Registration Dossier

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:
other: This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Remarks:
The study was conducted according to guideline in effect at time of study conduct.
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
Remarks:
The study was conducted according to guideline in effect at time of study conduct.
GLP compliance:
yes

Test material

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

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
Animal 1-3
Time point:
other: Calculated from the 24-, 48-,and 72-hour scores
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: Calculated from the 24-, 48-,and 72-hour scores
Score:
0.33
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: Calculated from the 24-, 48-,and 72-hour scores
Score:
1.33
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: Calculated from the 24-, 48-,and 72-hour scores
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:
other: not classified as an irritant
Remarks:
Criteria used for interpretation of results: other: Directive 67/548/EEC and Globally Harmonized System (GHS)
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.

The study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).
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. In accordance with the provisions of Directive 67/548/EEC, classification is not required based on the results of this study. According to the Globally Harmonized System (GHS) of classification and labelling of chemicals and under the conditions of this study, classification is not required.