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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
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Subchronic Toxicity of Barium Chloride Dihydrate Administered to Rats and Mice in the Drinking Water
- Author:
- D.D. Dietz, M.R, Elwell, W.E. Davis, Jr., E.F. Meirhenry
- Year:
- 1 992
- Bibliographic source:
- Fundamental and Applied Toxicology 19, 527-537
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- Version / remarks:
- adopted: 29 July 2016
- Deviations:
- yes
- Remarks:
- limited documentation
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Barium chloride dihydrate
- IUPAC Name:
- Barium chloride dihydrate
- Test material form:
- solid
- Details on test material:
- - State of aggregation: solid, white crystalline
- purity: 99 - 100%
- Lot/batch No.: 123120 and 423103 (obtained from J.T. Baker Chemical Company, Phillipsburg, NJ, USA)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Remarks:
- Fischer 344/N
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Simonsen Laboratories, Inc., Gilroy, CA, USA
- Age at study initiation: not specified
- Weight at study initiation: not specified
- Housing: 5 per cage (polycarbonate cages)
- Diet: ad libitum (NIH-07 open-formula pellets diet; Zeigler Brothers, Inc., Gardners, PA, USA)
- Water: ad libitum
- Acclimation period: 10 -11 days
DETAILS OF FOOD AND WATER QUALITY: diet contains less than 20 ppb barium
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 24
- Humidity (%): 40 - 62
- Air changes (per hr): 13.5
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: no details provided
- Details on mating procedure:
- - M/F ratio per cage: 1/1
- Length of cohabitation: 1 week
- Proof of pregnancy: sperm in vaginal smear - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- males: 60 days prior to mating
females: 30 days prior to mating - Frequency of treatment:
- continuously
Doses / concentrationsopen allclose all
- Dose / conc.:
- 1 000 ppm (nominal)
- Remarks:
- corresponding to 65 mg barium/kg bw/day for males and females
- Dose / conc.:
- 2 000 ppm (nominal)
- Remarks:
- corresponding to 110 or 115 mg barium/kg bw/day for males or females, respectively
- Dose / conc.:
- 4 000 ppm (nominal)
- Remarks:
- corresponding to 200 or 180 mg barium/kg bw/day for males or females, respectively
- No. of animals per sex per dose:
- 20
- Control animals:
- yes, plain diet
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: females were weighed when evidence of mating was found and on day of parturition
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
- Oestrous cyclicity (parental animals):
- no data
- Sperm parameters (parental animals):
- Parameters examined in all P male parental generations:
testis weight, epididymis weight, sperm motility, sperm morphology, density, and motility - Litter observations:
- PARAMETERS EXAMINED
The following parameters were examined in F1 offspring:
number and sex of pups, stillbirths, live births, postnatal mortality, presence of gross anomalies, weight gain
GROSS EXAMINATION OF DEAD PUPS:
yes, for external abnormalities; possible cause of death was not determined for pups born or found dead.
ASSESSMENT OF DEVELOPMENTAL NEUROTOXICITY: no
ASSESSMENT OF DEVELOPMENTAL IMMUNOTOXICITY: no - Postmortem examinations (parental animals):
- SACRIFICE
- Male animals: not specified
- Maternal animals: All surviving animals on Days 96 and 97
GROSS NECROPSY
- Gross necropsy consisted of examination of vagina, cervix, oviducts, and ovaries. Implantation sites in the uteri were counted.
HISTOPATHOLOGY / ORGAN WEIGHTS
no data - Postmortem examinations (offspring):
- SACRIFICE
- All offsprings were sacrificed at 5 days of age.
- These animals were subjected to postmortem examinations (macroscopic examination) for external abnormalities.
GROSS NECROPSY
- Gross necropsy consisted of external examinations.
HISTOPATHOLOGY / ORGAN WEIGTHS
not examined - Statistics:
- Each parameter for which individual values were available was subjected to a linear least squares regression over the dose levels and the direction of the slope and the p value indicating the significance of the deviation of the slope from 0 was determined. Group means and standard deviations or standard errors were calculated for continuous variables. The multiple comparison procedure of Dunnett was employed for pairwise comparisons of these variables between dosed groups and controls. Fisher's exact test was used to make pairwise comparisons of discrete variables between dosed groups and controls and the Cochran-Armitage test was used to assess the significance of dose-related trends. Temporal and dose-related variations were evaluated using a repeated measures analysis of variance. When a collection of measurements were made on each animal, a multivariate analysis of variance was used to test for the simultaneous equality of measurements across dose levels.
- Reproductive indices:
- No indices calculated, but gestation lenght was estimated.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- one female animal was terminated in a moribund state 21 days after mating
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- No effect of the test substance could be detected on vaginal cytology.
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- no effects observed
- Description (incidence and severity):
- No effect of the test substance could be detected on epididymal sperm counts, sperm motility, and sperm morphology.
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- Although the pregnancy rates (from 40% in controls to 65% in the 4000 ppm group) were below the generally accepted norms for reproduction studies, this problem was not corrected by remating due to restrictions in the study dosing schedule/design. All pregnant dams produced live litters except for one in the 4000 ppm group which was terminated in a moribund state 21 days after mating. The average gestation period of surviving dams was 22 to 22.5 days in the various groups. The average live litter size at birth and on Postpartum Day 5 was marginally reduced in the high-dose group (4000 ppm) rats compared with controls (Day 0, 9.0 ± 1.37 pups compared to 7.2 ± 0.52 pups; Day 5, 9.3 ± 1.16 pups compared to 7 .1 ± 0.56 pups; mean ± SEM) but not statistical significant (p < 0.05). The number of implants per pregnant dam was also marginally reduced from 9.6 ± 1.10 pups in controls to 7.7 ± 0.52 pups in the high-dose group and statistical significant (p < 0.05).
Details on results (P0)
Effect levels (P0)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 4 000 ppm (nominal)
- Based on:
- test mat.
- Remarks:
- equivalent to 200 or 180 mg barium/kg bw/day for male and female rats, respectively
- Sex:
- male/female
- Basis for effect level:
- other: no effects observed up to highest dose tested
Target system / organ toxicity (P0)
- Key result
- Critical effects observed:
- no
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not examined
- Mortality / viability:
- no mortality observed
- Description (incidence and severity):
- Pup survival to Day 5 was 99% or greater in all rat treatment groups.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- In the high-dose group, the live pup weight at birth (5.20 ± 0.06 g) was significantly less (p < 0.01) than the control values (5.70 ± 0.09 g). A comparison of pup weights on Day 5 (9.93 ± 0.20 g for high dose compared to 10.55 ± 0.26 g for controls) failed to show significant changes. Weight gain during this period, however, was comparable among all pup groups.
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No external abnormalities were observed in the rat offspring.
- Histopathological findings:
- not examined
- Other effects:
- not examined
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not examined
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not examined
Effect levels (F1)
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- >= 4 000 ppm (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no effects observed up to highest dose tested
Target system / organ toxicity (F1)
- Key result
- Critical effects observed:
- no
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Taken together all data of this study, there are no indications of a substantial impairment of fertility in rats up to the highest dose tested. Thus, the NOAEL was 4000 ppm (to average doses of 200 and 170 mg barium/kg bw/d to male and and female rats, respectively). NOAELs on developmental toxicity for rats of 4000 ppm were derived from this study. However, this NOAEL is of limited value to evaluate the potential for barium to induce developmental effects because there was no exposure of the females during gestation.
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