5-thiazolylmethanol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11 April - 31 August, 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was conducted according to OECD and in accordance with GLP. The study material is well characterized

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

92/69/EEC

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

5-thiazolylmethanol

EC Number:

414-780-9

EC Name:

5-thiazolylmethanol

Cas Number:

38585-74-9

Molecular formula:

C4H5NOS

IUPAC Name:

(1,3-thiazol-5-yl)methanol

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Seven male rabbits from Charles River, Montreal weighing 2- 3 kg (10 to 15 weeks) on arrival were allowed to acclimatise for 13 days before treatment. 6 animals were assigned to the study. 100 -130g Certified High Fibre Rabbit Chow was provided each day and water ad libitum. The temperature was maintained at 64 - 68°F. The animal room was on a 12 hour daily light cycle.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: other: right eye of each animal was untreated

Amount / concentration applied:

0.1ml

Duration of treatment / exposure:

0.1ml test material was placed in the conjunctival sac of the left eye and gently pulling the lower eye lid away from the eyeball. The upper and lower eyelid were held closed for about one second after treatment to prevent loose of material and then released. The right eye was left untreated to serve as the control.

Observation period (in vivo):

After the 24hr observation period the eyesof all rabbits were washed with lukewarm water.
All animals were observed daily for signs of ill health or toxicity.

Number of animals or in vitro replicates:

6 male rabbits

Details on study design:

On the day prior to treatment the eyes were checked by a veterinarian.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 1,24, 48,72 hours and day 4,7,14,21

Score:

0.8

Max. score:

1

Reversibility:

fully reversible within: day 21

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 1,24, 48,72 hours and day 4,7,14,21

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 1,24, 48,72 hours and day 4,7,14,21

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 21 days

Remarks on result:

other: value at end of observation period 2

Results 4

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

other: 1, 24, 48, 72 hours and day 4, 7, 14, 21

Score:

1.6

Max. score:

3

Reversibility:

not fully reversible within: day 21

Remarks on result:

other: value at end of observation period 2

Other effects:

Scattered or difuse areas of corneal capacity were observed in all six rabbits. However, the corneal opacity was reversible in all rabbits on or before day 21.
Severe chemosis and discharge were noted in the eyes in all rabbits by one hour of instillation of the test material. Also, various degrees of conjunctival redness were observed in the treated eyes of rabbits during the observation period following treatment. Complete recovery of the treated eye from occular irritation was observed in two rabbits by day 7, in a third rabbit by day 14 and in a forth rabbit by day 21. In the remaining two rabbits, some mild occular irritation persisted in the treated eye on the day of the final observation (day 21).

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Abbott-87440 was found to be irritating to the eyes of rabbits in this study.

Executive summary:

Scattered or difuse areas of corneal capacity were observed in all six rabbits. However, the corneal opacity was reversible in all rabbits on or before day 21.

Severe chemosis and discharge were noted in the eyes in all rabbits by one hour of instillation of the test material. Also, various degrees of conjunctival redness were observed in the treated eyes of rabbits during the observation period following treatment. Complete recovery of the treated eye from occular irritation was observed in two rabbits by day 7, in a third rabbit by day 14 and in a forth rabbit by day 21. In the remaining two rabbits, some mild occular irritation persisted in the treated eye on the day of the final observation (day 21).