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Diss Factsheets

Toxicological information

Toxicity to reproduction

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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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
BaO rapidly hydrolyzes to Ba(OH)2, a strongly alkaline substance, upon contact with water. Barium chloride dihydrate as well soluble barium salt was used to assess the potential of BaO to cause barium toxicity. The study did not follow a guideline, but the experimental setup meets basic scientific criteria.
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 et al.
Year:
1992
Bibliographic source:
Fundamental and Applied Toxicology 19, 527-537 (1992)

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Four dose levels were tested with 20 males and 20 females each: 0, 1000, 2000, and 4000 ppm Barium Chloride Dihydrate in drinking water. Males were treated for 60 consecutive days, females for 30 days. At the end of the treatment period, one male and one female were co-housed until signs of mating were detected, but for maximum 8 days. Live offspring were counted, weighed and examined on day 0 (day of birth) and again on day 5. Dead pups were colleced and examined. All females were terminated on days 96 or 97 and vagina, cervix, oviduct and ovaries were examined and implantation sites were counted.
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Reference substance name:
10326-27-9
EC Number:
600-412-6
Cas Number:
10326-27-9
IUPAC Name:
10326-27-9
Constituent 2
Reference substance name:
barium chloride dihydrate
IUPAC Name:
barium chloride dihydrate
Details on test material:
- Name of test material (as cited in study report): barium chloride dihydrate
- Molecular formula (if other than submission substance): BaCl2*2H2O
- Molecular weight (if other than submission substance): 244.27 g/mol
- Substance type: Salt
- Analytical purity: 99.5%

Test animals

Species:
rat
Strain:
other: Fischer-344/N
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Simonsen Laboratories, Gilroy (CA)
- Age at study initiation: 32 days
- Housing: 5 per cage
- Diet (e.g. ad libitum): NIH-07 pellets ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 10-11 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-24
- 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 mating procedure:
- M/F ratio per cage: 1/1
- Length of cohabitation: until detection of signs of mating, but for max. 8 days
- Proof of pregnancy: sperm in vaginal smear
- No replacement of male after unsuccessful pairing (no explanation)
- After successful mating each pregnant female was caged (how): no data
Analytical verification of doses or concentrations:
yes
Details on analytical verification of doses or concentrations:
Dosage analyses were conducted on all dose levels, once at the beginning and midway through the testing period. Detected dose levels were within 1-6% of expected dosage.
Duration of treatment / exposure:
Males: 60 days, Females: 30 days prior to mating
Frequency of treatment:
continuous
Details on study schedule:
- Males were treated for 60 days, females for 30 days with test substance in drinking water prior to mating
- 1 male was mated with 1 female
- animals were checked daily for signs of co-habitation and separated if positive, at the latest however 8 days after begin of the mating period
- live pups were counted and examined on day of birth and 5 days after
- females were sacrificed at days 96 and 97 and reproductive organs were examined
Doses / concentrations
Remarks:
Doses / Concentrations:
1000, 2000, 4000 ppm
Basis:
nominal in water
No. of animals per sex per dose:
20
Control animals:
yes, concurrent vehicle

Examinations

Parental animals: Observations and examinations:
CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Twice daily

DETAILED CLINICAL OBSERVATIONS: No data

BODY WEIGHT: Yes
- Time schedule for examinations: Females were weighed on the day of mating and on the day of parturition

WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
Oestrous cyclicity (parental animals):
not determined
Sperm parameters (parental animals):
Parameters examined in male parental generation:
testis weight, epididymis weight, sperm count, sperm motility, sperm morphology
Litter observations:
STANDARDISATION OF LITTERS
- Performed on day 4 postpartum: no

PARAMETERS EXAMINED
The following parameters were examined in F1 offspring:
number of pups, stillbirths, live births, postnatal mortality, presence of gross anomalies, weight gain, physical abnormalities

GROSS EXAMINATION OF DEAD PUPS:
yes, for external abnormalities
Postmortem examinations (parental animals):
SACRIFICE
- Male animals: no data
- Maternal animals: All surviving were terminated at days 96 and 97.

GROSS NECROPSY
- Gross necropsy consisted of vagina, cervix, oviducts, and ovaries (females). Implantation sites in uteri were counted.

Results and discussion

Results: P0 (first parental generation)

Details on results (P0)

CLINICAL SIGNS AND MORTALITY (PARENTAL ANIMALS): In the highest dose group (4000 ppm), one dam had to be sacrificed in a moribound state 21 days after impregnation. Necropsy revealed seven fetuses and one resorption site. No other mortalities were reported.

REPRODUCTIVE FUNCTION (PARANTAL ANIMALS):
- No differences in sperm count, motility or morphology were found.
- No effects on testis or epididymal weight.
- Vaginal cytology was negative for abnormalities.

REPRODUCTIVE PERFORMANCE (PARENTAL ANIMALS): Pregnancy rates ranged between 40% in controls to 65% in the highest treatment group.

Effect levels (P0)

Dose descriptor:
NOAEL
Effect level:
2 000 ppm (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: Animals did not show increased mortality, fertility rates, live pup numbers and weights were comparable to controls. No effects on sperm count, motility, and morphology, testis or epididymal weight.

Results: F1 generation

Details on results (F1)

The average litter sizes on D0 and D5 as well as the number of implants per pregnant dam were marginally reduced in the highest dose group (4000 ppm) compared to controls, however these changes were not statistically significant. The live pup weight on day of birth (D0) was significantly lower than that of controls, however at D5 no significant differences in pup weights could be found.

No external abnormalities were observed.

Effect levels (F1)

Dose descriptor:
NOAEL
Generation:
F1
Effect level:
2 000 ppm (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: Pup numbers, birth weight, and weight gain after birth were normal, no external abnormalities were detected.

Overall reproductive toxicity

Reproductive effects observed:
not specified

Any other information on results incl. tables

Reproductive toxicity:

 

0 ppm

4000 ppm

Pregnancy rate

40%

65%

Average litter size D0

9.0± 1.37

7.2± 0.52

Average litter size D5

9.3± 1.16

7.1± 0.56

Implants / pregnant dam

9.6± 1.10

7.7± 0.52

Live pup weight D0

5.7± 0.09

5.2± 0.06*

Live pup weight D5

10.55± 0.26

9.93± 0.20

*p0.01

Applicant's summary and conclusion