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EC number: 236-715-1 | CAS number: 13466-20-1
- 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: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 7 October 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
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:
- adopted July 2013
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hess. Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany
Test material
- Reference substance name:
- Barium bis(dihydrogenorthophosphate)
- EC Number:
- 236-715-1
- EC Name:
- Barium bis(dihydrogenorthophosphate)
- Cas Number:
- 13466-20-1
- Molecular formula:
- Ba(H2PO4)2
- IUPAC Name:
- barium bis(dihydrogenorthophosphate)
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Schlachthof Aschaffenburg, Aschaffenburg, Germany
- Characteristics of donor animals: at least 9 months old
- Storage, temperature and transport conditions of ocular tissue: The isolated eyes were stored in HBSS containing 1% (v/v) Penicillin/Streptomycin (100 units/mL penicillin and 100 μg/mL streptomycin) in the cooled slaughterhouse until transportation on the same morning to the laboratory using a Styrofoam box. The corneae were isolated on the same day after delivery of the eyes.
- Indication of any existing defects or lesions in ocular tissue samples: no
- Indication of any antibiotics used: streptomycin/penicilline
Test system
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.75 mL
- Concentration: 20%
VEHICLE
- Amount(s) applied: 0.75 mL
- Concentration (if solution): saline (0.9% NaCl in deionised water)
- Duration of treatment / exposure:
- 240 minutes
- Duration of post- treatment incubation (in vitro):
- none
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS: All eyes were carefully examined macroscopically for defects. Those presenting defects such as vascularization, pigmentation, opacity and scratches were discarded. The cornea was carefully removed from the eye using scalpel and rounded scissors. A rim of about 2 mm of tissue (sclera) was left for stability and handling of the isolated cornea. The corneae were directly used in the BCOP test on the same day.
QUALITY CHECK OF THE ISOLATED CORNEAS: The basal opacity of all corneae was recorded. Each cornea with a value of the basal opacity > 7 was discarded.
NUMBER OF REPLICATES: 3
NEGATIVE CONTROL USED: none
SOLVENT CONTROL USED: Saline (0.9% NaCl in deionised water)
POSITIVE CONTROL USED: 10% (w/v) Benzalkonium chloride in 0.9% (w/v) NaCl (saline)
APPLICATION DOSE AND EXPOSURE TIME: The test item was tested as a 20% suspension (w/v) in saline. 0.75 mL were applied on each surface of the cornea and incubated for 240 minutes.
TREATMENT METHOD: closed chamber
POST-INCUBATION PERIOD: no
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: the test item or control items, respectively, were rinsed off from the application side with saline
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: measured with opacitometer
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of microtiter plate reader at 490 nm (OD490)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
The following formula is used to determine the IVIS of the negative control:
IVIS = opacity value + (15 x OD490 value)
The following formula is used to determine the IVIS of the positive control and the test item:
IVIS = (opacity value – opacity value mean negative control) + (15 x corrected OD490 value)
The mean IVIS value of each treated group is calculated from the IVIS values.
DECISION CRITERIA: decision criteria as indicated in the OECD 437 was used;
IVIS <= 3: no category
IVIS > 3 and >= 55: no prediction can be made
IVIS > 55: serious eye damage according to CLP/GHS (Cat 1)
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 240 minutes
- Value:
- 131.94
- Vehicle controls validity:
- valid
- Remarks:
- IVIS = 1.43
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks:
- IVIS = 122.17
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: no
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
- Range of historical values if different from the ones specified in the test guideline: The historical data of the IVIS of the negative control spaced in a range of 0.73 – 2.04 with a mean IVIS of 1.32. The historical data of the IVIS of the positive control spaced in a range of 98.49 – 167.85 with a mean IVIS of 122.01.
Any other information on results incl. tables
Table 1: Results after 240 minutes incubation time
Test Group |
Opacity value = Difference (t240-t0) of Opacity |
Permeability at 490 nm (OD490) |
IVIS |
Mean IVIS |
Proposedin vitroIrritancy Score |
||
|
|
Mean |
|
Mean |
|
|
|
Negative Control |
1 |
0.33 |
0.074 |
0.073 |
2.11 |
1.43 |
No Category |
0 |
0.073 |
1.10 |
|||||
0 |
0.072 |
1.08 |
|||||
Positive Control |
118.67* |
0.043* |
119.31 |
122.17 |
Category 1 |
||
124.67* |
0.098* |
126.14 |
|||||
119.67* |
0.092* |
121.05 |
|||||
Test Item |
124.67* |
0.050* |
125.42 |
131.94 |
Category 1 |
||
127.67* |
0.036* |
128.21 |
|||||
141.67* |
0.036* |
142.21 |
* corrected values
Applicant's summary and conclusion
- Interpretation of results:
- other: Category 1 based on CLP GHS criteria (EU criteria according to Regulation (EC) No. 1272/2008)
- Conclusions:
- In conclusion, according to the current study and under the experimental conditions reported, Barium bis(dihydrogenorthophosphate) is considered to induce serious eye damage (CLP/GHS Cat 1).
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