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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004-07-27 - 2004-09-21

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 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Swiss Federal Office of Public Health, 2003

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:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne, France
- Age at study initiation: 13 weeks (males), 11 weeks (females)
- Weight at study initiation: 2306 g (male), 2398 g and 2335 g (females)
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bottles. Wood blocks (RCC Ltd., Füllinsdorf) and haysticks 4642 (batch no. 15/04, Provimi Kliba AG) were provided for gnawing
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet batch no. 33/04 (Provimi Kliba AG, CH-4303 Kaiseraugst, Switzerland); ad libitum
- Water (e.g. ad libitum): Community tap water from Füllinsdorf; ad libitum
- Acclimation period: Under laboratory conditions after health examination

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 /12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

4

Observation period:

14 days
Reading time points: 1, 24, 48 and 72 h and 7, 10 and 14 days

Number of animals:

1 male, 2 females

Details on study design:

TEST SITE
- Area of exposure: 10x10 cm of left flank
- Type of wrap if used: Surgical gauze patch (4x4 cm) covered with semi-occlusive dressing warpped around the abdomen

REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm tap water
- Time after start of exposure: 4 h

SCORING SYSTEM:
According to EEC Commision Directive 2004/73/EC, April 29, 2004

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: mean 24, 48 and 72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: mean 24, 48 and 72 h

Score:

1.67

Max. score:

2

Reversibility:

fully reversible within: 10 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: mean 24, 48 and 72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

other: mean 24, 48 and 72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Irritant / corrosive response data:

The animal with moistened skin prior to application showed very slight to well-defined erythema from 24h to day 7. Scaling was obserevd in this animal up to day 10. The other animals showed only very slight effcets 1 hour after application, which were completely reversibkle within 24 h.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Sodium triacetoxyborohydride was found to be not irritating to skin based on the mean erythema scores of 0, 1.67 and 0, and the edema scores of 0 after 24,48 and 72 h in the three treated rabbits, respectively.

Executive summary:

Sodium triacetoxyborohydride was tested for irritating properties in a GLP study performed according to OECD 404. 0.5 grams of Sodium triacetoxyborohydride was applied to the skin of three New Zealand White rabbits for 4 h under semi-occlusive conditions and the sites were evaluated for effects for 14 day. The mean erythema and edema scores after 24,48 and 72 h in the three rabbits were 0, 1.67, 0 (erythema) and 0 (edema), respectively. Thus, Sodium triacetoxyborohydride was found to be not irritating to skin.