Dipotassium tetraborate

Acute Toxicity: oral

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

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

Test material information

Constituent 1

Reference substance name:

potassium tetraborate

IUPAC Name:

potassium tetraborate

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 or test system 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:

other: see Remark

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.

Other findings:

The body weight gains for each group were within the normal limits for the rats of the age, sex and strain used.

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:

other: EU GHS criteria not met

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.