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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
Endpoint summary
Administrative data
Description of key information
No data regarding repeated dose toxicity is available for Barium bis(dihydrogen orthophosphate). Reliable data is available for the structural similar substance barium chloride dihydrate (CAS 10326 -27 -9).
Oral, subchronic (RA from CAS 10326 -27 -9; OECD 408; RL2), rat: NOAEL = 110.0 mg/kg bw/day for males and 115.0 mg/kg bw/day for females; LOAEL = 200 mg/kg bw/day for males and 180 mg/kg bw/day for females
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please refer to the analogue justification attached to chapter 13
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- rat
- Effect level:
- 2 000 ppm
- Based on:
- test mat.
- Remarks:
- equivalent to 110 and 115 mg barium/kg bw/day for males and females, respectively
- Sex:
- male/female
- Basis for effect level:
- histopathology: non-neoplastic
- mortality
- Dose descriptor:
- NOAEL
- Remarks:
- mouse
- Effect level:
- 2 000 ppm
- Based on:
- test mat.
- Remarks:
- equivalent to 205 and 200 mg barium/kg bw/day for males and females, respectively
- Sex:
- male/female
- Basis for effect level:
- histopathology: non-neoplastic
- mortality
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 4 000 ppm
- System:
- urinary
- Organ:
- kidney
- Treatment related:
- yes
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
- Conclusions:
- The no observed adverse effect level (NOAEL) for source substance barium chloride dihydrate in drinking water for rats and mice was estimated to be approximately 2000 ppm based on increased mortality and renal toxicity. The dose of 2000 ppm corresponds to NOAEL values of 110 and 115 mg barium/kg bw/day to male and female rats, respectively and of 200 and 205 mg barium/kg bw/day for male and female mice, respectively. As explained in the analogue justification the target and the source substances are considered to be similar in their toxicological behvior. Therefore, it is considered that the target and the source substances are unlikely to lead to differences in repeated toxicity.
Reference
Drinking water containing 125, 500, 1000, 2000, or 4000 ppm barium chloride dihydrate was estimated to deliver daily doses of 10, 30, 65, 110, or 200 mg barium/kg bw to male rats and 10, 35, 65, 115, or 180 mg barium/kg bw to female rats.
Drinking water containing 125, 500, 1000, 2000, or 4000 ppm barium chloride dihydrate was estimated to deliver daily doses of 15, 55, 100, 205, or 450 mg barium/kg bw to male mice and 15, 60, 110, 200, or 495 mg barium/kg bw to female mice.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 110 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- The available information comprises adequate, reliable (Klimisch score 2) and consistent studies, from a reference substance with similar structure and intrinsic properties. Read-across is justified based on similarities in PC/ECO/TOX properties (refer to endpoint discussion for further details).
The selected studies are thus sufficient to fulfil the standard information requirements set out in Annex VIII, 8.6, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006. - System:
- urinary
- Organ:
- kidney
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No data regarding repeated dose toxicity is available for barium bis(dihydrogen orthophosphate). Reliable data is available for barium chloride dihydrate (CAS 10326-27-9). Since the main toxicity of barium bis(dihydrogen orthophosphate) can be attributed to barium, barium chloride dihydrate can be used as read across. For more details please refer to the analogue justification provided in section 13.
Toxicology studies were performed within the National Toxicology Program (NTP) in order to characterize and evaluate the toxicological potential, including carcinogenic activity, of barium chloride dihydrate in rats and mice. A 13-week repeated dose toxicity study in rats and mice was performed similar to OECD guideline 408 (NTP, 1994). The following acceptable deviations from the guideline study were observed: parameters of clinical biochemistry were limited, no ophthalmologic examination was performed, and weights from spleen, ovaries and uterus were not measured. In the study with mice there were additionally no hematology and chemistry parameters examined.
Rats:
A 13-week study in rats similar to OECD guideline 408 (NTP, 1994) was performed with rats. Groups of 10 male and 10 female Fischer 344 rats received barium chloride dihydrate in the drinking water at concentrations of 0, 125, 500, 1000, 2000, or 4000 ppm for 13 weeks, corresponding to average daily doses of 10, 30, 65, 110, or 200 mg barium/kg bw/day to males and 10, 35, 65, 115, or 180 mg barium/kg bw/day to females. The selected doses were based on a range finding study. Three males and one female in the 4000 ppm groups died during the last week of the study. The final mean body weights of male and female rats receiving 4000 ppm were significantly lower (13% and 8%) than those of the controls. Water consumption by male and female rats in the 4000 ppm groups was approximately 30% lower than that by the controls. No clearly chemical-related clinical findings of toxicity or neurobehavioral or cardiovascular effects were noted. Serum phosphorus levels in 2000 and 4000 ppm male and female rats were significantly higher than those in controls, but there were no biologically significant differences in hematology parameters or in serum sodium, potassium, or calcium levels. Renal tubule dilatation in the outer stripe of the outer medulla and cortex occurred in male and female rats receiving 4000 ppm.
The no observed adverse effect level (NOAEL) for barium chloride dihydrate in drinking water for rats was estimated to be approximately 2000 ppm based on the final mean body weights, mean body weight gains, decreased water consumption, mortality, and renal toxicity. The dose of 2000 ppm corresponds to NOAEL values of 110 and 115 mg barium/kg bw/day to male and female rats, respectively. The LOAEL was 200 and 180 mg barium/kg bw/day for males and females, respectively.
Mice:
In a 13-week supporting study also performed similar to OECD 408 groups of 10 male and 10 female B6C3F1 mice received barium chloride dihydrate in the drinking water at concentrations of 0, 125, 250, 500, 1000, or 2000 ppm for 13 weeks, corresponding to average daily doses of 15, 55, 100, 205, or 450 mg barium/kg bw/day to males and 15, 60, 110,200, or 495 mg barium/kg bw/day to females (NTP, 1994). The doses were selected based on a dose range finding study. In the 13-week study six males and seven females that received 4000 ppm and one male that received 125 ppm died during the study. Final mean body weights of male and female mice receiving 4000 ppm were significantly lower (> 30%) than those of controls. Water consumption by male mice in the 4000 ppm group was 18% lower than that by the controls; water consumption by other exposed groups of male and female mice was similar to that by the controls. Clinical findings of toxicity were limited to debilitation in the surviving male and female mice receiving 4000 ppm. The absolute and/or relative liver weights of mice receiving 1000, 2000, and 4000 ppm were significantly lower than those of the controls. Multifocal to diffuse nephropathy characterized by tubule dilatation, regeneration, and atrophy occurred in 4000 ppm male and female mice. Atrophy of the thymus and spleen was observed in the majority of early death male and female mice receiving 4000 ppm. Grossly, the thymuses were small or not visible and the spleens were small and mottled or discolored. The thymic lesions consisted of necrosis or moderate to marked depletion of thymic lymphocytes. In some mice, the thymus consisted of only remnants of stromal cells, while in others, the thymus was not even identifiable in the tissue section. The splenic atrophy was characterized by a diminution of the hematopoietic elements of the red pulp and depletion of lymphocytes in the periarteriolar lymphoid sheath, leaving only a thin layer of mature lymphocytes surrounding the arterioles.
The no-observed-effect level (NOAEL) for barium chloride dihydrate in drinking water for mice was estimated to approximately 2000 ppm based on the final mean body weights, mean body weight gains, decreased water consumption, mortality, and renal toxicity. The dose of 2000 ppm corresponds to NOAEL values of 205 and 200 mg barium/kg bw/day to male and female mice, respectively.Justification for classification or non-classification
The available data on repeated dose toxicity do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.
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.
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