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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:
1993
Report Date:
1993

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
other: White russian (Albino)
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: 11-12 months
- Weight at study initiation: 2.60-3.40 kg
- Housing: individually
- Diet: 120 g/day x animal, standard diet sniff K, special diet for rabbits
- Water: ad libitum
- Acclimation period: 1 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.0-20.5°C
- Humidity (%): 53-73%
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 26.07.1993 To: 05.08.1993

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 59.1-61.1 mg
- Concentration: undiluted
Duration of treatment / exposure:
Single exposure, no washing
Observation period (in vivo):
1, 24, 48 and 72 hours after application
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE: The treated eye was not rinsed.
TOOL USED TO ASSESS SCORE: Cliptrix pencil light (Varta, Hannover, No. 645)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 1-3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: 1-3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: 1-3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal: 1-3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
The irritation index is 0.
Other effects:
There were no systemic toxic effects after conjunctival application of the test substance. The general condition of the animals was undisturbed.

Any other information on results incl. tables

In the cornea and iris of all three animals no alterations were detected during the observation period.

The conjunctiva of one animal reacted with hyperemia (grade 1) only at the application day. In the two other animals no changes were observed.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information