α-acetyl-γ-butyrolactone

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex 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:

2014

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU method B.48 (Isolated chicken eye test method for identifying occular corrosives and severe irritants)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

α-acetyl-γ-butyrolactone

EC Number:

208-235-2

EC Name:

α-acetyl-γ-butyrolactone

Cas Number:

517-23-7

Molecular formula:

C6H8O3

IUPAC Name:

3-acetyloxolan-2-one

Test animals / tissue source

Species:

other: chicken

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

30 µL

Duration of treatment / exposure:

10 seconds

Duration of post- treatment incubation (in vitro):

not applicable

Number of animals or in vitro replicates:

Three test item treated eyes, three positive control treated eyes and one negative control eye were examined during the study.

Details on study design:

NEGATIVE CONTROL USED : physiological saline (0.9% NaCl solution)

POSITIVE CONTROL USED : benzalkonium chloride solution (5%, w/v)

APPLICATION DOSE AND EXPOSURE TIME : 30 µl, 10 seconds

OBSERVATION PERIOD : at approximately 30, 75, 120, 180 and 240 minutes after the post-treatment rinse

REMOVAL OF TEST SUBSTANCE
- Volume and washing procedure after exposure period: the eyes were rinsed with 20 ml isotonic saline

Results and discussion

In vitro

Results

Results 1

Irritation parameter:

fluorescein retention score

Run / experiment:

mean

Value:

2.33

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Results 2

Irritation parameter:

cornea opacity score

Run / experiment:

mean

Value:

0.5

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Results 3

Irritation parameter:

percent corneal swelling

Run / experiment:

mean at up to 75 min

Value:

0

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Results 4

Irritation parameter:

percent corneal swelling

Run / experiment:

mean up to 240 min

Value:

0

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

None

Any other information on results incl. tables

Positive Control

Observation Value ICE Class*	Value ICE Class*	ICE Class*
Mean maximum corneal swelling at up to 75 min	0%	I
Mean maximum corneal swelling at up to 240 min	-7%	II
Mean maximum corneal opacity	3.50	IV
Mean fluorescein retention	2.83	IV
Other Observations	Loosening of epithelium was observed in two eyes (at 75 and 120 minutes after the post-treatment rinse)
Overall ICE Class*	2xI 1xIII

Negative Control

Observation Value ICE Class*	Value ICE Class*	ICE Class*
Mean maximum corneal swelling at up to 75 min	0%	I
Mean maximum corneal swelling at up to 240 min	0%	I
Mean maximum corneal opacity	0.00	I
Mean fluorescein retention	0.00
Other Observations	None
Overall ICE Class*	3xIII

Test item

Observation Value ICE Class*	Value ICE Class*	ICE Class*
Mean maximum corneal swelling at up to 75 min	0%	I
Mean maximum corneal swelling at up to 240 min	0%	I
Mean maximum corneal opacity	0.50	III
Mean fluorescein retention	2.33
Other Observations	None
Overall ICE Class*	2xI 1xIII

Applicant's summary and conclusion

Interpretation of results:

other: positive

Conclusions:

Based on this in vitro eye irritation test in isolated chicken eyes, the test item is not classified as severe irritant and not classified as non-irritant.

Executive summary:

The irritation effects of the test item were evaluated according to the OECD No. 438. After the zero reference measurements, the eyes were held in a horizontal position and the treatments (test item, positive, nagative controls) were applied onto the centre of the cornea such that the entire surface of the cornea was covered in all cases. After 10 seconds, the surface of the eyes was rinsed with isotonic saline solution. Corneal thickness, corneal opacity and fluorescein retention were measured and any morphological effects (e.g. pitting or loosening of the epithelium) evaluated.

The results from all eyes used in the study met the quality control standards. The negative control and positive control results were in good correlation with the historical control data. Thus, the experiment was considered to be valid.

Based on this in vitro eye irritation test in isolated chicken eyes, the test item is not classified as severe irritant and not classified as non-irritant.