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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1962
Reliability:
2 (reliable with restrictions)
Cross-reference
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
publication
Title:
Acute Oral and Parenteral Toxicity of four Titanate Compounds in the Rat
Author:
J.R. Brown, E. Mastromatteo
Year:
1962
Bibliographic source:
Industrial Medicine and Surgery, July 1962 302-304, Number 7, Volume XXXI

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Known dry weights of titanates were mixed with corn oil to form a 40% suspension. This was diluted for use as required in order that each animal should receive the same total volume in proportion to its body weight.
GLP compliance:
no
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
Young adult male Wistar rats weighing 200 grams or more were used. They were obtained from a commercial breeder. The animals were housed in seperate wire cages and supplied with water and a standard fox cube diet at libitium.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: corn oil
Details on oral exposure:
Because of the insolubiltiy of the titanates, corn oil was used as a vehicle for adminstration. Known dry weights of titanates were mixed with corn oil to form a 40% suspension. This was diluted for use as required in order that each animal should receive the same total volume in proportion to its body weight. For the determination of acute oral toxicity the sample was adminstered directly into the stomach in calculated amounts using a rubber catheder stomach tube and a graduated syringe.
Doses:
Dose levels:
1.5 g/kg bw
3.0 g/kg bw
6.0 g/kg bw
12.0 g/kg bw
No. of animals per sex per dose:
6 male animals per dose
Control animals:
yes
Details on study design:
All animales were maintend and observed for one month following observation of test materials. The time of death and any evidence of toxic effect were noted. The same amount of corn oil alone were given to a similar number of rats in each case of control.
Rats that died as a result of the adminstation of titantate were examined for evidence of toxic effects. Gross findings doses were first carried out by both oral and intraperitonal LD50 doses with their 95% fiducial limits, groups of six animal were given four dose level which varied by a constant geometric factor. those dose levels were based on the range finding data. The LD50 dose was calculated according to the tables and instructions given by Weil

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD0
Effect level:
1 500 mg/kg bw
Based on:
test mat.
Sex:
male
Dose descriptor:
LD0
Effect level:
3 000 mg/kg bw
Based on:
test mat.
Sex:
male
Dose descriptor:
LD0
Effect level:
6 000 mg/kg bw
Based on:
test mat.
Sex:
male
Dose descriptor:
LD0
Effect level:
12 000 mg/kg bw
Based on:
test mat.
Mortality:
All animales were maintend and observed for one month following observation of test materials. The time of death and any evidence of toxic effect were noted. Rats that died as a result of the adminstation of titantate were examined for evidence of toxic effects.
None of the rats died as a result of oral adminstration despite quite high dosage rates.
Clinical signs:
At the higher dosage levels with both routes of administration the rats were lethargic for the first few hours. Other findings on the high dosage levels were: reduced activity, temporary loss of appetite, and brownish colored discharge from the nose and eyes.
Rats that survived appeared normal at the end of one month.
Body weight:
Young adult male Wistar rats weighing 200 grams or more were used.
Body weight in the treated group after one month was the same as that for control animals.
Gross pathology:
Histologic study showed no specific changes .
There was evidence of inflammatory change in the liver, kidney, spleen, and lungs. There were also hemorrhagic areas noted in the kidneys

Any other information on results incl. tables

Table II

Acute Oral Toxicity

Ratio of Rats killed those treated at graduated dose levels

(grams of titanate compound per kilogram of body weigth)

Compound

Dose Level (gms/kg)

 

1,5

3,0

6,0

12,0

Barium Titanate

0/6

0/6

0/6

0/6

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 >5000 mg/kg bw. Hence, barium titanate need not be classified according to GHS.
Executive summary:

The minimal lethal doses by the oral route exceeds 12g/kg in the rat.