Registration Dossier

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:
1986
Report Date:
1986

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
other: solid, not further specified

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: The Broekman Institute, Someren, The Netherlands
- Age at study initiation: 13-15 weeks
- Weight at study initiation: 2.67-3.04kg
- Housing: Individually in plastic cages with perforated floors.
- Diet (e.g. ad libitum): Standard laboratory animal diet (LK-01, pellet diameter 4 mm; 100 g per day), obtained from Hope Farms, Woerden.
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 60-80, with an occasional peak of 90%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eyes served as controls
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 90±1 mg (equivalent to 0.1 mL)

Test substance preparation: Test substance was ground to a fine powder using a mortar and pestle. On the day of dose administration three portions of 90±1 mg of the powder were dispensed in glass containers with screw caps.

Test substance administration: On administration one of the portions of the test substance was instilled into the conjunctival sac of one of the eyes of each animal using a spatula. The lids were then held gently together for two seconds and released. The other eye remained untreated and served as control. Immediately after instillation the animals were observed and abnormalities were recorded.
Duration of treatment / exposure:
Not washed out
Observation period (in vivo):
100 minutes, 24, 48 and 72 hours, 7 and 14 days
Number of animals or in vitro replicates:
3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: Solution of 2% fluorescein approximately 24 hours after instillation, immediately after scoring of corneal opacity and alterations of iris and conjunctivae. The procedure was repeated 3 days after dose administration.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: 20% of corneal area affected on day 1, fully reversible by day 3
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: 25% of area affected on day 1, fully reversible by day 3
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: 20% of corneal area affected on day 1, fully reversible by day 3
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
0.7
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48, 72 hours
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48, 72 hours
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
Immediately after dosing all animals were observed to blink excessively, thereby removing some of the test substance from their treated eye. At the first observation time (100 min after instillation) hyperaemia of the blood vessels of the conjunctivae, affecting the eyelids and the scleral conjunctivae, was observed in all animals, as well as obvious swelling of the eyelids. Increased lacrimation was also observed in all animals at this time.

Treatment of the eyes with fluorescein 24 hours after treatment revealed 20-25% corneal epithelial damage, but other corneal effects were not observed. When fluorescein treatment was repeated 3 days after dosing the epithelial damage had disappeared. On day 1 injection of the capillaries in the iris was observed in all animals, as well as deepened rugae in 1/3 animals; in all animals the iris still reacted to light. In the animal with the deepened rugae the iris effects disappeared within the next 24 hours, while in the other 2 animals the injection of capillaries persisted for 48 to 72 hours. Slight conjunctival swelling persisted in all animals for 3 days, while slight redness was still observable on day 7. Fourteen days after dosing all adverse ocular effects had disappeared.
Other effects:
Signs of systemic intoxication were not observed.

Any other information on results incl. tables

Conclusion:

According to the criteria of EU Directive 67/548/EEC and Regulation (EC) No 1272/2008 the test substance does not have to be classified as irritating to the eyes.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information