Fatty acids, C14-18 and C16-18-unsatd., barium salts

Acute Toxicity: oral

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-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

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

Test material information

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 levels

Effect levels 1

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

Effect levels 2

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.