Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Batch number: sample no.1
- Purity: 90.5 %
- Before the treatment, the test substance was stored at -20°C and protected from light and was stored at +4 °C during the treatment
- The pH of the test substance specified in the test article description was between 5 and 7.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Sex: male
- Source: Elevage Cunicole de Val de Selle (80160 Prouzel, France)
- Age: no data
- Weight at study initiation: 2.6 ± 0.1 kg
- Controls: untreated right eye

ENVIRONMENTAL CONDITIONS
- Temperature : 20 ± 3°C
- Humidity : 50 ± 20% relative humidity
- Light/dark cycle: 12 hours of light/12 hours of dark
- The air was non-recycled and filtered by absolute filters.
- Food and water: ad libidum
- The animals were individually housed in polystyrene cages

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
- A single dose of 0.1 ml of the undiluted test substance in its original form was instilled into the conjunctival sac of the left eye of 3 animais after gently pulling the lower lid away from the eyeball. The lower and upper eyelids were held together for several seconds to avoid any loss of the test substance. The right eye, which remained untreated, served as a control.
- The eyes were not rinsed after administration of the test substance.
Observation period (in vivo):
4 days
Number of animals or in vitro replicates:
3
Details on study design:
EXAMINATIONS:
- Ophthalmoscopic examination: Yes
- Scoring system: Draize's scale
- Observation period: 1h, 24h, 48h and 72h after administration of the test substance
- Tool used to assess score: fluorescein:
To determine the presence or absence of corneal opacification and to evaluate the affected area, one or 2 drops of sodium fluorescein 0.5% solution can be instilled in the eye (however this must be performed after a period of 24 hours). If corneal opacification is difficult to determine, the eye can be examined under a U.V. lamp (a clear fluorescence is visible in the areas of opacification).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
Slight (score of 1) conjonctival (chemosis, redness) reactions were observed in all animals one hour after instillation. No occular reactions remained after 24, 48 and 72 hours.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Under the experimental conditions, the substance was not irritating to eyes in rabbits.
Executive summary:

The eye irritation potential of the substance was assessed in an in vivo test (OECD 405, GLP). Having confirmed that the test substance had an irritant effect when administered by cutaneous route, the study began with one animal. Then, the results were confirmed with 2 additional animais. A single dose of 0.1 ml of the test substance in its original form was instilled into the conjunctival sac of the left eye of 3 male New Zealand White rabbits. The eyes were not rinsed after instillation of the test substance. The ocular reactions were observed one hour, 24, 48 and 72 hours after the instillation. The mean score of the scores recorded after 24, 48 and 72 hours for each animal was calculated. Slight (score of 1) conjonctival (chemosis, redness) reactions were observed in all animals one hour after instillation. No ocular reactions remained after 24, 48 and 72 hours. Therefore the test substance is considered as ion-irritant when administered by ocular route in rabbits.