Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

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:
1998
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
(1987)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The test substance was tested in solution approx. in 75 % in 2−Methoxy−1−methylethylacetate/Solventnaphtha 100 (8:17)
Appearance: colourless to yellowish liquid

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Sex: male
- Source: CHR. FRED LEUSCHNER & CO., 24601 Loehndorf/Post Wankendorf, Germany
- Age at study initiation: approx. 4 months
- Weight at study initiation: 2.1-2.2 kg
- Housing: separately in cages with dimensions of 425 mm x 600 mm x 380 mm (manufacturer: Dipl. Ing. W. EHRET GmbH, 0-16352 Schoenwalde)
- Diet and water: ad libitum
- Acclimation period: at least 20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
other: unchanged (no vehicle), but commercial product tested with a content of 75 % act. ingr. in solvent
Controls:
other: The left eye, which remained untreated, served as a control.
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
The lid was then gently held together for about one second in order to prevent loss of test material.
Observation period (in vivo):
Animals were monitored until the changes had completely subsided, however for not more than 21 days after application.
Number of animals or in vitro replicates:
3
Details on study design:
A dose of 0.1 mL test item was administered into the conjunctival sac of the right eye of rabbits after gently pulling the lower lid away from the eyeball. The lid was then gently held together for about one second in order to prevent loss of test material. The eyes were examined ophthalmoscopically with a slit lamp prior to the administration and also 1, 24, 48 and 72 hours after the administration. The eye reactions were observed and registered. 24 hours after administration the eyes were treated additionally with fluorescein and examined.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Other effects:
There were no systemic intolerance reactions.

Applicant's summary and conclusion

Executive summary:

An eye irritation/corrosion test according to OECD TG 405 was conducted with the test substance, which is 75 % in solvent. A single application of 0.1 mL test substance per animal into the conjunctival sac of the right eye did not cause any changes. There were no systemic intolerance reactions.