Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
72 hours
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Modern GLP study conducted in accordance with modern guidelines

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Individual bodyweight data (at the start and end of the test) are not provided. The rationale for in vivo testing is not included in the study report
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Individual bodyweight data (at the start and end of the test) are not provided. The rationale for in vivo testing is not included in the study report.
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan France
- Age at study initiation: 12–20 weeks old
- Weight at study initiation: 2.0–3.5 kg
- Housing: Individually housed in suspended cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least five days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): set to achieve limits of 17–23 deg C
- Humidity (%): set to achieve limits of 30–70%
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light (06:00–18:00)


IN-LIFE DATES: From: 30 January 2008 To: 07 Febraury 2008

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye of each animal served as controls
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml weighing approximately 58 mg
Duration of treatment / exposure:
The test material was applied to the conjunctival sac and left to be removed by natural processes
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM:
Assessment of ocular damage/irritation was made according to the Draize scale

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 hour
Score:
ca. 9
Max. score:
10
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Score is equal to 2 x (sum of the scores for redness, chemosis and discharge)
Irritant / corrosive response data:
1-hour observation: Moderate conjunctival irritation was noted in all treated eyes.
24-hour observation: Minimal conjunctival irritation noted in all treated eyes
48-hour observation: Minimal conjunctival irritation noted in one treated eye; other two eyes appeared normal
72-hour observation: All treated eyes appear normal.
Other effects:
Immediately following administration of the test material to the conjunctival sac, Initial Pain Reaction (IPR) scores were '2' ('slight initial pain - rabbit blinks and tries to open eye, but reflex closes it') for each animal.

No other effects were reported.

Any other information on results incl. tables

There was no evidence of corneal opacity or iritis in any animal at any time point.

Level 2 conjunctival redness was seen in each treated eye at the 1-hour observation, decreasing to Level 1 conjunctival redness in each treated eye at the 24-hour observation, one treated eye at the 48-hour observation and no treated eyes at the 72-hour observation.

Level 2 conjunctival oedema (chemosis) was seen in one treated eye at the 1-hour observation, decreasing to Level 1 by 24 hours and zero by 48 hours. In the other two treated eyes, Level 1 chemosis was observed at the 1-hour observation, but was absent by the 24-hour observation.

The average conjunctival redness scores and the average conjunctival oedema scores (mean average of the 24, 48 and 72-hour observation scores) were each less than 2 in each animal.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information based on EU CLP Regulation 1272/2008 as amended Criteria used for interpretation of results: EU
Executive summary:

The test material was evaluated for ocular irritancy in a GLP study conducted according to OECD Test Guideline 405.

0.1 ml (approximately 58 mg) of test material was applied to the conjunctival sac of one eye of a New Zealand white rabbit. After consideration of the ocular responses produced, two additional rabbits were treated. The animals were observed for signs of ocular irritation 1, 24, 48 and 72 hours after treatment and scored according to the Draize scoring system. Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.

No corneal or iridial effects were noted. Moderate conjunctival irritation was noted in all three treated eyes one hour after treatment. Minimal conjunctival irritation was noted in all three treated eyes the 24-hour observation and persisted in one treated eye at the 48-hour observation. Two treated eyes appeared normal at the 48-hour observation and the remaining treated eye appeared normal at the 72-hour observation. Overall, the study authors concluded the test material to be a mild ocular irritant, based on a modified Kay and Calendra classification system, but using the CLP Regulation criteria no classification for eye irrritation is required.