P-1401

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

3 August 2015 - 19 August 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

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:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Experimental Department of the National Research Institute of Animal Production in Balice near Kraków.
- Age at study initiation: 6-month-old
- Weight at study initiation: 2.9-3.6 kg
- Housing: Individually housed in metal cages (73 x 70 x 45 cm).
- Diet (e.g. ad libitum): ad libitum (LSK)
- Water (e.g. ad libitum): ad libitum (tap water)
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25 ºC
- Humidity (%): 50-90%
- Air changes (per hr): 16 times per hour
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light

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 (0.0680 g)

Duration of treatment / exposure:

1 hour

Observation period (in vivo):

14 days

Number of animals or in vitro replicates:

3 male rabbits

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test item was not removed from the eye by physiological mechanism, so the eye was rinsed with saline.
- Time after start of exposure: 1 hour.

SCORING SYSTEM:
Ocular lesions were graded according to OECD Guideline 405/EU Method B5.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: Mean 24-72 h

Score:

0

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: Mean 24-72 h

Score:

0

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: Mean 24-72 h

Score:

0

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: Mean 24-72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 24 h

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: Mean 24-72 h

Score:

0

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

other: Mean 24-72 h

Score:

0.7

Max. score:

1

Reversibility:

fully reversible within: 72 h

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: Mean 24-72 h

Score:

1.3

Max. score:

2

Reversibility:

fully reversible within: 7 d

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: Mean 24-72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 72 h

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: Mean 24-72 h

Score:

1.7

Max. score:

2

Reversibility:

fully reversible within: 7 d

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: Mean 24-72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 48 h

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: Mean 24-72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 48 h

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: Mean 24-72 h

Score:

1.3

Max. score:

2

Reversibility:

fully reversible within: 7 d

Other effects:

No other adverse effects were observed.

Any other information on results incl. tables

Evaluation of the animals’ ocular lesions:

Animal No.	Part of the eye		Readings after					Average 24-72 h
			1 h	24 h	48 h	72 h	7 d
1	Cornea		0	0	0	0	0	0.0
	Iris		1	1	0	0	0	0.3
	Conjuctiva	Erythema	3	2	1	1	0	1.3
		Swelling	2	1	0	0	0	0.3
2	Cornea		0	0	0	0	-	0.0
	Iris		0	0	0	0	-	0.0
	Conjuctiva	Erythema	2	2	1	0	-	1.0
		Swelling	2	1	0	0	-	0.3
3	Cornea		0	0	0	0	0	0.0
	Iris		1	1	1	0	0	0.7
	Conjuctiva	Erythema	3	2	2	1	0	1.7
		Swelling	3	2	1	1	0	1.3

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

CLP Implementation.

Conclusions:

The test item was determined to be not irritating to the eye in rabbits.

Executive summary:

The acute eye irritation/corrosion study was performed in albino New Zealand rabbits according to OECD Guideline 405 (GLP study). The test item in an amount of 0.068 g was applied to the conjunctival sac of one eye of one animal. The other eye, which remained untreated, served as a control. The animal was observed for 7 days. Following the examination of the treated eye, the test item was applied to the eyes of rabbits no. 2 and 3 to confirm the irritant or negative response. General clinical observations of the animals for morbidity and mortality were performed several times a day during the first 3 days, and twice a day on the remaining days of the experiment. Detailed clinical observations for changes in the cornea, iris, and conjunctiva were performed 1, 24, 48, and 72 hours and 7 days after the application. Body weights of the animals were determined on the application day (day 0), i.e. directly before the application, and on the last day of the experiment. After the observation period, the animals were euthanized. After application of the test item, changes in the iris of two rabbits and changes in the conjunctiva of three rabbits were stated (cornea scores = 0; iris scores <1, conjuctiva scores <2, chemosis scores <2). These changes were transient and fully reversible by day 7. The substance was determined to be not irritating to the eye.