Boron, (acetonitrile)trifluoro-, (T-4)-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1997

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Acetonitrile

EC Number:

200-835-2

EC Name:

Acetonitrile

Cas Number:

75-05-8

Molecular formula:

C2H3N

IUPAC Name:

acetonitrile

Details on test material:

- Name of test material (as cited in study report): Acetonitrile HPLC Grade

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Each rabbit was identified by Monel® metal ear tag bearing the individual animal number.

TEST ANIMALS
- Source: Covance Research Products, Inc., Kalamazoo, MI.
- Age at study initiation: approximately 8 months of age.
- Weight at study initiation: 3393 - 3623 g
- Housing: animals were housed in individual stainless steel slatted floor cages
- Diet: Certified Rabbit Chow® #5322, PMI Feeds, Inc., St. Louis, Missouri, was limited upon arrival and then available up to 125 g/day.
- Water: ad libitum.

ENVIRONMENTAL CONDITIONS
- Temperature: 66-70 F (18.9 - 21.1 °C)
- Humidity: 55-70%
- Photoperiod: 12 hours light and 12 hours dark

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: control was opposite eye of animal.

Amount / concentration applied:

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

Duration of treatment / exposure:

The test article was administered into the cupped conjunctiva sac of the right (test) eye of each rabbit and the eyelid was then gently held together for 1 second before release.

Observation period (in vivo):

Scoring was conducted according at 1, 24, 48, and 72 hours after dosing, as well as 4, 7, 14, and 21 days after dosing.

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eyes remained unwashed.

SCORING SYSTEM: Draize Scoring Method at 1, 24, 48, and 72 hours after dosing, as well as 4, 7, 14 and 21 days after dosing (study days 5, 8, 15, and 22, respectively). A sodium fluorescein examination was conducted after scoring at the 24 hour, 72 hour, and day 7, 14, and 21 post-dose intervals.

TOOL USED TO ASSESS SCORE:
- Sodium fluorescein examinations were conducted after scoring at the 24 hour, 72 hour, and 7,
14, and 21 day post-dose intervals.
- The treated (right) eyes and control (left) eyes of all animals were examined with the aid of a penlight.

Results and discussion

In vivo

Results

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

other: 24 hours post-dose

Score:

31 - 61

Max. score:

46

Reversibility:

not fully reversible within: 21 days

Irritant / corrosive response data:

All animals displayed ocular irritation at 1 hour post-dose, continuing to day 21 post-dose in 4 of 6 animals, with the eyes of 2 animals returning to normal by day 14 or 21 post-dose. Diffuse beefy red conjunctival color was observed in all animals, with obvious swelling, partially everted lids, and considerable discharge around the eye. Blanching and petechiae was observed in all animals. The conjunctivae of 2 animals returned to normal by day 7 or 14 post-dose, while the remaining animals continued to exhibit slight to diffuse redness, slight swelling, and slight discharge at study termination.

Diffuse to easily discernible corneal opacity, covering more than ¾ of the area in some animals, was observed in all animals. Corneal opacity cleared in 3 animals by day 7 or 14 post-dose, but diffuse opacity continued to day 21 post-dose in the remaining animals. Corneal vascularization was observed in 3 of 6 animals. Slight iris irritation was observed in all animals, clearing by 48 hours (1 animal) and 7 or 14 days post-dose.

Other effects:

No other signs of toxicity or ill health were observed.

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU