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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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
Endpoint summary
Administrative data
Description of key information
Skin irritation (OECD 402 including dermal irriation scoring), rat: not irritating
Eye irritation (OECD 437), in vitro: Eye Dam. Cat. 1 (H318)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because an acute toxicity study by the dermal route does not indicate skin irritation up to the relevant limit dose level (2 000 mg/kg body weight)
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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
- 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
- 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 - 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) - 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. - 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).
Reference
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
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin:
According to Annex VII of the Reach Regulation (EC) 1272/2008 no skin irritation study has to be conducted if an acute toxicity study by the dermal route does not indicate skin irritation up to the limit dose level (2 000 mg/kg bw). The available acute toxicity study by dermal route up to the limit dose of 2000 mg/kg bw in rats (LPT, 2017) with the test substance did not show any skin irritation throughout the observation period. Thus it is conlcuded, that the test substance is not a skin irritant.
Eye:
The eye irritation potential of the test substance was determined in a bovine corneal opacity and permeability test (BCOP test) according to OECD Guideline 437 and in compliance with GLP (Envigo, 2017). After a first opacity measurement of the fresh bovine corneae, 750 µL of a 20% suspension (test substance in saline) was applied directly to the epithelial surface of three cattle corneae in an incubation chamber in horizontal position for 240 min at 32 ± 1°C. After the incubation phase the test substance was rinsed from the corneae. Afterwards, opacity was measured a second time. In addition, the permeability of the corneae was determined by measuring spectrophotometrically the transfer of sodium fluorescein after incubation in a horizontal position for 90 ± 10 min at 32 ± 1°C. The results of the opacity and permeability measurement of the test substance were used to calculate an in vitro irritation score (IVIS) of 131.94. With the negative control saline neither an increase of opacity nor permeability of the corneae could be observed. The mean IVIS of the negative control was 1.43. The mean IVIS of the positive control (benzalkonium chloride) was 122.17. Based on the results, the test substance was damaging to the eye under the conditions of the test.
Justification for classification or non-classification
The available data on skin irritation does not meet the criteria for classification according to Regulation (EC) 1272/2008, and is therefore conclusive but not sufficient for classification. The available data on eye irritation meets the criteria for classification according to Regulation (EC) 1272/2008, and is therefore classfied as Eye Dam. Cat. 1 (H318).
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.