3-ethyloxetane-3-methanol

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

not specified

Principles of method if other than guideline:

Not relevant

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-ethyloxetane-3-methanol

EC Number:

221-254-0

EC Name:

3-ethyloxetane-3-methanol

Cas Number:

3047-32-3

Molecular formula:

C6H12O2

IUPAC Name:

(3-ethyloxetan-3-yl)methanol

Specific details on test material used for the study:

- Name of test material (as cited in study report): TPM oxetane, 2-ethyl-2-hydroxylmethyl oxetane
-CAS 3047-32-3
- Physical state: Colourless liquid.
- Analytical purity: No information provided.
- Purity test date: No information provided.
- Lot/batch No.: No information provided. JNS 980121 F 1-3
- Stability under test conditions: No information provided.
- Storage condition of test material: Stored in a refrigerator at 2 - 8°C in the dark.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, Stolzenseeweg 32-36, D-88353 Kisslegg, Germany.
- Age at study initiation: No information provided.
- Weight at study initiation: 2.8kg
- Housing: Individually housed in PPO/HIPS cages (floor area of 2576 cm2) with perflorated floor.
- Diet (e.g. ad libitum): A pelleted complete rabbit diet (Altromin 2123) was available ad libitum.
- Water (e.g. ad libitum): Free access to bottles with domestic quality drinking water acidified with hydrochloric acid to pH 2.5 to prevent microbial growth.
- Acclimation period: At least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 55% ± 15%
- Air changes (per hr): 10 air changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark.

IN-LIFE DATES: From: 4th May 1998 To: 18th May 1998

Test system

Vehicle:

not specified

Controls:

other: Untreated eye acted as control.

Amount / concentration applied:

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

Duration of treatment / exposure:

Single exposure.

Observation period (in vivo):

14 days.

Number of animals or in vitro replicates:

One

Details on study design:

0.1ml of the test article was placed in the left eye of the rabbit by gently pulling the lower lid away from the eyeball to form a cup into which the article was dropped. The lids were then gently held together for 1 second. The eye was examined and the grade of ocular reaction was recorded 1 and 24 hours later. After the 24 hour reading, Fluorescein was instilled. After rinsing with 20ml 0.9% sodium chloride solution the eye was examined again using UV light to detect possible corneal damage. The eye was also examined 48 and 72 hours as well as 7 and 14 days after treatment. Because of the corneal damage observed at the 24 hour examination, fluorescein was also used at subsequent examinations.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No information provided.
- Time after start of exposure: No information provided.

SCORING SYSTEM: Scored between 1 and 4.

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

opacity

Basis:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 14 days.

Results 2

Irritation parameter:

iris score

Remarks:

lesion

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: Not applicable.

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 14 days.

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 14 days.

Irritant / corrosive response data:

Marked signs of conjunctival irritation (chemosis, redness and discharge) were observed 1 hour to 7 dys after termination of exposure. Cornea showed diffuse opacity during the same period. From 1 to 72 hours after termination of exposure, superficial damage to more that 2/3 of the cornea was observed when oculoguttae fluoresceini was installed. At the 7 day reading, the suoperficial damage only involved 1/4 of the eye.

Other effects:

No other abnormalities were observed after 14 days.

Any other information on results incl. tables

No additional information.

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study, TPM oxetane was found to be irritating to the eyes and meets the criteria for clasification as an eye irrtant.

Executive summary:

The eye irritant effect of TMP oxetane was investigated in rabbit eye. One albino rabbit was exposed to 0.1ml of the test material in the left eye. The eye was examined and the changes were graded according to a numerical scale 1, 24, 48 and 72 hours as well as 7 and 14 days after dosing. Marked signs of corneal and conjunctival irritation were observed in the rabbit 1 hour to 7 days after termination of exposure. On day 14, no abnormalities were observed in the rabbit. The following mean values based on the 24, 48 and 72 hour readings are 1.0 for corneal opacity, 0 for iris lesions, 3.0 for conjunctiva oedema and 3.0 for conjunctival redness. Under the conditions of this study, TMP oxetane was found to be irritating to the eyes and meets the criteria for classification as an eye irritant.