Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
not stated
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Not stated in the report: - acclimasation period and weight of animals were not stated - volume given to animals was not stated - Weight of animals was not stated - No information of environmental, housing and feeding conditions - No statement about fasting period, mortality, clinical observations, weighing, pathology, strain or source of animals
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1980
Report date:
1980

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:
some details are not stated in the report
Principles of method if other than guideline:
Not stated in the report:
- acclimasation period and weight of animals were not stated
- volume given to animals was not stated
- Weight of animals was not stated
- No information of environmental, housing and feeding conditions
- No statement about fasting period, mortality, clinical observations, weighing, pathology, strain or source of animals
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
Barium chloride
EC Number:
233-788-1
EC Name:
Barium chloride
Cas Number:
10361-37-2
IUPAC Name:
barium dichloride
Details on test material:
- Name of test material (as cited in study report): BaCl2 (obtained from Fisher Scientific Company)
- Analytical purity: at least 98 % pure
No further significant information on test material was stated.

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
Age at study initiation: adult: 60 -70 days of age; weanling: 21 - 25 days of age
No further significant information was stated.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
BaCl2 was dissolved in distilled water and administered as a single dose by gavage.
Doses:
At least eight dose levels for adults
At least eight dose levels for weanlings
No. of animals per sex per dose:
10 animals per level
Control animals:
not specified
Details on study design:
Duration of observation period following administration: 14 days

No further significant information on study design was stated.

Statistics:
Statistical analyses were done separately for each sex at a significance of p<0.05.

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
500 mg/kg bw
95% CL:
424 - 600
Remarks on result:
other: LD50 for the weanling animals
Sex:
male/female
Dose descriptor:
LD50
Effect level:
300 mg/kg bw
95% CL:
255 - 369
Remarks on result:
other: LD 50 value for adult animals
Mortality:
not stated
Clinical signs:
other: not stated
Gross pathology:
not stated
Other findings:
not stated

Any other information on results incl. tables

The acute oral toxicity study was performed initally as a dose range finder to a 4, 8 and 13 week study (see Section 7.5.1 Repeated dose toxicity oral: s_Tardiff_1980).

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category III
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The results indicated that LD50 of BaCl2 for the weanling animals was 500 mg /kg bw.; confidence limits, 424 - 600 with a slope of 6.2; whereas, the LD 50 of BaCl2 for the adult animals was 300 mg/kg bw.; confidence, 255 - 369 with a slope of 7.2. However, due to the fact that test animals which are between 8-12 of age should be used for testing, the relevant LD50 is 300 mg/kg bw. Accroding to GHS the substance has to be classified as toxic category III.

The results of the study indicates that BaCl2 was toxic cat 4 to adults and to weanlings.
Executive summary:

The results indicated that LD50 of Ba2+ for the weanling animals was 220 mg/kg bw. and the LD 50 of Ba2+ for the adult animals was 132 mg/k bw.