Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1981
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
-Source: Abbaye de Belle Fontaine (49122 Bégrolles en Mauges, France)
-Weight at study initiation: 2.558 kg
-Housing: the rabbits were housed individually in polystyrene cages (0,35 x 0,55 x 0,32 m). Each cage was equipped with a food container and a water bottle.
-Diet: the animals were fed ad libitum with a certified pelleted diet Rabbit Diet SOC (Special Diets Services Ltd, Nitham, Essex, England) during the study.
-Water: the animals had free access to tap water filtered with Millipore filters (0,22 micron) in water bottles.
-Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
-Temperature: 18 ± 3 °C
-Humidity: 50 ± 20 %
-Air changes: The animals were maintained in an air conditioned room. The incoming, non-recycled air, was filtered by znw absolute filter.
-Photoperiod: the light/dark cycle was 12 hours per day.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount applied : 0.1 g
Duration of treatment / exposure:
Single injection into the inferior conjunctival sac of the left eye of each rabbit.
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
6 males rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM
CORNEA
-Opacity: degree of density (area most dense taken for reading)
No ulceration or opacity: 0
Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible: 1
Easily discernible translucent area, details of iris slightly obscured: 2
Nacreous areas, no details of iris visible, size of pupil barely discernible: 3
Opaque cornea, iris not discernible through the opacity: 4
-Area of cornea affected
No ulceration or opacity: 0
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
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia, or injection,
any of these or any combination thereof, iris still reacting to light (sluggish reaction is positive): 1
No reaction to light, haemorrhage, gross destruction (any or all of these): 2
CONJUNCTIVAE
-Redness: (refers to palpebral and bulbar conjunctivae, excluding cornea and iris).
Blood vessels normal
Some blood vessels definitely hyperaemic (injected): 1
Diffuse, crimson colour, individual vessels not easily discernible: 2
Diffuse beefy red: 3
-Chemosis: lids and/or nictating membrane
No swelling: 0
Any swelling above normal (includes nictating membrana): 1
Obvious swelling with partial eversion of lids: 2
Swelling with lids about half closed: 3
Swelling with lids more than half 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, in a considerable area around the eye: 3.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: unrinsed eye
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: unrinsed eye
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: unrinsed eye
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: #2, #3, #4, #5
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 8 d
Remarks on result:
other: unrinsed eye
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #6
Time point:
24/48/72 h
Score:
2
Reversibility:
fully reversible within: 8 d
Remarks on result:
other: unrinsed eye
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: unrinsed eye
Irritation parameter:
chemosis score
Basis:
animal: #2, #3
Time point:
24/48/72 h
Score:
0.33
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: unrinsed eye
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 4 d
Remarks on result:
other: unrinsed eye
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.67
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: unrinsed eye
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 6 d
Remarks on result:
other: unrinsed eye
Irritant / corrosive response data:
The instillation of the test sample provoked conjunctival reactions only.
One hour after instillation of the test sample, a swelling above normal and significant lachrymation were Observed in all animals.
The conjunctival redness and the iridial and corneal reactions were not scored due to the staining of the eye by the test compound. On Day 1, a swelling of the conjunctiva was observed in five animals and a slight redness (some blood vessels definitely hyperaemic) was observed in five animals althrough diffuse crimson coloured individual vessels were not easily visible in one animal. A slight staining covering half of the surface of the eye was noted in three animals.
On Day 3, the swelling was observed in two animals and the redness in five animals. It was decided to extend the observation period due to persistent ocular irritation in order to test the reversibility of the reactions.
The swelling regressed progressively in all animals up to Day 5.
The redness was still persistent in five animals on Day 6 and three animals on Day 7.
On Day 8, no reaction was noted.

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to the CLP Regulation (EC 1272/2008)
Conclusions:
The substance was considered as non irritating for rabbit eye.
Executive summary:

The acute eye irritation potential of test item was evaluated in an in vivo study according to the OECD Guideline N 405 (1981). 0.5 g of test item was applied into the left eye of six rabbits; the right eye untreated was used as control. The eye observations were performed without rinsing the treated eye during a study period of 8 days after the test item application.

Corneal opacity and iritis scores (mean values 24/48/72 h) were 0 in all animals. Conjunctival redness scores (mean values 24/48/72 h) were< 2 in all animals;conjunctival oedema (chemosis) scores (mean values 24/48/72 h) were < 2 in all animals expect for one animal (2 in animal #6). All effects observed were fully reversible within the observation period.