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EC number: 233-791-8 | CAS number: 10361-44-1
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation
- Remarks:
- other: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Experimental starting and completion date was 2010-01-29.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline for Testing of Chemicals 437: Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants (September, 2009)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed by Hessisches Minesterium für Umwelt, ländlichen Raum und Verbraucherschutz (2009-03-30)
Test material
- Reference substance name:
- 10035-06-0
- Cas Number:
- 10035-06-0
- IUPAC Name:
- 10035-06-0
- Reference substance name:
- Bismuth trinitrate
- EC Number:
- 233-791-8
- EC Name:
- Bismuth trinitrate
- Cas Number:
- 10361-44-1
- Molecular formula:
- Bi(NO3)3
- IUPAC Name:
- bismuth(3+) trinitrate
- Reference substance name:
- bismuth(III)trinitrate, pentahydrate
- IUPAC Name:
- bismuth(III)trinitrate, pentahydrate
- Details on test material:
- - Name of test material (as cited in study report): Bismuth(III)trinitrate, pentahydrate
- Molecular formula (if other than submission substance): Bi(NO3)3 * 5H2O
- Molecular weight (if other than submission substance): 485.07 g/mol
- Physical state: solid, colourless crystals
- Storage condition of test material: Keep container closed and store substance in a cool and dry place. The test item is hygroscopic.
Constituent 1
Constituent 2
Constituent 3
Test animals / tissue source
- Species:
- other: in vitro testing with freshly isolated bovine cornea
- Details on test animals or tissues and environmental conditions:
- not applicable
Test system
- Vehicle:
- physiological saline
- Controls:
- yes
- Amount / concentration applied:
- Prior to the application the test item was suspended in saline (20% (w/v)).
- Duration of treatment / exposure:
- The incubation time lasted 240 minutes (± 5 minutes).
- Observation period (in vivo):
- direct after removal of test substance or positive control substance (t240)
- Number of animals or in vitro replicates:
- not applicable
- Details on study design:
- Total Number of Corneae: 9:
Number of Corneae per Group: 3
Number of Test Item Group: 1
Number of Negative Control Group: 1
Number of Positive Control Group: 1
OPACITY MEASUREMENT:
The opacitometer was calibrated and the opacity of each of the corneae was determined by reading each holder placed in the photoreceptor compartment for treated cornea. Complete medium was completely removed from the anterior compartment and replaced by the test item, positive or negative control. The anterior compartment was plugged. The cornea was turned to a horizontal position and slightly rotated to ensure uniform covering of the cornea with the test item and was incubated in a water-bath at 32 ± 2 °C. Afterwards, the opacity was measured again.
PERMEABILITY DETERMINATION:
Following to the opacity readings, the permeability endpoint was measured as an indication of the integrity of the epithelial cell sheets. After the final opacity measurement was performed, the complete medium was removed from the anterior compartment and replaced by 1 mL of a 0.5% (w/v) fluorescein solution in HBSS. Corneae were incubated again in a horizontal position for 90 minutes in a water-bath at 32 ± 2 °C. Complete medium from the posterior compartment was removed with a 5 mL-syringe, well mixed and the optical density at 490 nm (OD490) was determined with a spectrophotometer.
SCORING SYSTEM:
0-3 = non eye irritant
3.1-25 = mild eye irritant
25.1-55 = moderate eye irritant
55.1-80 = severe eye irritant
>80 = very severe eye irritant
TOOL USED TO ASSESS SCORE:
- Opaccity: For measurement of the corneae opacity the OP_KiT opacimeter (Electro Design, 63 -Riom France) was used.
- Permeability of the cornea: measured spectrophotometrically at 490 nm
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: in vitro score
- Basis:
- mean
- Time point:
- other: after 240 minutes incubation
- Score:
- 1.25
- Max. score:
- 1.98
- Reversibility:
- not specified
- Remarks on result:
- other: in vitro score of the negative control
- Irritation parameter:
- other: in vitro score
- Basis:
- mean
- Time point:
- other: after 240 minutes incubation
- Score:
- 181.26
- Max. score:
- 187.78
- Reversibility:
- not specified
- Remarks on result:
- other: in vitro score of the positive control substance
- Irritation parameter:
- other: in vitro score
- Basis:
- mean
- Time point:
- other: after 240 minutes incubation
- Score:
- 435.13
- Max. score:
- 436.47
- Reversibility:
- not specified
- Remarks on result:
- other: in vitro score of bismuth(III)trinitrate, pentahydrate
- Irritant / corrosive response data:
- For information see table above.
- Other effects:
- With the negative control (0.9% NaCl solution) neither an increase of opacity nor permeability of the corneae could be observed. The mean in vitro score was calculated as 1.25.
The positive control (10% (w/v) Benzalconium chloride) showed clear opacity and distinctive permeability of the corneae and therefore, is classified as very severe eye irritant. The mean in vitro score was calculated as 181.26.
The test item Bismuth(III) trinitrate, pentahydrate caused opacity and permeability of the corneae compared with the results of the negative control. The calculated in vitro score was 435.13 and therefore, the test item was classified as very severe eye irritant.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item Bismuth(III) trinitrate, pentahydrate caused opacity and permeability of the corneae compared with the results of the negative control. The calculated mean in vitro score was 435.13 and therefore, the test item was classified as very severe eye irritant.
In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item Bismuth(III) trinitrate, pentahydrate is considered to be a very severe eye irritant. - Executive summary:
This in vitro study was performed to assess the corneal irritation and damage potential of Bismuth(III) trinitrate, pentahydrate by means of the BCOP assay using fresh bovine corneae.
After a first opacity measurement of the fresh bovine corneae (t0), the 20% (w/v) suspension in saline (0.9% (w/v) NaCl in deionised water) of the test item Bismuth(III) trinitrate, pentahydrate, the positive, and the negative controls were applied to corneae and incubated for 240 minutes at 32 ± 2 °C. The posterior chamber contained MEM medium supplemented with sodium bicarbonate and L-glutamine and 1% fetal calf serum (FCS) (complete medium = cMEM). After the incubation phase the test item, the positive, and the negative controls were each rinsed from the corneae and opacity was measured again (t240).
After the opacity measurements permeability of the corneae was determined while application of 1 mL of a fluorescein solution for 90 minutes at 32 ± 2 °Cin a horizontal position. The liquid coming out was measured spectrophotometrically.
With the negative control (0.9% NaCl solution) neither an increase of opacity nor permeability of the corneae could be observed.
The positive control (10% (w/v) Benzalconium chloride) showed clear opacity and distinctive permeability of the corneae and therefore, is classified as very severe eye irritant.
The test item Bismuth(III) trinitrate, pentahydrate caused opacity and permeability of the corneae compared with the results of the negative control. The calculated mean in vitro score was 435.13 and therefore, the test item was classified as very severe eye irritant.
In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item Bismuth(III) trinitrate, pentahydrate is considered to be a very severe eye irritant.
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