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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline-conform study performed under GLP without deviations

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
other: SPF albino rabbits of the stock Mol:Russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Mollegaard Breeding and Research Centre Ltd., Ejby, DK-4623 Lille Skensved
- Age at study initiation: not reported
- Weight at study initiation: 2.5 - 2.6 kg
- Housing: caged single in PPL cages with perforated floor
- Diet (e.g. ad libitum): free access to feed pellets
- Water (e.g. ad libitum): free access to bottles with domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye remained untreated and served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
single application
Observation period (in vivo):
The eyes were examined and the grade of ocular reaction was recorded 1 and 24 hours after application. After the first 24 hour reading, Fluoreszein was instilled. After rinsing with 20 mL 0.9% sodium chloride solution, the eyes were examined again using UV-light to detect possible corneal damage. The eyes were also examined 48 and 72 hours as well as on day 7 after the treatment.
Number of animals or in vitro replicates:
3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM:
CORNEA:
Opacity degree of density (Area most dense taken for reading)
0: No ulceration or opacity
1: Scattered or diccuse area of opacity (other than slight dulling of normal luster), details of iris clearly visible.
2: Easily discernible translucent areas, details of iris slightly obscured.
3: Nacreous areas, no details of iris visible, size of pupil barely discernible
4: Complete corneal opacity, iris not discernible

Area of cornea involved
1: One quarter (or less) but not 0
2: More than 1 quarter, but less than half
3: More than half, but less than 3 quarters
4: More than 3 quarters, up to whole area

IRIS
0: Normal
1: Markedly deepened folds, congestion, swelling, moderate circumcorneal injection (any of these or combination of any thereof), iris still reacts to light (sluggish reaction is positive)
2: No reaction to light, haemorrhage, gross destruction (any or all of these)

CONJUNCTIVA
Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
0: vessels normal
1: Some vessels definitely injected
2: Diffuse, crimson red, individual vessels not easily discernible
3: Diffuse beefy red

Chemosis
0: No swelling
1: Any swelling above normal (includes nictitating membrane)
2: Obvious swelling with partial eversion of lids
3: Swelling with lids about half closed
4: Swelling with lids more than half closed

Discharge
0: No discharge
1: Any amount different from normal (does not include small amounts observed in inner canthus of normal animals)
2: Discharge with moistening of the lids and hairs just adjacent to lids
3: Discharge with moistening of the lids and hairs, and considerable area around the eye

TOOL USED TO ASSESS SCORE: hand held inspection lamp fitted with white and UV-light with 2 x magnification, fluorescein (after first 24 hour reading)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: mean of scores at 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: mean of scores at 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: mean of scores at 24, 48 and 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Redness
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: mean of scores at 24, 48 and 72 h
Score:
0.8
Max. score:
4
Reversibility:
fully reversible within: 7 days

Applicant's summary and conclusion

Interpretation of results:
other: EU CLP criteria
Remarks:
not classified
Conclusions:
The substance was not irritating to the eye under the conditions of the test.
Executive summary:

The primary eye irritant effect of the test substance was investigated according to OECD TG 405.

Three female albino rabbits were exposed to 0.1 mL of the test article in the left eye. The eyes were examined and the changes were graded according to a numerical scale 1, 24, 48, 72 and on day 7 hours after dosing. After the treatment, only slight changes were observed in the eyes. The following mean values, based on the results from the 24, 48 and 72 hour readings, were calculated: Cornea opacity: 0/4, iris lesion: 0/2, redness of conjunctiva: 1/3, odema of conjunctiva: 0.8/4.

It is concluded that the test substance caused no eye irritation under the conditions of the test.