Fatty acids, C16-18, 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

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: Significant methodological deficiencies

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

publication

Title:

Tierexperimentelle Untersuchungen zur Toxizität des Bariumstearates

Author:

Schmidt, P. et al.

Year:

1975

Bibliographic source:

Zeitschrift für die gesamte Hygiene und ihre Grenzgebiete 21: 613 - 617.

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted 1981-05-12

Deviations:

yes

Remarks:

observation period after test item administration to short; information on dose levels, concentrations, strain of rats and age of rats & on the examination of the animals were not provided; information if dead animals were observed was missing

GLP compliance:

not specified

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

Barium stearate

IUPAC Name:

Barium stearate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

Species:

rat

Strain:

not specified

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: from own institute random breeding
- Weight at study initiation: 199 g (175 - 210 g)
- Fasting period before study: 18 hours before administration of the test substance
- Housing: in groups of 10 rats
- Diet: pelletised standard feed (Sorte K) of the Staatlichen Zentralstelle für Versuchstierzucht und - versorgung Berlin
- Water (ad libitum)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

peanut oil

Details on oral exposure:

no data

Doses:

6 doses (the number of doses was derived from the total number of animals divided by the number of animals used per dose; the doses were not further described)

No. of animals per sex per dose:

15 female rats

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 2 days
- Frequency of observations and weighing: the examination of the surviving animals were conducted from 8:00 to 12:00 o'clock, if not otherwise stated.
- The animals were killed through exsanguination after etherisation.

Statistics:

The lethal dose was calculated according to Litchfield and Wilcoxon (1949)*

* Reference:
Litchfiled, jr., I.T., and W.F. Wilcoxon: J. Pharmacol. exper. Therapeut. 96 (1949), 99.

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

3 400 mg/kg bw

Based on:

test mat.

95% CL:

2 075 - 3 800

Remarks on result:

other: LD50 of barium stearate was calculated 2 days after study initiation

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

646 mg/kg bw

Based on:

element

95% CL:

505 - 740

Remarks on result:

other: LD50 of barium was calculated 2 days after study initiation.

Mortality:

no data

Clinical signs:

other: no data

Gross pathology:

no data

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

LD50 (female rats): 3400 mg barium stearate/kg
LD50 (female rats): 646 mg barium/kg
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, the test substance is not classified as acute toxic via the oral route.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as acute toxic via the oral route.