Registration Dossier

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:
1999
Report Date:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
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: Chr. Fred Leuschner & Co., Löhndorf/Post Wankendorf
- Sex: males
- Age at study initiation: approx. 4.5-5 month
- Weight at study initiation: 2.0-2.2 kg
- Housing: singly
- Diet and water: ad libitum
- Acclimation period: at least 20 days

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye, which remained untreated, served as control.
Amount / concentration applied:
100 µl
Duration of treatment / exposure:
After administration of the test substance into the conjunctival sac the lids were gently held together for about one second in order to prevent loss of the test material. No rinsing of the eyes was reported.
Observation period (in vivo):
Eye irritation was scored 1, 24, 48, 72 hours after administration and until the changes have completely subsided, however for not more than 21 days after application.
Number of animals or in vitro replicates:
3 males
Details on study design:
STUDY DESIGN
After gently pulling the lower lid away from the eyeball 100 µl test substance were administered into the conjunctival sac of the right eye of the rabbits.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not reported

SCORING SYSTEM: Draize


TOOL USED TO ASSESS SCORE:
The eyes were examined ophthalmoscopically with a slit lamp prior to and after the administration. 24 hours after administration the eyes were treated additionally with fluorescein and examined.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Other effects:
All animals showed a transparent film on the cornea (probably substance) until 24 hours after instillation. There were no systemic intolerance reactions.

"ENGLISH"

All animals showed a transparent film on the cornea

until 24 hours after instillation.

There were no systemic intolerance reactions.

Applicant's summary and conclusion

Executive summary:

The test item was instilled into the conjunctival sac of the right eye of 3 male rabbits in a study according to OECD TG 405. Eye irritation was assessed using the Draize scale.

The cornea, iris and conjunctivae were not affected by instillation of the test compound. Only a transparent film, consisted probably of test compound, could be observed on the cornea up to 24 hours after exposure. No systemic intolerance reactions were reported.