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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted in accordance with the requirements ofthe following directives: - OECD GUIDELINES FOR TESTING OF CHEMICALS, W 405 "Acute Eye Irritation/Corrosion", adopted by the Council on 24th Feb. 1987

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
other: White New Zealanders
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, D-97320 Sulzfeld
- Age at study initiation:
- Weight at study initiation:
animal no 1: 3714g
animal no 2: 3692g
animal no 3: 3277 g
- Weight at conclusion of the study:
animal no 1: 3754g
animal no 2: 3755g
animal no 3: 3325 g
- Housing: Cages of stainless steel with bottom grid of oval steel and with tub far faeces, dimensions of the cages: 50 x 55 x 40 cm, Bedding: ALTROMIN Type S8115, granulated soft wood bedding
Batches: 120500
- Diet (e.g. ad libitum): ALTROMIN 2123, standard diet for rabbits ad libitum (ALTROMIN, D-32791 LagelLippe), Batch: 05020111049
- Water (e.g. ad libitum): tap water, ad libitum (municipal supply), Makrolon® bottles, changed daily
- Acclimation period: 2 month before administration

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 20°C
- Relative Humidity (%): 35 - 50%
- Air changes (per hr): air conditioning
- Photoperiod (hrs dark / hrs light): artificiallight was set to give a cycle of 12 hours light and 12 hours dark; the light phase was from 6.30 a.m. - 6.30 p.m.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: other eye of each animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g of the test item after crushing with a pestle and mortar to a fine dust.
Duration of treatment / exposure:
24 h
Observation period (in vivo):
The animals were monitored for general clinical condition continuously on the day of administration and once daily thereafter (in the morning).
The conjunctivae, cornea and iris of the eyes were examined at 1, 24, 48 and 72 hours and on the 4th day after instillation.
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated eyes were rinsed out with distilled water carefully.
- Time after start of exposure: 24 h

SCORING SYSTEM: see table 1

TOOL USED TO ASSESS SCORE: hand-slit lamp (Heine Optotechnik)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 1,2,3
Time point:
other: 1/24/48/72/96 h
Score:
0
Max. score:
4
Reversibility:
other: not affected
Irritation parameter:
iris score
Basis:
animal: 1,2,3
Time point:
other: 1/24/4872/96 h
Score:
0
Max. score:
2
Reversibility:
other: not affected
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1/24/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 96 h
Remarks on result:
other: conjunctivae redness
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 96 h
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: conjunctivae redness
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 1/24 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: conjunctivae redness
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 48/ 72/96 h
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: conjunctivae redness
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 1/24 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: conjunctivae redness
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 48/72/96 h
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: conjunctivae redness
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 96 h
Remarks on result:
other: conjunctivae chemosis
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 96 h
Remarks on result:
other: conjunctivae chemosis
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 96 h
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: conjunctivae chemosis
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 1 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: conjunctivae chemosis
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24/48/72/96 hours
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: conjunctivae chemosis
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 1 hour
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: conjunctivae chemosis
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24/48/72/96 hours
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: conjunctivae chemosis
Irritant / corrosive response data:
A slight redness of the conjunctivae of the treated eyes was observed in 2 animals until 24 and in 1 animal until 72 h after instillation. A slight swelling of the conjunctivae was observed in 1 animal until 72 h after instillation. This swelling was shortly increased to a clear swelling 1 h after instillation. In the 2 further animals a slight to clear swelling was observed only 1 h after instillation. The cornea and iris were not affected. 4 d after instillation no signs of irritation were observed.
Other effects:
None of the animals died or showed clinical signs during the course of testing.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The alterations of the eyes after instillation of the test item do not meet the criteria for classification of a substance as an eye irritant.
In accordance with the results of this study and in compliance with the criteria of Annex IV of Council Directive 93121/EEC of27th April 1993 the test item has not to be classified as a substance that is irritant to the eye.
Executive summary:

The acute eye irritation/corrosion of the test item was tested in 3 Albino Rabbits. The test item was instilled as the original substance after crushing with a pestle and mortar to a fine dust at a single dose of 0.1 g to one of the eyes in each animal. The untreated eye was used for control.

The animals were examined for clinical signs and the eyes were examined for lesions of the conjunctivae, cornea and iris 1, 24, 48 and 72 h and on the 4th day after instillation of the test item.

The grades for ocular lesions were recorded in accordance with OECD 405.

The instillation of the test item caused a slight redness of the conjunctivae and a slight to short clear swelling of the conjunctivae in 3 three animals.

On the 4thday after instillation no signs of irritations were observed. The cornea and iris were not affected. None of the animals died or showed clinical signs during the course of testing. Signs of systemic effects of the test item were not observed.