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: Study according to OECD guideline 405 under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: powder

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: adult
- Weight at study initiation: 3.2 kg (average)
- Housing: single cage
- Diet (e.g. ad libitum): Altromin, Lage, ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C +/- 2°C
- Humidity (%): 50-60%
- Photoperiod (hrs dark / hrs light): 12 hours

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
72h
Observation period (in vivo):
Readings of eye alterations were made after 1, 2, 4, 8, 24, 48, 72 hours.
Number of animals or in vitro replicates:
3
Details on study design:
Before and after the test, the eyes of all animals were examined under UV. After weighing (16 hours starved) 0.1 g of the substance was applicated into the conjunctival pouch of the left eye. The right one stayed untreated and served as control.
The eye lesions were scored according to the system of Draize.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test substance was not removed


SCORING SYSTEM:
1. Cornea
a) Degree of opacity (A):
- No opacity (nor loss of brilliancy or lustre): 0
- Presence of an irritated area of diffused or disseminated appearance, details of the iris clearly visible: 1
- Presence of a translucid, irritated area easily identifiable, details of the iris slightly obscured: 2
- Presence of an opalescent, irritated area, details of the iris visible, outline of the pupil can scarcely be observed: 3
- Presence of opacity making the iris invisible: 4

b) Area of opacity (B):
- 1/4 (or less), but not zero: 1
- Between 1/4 and 1/2: 2
- Between 1/2 and 3/4: 3
- From 3/4 to the whole area: 4

The total mark is determined by multiplying the two scores by 5: A X B x 5 (maximum = 80)

2. Iris (C)
- Normal: 0
- Clearly more plicate than normal, congestion, swelling circumcorneal injection (one or several of these characteristics), iris still reacting to light (a slow reaction is a positive reaction): 1
- No reaction to light, heamorrhage, significant "destruction" (one, several or all of these characteristics): 2

The total mark is determined by multyplying the score by 5: C x 5 (maximum = 10)

3. Conjunctiva, Chemosis and Lacrimation
a) Conjuctiva (D):
- Reddening of the palpebral conjunctiva: vessels normal: 0
- Vessels clearly more injected than normal: 1
- Bright red colour, more diffuse, vessels difficult to distinguish: 2
- Diffuse blood red colour: 4

b) Chemosis (E):
- No swelling: 0
- Slight swelling, including the nictating membrane: 1
- Pronounced swelling, with inversion of the eyelid: 2
- Swelling with eyelids half closed: 3
- Swelling with eyelid closed more than half-way or completely closed: 4

c) Lacrimation (F):
- Absence: 0
- Slight lacrimation (do not take into account slight secretions normally in the inside corner): 1
- Lacrimation with moistening of the eyelids and hairs around the eyelids: 2
- Lacrimation with moistening of the eyelids and heirs on wide areas around the eye: 3

The total mark is determined by adding the three scores and multiplication of the sum by 2: (D + E + F) x 2 (maximum = 20)


TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
Some conjunctiva redness (up to scores of 2) and some lacrimation were observed in all rabbit until 8h after application
Other effects:
Body weights and body weight gains were normal in all animals.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results and according to the EC criteria for classification and labelling according to DSD (Directive 67/548/EEC) or GHS/CLP (Regulation (EC) No. 1272/2008), the test item does not have to be classified and has no obligatory labelling requirement as irritating to eyes.
Executive summary:

As no eye reaction were observed in a GLP study acc. to OECD guideline no. 405 at 24, 48 and 72 h,

the test item is considered as not eye irritating.