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Diss Factsheets
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EC number: 244-214-4 | CAS number: 21109-95-5
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Toxicity to reproduction
Administrative data
- Endpoint:
- fertility, other
- Remarks:
- based on test type (migrated information)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study well documented, meets generally accepted scientific principles, acceptable for assessment. Data and Rating according to the SIDS 2005 on barium cabonate. Deviances when comparing to OECD421: dosing only prior to mating, no individual animal data/tables provided, histopathologic examination, data on food consumption only provided for core study animals, no humidity, sex of pups, and data on stability of test substance in vehicle given. Only the average results of the controls and the high dose groups of each species were available.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Subchronic toxicity of barium chloride dihydrate administered to rats and mice in the drinking water.
- Author:
- Dietz, D.D.; et al.
- Year:
- 1 992
- Bibliographic source:
- Fund. Appl. Tox. 19, 527-537
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Deviations:
- not applicable
- Principles of method if other than guideline:
- In parallel with a subchronic toxicity core study, a premating study was performed with separate groups of rats and mice. Premating exposure period with Barium chloride dihydrate was 60 days for males and 30 days for females.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 10326-27-9
- EC Number:
- 600-412-6
- Cas Number:
- 10326-27-9
- IUPAC Name:
- 10326-27-9
- Reference substance name:
- barium chloride dihydrate
- IUPAC Name:
- barium chloride dihydrate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Barium chloride dihydrate
- EC number: 233-788-1
- Molecular formula (if other than submission substance): BaCl2 x 2H2O
- Molecular weight (if other than submission substance): 226.3 g (calculated from molecular formula)
- Smiles notation (if other than submission substance):
- InChl (if other than submission substance):
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type: technical product
- Physical state: white, crystalline solid
- Analytical purity: 99.5 % (by EDTA titration)
- Lot/batch No.: 123120 (from Baker Chemical Co., Phillipsburg, NJ)
- no further significant details stated
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: Fischer 334/N
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Simonson Laboratories, Gilroy, CA
- Age at study initiation: (P) 32 days
- Housing: five per cage in drawer-type polycarbonate cages (shelves covered with filter sheets, bedding, cages and water bottles were changed twice a week, feeders once a week, racks and filters every other week); after 60 days of exposure, the males were placed in individual cages and one female receiving the same dose level (but exposed for 30 days) was cohabited with the male. After mating the females were separated.
- Diet: NIH-o7 pellets (Ziegler Brothers, Gardners, PA)
- Water: ad libitum (dosed or undosed) for 92 consecutive days
- Acclimation period: 10 to 11 days (quarantined)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 24 °C
- Air changes (per hr): 13.5 room vol.
- Photoperiod (hrs dark / hrs light): 12/12 (fluorescent lighting)
- no further significant details stated
Administration / exposure
- Route of administration:
- oral: drinking water
- Type of inhalation exposure (if applicable):
- other: not applicable
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
VEHICLE
- Solutions were made weekly in 19-liter quantities by dissolving weighed portions of the test substance in glass-distilled water.
- Concentration in vehicle: 0, 1000 and 4000 ppm
- no further significant details stated - Details on mating procedure:
- - M/F ratio per cage: 1 male / 1 female rat
- Length of cohabitation: up to one week
- Proof of pregnancy:Examination of microscopic evidence of sperm in vaginal swab every morning
- When evidence of mating was found, the females was separated from the male.
- After mating determinations were made on the eighth day of cohabition and all remaining pairs were separated.
- No remating was performed although pregnancy rate was low.
- no further significant details stated - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Analyses were performed on all levels before and after use, and at the beginning and midway through the test period. The concentrations were within 1 to 6 % of the theoretical concentration. Method of analysis was not stated.
- Duration of treatment / exposure:
- Premating exposure period: 60 days for males and 30 days for females
- Frequency of treatment:
- continuous
- Details on study schedule:
- - no further significant details stated
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
1000 ppmBaCl2 x 2H2O
Basis:
nominal in water
calculated average dose: 63.5 mg Ba/kg bw/d to males and 64.5 mg Ba/kg bw/d to females
- Remarks:
- Doses / Concentrations:
2000 ppm BaCl2 x 2H2O
Basis:
nominal in water
calculated average dose: 112 mg Ba/kg bw/d to males and 114 mg Ba/kg bw/d to females
- Remarks:
- Doses / Concentrations:
4000 ppm BaCl2 x 2H2O
Basis:
nominal in water
calculated average dose: 201.5 mg Ba/kg bw/d to males and 179.5 mg Ba/kg bw/d to females
- No. of animals per sex per dose:
- 20 male and 20 female rats
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Other: No remating was performed due to restriction in the study dosing schedule/design.
- no further significant details stated - Positive control:
- not required
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily
CLINICAL OBSERVATIONS: Yes
- Time schedule: twice daily
BODY WEIGHT: Yes
- Time schedule for examinations: weekly and females were weighed when evidence of mating was found an on the day of parturition.
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes
- Time schedule for examinations: twice weekly
OTHER:
- determination of pregnancy rates in dosed and control animals
- determination of average gestation period
- no further significant details stated - Oestrous cyclicity (parental animals):
- - Evaluation of vaginal cytology was performed among treated and control groups.
- Sperm parameters (parental animals):
- Parameters examined in P male parental generations:
- An evaluation of sperm morphology, density, and motility and sperm count was performed among treated and control groups.
- no further significant details stated - Litter observations:
- PARAMETERS EXAMINED
The following examinations were performed in F1 offspring:
- pups were examined at birth and day 5
- number of live litter, average litter size at day 0 and 5, pup survival to day 5, pup weight at birth and day 5, external abnormalities
GROSS EXAMINATION OF DEAD PUPS:
- yes, dead pups were examined for external abnormalities
- no further significant details stated - Postmortem examinations (parental animals):
- SACRIFICE
- Male animals: not stated
- Maternal animals: All surviving animals were terminated on days 96 and 97.
GROSS NECROPSY
- The vagina, cervix, oviducts, and ovaries were grossly examined and the implantation sites in the uteri were counted.
- The male reproductive organ weights (testis, epidimymal) was determined among treated and control groups.
HISTOPATHOLOGY / ORGAN WEIGHTS
- Complete histologic exams were performed in the parallel animal groups which were not used for reproductive and fertility assessment.
- no further significant details stated - Postmortem examinations (offspring):
- - no data
- Statistics:
- Each parameter for which individual values were available was subjected to a linear least squares regression over the doselevels 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 (1955) was used for comparison between dosed and control groups. Further, Fisher's extract test, the Cochran-Armitage test (Armitage, 1971; Gart et al., 1979) was used as well as repeated measures analysis of variance (WInter, 1971) and a multivariate analysis of variance (Morrison, 1976).
- Reproductive indices:
- - no significant details stated
- Offspring viability indices:
- - no significant details stated
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- not examined
- Other effects:
- effects observed, treatment-related
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
Details on results (P0)
- one pregnant dam in the 4000 ppm group was terminated in a moribund state 21 days after mating
TEST SUBSTANCE INTAKE (PARENTAL ANIMALS)
- only determined for core study animals
REPRODUCTIVE FUNCTION: ESTROUS CYCLE (PARENTAL ANIMALS)
- There were no treatment-related effects of barium chloride dihydrate on vaginal cytology up to 4000 ppm.
REPRODUCTIVE FUNCTION: SPERM MEASURES (PARENTAL ANIMALS)
- There were no treatment-related effects of barium chloride dihydrate on epididymal sperm count, sperm motility, sperm morphology, up to 4000 ppm.
REPRODUCTIVE PERFORMANCE (PARENTAL ANIMALS)
- The pregnancy rates were below generally accepted norms: from 40 % in the controls and 65 % in the 4000 ppm group.
- All pregnant dams produced litters except for one in the 4000 ppm group, which was terminated
- The average gestation period of surviving dams was 22 to 22.5 days (in various groups).
- The number of implants per pregnant dam was marginally reduced in the 4000 ppm group compared with the controls (but without statistical significance at p<0.05)
ORGAN WEIGHTS (PARENTAL ANIMALS)
- no effect could be detected on testis or epididymal weight
GROSS PATHOLOGY (PARENTAL ANIMALS)
- necropsy of the terminated dam revealed 7 fetuses and one resorption site
- no further significant details stated
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 4 000 ppm (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: fertility impairment
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Histopathological findings:
- not examined
Details on results (F1)
- Pup survival to day 5 was 99 % or greater in all treatment groups.
CLINICAL SIGNS (OFFSPRING)
- No external abnormalities were observed in the rat offspring.
BODY WEIGHT (OFFSPRING)
- Rats receiving 4000 ppm exhibited significant although marginal reductions in pup weights at birth (5.20 +/- 0.06 g compared to 5.70 +/- 0.09 g); a comparision of pups weight on day 5 showed no significant differences. Weight gain was comparable among all pup groups.
OTHER
- The average litter size at birth and on postpartum day 5 was marginally reduced in the 4000 ppm group compared with the controls (but without statistical significance at p<0.05)
- no further significant details stated
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 4 000 ppm (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: development toxicity, but the NOAEL is of limited value to evaluate the potential for barium to induce developmental effects
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Only the average results of the controls and the high dose groups of each species were available.
No-observed-adverse-effect level (NOAEL) for fertility impairmentwas 4,000ppm in rats. These NOAEL values correspond to average doses of 201.5 and 179.5 mg Ba/kg bw/d to male and and female rats, respectively.
A NOAEL on developmental toxicityof 4,000 ppm is also reported. However, the NOAEL is of limited value to evaluate the potential for barium to induce developmental effects. The reason for this limitation is based on the fact that the premating study design did not include exposure of female animals during the gestational period to barium chloride. Therefore, the premating study has to be considered as an inadequate study of developmental toxicity and cannot be used to determine the occurrence of developmental toxicity.
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 201.5 and 179.5 mg Ba/kg bw/d to male and and female rats, respectively). No-observed-adverse-effect levels (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.
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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