3-Oxazolidineethanol, 2-(1-methylethyl)-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2007-11-30

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2008

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The rabbit enucleated eye test is used (in-house), as a first stage in the assessment of ocular irritancy potential. The preferred species of choice is the rabbit. The assay has undergone inter-laboratory validation and has been shown to reliably detect test materials that are negligible, or moderate to severe ocular irritants.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2-[2-(propan-2-yl)-1,3-oxazolidin-3-yl]ethan-1-ol

EC Number:

608-245-0

Cas Number:

28770-01-6

Molecular formula:

C8H17NO2

IUPAC Name:

2-[2-(propan-2-yl)-1,3-oxazolidin-3-yl]ethan-1-ol

Test material form:

other: liqiud

Test animals / tissue source

Species:

other: rabbit enucleated eye

Details on test animals or tissues and environmental conditions:

not applicable

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: two control enucleated eyes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 mL to the surface of the cornea

Duration of treatment / exposure:

10 sec

Duration of post- treatment incubation (in vitro):

60, 120, 180 and 240 minutes following treatment

Number of animals or in vitro replicates:

three enucleated eyes

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: 20 mL saline solution
- Time after start of exposure: 10 sec after substance application

SCORING SYSTEM: Rabbit enucleated eye test parameter

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein

Results and discussion

In vitro

Results

Results 1

Irritation parameter:

cornea opacity score

Run / experiment:

mean - 60/120/180/240 min

Value:

>= 4

Remarks on result:

other: not reversible; Exceeds cut-off value indicating severe ocular irritation

Results 2

Irritation parameter:

fluorescein leakage

Remarks:

uptake

Run / experiment:

mean - 60 min

Value:

>= 4

Remarks on result:

other: not reversible; Exceeds cut- off value indicating severe ocular irritation

Results 3

Irritation parameter:

percent corneal swelling

Remarks:

(%)

Run / experiment:

mean - 60 min

Value:

59.1

Remarks on result:

other: not reversible

Results 4

Irritation parameter:

percent corneal swelling

Remarks:

(%)

Run / experiment:

mean - 120 min

Value:

81.4

Remarks on result:

other: not reversible

Results 5

Irritation parameter:

percent corneal swelling

Remarks:

(%)

Run / experiment:

mean - 240 min

Value:

101

Remarks on result:

other: not reversible

Results 6

Irritation parameter:

other: condition of corneal epithelium

Remarks on result:

other: sloughing

Other effects / acceptance of results:

Moderate loss of corneal transparency was noted in all test eyes during the study period. No corneal effects were noted in the control eyes during the study period.
Corneal swelling of the test eyes during the study period was considerably greater than that observed in the control eyes over the same period. Sloughing of the corneal epithelium was noted in all test eyes during the study period. The condition of the corneal epithelium of the control eyes appeared normal during the study period. Fluorescein uptake was noted in the test eyes 240 minutes after treatment. No fluorescein uptake was noted in the control eyes 240 minutes after treatment.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

Following assessment of the in vitro eye corrosion test, the test material was considered to have the potential to cause severe ocular damage in vivo.

Executive summary:

A study was performed to assess the ocular irritancy potential of the test material in the rabbit following application onto the cornea of the enucleated eye. The results of the study are believed to be of value in predicting the ocular irritation potential of the test material in man.

0.1 mL of the test material was applied onto the cornea of each of three enucleated eyes which had been maintained at a temperature of 32 ± 1.5 °C within the superfusion chamber. A further two enucleated eyes were treated, for control purposes, with saline solution (0.9 % Sodium Chloride). 

Moderate loss of corneal transparency was noted in all test eyes during the study period. No corneal effects were noted in the control eyes during the study period. Corneal swelling of the test eyes during the study period was considerably greater than that observed in the control eyes over the same period. Corneal swelling of the test eyes during the study period was considerably greater than that observed in the control eyes over the same period. Fluorescein uptake was noted in the test eyes 240 minutes after treatment. No fluorescein uptake was noted in the control eyes 240 minutes after treatment. Following assessment of the data for all endpoints the test material was considered to have the potential to cause severe ocular damage in vivo.