Oxydipropanol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPP 81-4 (Acute Eye Irritation)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Oxydipropanol

EC Number:

246-770-3

EC Name:

Oxydipropanol

Cas Number:

25265-71-8

Molecular formula:

C6H14O3

IUPAC Name:

1,1-Oxydi-2-Propanol

Details on test material:

- Name of test material (as cited in study report): dipropylene glycol
- Physical state: clear viscous liquid
- Analytical purity: 100%
- Lot/batch No.: TB 41213-04-2
- Storage condition of test material: in the original container (blue metal can) at room temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: bred in the laboratory colony (Branchville)
- Age at study initiation: approximately 12 weeks
- Weight at study initiation: 2.0 to 2.1 kilograms
- Housing: housed individually under standard laboratory conditions in the study room
- Diet (e.g. ad libitum): Blue Seal Rabbit Feed, ID 1053 KLA, or equivalent, supplemented with oats if necessary
- Water (e.g. ad libitum): potable municipal water ad libitum
- Acclimation period: at least five days


ENVIRONMENTAL CONDITIONS
- Temperature: 68-74ºF
- Humidity (%): 35-65%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours on/12 hours off cycle

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

One eye of each animal was dosed with 0.1 ml of the test substance, while the other eye served as an untreated control.

Duration of treatment / exposure:

The eyes were not washed after instillation of the test substance unless, one hour later, the accumulation of debris/discharge interfered with eye examination and this was noted in the observations.

Observation period (in vivo):

All treated and control eyes were graded and scored at approximatly 1, 24, 48 and 72 hours. If positive ocular scores persisted at 72 hours, those eyes were re-examined on Day 4 using the same criteria and every three or four days thereafter, until the irritation became "not positive" or the healing was considered likely to be very prolonged.

Number of animals or in vitro replicates:

6 animals; 3 male, 3 female

Details on study design:

Twenty-four hours prior to dosing, both eyes of each rabbit were examined using a hand held ophthalmoscope and then by an ultraviolet light to detect fluorscein retentin. For this procedure one drop of Fluorescein Sodium Ophthalmic Solution USP was dropped onto the cornea and 10-15 seconds later it was washed away with tap water. The eyes were examined for dye retention. Only animals free of apparent ocular defects were selected for this study. At the time of dosing, the animal was held quiet and the lower lid was everted from the eyeball to form a cup into which the test substance was placed at the specified dose. The eyelids were then gently held together for one second. The eyes were not washed after instillation of the test substance unless, one hour later, the accumulation of debris/discharge interfered with eye examination and this was noted in the observations. Any reaction to the instillation of the test substance was noted. If any rabbit showed evidence of severe pain, the protocol required use of a local anesthetic, euthanasia of that animal, or termination of the test.
All treated and control eyes were graded and scored at approximatly 1, 24, 48 and 72 hours using the criteria established in the 'Illustrated Guide for Grading Eye Irritation by Hazardous Substances" which uses a modified Draize scoring method. A hand held ophthalmoscope or slit lamp was used to facilitate examination. In addition, at approximatly 24 and 72 hours, both eyes were examined using the fluorescein method as perviously described.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects at 24 h and thereafter

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: no effects at 24 h and thereafter

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: no effects at 24 hr and thereafter

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects at 24 hr and thereafter

Irritant / corrosive response data:

At one hour there was very slight irritation characterized by conjunctival redness (grade 1) in all eyes with two also showing chemosis (Grade 1). At 24 hours all eyes appeared normal and remained normal through 72 hours. At no time was there any corneal involvement and there was no corrosive effect on the eye.

Other effects:

No evidence of any systemic effect was observed. Immediately following application of the test substance to the dosed eyes there was no evidence of pain, such as prolonged blepharospasm, excessive struggling of vocalization.