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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
Study period:
2002-05-10 to 2002-06-17
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Laboratory of Pharmacology and Toxicology
- Age at study initiation: Approximately four months.
- Weight at study initiation: 2.0-2.1 kg
- Housing: Singly in cages measuring 425 mm x 600 mm x 380 mm
- Diet: Standard diet for rabbits ssniff K-H V2333, ad libitum
- Water: drinking water, ad libitum
- Acclimation period: 20 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±3
- Humidity (%): 55 ±15
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12


Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
The eyes were not rinsed, so the duration of exposure was until the end of the observation period.
Observation period (in vivo):
The eyes were examined 1, 24, 48 and 72 hours after instillation of the test substance.
Number of animals or in vitro replicates:
Three male
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not washed


SCORING SYSTEM: According to OECD 405.


TOOL USED TO ASSESS SCORE: eyes were examined ophthalmoscopically using a hand-slit lamp. 24 hours after administration of the test substance the eyes were additionally treated with fluorescein and examined.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Basis:
animal: 1, 2 and 3
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: 1, 2 and 3
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal: 1, 2 and 3
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: 1 and 2
Time point:
other: 24 hours
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
cornea opacity score
Basis:
animal: 3
Time point:
other: 24 hours
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: 1, 2 and 3
Time point:
other: 1, 48 and 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
Grade 1 corneal opacity was observed in two of the animals at 24 hours after treatment. The fluorescein test performed after 24 hours revealed corneal staining in these animals over a quarter of the surface.
Other effects:
No other effects observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In the eye irritation study, conducted according to OECD TG 405, and in compliance with GLP, the test material was reported to be not irritating to the eyes of rabbits.
Executive summary:

The test material was instilled (0.1 ml) into the conjunctival sac of the right eye of three male Himalayan rabbits and not washed. Left eyes served as negative controls. The eyes were then examined after 1, 24, 48 and 72 hours. After 24 hours the eyes were treated with fluorescein and examined. The iris and conjunctivae were not affected by the instillation of the test substance. There was grade 1 corneal opacity in two of the rabbits after 24 hours, and the fluorescein test revealed corneal staining in these animals after 24 hours. Overall the test substance was concluded not to be irritating to the eye.