2-Hydroxyethylmethacrylate, reaction products with proyleneoxide and Phthalic anhydride

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:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Details on test material:

-Purity: 100%

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: Young adult
- Weight at study initiation: 2277 - 2595 g
- Housing: The animals were individually housed in suspended stainless steel caging with mesh floors
- Diet: Harlan Teklad Global High Fiber Rabbit Diet® #2031. A designated amount of the diet was available to each rabbit (approximately 150 grams/day).
- Water: Filtered tap water was supplied ad libitum.
- Acclimation period: 5-6 days


ENVIRONMENTAL CONDITIONS
- Temperature: 19-22 C°C
- Humidity (%): 55-80%
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The other eye of each rabbit remained untreated with the test substance and served as a control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 mL

Duration of treatment / exposure:

Single administration

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3

Details on study design:

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

SCORING SYSTEM: Draize et al.

TOOL USED TO ASSESS SCORE: Ocular irritation was evaluated using a high-intensity white light. The fluorescein dye evaluation procedure was used in the treated eye at 24 hours to verify the absence of corneal damage.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

other: one rabbit showed a score of 1 at 1 hour

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

other: discharge

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

other: disharge (score of 1 or 2) was observed in all 3 animals at 1 hour

Irritant / corrosive response data:

No corneal opacity, iritis, or conjunctival chemosis was observed. Conjunctival redness (score of 1) was noted in the treated eye of one rabbit and discharge (scores of 1 or 2) was noted in the treated eye of all three rabbits. Irritation cleared in the treated eye of all rabbits by 24 hours.

Other effects:

All animals appeared active and healthy and gained weight during the study. No clinical signs were observed.

Any other information on results incl. tables

	Rabbit No.: 3401 (Female)				Rabbit No.: 3402 (Female)				Rabbit No.: 3403 (Female)
	Hour				Hour				Hour
	1	24	48	72	1	24	48	72	1	24	48	72
I. Cornea
A. Opacity	0	0^1	0	0	0	0^1	0	0	0	0^1	0	0
II. Iris
A. Values	0	0	0	0	0	0	0	0	0	0	0	0
III. Conjunctivae
A. Redness	0	0	0	0	0	0	0	0	1	0	0	0
B. Chemosis	0	0	0	0	0	0	0	0	0	0	0	0
C. Discharge	1	0	0	0	2	0	0	0	1	0	0	0

1 2% ophthalmic fluorescein sodium used to verify the absence of corneal opacity.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

No corneal opacity, iritis, or conjunctival chemosis was observed. Conjunctival redness (score of 1) was noted in the treated eye of one rabbit and discharge (scores of 1 or 2) was noted in the treated eye of all three rabbits. Irritation cleared in the treated eye of all rabbits by 24 hours.

Executive summary:

A primary eye irritation test was conducted with rabbits to determine the potential for the test substance to produce irritation from a single instillation via the ocular route. Initially, one-tenth of a millilitre of the test substance was instilled into the conjunctival sac of the right eye of one healthy rabbit by pulling the lower lid away from the eyeball. The upper and lower lids were then gently held together for about one second before releasing to minimize loss of the test substance. The left eye remained untreated and served as a control. Ocular irritation was evaluated by the method of Draize et al.. Since irritation cleared by 24 hours and there was no significant irritation observed in this animal, the test was completed on two additional animals, as described above.

No corneal opacity, iritis, or conjunctival chemosis was observed. Conjunctival redness (score of 1) was noted in the treated eye of one rabbit and discharge (scores of 1 or 2) was noted in the treated eye of all three rabbits. Irritation cleared in the treated eye of all rabbits by 24 hours.