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EC number: 231-784-4 | CAS number: 7727-43-7
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- not stated
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Minor deviations: - Information on source of animals and environmental conditions were missing
Data source
Reference
- Reference Type:
- publication
- Title:
- The acute toxicity of barium sulfate administered intragastrically
- Author:
- Boyd, E.M &Abel, Miriam
- Year:
- 1 966
- Bibliographic source:
- Canad. Med. Ass. J. 94: 849-853
- Report date:
- 1966
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- adopted: 24 Feb. 1987
- Deviations:
- yes
- Remarks:
- See principles of method other than guideline
- Principles of method if other than guideline:
- Minor deviations:
- Information on source of animals and environmental conditions were missing - GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Barium sulfate
- EC Number:
- 231-784-4
- EC Name:
- Barium sulfate
- Cas Number:
- 7727-43-7
- Molecular formula:
- BaO4S
- IUPAC Name:
- barium sulfate
- Details on test material:
- - Name of test material (as cited in study report): Barium sulfate
- Analytical purity: Fisher Certified Reagent grade
No further significant information on test material was stated.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 130-160 g
- Fasting period before study: 16 hours (overnight)
- Housing: rats were housed individually in a metabolism cage
No further significant information on test animals were stated.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- DOSAGE PREPARATION: Barium suspensions in distilled water were stabilised by the addition of 0.2 % (w/v) gum tragacanth.
The study consisted of divided administration of 150 % (w/v) suspension. The suspension was divided as follow: 40 % of the total dose in the first administration, 35 % after three hours and the remaining 25 % after a further four hours. This was done according to an outcome of a pilot study in which a suspension containing 150 g in a final volume of 100 ml produced stomach rupture when given in a single administration much larger than 100 ml/kg.
MAXIMUM DOSE VOLUME APPLIED: 375000 mg/kg bw
No further significant information on oral expsoure was stated
- Doses:
- Treatment group: 188000,225000, 263000, 300000, 338000,and 375000 mg/kg of Barium sulfate
Control group: Received distilled water in similarly divided administration and at a total volme of 185 ml./kg - No. of animals per sex per dose:
- Treatment group: 16 to 26 animals
Control group: 50 animals - Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: for three to 14 days, or until death occurred or recovery appeared obvious
- Necropsy of survivors performed: yes. Gross pathology was recorded on all animals which died. Organ weights and water levels were measured in animals which could be autopsied within one hour of death. Wet weight was measured on the following organs: adrenal glands, brain, cardiac stomach, pyloric stomach, small bowl, cecum, colon, heart, kidneys, liver, lungs, muscle (left half of the anterior abdominal wall muscle layer) skin, spleen, testes, thymus gland and residual carcass. Microscopic examinations were made on blocks of tissue fixed in Lillie's buffered formalin and sections stained with hematoxylinphloxine-saffron.
- Other examinations performed: Daily measurements included body weight, food consumption, water consumption, and colonic temperature - Statistics:
- Statistical methods were those of Croxton.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 307 other: g/kg
- Based on:
- test mat.
- Remarks on result:
- other: S.E. +/- 29 g/kg; death due to stomach rupture
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 364 other: g/kg
- Based on:
- test mat.
- Remarks on result:
- other: S.E. +/- 41 g/kg; death due to bowel obstruction
- Sex:
- male
- Dose descriptor:
- LD0
- Effect level:
- 163 other: g/kg
- Based on:
- test mat.
- Remarks on result:
- other: no death due to bowel obstruction
- Sex:
- male
- Dose descriptor:
- LD100
- Effect level:
- 564 other: g/kg
- Based on:
- test mat.
- Remarks on result:
- other: death due to bowel obstruction
- Mortality:
- Fifty animals died from stomach rupture. The interval to death decreased with increasing dose of barium sulfate. Death in animals which survived stomach rupture was due to bowel obstruction. The interval to death was not dose-dependent and averagd (+/- S.D.) 40 +/- 12 hrs.
- Clinical signs:
- other: FINDINGS- STOMACH RUPTURE Following drug administration, the animals exhibited sedationand piloerection but otherwise appeared and acted normally. All rats which died of stomach rupture ate little or no food, drank little or no water, produced no urine, b
- Gross pathology:
- FINDINGS- STOMACH RUPTURE
Stomach autopsy revealed that the ruptures varied from 0.4 to 1.0 cm. in length, depending on dose, and were most commonly found on the lesser curvature never on the greater curvature. In 90 % of animals there were hemorrhagic areas in the gastric mucosa, mainly on the anterior and posterior surfaces rather than on the lateral borders. The adrenal glands were enlarged, the liver was small and the stretched abdominal muscle had a watery consistency.
Microscopically, the gastric hemorrhagic areas seen to be due to local penetration from barium sulfate through the mucosal layer to about the muscularis mucosae or occasionally into the submucosa.
FINDINGS- BOWEL OBSTRUCTION
At autopsy, impactation was always found in the small bowel and usually in the colon as well. Other gross pathology was limited to gastric haemorrhages and enteritis.
Microscopically, it could be seen that masses of barium sulfate had penetrated areas of the stratified squamous epithelium of the cardiac stomach and the glandular lining of the pyloric stomach, producing the hemorrhages visible macroscopically. - Other findings:
- FINDINGS -STOMACH RUPTURE
Histology: Histopathology in other parts of the body appeared to be due mainly to arteriovenous thrombosis which apparently had occurred in the interval between stomach rupture and death.
FINDINGS - BOWEL OBSTRUCTION
- Organ weights and water levels: Most organs lost weight and water. Exceptions were adrenal glands and cardiac stomach, which gained weight, brain with an unaltered weight and water level, and stomach, liver and abdominal wall muscle which gained water, the latter possibly as a result of stretching.
- Histopathology: Arteriovenous thrombosis, seen in animals which died of stomach rupture, was even more marked in those which died of bowel obstruction and could be found in all organs.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50 >5000 mg/kg bw. Hence, Barium sulfate must not be classified according to GHS.
- Executive summary:
Barium sulfate administered intragastrically to albino rats did not produce death until doses administered reached 25 % to 40 % of body weight. These doses produced stomach rupture with death from four to 28 hours or bowel obstruction with death in 28 to 52 hours. In both instances there was gastrointestinal bleeding and extensive arteriovenous thrombosis of body organs. The latter was apparently responsible for other toxic reactions in many organs. The immediate cause of death was hypothermic respiratory failure. The LD 50 +/- S.E. producing death by bowel obstruction was 364 +/- 41 g/kg. The results suggest that barium sulfate used as a diagnostic radiopaque agent could probably not be taken in a single dose sufficiently great enough to produce signs of acute toxicity.
LD50 (male): 307 g/kg +/- 29 g/kg (death due to stomach rupture)
LD50 (male): 364 g/kg +/- 41 g/kg (death due to bowel obstruction)
LD0 (male): 163 g/kg (no death due to bowel obstruction)
LD100: 564 g/kg (death due to bowel obstruction)
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