Registration Dossier

Administrative data

Endpoint:
eye irritation, other
Remarks:
in vivo
Type of information:
other: read across from supporting substance (analogue substance or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test was performed according to internationally accepted testing guidelines.The complete justification for the Read Across approach is reported in the Section 13.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO)
GLP compliance:
no
Remarks:
pre-GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Russian breed
- Housing: cages
- Diet and water: standard diet of Nafag and drinking water ad libitum.
Only rabbits showing normal ophthalmic findings were included in the test.

ENVIRONMENTAL CONDITIONS
- Temperature: 18 ± 1 °C
- Humidity: 55 ± 5 %
- Photoperiod (hrs dark / hrs light): 14 hours light/day

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
Amounts of 0.1 g of the test substance were introduced into the conjunctival sac of the left eye with a spatula. After application, the eyelids were held
open for a few seconds.
Duration of treatment / exposure:
The eyes of 3 animals were rinsed 1 minute after application
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
6 (3 males and 3 females) rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): physiologic saline
- Time after start of exposure: 1 minute

TOOL USED TO ASSESS SCORE: hand-slit lamp

SCORING SYSTEM: the reactions were appraised after 1 and 6 hours; 1, 2, 3, 6 and 8 days on the basis of the "Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).

CORNEA
- Opacity-degree of density (area most dense taken for reading)
No opacity: 0
Scattered or diffuse area, details of iris clearly visible: 1
Easily discernible translucent areas, details of iris slightly obscured: 2
Opalescent areas, no details of iris visible, size of pupil barely discernible: 3
Opaque, iris invisible: 4
- Area of cornea involved
One quarter (or less) but not zero: 1
Greater than one quarter, but less than half: 2
Greater than half, but less than three quarters: 3
Greater than three quarters, up to whole area: 4

IRIS
Normal: 0
Folds above normal, congestion, swelling, circumcorneal injection (any or all of these or combination of any thereof) iris still reacting to light (sluggish reaction is positive): 1
No reaction to light, hemorrhage, gross destruction (any or all of these): 2

CONJUNCTIVAE
- Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
Vessels normal: 0
Vessels definitely injected above normal: 1
More diffuse, deeper crimson red, individual vessels not easily discernible: 2
Diffuse beefy red: 3
- Chemosis
No swelling: 0
Any swelling above normal (includes nictitating membrane): 1
Obvious swelling with partial eversion of lids: 2
Swelling with lids about half closed: 3
Swelling with lids about half closed to completely closed: 4
- Discharge
No discharge: 0
Any amount different from normal (does not include small amounts observed in inner canthus of normal animals): 1
Discharge with moistening of the lids and hairs just adjacent to lids: 2
Discharge with moistening of the lids and hairs, and considerable area around the eye: 3

Results and discussion

In vivo

Results
Remarks on result:
other: see results below
Irritant / corrosive response data:
The substance was found to cause transient minimal to slight irritation in un-rinsed and minimal irritation in rinsed eyes, in both cases after 6 hours. The irritation consisted of conjunctival reaction. Reflective hyperemia of the iris was observed 6 hours after installation in 1/3 unrinsed eyes only.After 24 hours, there was complete recovery in 2/3 unrinsed and 3/3 rinsed eyes.


Any other information on results incl. tables

time 1 hour 6 hours 
Eye, left/right not rinsed rinsed after 1 minute not rinsed rinsed after 1 minute
Animal n. 142 107 143 152 140 191 142 107 143 152 140 191
cornea opacity 0 0 0 0 0 0 0 0 0 0 0 0
area involved 0 0 0 0 0 0 0 0 0 0 0 0
iris   0 0 0 0 0 0 0 1 0 0 0 0
conjunctivae redness 2 2 1 1 2 2 1 2 2 1 1 2
chemosis 1 2 1 0 1 1 1 2 1 0 0 1
discharge 2 3 1 1 1 2 1 2 1 0 0 1

time 24 h 48 h
Eye, left/right not rinsed rinsed after 1 minute not rinsed rinsed after 1 minute
Animal n. 142 107 143 152 140 191 142 107 143 152 140 191
cornea opacity 0 0 0 0 0 0 0 0 0 0 0 0
area involved 0 0 0 0 0 0 0 0 0 0 0 0
iris   0 0 0 0 0 0 0 0 0 0 0 0
conjunctivae redness 1 0 0 0 0 0 0 0 0 0 0 0
chemosis 0 0 0 0 0 0 0 0 0 0 0 0
discharge 0 0 0 0 0 0 0 0 0 0 0 0

time 72 h 6 days 8 days
Eye, left/right not rinsed rinsed after 1 minute not rinsed rinsed after 1 minute not rinsed rinsed after 1 minute
Animal n. 142 107 143 152 140 191 142 107 143 152 140 191 142 107 143 152 140 191
cornea opacity 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
area involved 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
iris   0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
conjunctivae redness 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
chemosis 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
discharge 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information according to the CLP Regulation Criteria used for interpretation of results: EU
Conclusions:
Not irritating
Executive summary:

METHOD

The eye irritation test was performed to rabbit eye using a single administration, according to the "Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).

RESULT

The substance was found to cause minimal to slight irritation when applied to the rabbit eye mucosa. The substance was found to cause transient minimal to slight irritation in un-rinsed and minimal irritation in rinsed eyes, in both cases after 6 hours (during the test, the eyes of three animals were rinsed 1 minute after application, with physiologic saline solution). The irritation consisted of conjunctival reaction. Reflective hyperemia of the iris was observed 6 hours after installation in 1/3 unrinsed eyes only. After 24 hours, there was complete recovery in 2/3 unrinsed and 3/3 rinsed eyes.

CONCLUSION

The criteria for the evaluation of the eye irritation potential followed in the test are different from those reported into the OECD guideline. Nevertheless, the scoring system used for the cornea opacity and degree of density, for the iris and conjunctivae redness and chemosis are the same of that reported into the OECD. Since the raw tables are included into the study report, it is possible to re-evaluate the results according to the CLP Regulation (EC n. 1272/2008).

The mean values at 24, 48 and 72 hours for both rinsed and unrinsed eyes were lower than 1 for corneal opacity, lower than 1 for irtitis, lower than 2 for both conjunctival redness and oedema, in all animals.

Therefore, the test substance can be classified as NON IRRITATING, according to the CLP Regulation (EC n. 1272/2008).