Borate(1-), tris(acetato-.kappa.O)hydro-, sodium, (T-4)-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004-01-06 - 2004-03-29

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD guideline study according GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Swiss Federal Office of Public Health, 2003

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

435-580-8

EC Name:

-

Cas Number:

56553-60-7

Molecular formula:

C6H10BNaO6

IUPAC Name:

sodium bis(acetyloxy)boranuidyl acetate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Sodium triacetoxyborohydride
- Physical state: solid
- Analytical purity: 95%
- Lot/batch No.: LOT 30102
- Expiration date of the lot/batch: December 01, 2004
- Storage condition of test material: at room temperature at about 20°C, away from sunlight under nitrogen

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CRR Ltd., Laboratory Animal Services, CH-4414 Füllinsdorf, Switzerland
- Age at study initiation: 10 – 11 weeks
- Weight at study initiation: mean 175.7
- Housing: In groups of three in Macrolon type-4 cages with wire mesh tops and standard softwood bedding (“Lignocell”, Schill AG, CH-4132 Muttenz, Switzerland
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch No. 54/03 and 78/03 (Provimi Kliba AG, CH-4303 KAiseraugst, Switzerland); ad libitum
- Water (e.g. ad libitum): Community tap water from Füllinsdorf; ad libitum
- Fasting period before study: 15-19 h
- Acclimation period: not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 0.2, 0.03 g/mL
- Amount of vehicle (if gavage): 10 mL/kg
- Lot/batch no. (if required): 45256603

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: based on previous non-GLP study

Doses:

300 and 2000 mg/kg bw

No. of animals per sex per dose:

300 mg/kg bw: 6 females
2000 mg/kg bw: 3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for mortality /viability daily during acclimatization and twice daily during day 1-5; observation for clinical signs daily during acclimatization and approx. 0, 1, 2, 3 and 5 h after administration, once during days 2-15; weighing on day 0 prior to administration, days 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 300 - < 2 000 mg/kg bw

Based on:

test mat.

Mortality:

All animals of the high dosage group were found dead 50 min - 60 min after administration and on day 2, respectively. All animals of the low dose groups survived.

Clinical signs:

2000 mg/kg bw: Moderate salivation, ruffled fur, sedation, ventral, recumbency, hunched posture, bluish discoloured feets and tail (only in 1 animal)
300 mg/kg bw: No clinical signs

Body weight:

All body weight were in normal range common for this strain.

Gross pathology:

2000 mg/kg bw: distended stomach with gas, discoloured left lateral lobe of liver, partly black forestomach and spleen, dark- red to black small intestine, pale to yellow discoloured kidneys
300 mg/kg bw: No macroscopic findings

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of Sodium triacetoxyborohydride was found to be >300 and < 2000 mg/kg bw in female rats.

Executive summary:

Acute oral toxicity of Sodium triacetoxyborohydride was evaluated in a GLP study performed according to OECD 423, where groups of female Wistar rats were administered with 300 ad 2000 mg/kg bw in corn oil, respectively. Based on mortality and clinical signs observed in the high dose group, the LD50 was found to be >300 and < 2000 mg/kg bw.