Lecithins, acetylated

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:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Lecithins, acetylated

EC Number:

293-316-5

EC Name:

Lecithins, acetylated

Cas Number:

91053-50-8

Molecular formula:

Not applicable- complex UVCB substance

IUPAC Name:

91053-50-8

Details on test material:

Purity: Unknown variable composition biological substance (UVCBS)
Composition of test material, percentage of components: Unknown variable composition biological substance (UVCBS)

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: 2132-2717 g
- Housing: Singly in suspended, stainless steel, wire-mesh cages
- Diet (e.g. ad libitum): Not reported
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 or 12 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23 ºC
- Humidity (%): 61-73%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light):12 hour light/dark cycle

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The left eye of each rabbit was not treated and served as a control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): undiluted

Duration of treatment / exposure:

Single exposure

Observation period (in vivo):

1, 24, 48, and 72 hours and/or at 4 days post-instillation.

Number of animals or in vitro replicates:

3 animals: 2 male, 1 female

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eyes remained unwashed.

SCORING SYSTEM: Draize scale

TOOL USED TO ASSESS SCORE: Ocular irritation was evaluated using a high-intensity white light (Mag Lite)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0.33

Max. score:

2

Reversibility:

fully reversible

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

1.33

Max. score:

3

Reversibility:

fully reversible

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible

Irritant / corrosive response data:

Corneal opacity was evident in two treated eyes at one hour after dosing, and all three treated eyes exhibited iritis and conjunctivitis. All animals were free of ocular irritation by Day 4. See Table 1 for complete rabbit scores

Any other information on results incl. tables

Table 1: Individual Scores for Ocular irritation

	Rabbit No.:3401 (male)					Rabbit No.:3402 (male)				Rabbit No.:3403 (female)
	Hours					Hours				Hours
	1	24	48	72	4 days	1	24	48	72	1	24	48	72
I. Cornea
A. Opacity	1	0	0	0	0	1	0	0	0	0	0	0	0
B. Area	4	4	4	4	4	4	4	4	4	4	4	4	4
II. Iris
A. Values	1	1	0	0	0	1	0	0	0	1	1	0	0
III. Conjunctivae
A. Redness	2	2	1	1	0	2	1	1	0	2	2	1	0
B. Chemosis	1	1	0	0	0	1	0	0	0	1	1	0	0
C. Discharge	2	1	1	1	0	1	1	0	0	2	1	1	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

not classified as an irritant

Conclusions:

Corneal opacity was evident in two treated eyes at one hour after dosing, and all three treated eyes exhibited iritis and conjunctivitis. All animals were free of ocular irritation by Day 4.

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. The study was conducted in a stepwise fashion. Initially, 0.1 mL 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. Since irritation cleared by Day 4 and there was no significant irritation observed in this animal, the test was completed on two additional animals, as described above. Corneal opacity was evident in two treated eyes at one hour after dosing, and all three treated eyes exhibited iritis and conjunctivitis. All animals were free of ocular irritation by Day 4. According to the Globally Harmonized System (GHS) of classification and labelling of chemicals and under the conditions of this study, classification is not required.