Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-06-09 to 2008-06-25
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Liquid
Details on test material:
- Name of test material (as cited in study report): LCE08086
- Substance type: Lipoamino acid
- Physical state: liquid
- Analytical purity: 31% dry matter
- Purity test date: 2008-03-29
- Lot/batch No.: 0807000020
- Retest date of the lot/batch: 2011/03/10
- Stability under test conditions: stable
- Storage condition of test material: Room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Elevage de Gérome (Quartier Labaste– F40260 Linxe)
- Age at study initiation: 12 to 13 weeks
- Weight during the test: 2.53 kg and 3.22 kg
- Housing:
Each animal was kept in an individual box installed in conventional air conditioned animal
husbanding; the environmental conditions were:
- temperature : between 19°C and 23°C
- relative humidity : between 39% and 63%
- lighting time: 12 hours daily
- rate of air exchange: at least ten changes per hour
- Diet (e.g. ad libitum): supplied freely (foodstuff (SDS- C15)
- Water (e.g. ad libitum): supplied freely (tap-water from public distribution system)
- Acclimation period: minimal 5-day

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL of the test item was instilled, as supplied
Duration of treatment / exposure:
9 days
Observation period (in vivo):
1hour, 24, 48 and 72 hours following treatment
Number of animals or in vitro replicates:
Three female
Details on study design:
0.1 mL of the test item was instilled, as supplied, into the conjunctival sac of one eye. The other eye remained untreated serving as control.
Initially, a single animal was treated. After consideration of the ocular responses produced in the first treated animal at D7, two additional animals were treated

Ocular examinations were performed on both right and left eyes 1 hour, 24, 48 and 72 hours following
treatment, according to the numerical evaluation given below.
NOTE :
If no reaction is observed 72 hours after instillation, the study is terminated. In case of persistent reactions, additional
observations can be carried out from D4 to D21 in order to determine the reversible character of the lesions observed.


EVALUATION OF OCULAR IRRITATION
Eye examinations are carried out using the scale of lesion scores in the following order:

CHEMOSIS (A)
• No swelling ................................................................................................................................... 0
• Slight swelling, including the nictitating membrane................................................................1
• Swelling with eversion of the eyelid ...........................................................................................2
• Swelling with eyelid half-closed ................................................................................................. 3
• Swelling with eyelid more than half-closed .............................................................................. 4

DISCHARGE (B)
• No discharge ................................................................................................................................. 0
• Slight discharge (normal slight secretions in the inner corner not to be
taken into account) .......................................................................................................................... 1
• Discharge with moistening of the eyelids and neighbouring hairs....................................... 2
• Discharge with moistening of the eyelids and large areas around the eye ......................... 3

REDNESS (C)
• Blood vessels normal .................................................................................................................... 0
• Vessels significantly more prominent than normal ................................................................. 1
• Vessels individually distinguishable with difficulty
- Generalised red coloration........................................................................................................... 2
- Generalised deep red coloration ................................................................................................ 3

IRIS (D)
• Normal ............................................................................................................................................ 0
• Iris significantly more wrinkled than normal, congestion,
swelling of the iris which continues to react to light, even slowly............................................. 1
• No reaction to light, haemorrhage, significant damage
(any or all of these characteristics)................................................................................................ 2

CORNEA: DEGREE OF OPACITY (E)
• No modification visible either directly or after
instillation of fluorescein (no loss of glint or polish) .................................................................... 0
• Translucent areas (diffuse or disseminated), iris details clearly visible .................................. 1
• Easily identifiable translucent area, iris details slightly obscured............................................. 2
• Opalescent area, no iris details visible, pupil outline scarcely distinguishable ...................... 3
• Total corneal opacity, completely obscuring the iris and pupil................................................. 4

CORNEA: EXTENT OF OPACITY (F)
• Opaque area present but covering one quarter or less.............................................................. 1
• Between one quarter and half........................................................................................................... 2
• Between half and three quarters ..................................................................................................... 3
• Between three quarters and the entire surface.............................................................................. 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24;48 and 72h
Score:
ca. 1
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: Redness
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24;48 and 72h
Score:
ca. 2
Max. score:
2
Reversibility:
not reversible
Remarks:
within 72h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24;48 and 72h
Score:
ca. 0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24;48 and 72h
Score:
ca. 1.3
Max. score:
2
Reversibility:
fully reversible within: 72h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24;48 and 72h
Score:
ca. 1.3
Max. score:
2
Reversibility:
not fully reversible within: 72h
Remarks on result:
other: Redness
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24;48 and 72h
Score:
ca. 1.7
Max. score:
2
Reversibility:
not fully reversible within: 72h
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24;48 and 72h
Score:
ca. 0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24;48 and 72h
Score:
ca. 2
Max. score:
2
Reversibility:
not reversible
Remarks:
within 72h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24;48 and 72h
Score:
ca. 1.3
Max. score:
2
Reversibility:
not fully reversible within: 72h
Remarks on result:
other: Redness
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24;48 and 72h
Score:
ca. 1.7
Max. score:
2
Reversibility:
not fully reversible within: 72h
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24;48 and 72h
Score:
ca. 0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24;48 and 72h
Score:
ca. 1.7
Max. score:
2
Reversibility:
not fully reversible within: 72h
Irritant / corrosive response data:
The ocular reactions observed during the study have been moderate, and totally reversible in the three
animals:
- at the conjunctivae level: a moderate redness, noted 1 hour after the test item instillation and totally
reversible between D7 and D9, associated with a moderate chemosis, noted 1 hour after the test item
instillation and totally reversible between D3 and D4;
- at the corneal level: a moderate opacity, registered 24 hours after the test item instillation and totally
reversible between D3 and D7.

Applicant's summary and conclusion

Interpretation of results:
Category 2A (irritating to eyes) based on GHS criteria
Remarks:
Migrated information
Conclusions:
The results obtained, under these experimental conditions, enable to conclude that the test item
LCE08086:
- is moderately irritant for the eye (Max. O.I = 28) according to the classification established in the
Journal Officiel de la République Française dated July 10th, 1992.
- and, must not be classified according to the criteria for the classification, packaging and labelling of
dangerous substances in compliance with the E.E.C. Directive n° 67/548, 2001/59 and 99/45. No
symbol and risk phrase are required.
In accordance with the Globally Harmonized System (COM(2007)355 final), the test item must be
classified in category 2 “irritating to eyes”. The signal word “Warning” and hazard statement H319
“Causes serious eye irritation” are required.
Executive summary:

The test item LCE08086 was instilled as supplied, into the eye of three New Zealand rabbits at the dose of 0.1 mL. The experimental protocol was established on the basis of the official method as defined in the O.E.C.D. guideline n° 405 dated April 24th, 2002 and the test method B.5 of the directive 2004/73/EC. The ocular reactions observed during the study have been moderate, and totally reversible in the three animals: - at the conjunctivae level: a moderate redness, noted 1 hour after the test item instillation and totally reversible between D7 and D9, associated with a moderate chemosis, noted 1 hour after the test item instillation and totally reversible between D3 and D4; - at the corneal level: a moderate opacity, registered 24 hours after the test item instillation and totally reversible between D3 and D7. In conclusion, the results obtained, under these experimental conditions, enable to conclude that the test item LCE08086 must not be classified according to the criteria for the classification, packaging and labelling of dangerous substances in compliance with the E.E.C. Directive n° 67/548, 2001/59 and 99/45. No symbol and risk phrase are required. In accordance with the Globally Harmonized System (COM(2007)355 final), the test item must be classified in category 2 “irritating to eyes”. The signal word “Warning” and hazard statement H319 “Causes serious eye irritation” are required