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EC number: 232-113-8 | CAS number: 7787-41-9
- 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: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September 2017 - March 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Test data is required for classification purposes.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- October 2017
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The GLP certificate is included within the attached study report
Test material
- Reference substance name:
- Barium selenate
- EC Number:
- 232-113-8
- EC Name:
- Barium selenate
- Cas Number:
- 7787-41-9
- Molecular formula:
- Ba.H2O4Se
- IUPAC Name:
- barium selenate
- Test material form:
- solid: crystalline
Constituent 1
- Specific details on test material used for the study:
- Analytical purity – 97.60% (BaSeO4)
Physical state – Rhombohedral crystals
Colour – White
Molecular weight – 280.32 g/mol
Expiry date – 24th April 2019
Storage conditions – Room temperature
Stability under test conditions - Acceptable
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- The assay uses isolated corneas obtained as a by-product from animals freshly slaughtered at the abattoir A. Moksel AG, Buhloe, Germany.
Test system
- Vehicle:
- other: RPMI 1640 without phenol red
- Remarks:
- (RPMI = Roswell Park Memorial Institute)
- Amount / concentration applied:
- 750 μL of the test item (barium selenate) or control substance (positive control – 20% imidazole in physiological saline 0.9%; negative control – physiological saline 0.9% NaCl)
- Duration of treatment / exposure:
- Samples were mounted in the chambers of the corneal holder and filled with RPMI (without phenol red) containing 1% FBS and 2 mM L-glutamine (complete RPMI). The posterior chamber was always filled first. The corneas were incubated for 1 hour at 32 ±1 oC.
- Duration of post- treatment incubation (in vitro):
- Not applicable.
- Number of animals or in vitro replicates:
- 3 for each group (test item, negative control and positive control)
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Test item (barium selenate)
- Value:
- 24.13
- Vehicle controls validity:
- not examined
- Negative controls validity:
- other: The negative control responses should result in opacity and permeability values that are less than the established upper limits for the background bovine corneas treated with the respective negative control.
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The eye irritancy potential of Barium Selenate was investigated in the bovine opacity and permeability assay.
The test item was suspended with physiological saline 0.9% NaCl (see 10.3) to give a 20% concentration.
All 3 corneas treated with Barium Selenate showed opacity of the tissue
The following mean in vitro irritation score was calculated: 24.13
No prediction can be made regarding the classification of the test substance Barium Selenate according to the evaluation criteria.
The in vitro irritation score obtained with the positive control fell within two standard deviations of the current historical mean and therefore this assay is considered to be valid.
The negative control responses should result in opacity and permeability values that are less than the established upper limits for the background bovine corneas treated with the respective negative control.
Any other information on results incl. tables
Opacity of treated bovine corneas
Cornea No. |
Test item |
Initial opacity |
Final opacity |
Change of opacity value |
Corrected opacity value |
1 2 3 Mean value (MV) |
Negative control |
0.73 0.39 0.52 0.55 |
1.36 0.49 1.19 1.01 |
0.63 0.10 0.66 0.46 |
|
4 5 6 MV |
Positive control |
1.15 1.19 1.26 1.20 |
98.20 84.99 100.26 94.49 |
97.05 83.81 99.01 93.29 |
96.59 83.34 98.54 92.82 |
7 8 9 MV |
Barium selenate test item |
1.04 -0.02 -0.38 0.22 |
27.13 33.82 13.97 24.63 |
26.09 33.84 13.97 24.63 |
25.63 33.37 13.51 24.17 |
Permeability
Cornea No. |
Test item |
OD490 |
Corrected OD490 value |
||||
1 2 3 Mean value (MV) |
Negative control |
0.012 0.010 0.006 0.009 |
|
||||
4 5 6 MV |
Positive control |
2.110 1.745 1.443 1.766 |
2.101 1.736 1.434 1.757 |
||||
7 8 9 MV |
Barium selenate test item |
0.010 0.005 0.005 0.007 |
0.001 -0.004 -0.004 -0.003 |
In vitro irritation score
Cornea No. |
Test item |
OD490 |
Corrected OD490 value |
IVIS |
1 2 3 Mean value (MV) |
Negative control |
0.63 0.10 0.66 0.46 |
0.,012 0.010 0.006 0.009 |
0.060 |
4 5 6 MV |
Positive control |
96.59 83.34 98.54 92.82 |
2.101 1.736 1.434 1.757 |
119.17 |
7 8 9 MV |
Barium selenate test item |
25.63 33.37 13.51 24.17 |
0.001 -0.004 -0.004 -0.003 |
24.13 |
Historical mean in in vitro irritation score of the positive control
|
IVIS positive control – imidazole 20% |
Mean value (MV) Standard deviation (SD) MV-2xSD MV+2xSD |
123.84 17.61 |
88.61 159.07 |
|
Number of replicates providing historical mean 30 |
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Based on the results of this test, no prediction can be made regarding the classification of the test substance Barium Selenate, according to the evaluation criteria.
- Executive summary:
The eye irritancy potential of Barium Selenate was investigated in the bovine corneal opacity and permeability assay. The test item (barium selenate) was suspended with physiological saline 0.9% NaCl, to give a 20% concentration.
The three corneas treated with the test item showed opacity of the tissue – the calculated mean in vitro irritation score is 24.13. No prediction could be made regarding the classification of the test substance, according to the evaluation criteria.
The in vitro irritation score obtained with the positive control fell within the two standard deviations of the current historical mean and therefore this assay is considered to be valid.
The negative control responses resulted in opacity and permeability values that are less than the established upper limits for background bovine corneas treated with the respective negative control.
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