.beta.-D-Ribofuranose, 5-deoxy-, 1,2,3-triacetate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20 September 2012 to 2 July 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Fully GLP compliant and in accordance with current test guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Acetylfuranoside

IUPAC Name:

Acetylfuranoside

Constituent 2

Reference substance name:

ß-D-Ribofuranose, 5-deoxy-, triacetate (6CI,9CI)

EC Number:

612-957-7

Cas Number:

62211-93-2

Molecular formula:

C11 H16 O7

IUPAC Name:

ß-D-Ribofuranose, 5-deoxy-, triacetate (6CI,9CI)

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Name: Acetylfuranoside (also known as ß-D-Ribofuranose, 5-deoxy-, 1,2,3-triacetate)
CAS number: 62211-93-2
Batch number: 201203272009
Quantity received: 1.2 kg
Purity: 98.7%
Expiry date: 31 Mar 2013
Date of receipt: 14 September 2012
Storage details: When not in use the test article was stored in a sealed container, at room temperature (15 to 30°C) in the dark.

Test animals / tissue source

Species:

other: Bovine

Details on test animals or tissues and environmental conditions:

Bovine corneas were supplied by a local abattoir. The eyes were removed after slaughter, completely immersed in Hanks’ Balanced Salt Solution (containing penicillin at 100 IU/mL and streptomycin at 100 µg/mL) in a suitably sized container and transported on the same day to the testing facility.
On arrival at the test facility the eyes were carefully examined for defects including increased opacity, scratches and neovascularisation. Only corneas free from such defects were used.

Test system

Vehicle:

other: 0.9% sodium chloride solution

Controls:

yes

Amount / concentration applied:

A volume of 750 µL of the test article formulation or, negative and positive control as applicable was applied to each of three corneas followed by a four hour incubation at 32°C. After this incubation, each cornea was washed with media containing phenol red (as a pH indicator) until this indicator showed no pH effect occurring (and demonstrating that the test article had been removed successfully). The corneas were then washed once in media without phenol red, the opacities measured and the anterior chamber emptied. For the permeability endpoint, 1 mL of sodium fluorescein (5 mg/mL solution) was added into the anterior chamber and the corneas were incubated in the vertical position for 1.5 hours ± 5 minutes. Following this period, the media in the posterior chamber was removed and held in a labelled tube. Three 350 µL aliquots of this media (per cornea) were analysed for optical density at 490 nanometers (OD490).
A volume of 750 µL of the negative or positive control was similarly applied to further groups of three corneas. These groups were subject to the procedures detailed above.

Duration of treatment / exposure:

Four hour incubation.

Details on study design:

Fresh corneas, mounted onto specifically designed holders were treated topically with the test material. Eye corrosion / severe irritation potential was based on the combined effect of the test article on the opacity of the cornea following the treatment and the cornea’s ability to resist penetration of a fluorescent dye through the tissue.

Results and discussion

In vitro

Results

Results 1

Irritation parameter:

cornea opacity score

Run / experiment:

1

Value:

>= 10.7 - <= 14

Results 2

Irritation parameter:

fluorescein leakage

Run / experiment:

1

Value:

>= 0.088 - <= 0.274

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: not specified

Conclusions:

The test article, Acetylfuranoside, produced an IVIS score of 11.98 and was not considered to be corrosive or severely irritating to the eye.
The assay acceptance criteria were met for the positive and negative control materials.

Executive summary:

This study was conducted to determine whether the test article causes corrosion or severe irritation to excised bovine corneas using the bovine corneal opacity and permeability (BCOP) assay.

A volume of 750 µL of the test article formulation was applied to each of three corneas followed by a four-hour incubation at 32°C. After this incubation, each cornea was washed with media containing phenol red followed by media without phenol red, the opacities measured and then the anterior chamber emptied. For the permeability endpoint, sodium fluorescein solution was added into the anterior chamber and the corneas were incubated in the vertical position for 1.5 hours ± 5 minutes. Following this period, the media in the posterior chamber was removed and three 350 µL aliquots of this media (per cornea) were analysed for optical density at 490 nanometers (OD₄₉₀).

A volume of 750 µL of the negative or positive control was similarly applied to further groups of three corneas. These corneas were subject to the procedures detailed above.

The mean opacity reading for the test article was 10.7, for the negative control was 0.0 and for the positive control was 56.3.

The mean group corrected optical density for the test article was 0.088, for the negative control was 0.0 and for the positive control was 0.910.

The assay acceptance criteria were met for the positive and negative control materials.

The test article, Acetylfuranoside, produced an IVIS score of 11.98 and was not considered to be corrosive or severely irritating to the eye.