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

Endpoint summary

Description of key information

Oral: 300 mg/kg bw < LD50 < 2000 mg/kg bw (OECD 423)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

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

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

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

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

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

300 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2005-04-06 - 2005-05-20

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD guideline study according GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Swiss Federal Office of Public Health, 2003

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/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: 8 - 9 weeks (males), 11 – 12 weeks (females)
- Weight at study initiation: mean 248.1 g (males), mean 197.7 g (females)
- 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

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

Type of coverage:

semiocclusive

Vehicle:

polyethylene glycol

Details on dermal exposure:

TEST SITE
- Area of exposure: back
- % coverage: 10
- Type of wrap if used: semi-occlusive dressing wrapped around the body and fixed with adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with PEG 300, the dried with paper towel
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 mL/kg bw
- Concentration (if solution): 0.5 g/mL
- Constant volume or concentration used: yes

VEHICLE
- Amount(s) applied (volume or weight with unit): 4 mL/kg bw
- Lot/batch no. (if required): 1078164 12004034

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

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

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality during the study.

Clinical signs:

Slight general erythema in three animals on days 2 and 3 and in one animal on day 4.

Body weight:

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

Gross pathology:

No macroscopic findings.

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of Sodium triacetoxyborohydride for acute dermal toxicty was found to be >2000 mg/kg bw.

Executive summary:

Acute dermal toxicity of Sodium triacetoxyborohydride was evaluated in a GLP study performed according to OECD 402, where groups of five male and female female Wistar rats were treated with 2000 mg/kg bw in PEG300 under semi-occlusive conditions for 24 h, respectively. Based on the absence of clinical signs and mortality, the LD50 was found to be >2000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

Acute oral toxicity of Sodium triacetoxyborohydride was evaluated in a GLP acute 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.

Acute dermal toxicity of Sodium triacetoxyborohydride was evaluated in a GLP study performed according to OECD 402, where groups of five male and female female Wistar rats were treated with 2000 mg/kg bw in PEG300 under semi-occlusive conditions for 24 h, respectively. Based on the absence of clinical signs and mortality, the LD50 was found to be >2000 mg/kg bw.

Justification for selection of acute toxicity – oral endpoint
Reliable OECD guideline study according to GLP

Justification for selection of acute toxicity – dermal endpoint
Reliable OECD guideline study according to GLP

Justification for classification or non-classification

The available data on acute toxicity of the test substance meet the criteria for classification as Acute Tox. 4 (H302: Harmful if swallowed) according to Regulation (EC) 1272/2008.