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EC number: 233-788-1 | CAS number: 10361-37-2
- 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 vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010-05-18 to 2010-06-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study reliable without restrictions
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:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- , 2002-04-24
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- barium(2+) dichloride dihydrate
- EC Number:
- 600-412-6
- Cas Number:
- 10326-27-9
- Molecular formula:
- BaCl2.2(H2O)
- IUPAC Name:
- barium(2+) dichloride dihydrate
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): Barium chloride dihydrate
- EC number: 233-788-1
- Molecular formula: BaCl2 * 2H2O
- Molecular weight: 244.26
- Physical state: White crystalline powder (determined at NOTOX)
- Storage condition of test material: At room temperature in the dark
- Stability under storage conditions: Stable
- pH: 5.5 - 7.5 (100 g/L at 20 °C)
- Stability in water: not indicated
Solubility in water 400 g/L (20 °C)
No further information on the test material was stated
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan, Belton, Leics, England
- Age at study initiation: 9 - 11 weeks old
- Weight at study initiation: 2.210 kg - 2.261 kg
- Housing: Animals were individually housed in labeled cages with perforated floors (Ebeco, Germany, dimensions 67 x 62 x 55 cm) and shelters (Ebeco, Germany, dimensions 40 x 32 x 23 cm).
- Diet: Pelleted diet for rabbits (Global Diet 2030 from Harlan Teklad®, Mucedola, Milanese, Italy) approximately 100 grams per day. Hay (TecniLab-BMI BV, Someren, The Netherlands) was provided at least three times a week.
- Water (ad libitum): Tap water
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 18.8 – 23.4ºC
- Relative humidity: 38 - 81%
- Air changes: Approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12
No further information on the test animals was stated.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): On average 99.5 mg (range 98.9 - 99.9 mg) of the test substance was installed in the conjunctival sac of one of the eyes after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test substance. The other eye remained untreated and served as the reference control.
No further information on the amount/concentration applied was stated. - Duration of treatment / exposure:
- No data
- Observation period (in vivo):
- Approximately 1, 24, 48 and 72 hours and 7 and 14 days (all animals) and 21 days (two animals) after instillation of the test substance.
- Number of animals or in vitro replicates:
- 3 male rabbits
- Details on study design:
- The study was performed in a stepwise manner and was started by treatment of a single rabbit (sentinel). The two other animals were treated in a similar manner 3 weeks later, after considering the degree of eye irritation observed in the first animal.
SCORING SYSTEM: draize scoring system was used. In cases of equivocal results when comparing the treated and untreated eyes, the illustrated guide from the Consumer Product Safety Commission, Washington, D.C. 20207 was used for additional control purposes.
TOOL USED TO ASSESS SCORE: Immediately after the 24-hour observation, a solution of 2% fluorescein (Merck, Darmstadt, Germany) in water was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage. Where standard lighting was considered inadequate for observing minor effects, eye examinations were performed using an ophthalmic examination lamp.
OBSERVATIONS.
Mortality/Viability: Twice daily
- Toxicity: At least once daily
- Body weight: Day of treatment (prior to instillation) and after the final observation
Necrospy: no necropsy was performed.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- The corneal injury consisted of opacity (maximum grade 1: Scattered or diffuse areas of opacity, details of iris clearly visible) and epithelial damage (maximum 10, 15 or 20% of the corneal area). Slight dulling of the normal luster of the cornea was also observed. The corneal injury fully resolved within 72 hours in two animals and within 7 days in the other animal.
Iridial irritation grade 1(Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia, or injection, any of these or combination thereof, iris still reacting to light (sluggish reaction is positive)) was observed and resolved within 24 hours in one animal and within 48 hours in the other two animals.
The irritation of the conjunctivae consisted of redness (maximum grade 3: Diffuse beefy red), chemosis (maximum grade 3: Swelling with lids about half closed) and discharge (Discharge with moistening of the lids and hairs just adjacent to lids to any amount different from normal and/or lacrimation) and completely resolved within 14 days in one animal and within 21 days in the other two animals.
There was no evidence of ocular corrosion.
No staining of (peri) ocular tissue by the test substance was observed and no test substance remnants were seen. - Other effects:
- Toxicity/Mortality:
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- According to the Regulation (EC) No 1272/2008, barium chloride dihydrate should be classified as Irritating to eyes (Category 2).
According to the criteria specified by Directive 67/548/EEC and subsequent regulations, the test item is classified as eye irritant ("irritating to eyes"
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