Sodium tetrahydroborate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)

Deviations:

no

GLP compliance:

yes

Test type:

up-and-down procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium tetrahydroborate

EC Number:

241-004-4

EC Name:

Sodium tetrahydroborate

Cas Number:

16940-66-2

Molecular formula:

BH4.Na

IUPAC Name:

Sodium tetrahydridoborate(1–)

Details on test material:

- Name of test material (as cited in study report): Venpure SF Powder
- Physical state: solid, powder
- Analytical purity: 99.2%
- Lot/batch No.: 1686951
- Expiration date of the lot/batch: June 12, 2008
- Storage condition of test material: room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ace Animals, Inc, Boyertown, Pennsylvania, USA
- Age at study initiation: 10-11 weeks
- Weight at study initiation: 196-229 g
- Fasting period before study: overnight
- Housing: one/cage in suspended stainless steel cages
- Diet (e.g. ad libitum): Purina rodent chow #5012
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 13-20 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-24 deg C
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light


IN-LIFE DATES: From: July 11, 2005 To: July 25, 2005

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: mineral oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25% w/w suspension

Doses:

32 and 100 mg/kg

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality, signs of gross toxicity, and behavioral changes during the first several hours post-dosing and at least once daily thereafter for 14 days after dosing or until death occurred.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Observations included gross evaluation of skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behavior pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhea, and coma.

Statistics:

Not reported

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

56.57 mg/kg bw

95% CL:

ca. 32 - ca. 100

Mortality:

All animals survived at 32 mg/kg.
All animals at 100 mg/kg died within three hours of administration.

Clinical signs:

other: No effects at 32 mg/kg. Incidence of hypoactivity, hunched posture, piloerection were observed prior to death at 100 mg/kg.

Gross pathology:

No gross abnormalities were observed at 32 mg/kg.
At 100 mg/kg, intestines were extremely red.

Other findings:

none

Applicant's summary and conclusion

Interpretation of results:

toxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral LD50 was determined to be 56.57 mg/kg.