known: SPF
- Age at study initiation: 8 to 12 weeks old
- Weight at study initiation: 15 to 23 g
- Housing: Housed in suspended solid floor poylpropylene cages furnished with softwood wood flakes.
- Diet (e.g. ad libitum): Free access to rodent diet (Teklad Global Rodent diet).
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least 5 days
- Indication of any skin lesions: None noted
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): At least 15 per hour
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- 10, 25 and 50 (%w/w) in dimethyl sulfoxide
- No. of animals per dose:
- 5 females per dose
- Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: Substance prepared as a suspension in DMSO.
- Irritation: No signs observed
- Systemic toxicity: No signs observed
- Ear thickness measurements: Not indicated (< 25% increase in ear thickness measurements)
- Erythema scores: No signs of local skin irritation noted.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Assigned at random to dose groups
- Criteria used to consider a positive response: The test item is regarded as a skin sensitiser if at least one concentration results in a threefold or greater increase in 3HTdR incorporation compared to control values. A test item producing a less than 3 fold increase will be classified as a non-skin sensitiser.
TREATMENT PREPARATION AND ADMINISTRATION: Test substance prepared as a suspension in DMSO. This vehicle produced the highest concentration that was suitable for dosing. The test item was formulated within 2 hours of being applied to the test system. It is assumed that the formulation was stable. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Data was processed to give group mean values for disintergrations per minute and standard deviations where appropriate. Individual and group mean disintergrations per minute values were assessed for dose response relationships. Data was first assessed for suitability by analysis of normality and homogeniety of variance. If the assumptions that the data are both normally distributed and has homogeniety of variances, then parametric one way analysis of variance (Anova) and Dunnett's multiple comparison procedure were used to determine statistical significance.
If the assumptions are not met, non-parametric Kruskal-Wallis Rank sum and Mann-Whitney U test procedures were used.
Results and discussion
- Positive control results:
- Positive control data from 24/02/2015 to 15/06/2017 was provided in various vehicles (including DMSO). All classifications of the positive control (i.e. positive response) were noted. The latest positive control study was conducted within 6 months of the currently reported study in the relevant vehicle.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1.28
- Test group / Remarks:
- 10 % (w/w)
- Parameter:
- SI
- Value:
- 1.52
- Test group / Remarks:
- 25 % (w/w)
- Parameter:
- SI
- Value:
- 2.1
- Test group / Remarks:
- 50 % (w/w)
- Cellular proliferation data / Observations:
- DETAILS ON STIMULATION INDEX CALCULATION
: The proliferation response of lymph node cells was expressed as the number of disintergrations per minute per animal and as the ratio of 3HTdR incorporation into lymph node cells of test nodes relative to that recorded for the control nodes (stimulation index).
EC3 CALCULATION: Not calculated as all SI values were less than 3.
CLINICAL OBSERVATIONS: No signs of systemic toxicity were noted in the test or control animals during the test. A greater than 25% increase in ear thickness were noted on Days 3 and 6 for the animals treated with the test subsance at concentrations of 25 and 50%. The Day 3 increase could be explained, in part, by the presence of residual test item on the ears post dose. The Day 6 result could be indicative of excessive irritation although this was not supported in the sighting test which showed the concentration to be suitable.
BODY WEIGHTS: Body weight change of the test animals between Days 1 and 6 were comparable to that observed in the corresponding control group animals over the same period.
Any other information on results incl. tables
Individual DPM per minute and SI.
Concentration (%w/w) in DMSO |
Animal No. |
dpm/animal |
Mean dpm/animal (SD) |
SI |
Result |
Vehicle |
1-1 |
2092.49 |
2897.57 (±871.92) |
Na |
Na |
1-2 |
4204.67 |
||||
1-3 |
3096.01 |
||||
1-4 |
2994.35 |
||||
1-5 |
2100.34 |
||||
10 |
2-1 |
3281.95 |
3700.47 (±595.64) |
1.28 |
Negative |
2-2 |
3530.60 |
||||
2-3 |
4653.61 |
||||
2-4 |
3864.59 |
||||
2-5 |
3171.60 |
||||
25 |
3-1 |
2768.79 |
4403.68 (±1138.93) |
1.52 |
Negative |
3-2 |
5262.12 |
||||
3-3 |
5033.65 |
||||
3-4 |
5304.95 |
||||
3-5 |
3648.87 |
||||
50 |
4-1 |
5276.66 |
6070.67*** (±1116.74) |
2.10 |
Negative |
4-2 |
6070.55 |
||||
4-3 |
7223.04 |
||||
4-4 |
7109.31 |
||||
4-5 |
4673.80 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was considered not to be a skin sensitiser under the conditions of the test as the SI index values calculated were all less than 3.
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.