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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: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
(1987)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Regal Group UK, Great Bookham, Surrey, UK.
- Age at study initiation: approx. 14 to 17 weeks
- Weight at study initiation: weight range of 3.4 - 3.8 kg
- Housing: individually in metal cages with perforated floors
- Diet and water: ad libitum
- Acclimation period: All rabbits were acclimatised to the experimental environment. No information concerning period of time.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-19.5
- Humidity (%): 44-76
- Air changes (per hr): approx. 19
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the contralateral eye remained untreated and served as control
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
The eyelids were gently held together for one second before releasing.
Observation period (in vivo):
Examinations were terminated after 7 days, since all changes had completely subsided then.
Number of animals or in vitro replicates:
3 (two males, one female)
Details on study design:
PROCEDURE: The eyes of each animal were examined prior to instillation of the test substance to ensure that there was no pre-existing corneal damage, iridial or conjunctival inflammation.
One animal was treated in advance of the others, to ensure that if a severe response was produced, no further animals would be exposed. Approximately 0.1 mL of the test substance was placed into the lower everted lid of one eye of each animal. The eyelids were gently held together for one second before releasing.

SCORING SYSTEM:
Cornea opacity - degree of density: 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 areas, 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
Iris: Normal 0; Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection, any of these or combination of any 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: Blood vessels normal 0; Some blood vessels definitely hyperaemic (injected) 1; Diffuse, crimson colour, individual vessels not easily discernible 2; Diffuse beefy red 3
Chemosis: No swelling 0; Any swelling above normal (includes nictating membranes) 1; Obvious swelling with partial eversion of lids 2; Swelling with lids about half-closed 3; Swelling with lids more than half-closed 4

TOOL USED TO ASSESS SCORE: Observation of the eyes was aided by the use of a handheld light.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal: #2, #3
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 4 days
Irritation parameter:
chemosis score
Basis:
animal: #1, #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
0 - 1
Max. score:
4
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: mean score: 0.7
Irritant / corrosive response data:
No corneal damage or iridial inflammation was observed. Hyperaemia of blood vessels with slight swelling was seen in all animals. These reactions had resolved in all instances by four or seven days after instillation.
Other effects:
There were no signs of toxicity or ill health in any rabbit during the observation period.

Applicant's summary and conclusion

Executive summary:

An Acute Eye Irritation/Corrosion test was conducted according to OECD TG 405. In this study no corneal damage or iridial inflammation was observed (all scores zero). Hyperaemia of blood vessels with slight swelling was seen in all animals (Mean scores for time points 24, 48, and 72 h: 1 for conjuntiva/redness, 0.2 for chemosis). These reactions had resolved in all instances by four or seven days after instillation. No signs of toxicity or ill health were observed.