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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:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Regulations for the Enforcement of the Federal Hazardous Substances Act (revised Federal Register) 1964.
Deviations:
not specified
GLP compliance:
no
Remarks:
Study pre-dates GLP
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: Potassium tetraborate granular
- Physical state: White granular material with no appreciable odour

Test animals

Species:
rat
Strain:
not specified
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Industries
- Weight at study initiation: 208 to 262 g
- Fasting period before study: 18 h
- Housing: In groups in wire mesh cages suspended above the droppings.
- Diet: Ad libitum
- Water: Ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50 % w/v
Doses:
0.464, 1.00, 2.15, 4.64 and 10.0 g/kg bw.
No. of animals per sex per dose:
Five
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Frequently during the day of dosing; at least once daily thereafter.
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs; body weight at the end of the study
Statistics:
Statistical analysis of the mortality data was by the moving average method.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
3.69 other: g/kg
Based on:
test mat.
95% CL:
2.71 - 5.01
Mortality:
See table.
Clinical signs:
All of the rats at the 0.464 and 1.00 g/kg levels exhibited normal appearance and behaviour on the day of dosage and throughout the observation period.
Two rats at the 2.15 g/kg level exhibited mucoid diarrhoea on the day of dosage. On the first day post-dosage, three rats exhibited diarrhoea stains. On Day 2 and for the remainder of the study all rats appeared grossly normal.
At the 4.64 g/kg level on the day of dosage, all the rats exhibited depression and mucoid diarrhoea. On the first post-dosage day the surviving rats exhibited depression, depressed righting reflex , diarrhoea stains, hypothermia, laboured respiration and serosanguinous stains around the nose. On the second pos-dosage day the remaining rat exhibited emaciation and diarrhoea stains. The emaciation in this rat lasted through the 4th day post-dosage day, after which he exhibited normal appearance and behaviour.
Following sample administration, all rats at the 10.0 g/kg level exhibited depression and mucoid diarrhoea. Toxic signs increased in intensity and by the end of the working day the three surviving rats exhibited depression, depressed righting, placement and pain reflexes, ataxia, laboured respiration and mucoid diarrhoea. These rats were found dead in the morning of the first post-dosage day.
Body weight:
The weight gains for each group were within the normal limits for the rats of the age, sex and strain used.
Gross pathology:
Gross necropsies performed on all the rats that died revealed external evidence of diarrhoea in all of the rats and excessive salivation stains in three rats. Internally the majority of the rats showed congestion of the lungs, adrenals and kidneys; diffuse irritation of the entire gastrointestinal tract which contained a fluid resembling the sample,; irritation of the peritoneal walls; and evidence of autolytic alterations. The liver of one rat was pale.

Necropsies performed at termination revealed no significant gross pathological alterations.

Any other information on results incl. tables

Mortality during the 14 -day observation period; values are number of animals dead/number of animals tested:

Dose

g/kg

Time of death

Hours

Days

1

2

4

24

2

3

4

5

6

7-14

0.464

0/5

0/5

0/5

0/5

0/5

0/5

0/5

0/5

0/5

0/5

1.00

0/5

0/5

0/5

0/5

0/5

0/5

0/5

0/5

0/5

0/5

2.15

0/5

0/5

0/5

0/5

0/5

0/5

0/5

0/5

0/5

0/5

4.64

0/5

0/5

0/5

3/5

4/5

4/5

4/5

4/5

4/5

4/5

10.0

0/5

1/5

2/5

5/5

-

-

-

-

-

-

LD50, g/kg

3.69; 95 % confidence limits 2.71- 5.01 g/kg

Applicant's summary and conclusion

Interpretation of results:
toxic
Remarks:
Migrated information Criteria used for interpretation of results: other: Regulations for the Enforcememnt of the Federal Hazardous Substances Act, 1964.
Conclusions:
The acute oral toxicity of potassium tetraborate granular was evaluated in accordance with the techniques specified in the Regulations for the enforcement of the federal hazardous Substances Act (Revised Federal Register, 1964). The acute oral LD50 of the test substance in male albino rats was found to be 3.69 g/kg with 95 % confidence limits of 2.71 - 5.01 g/kg bw.
Based on these results, potassium tetraborate granular was classified as toxic by ingestion under the above cited regulations.