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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

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 material form:
other: red granulate
Details on test material:
Content: at least 97 %

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: 5 months
- Weight at study initiation: 2.8-3 kg
- Housing: singly
- Diet ad libitum
- Water ad libitum
- Acclimation period: at leats 20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Humidity (%): 50
- Photoperiod (hrs dark / hrs 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the left eye served as control
Amount / concentration applied:
100 mg/animal
Duration of treatment / exposure:
once
Observation period (in vivo):
Up to 72 hours
Number of animals or in vitro replicates:
3 males
Details on study design:
A dose of 100 mg Macrolex Rot E2G was administered into th conjunctival sac of the right eye of each of 3 male rabbits after gently pulling the lower lid away fron the eyeball. The lid was thengently held together for about one second in order to prevent losss of test material.The left eye which remains untreated seved as a control.. the eyes were examined phthalmoscopically with a slit lamp prior to the administration and also 1,24, 48 and 72 hours after administration. Eyes were evaluated for cornea opacity, iris and conjunctival changes Scoring was done according to Draize.
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:
mean
Time point:
other: before dosing, and 1, 24, 48 and 72 hours afterwards
Score:
0
Max. score:
4
Remarks on result:
other: no effects were observed
Irritation parameter:
iris score
Basis:
mean
Time point:
other: before and 1, 24, 48, 72 hours post application
Score:
0
Max. score:
2
Remarks on result:
other: no effects were observed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: before and 1, 24, 48, 72 hours post application
Score:
0
Max. score:
3
Remarks on result:
other: no effects were observed
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: before and 1, 24, 48, 72 hours post application
Score:
0
Max. score:
4
Remarks on result:
other: no effects were observed
Irritant / corrosive response data:
No irritational effects were observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Cornea, iris, conjunctiva and chemosis score = 0 at any time point (before dosing, and 1, 24, 48 and 72 hours afterwards).
Executive summary:

According to OECD 405 and GLP each of 3 male rabbits received instillations of 100 mg test substance into the conjunctival sac of the right eye; the respective left eye remained untreated and seved as control. The eyes of the animals were observed 1, 24, 48 and 72 hours post application. Additionally, 24 hours post application the eyes were treated with fluorescein and examined. The scoring was done according to Draize. In none of the animals the eyes were affected by treatment. Therefore the test substance was evaluated to be non-irritating to the eyes of rabbits.