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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: Buideline study under GLP condition

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

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: yellow powder
Details on test material:
content not specified

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: adult
- Weight at study initiation: females 3.2-3.6 kg
- Housing: individually
- Diet ad libitum
- Water ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Humidity (%): 50
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 /12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the opposite eye served as control
Amount / concentration applied:
100 µl equivalent to approd >30 mg
Duration of treatment / exposure:
24 h
Observation period (in vivo):
planned for 21 days but terminated after 7 days because no effects were observed
Number of animals or in vitro replicates:
3 females
Details on study design:
A dose ofapprox >30 mg Macrolex Gelb G was administered into th conjunctival sac of the right eye of each of 3 female rabbits after gently pulling the lower lid away fron the eyeball. The lids were then gently held together for about one second in order to prevent losss of test material.The left eye which remains untreated served as a control. 24 hours later the eyes were rinsed with saline. The eyes were examined ophthalmoscopically 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: 1, 24, 48, 72 h
Score:
0
Max. score:
4
Remarks on result:
other: no effects were observed
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
2
Remarks on result:
other: no effects were observed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
3
Remarks on result:
other: no effects were observed
Irritant / corrosive response data:
no irritational effects were observed

Applicant's summary and conclusion

Executive summary:

According to OECD 405 and GLP each of 3 female rabbits received instillations of about 30 mg test substance into the conjunctival sac of the right eye; the respective left eye remained untreated and served 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 wutg fluorescein and examined . The scoring was done according to Draize. In none of the animals eyes were affected by treatment. Therefore Macrolex Gelb G was evaluated to be non-irritating to the eyes of rabbits.