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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12 April 2013 - 27 May 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
the animals were acclimated to the study conditions for a period of 4 days instead of at least 5 days.
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: breeder: CEGAV, Argenvilliers, France.
- Age at study initiation: 2 to 4 months old on the day of treatment
- Mean body weight at study initiation: 2590 g to 3130 g
- Fasting period before study: no
- Housing: individually housed in noryl cages
- Diet: 110 pelleted diet (free access)
- Water: tap water filtered with a 0.22 µm filter (free access)
- Acclimation period: for a period of 4 days before the beginning of the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3°C
- Humidity (%): 50 ± 20%
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12 h/12 h

IN-LIFE DATES: 14 May 2013 to 24 May 2013

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated right eye served as a control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL/animal
Duration of treatment / exposure:
Not applicable: single application followed by rinsing performed before 24-hour reading.
Observation period (in vivo):
1, 24, 48 and 72 h.
Number of animals or in vitro replicates:
Three males.
Details on study design:
REMOVAL OF TEST SUBSTANCE: Yes.

SCORING SYSTEM: Draize scale.

- Conjunctival chemosis (lids and/or nictitating membranes):
0 no swelling
1 any swelling above normal
2 obvious swelling with partial eversion of lids
3 swelling with lids about half-closed
4 swelling with lids more than half-closed

- Conjunctival redness (palpebral and bulbar conjunctivae, excluding the cornea and iris):
0 blood vessels normal
1 a number of blood vessels definitely hyperemic (injected)
2 diffuse, crimson colour, individual vessels not easily discernible
3 diffuse, beefy red

- Iris lesions
0 normal
1 markedly deepened rugae, congestion, swelling, moderate circum-corneal hyperemia, or injection, any or a combination of any there findings, but iris still reacting to light (sluggish reaction is positive)
2 no reaction to light, haemorrhage, gross destruction (any or all of these)

- Corneal intensity of opacity (direct examination and, if necessary, with an UV lamp)
0 no ulceration or opacity
1 scattered or diffuse areas of opacity (other than slight dulling or normal lustre), details of iris clearly visible
2 easily discernible translucent area, details of iris slightly obscured
3 nacreous areas, no details of iris visible, size of pupil barely discernible
4 opaque cornea, iris not discernible through the opacity

- Corneal area of opacity (direct examination and, if necessary, with an UV lamp)
1 one quarter (or less) but not zero
2 greater than one quarter but less than a half
3 greater than one half but less than three quarters
4 greater than three quarters up to whole area

- Any other lesions observed were noted

TOOL USED TO ASSESS SCORE: UV lamp after instillation of 0.5% sodium fluorescein solution

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
other: 3 rabbits
Time point:
other: 24, 48 and 72 h (mean)
Score:
0
Max. score:
4
Reversibility:
other: not applicabke
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
other: 3 rabbits
Time point:
other: 24, 48 and 72 h (mean)
Score:
0
Max. score:
3
Reversibility:
other: not applicabke
Irritation parameter:
iris score
Basis:
other: 3 rabbits
Time point:
other: 24, 48 and 72 h (mean)
Score:
0
Max. score:
2
Reversibility:
other: not applicabke
Irritation parameter:
cornea opacity score
Remarks:
(intensity)
Basis:
other: 3 rabbits
Time point:
other: 24, 48 and 72 h (mean)
Score:
0
Max. score:
4
Reversibility:
other: not applicabke
Irritant / corrosive response data:
In the left treated eye, slight chemosis and slight or moderate redness of the conjunctiva were observed in all animals on day 1.
Then, no ocular reactions were observed in any animals until the end of the observation period.
Other effects:
No unscheduled deaths occurred during the study and no clinical signs were noted in any animals.
The body weight of the animals was unaffected by the test item treatment.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the experimental conditions of this study, the test item was very slightly irritant when administered by ocular route to rabbits.
Therefore, the test item should not be classified as irritating to the eyes according to the criteria of CLP Regulation.


Executive summary:

The objective of this study was to evaluate the potential irritant properties of the test item for the eye following a single administration to rabbits.

This study was conducted in compliance with OECD Guideline No. 405 and the principles of Good Laboratory Practices.

The test item was first administered to a single male New Zealand White rabbit. As mean value from grading at 24, 48 and 72 hours after instillation was < 2 for conjunctival edema (chemosis) and for conjunctival redness and was < 1 for iris lesion and for corneal opacity, the test item was administered in the left eye of two other animals. The test item was administered inthe conjunctival sac of the left eye. The right eye remained untreated and served as control. A dosage-volume of 0.1 mL/animal was used. For all animals,a local anesthetic was used prior to treatment.

Before 24-hour reading, both eyes were rinsed with a sterile isotonic saline solution (0.9% NaCl).

Each animal was observed at least once a day for mortality and clinical signs. Ocular reactions were observed approximately 1, 24, 48 and 72 hours after the administration (i.e. until the end of the observation period). The mean values of the scores for chemosis, redness of the conjunctiva, iris lesions and corneal opacity were calculated for each animal. Body weight was recorded on the day of treatment and at the end of the evaluation of ocular reactions.

On completion of the observation period, the animals were sacrificed then discarded without macroscopic post-mortem examination.

 

Results

 

No unscheduled deaths occurred during the study and no clinical signs were noted in any animals.

The body weight of the animals was unaffected by the test item treatment.

In the left treated eye, slight chemosis and slight or moderate redness of the conjunctiva were observed in all animals on day 1. Then, no ocular reactions were observed in any animals until the end of the observation period.

 

Mean scores calculated for each animal over 24, 48 and 72 hours were as follows:

. chemosis: 0.0, 0.0 and 0.0; showing no significant eye irritation,

. redness of the conjunctiva: 0.0, 0.0 and 0.0; showing no significant eye irritation,

. iris lesions: 0.0, 0.0 and 0.0; showing no eye irritation,

. corneal opacity: 0.0, 0.0 and 0.0; showing no eye irritation.

 

Conclusion

Under the experimental conditions of this study, the test item was very slightly irritant when administered by ocular route to rabbits.

Therefore, the test item should not be classified as irritating to the eyes according to the criteria of CLP Regulation.