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

Acute Toxicity: dermal

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

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

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: 98%
- Lot/batch No.: STAB50104
- Expiration date of the lot/batch: January 04, 2006
- Storage condition of test material: at room temperature at about 20°C, protected from light and moisture under nitrogen

Test animals

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

Administration / exposure

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

Results and discussion

Effect levels

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.

Applicant's summary and conclusion

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.