1,2-diethoxypropane

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19th August 1991 - 2nd December 1991

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,2-diethoxypropane

EC Number:

412-180-1

EC Name:

1,2-diethoxypropane

Cas Number:

10221-57-5

Molecular formula:

C7H16O2

IUPAC Name:

1,2-diethoxypropane

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- lot/batch No.of test material: 9059

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: The test material, a colourless liquid, was stored in the dark under ambient conditions.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Interfauna UK Limited, Abbots Ripton Road, Wyton, Huntingdon
- Age at study initiation: young adult
- Housing: The rabbits were housed individually in aluminium cages with grid floors beneath which were peat moss filled trays.
- Diet: Standard Rabbit Diet, supplied by Special DietsServices, 1 Stepfield, Witham, Essex, CM8 3AD ad libitum
- Water: tap water ad libitum
- Acclimation period: 11 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21°C
- Humidity (%): 60%
- Photoperiod (hrs dark / hrs light): A 12 h light/dark cycle was in operation

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

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

Duration of treatment / exposure:

The eye was not washed after treatment.

Observation period (in vivo):

1, 24, 48 and 72 h after instillation.

Number of animals or in vitro replicates:

3 males

Details on study design:

Approximately 24 h before test commencement; both eyes of the rabbits were examined and only animals with no ocular defects were used in the test.The rabbit was held firmly but gently and the test material placed into the right eye by gently pulling the lower eyelid away from the eyeball to form a sac into which the test material was dropped. The lids were then gently held together for one or 2 s. One rabbit was treated first and observed 1 h after instillation for signs of severe irritation. As none were noted, the remaining 2 rabbits were then treated the following day.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No

SCORING SYSTEM: The OECD Recommended Scoring System in OECD 405 was used.

TOOL USED TO ASSESS SCORE: The eyes were examined for irritation, using a hand held magnifier and pen torch (Pifco)

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

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24 h

Score:

1

Max. score:

3

Reversibility:

fully reversible

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal: 2,3

Time point:

other: 48/72 hrs

Score:

0

Max. score:

3

Results 5

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible

Results 6

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Details of reaction scores are given in the Table. No corneal or iridial responses were noted. Slight conjunctival redness and chemosis and a slight discharge were noted up to 24 h post instillation. Full recovery was noted in all treated eyes at 48 h post instillation.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an in vivo eye irritation study in New Zealand rabbits, the substance 1,2-Diethoxypropane is not irritating.

Executive summary:

In a primary eye irritation study (8281), 0.1mL of 1,2-Diethoxypropane (undiluted) was instilled into the conjunctival sac of the right eye of young adult New Zealand White rabbits (3 males). The eye was not washed after instillation of the test article. Animals were observed for 1 hr, 24 hr, 48 hr and 72 hrs after dosing. Irritation was scored by the method of Draize.

The following mean values, based on the results from the 24, 48 and 72 hour readings were calculated - cornea opacity: 0; iris lesion: 0; oedema of conjunctiva (chemosis): 0; redness of conjunctiva: 0.33 (fully revsersible).

In this study, 1,2-Diethoxypropane is not an eye irritant.