Sodium metaborate, anhydrous

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

No data

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1963

Report date:

1963

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Regulations to the Federal Hazardous Substances Labelling Act.

Deviations:

not specified

GLP compliance:

no

Remarks:

Substance pre-dates GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium metaborate tetrahydrate

EC Number:

600-663-1

Cas Number:

10555-76-7

Molecular formula:

NaBO2*4H2O

IUPAC Name:

Sodium metaborate tetrahydrate

Details on test material:

- Name of test material: 8 mol sodium metaborate
- Physical state: White crystalline solid with no niticeable odour.
- Analytical purity: Equivalent to 101 %

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dublin Laboratory Animals.
- Weight at study initiation: 210 to 258 g males
- Fasting period before study: 18 h
- Housing: Housed in groups in ire mesh cages suspended above te droppings.
- Diet: Ad libitum
- Water: Ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

No data

Doses:

Actual dose levels of 0.213, 0.459, 0.990, 2.13, 4.59 and 9.90 g/kg of bw.
On a corrected basis these doses are equivalent to 0.215, 1.0, 2.15, 4.64 and 10 g/kg respectively.

No. of animals per sex per dose:

5 males

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs

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:

2.33 other: g/kg

Based on:

test mat.

95% CL:

1.6 - 3.39

Remarks on result:

other: Corrected basis

Mortality:

Deaths occurred at 2.15, 4.64 and 10.0 g/kg dose groups.

Clinical signs:

other: see Remark

Gross pathology:

Gross autopsies performed on the rats which died showed congested lungs, kidneys and adrenals and severe irritation of the gastrointestinal tract. Additional findings noted consistently among the rats at the 10.0 mg/kg dosage level included small haemorrhagic areas present in the mucosal layer of the pyloric portion of the stomach and in the intestinal tract.
Gross autopsies performed on the surviving rats at termination showed all organs to be within normal limits.

Other findings:

The average body weight gain for each group was within the normal range of values for rats of the sex, age and strain used in this study.

Any other information on results incl. tables

Mortality results during the 14-day observation period are presented below. Values are numbers of animals dead/number of animals tested, cumulative.

Dose (g/kg)	Time of death
	Hours				Days
	1	2	4	24	2	3	4	5	6	7
0.215	0/5	0/5	0/5	0/5	0/5	0/5	0/5	0/5	0/5	0/5
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	2/5	2/5	2/5	2/5	2/5	2/5	2/5
4.64	0/5	2/5	2/5	5/5
10.0	0/5	2/5	4/5	5/5

Applicant's summary and conclusion

Interpretation of results:

other: EU GHS criteria not met

Conclusions:

The acute oral toxicity of 8 mol sodium metaborate was evaluated in male albino rats in accordance with the technique specified in the Regulations to the Federal Hazardous Substances Labelling Act. The acute oral LD50 was found to be 2.33 g/kg bw with 95 % confidence limits from 1.60 to 3.39 g/kg. On the basis of these result, 8 mol sodium metaborate was classed as toxic by ingestion.