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

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004-08-24 - 2004-10-28

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 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

only 1 animal was treated, remaining two animals were not treated due to severe effects

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

only 1 animal was treated, remaining two animals were not treated due to severe effects

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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne, France
- Age at study initiation: 11 weeks (female)
- Weight at study initiation: 2263 g
- 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

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

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

Duration of treatment / exposure:

Single application without washing

Observation period (in vivo):

21 days
Reading time points: 1, 24, 48 and 72 h and 7, 10, 14, 17 and 21 days

Number of animals or in vitro replicates:

1 female

Details on study design:

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

TOOL USED TO ASSESS SCORE: hand-slit lamp (Varta Cliptrix diagnostic lamp (Roth AG, CH-4135 Reinach, Switzerland)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: Mean 24, 48 and 72 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks:

within 21 days

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: Mean 24, 48 and 72 h

Score:

0.67

Max. score:

2

Reversibility:

fully reversible within: 17 days

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: Mean 24, 48 and 72 h

Score:

1.67

Max. score:

3

Reversibility:

not fully reversible within: 21 days

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: Mean 24, 48 and 72 h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 21 days

Irritant / corrosive response data:

Corneal opacity: very sligh to moderate from 1h to day 21
Iris: reduced light effect from 48 h to day 7 and on day 14. Absence of light reflex on day 10
Conjunctivy: sligh to moderate from 1h to day 21
Chemosis: marked swelling with half-closed lid or closed lid from1 to 72 h. Obvious swelling with partial eversion of lid up to day 21
Sclera: redding from 1 to 72 h, marked to slight redding from day 7 to 21
Discharge: marked from 48 to day 7

Other effects:

No cinical sings of systemic roxicity was observed and no mortality occured.

Any other information on results incl. tables

BAsed on the sever effects in the treated animl, no further animals were treated.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the effect on cornea and conjunctivae still persistent on day 21 at the end of observation period, Sodium triacetoxyborohydride was found to have irreversible effects on the eye.

Executive summary:

 Sodium triacetoxyborohydride was tested for irritating properties in a GLP study performed according to OECD 405. Since irritating effects were expected, 0.1 g of Sodium triacetoxyborohydride was instilled in the eye of only one New Zealand White rabbit. The mean scores for corneal opacity, iris, conjunctival erythema and chemosis were 2, 0.67, 1.67 and 4.0, respectively. In addition, the strong effects on cornea and conjunctivae still persistent on day 21 at the end of observation period, so that Sodium triacetoxyborohydride was found to have irreversible effects on the eye.