Registration Dossier

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
Study period:
1997-05-20 to 1997-06-03
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
92/69/EEC
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: OP 301 D 20029

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH
- Weight at study initiation: 3.9 kg
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 1 week under study conditions

ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/- 3°C
- Humidity: 50 +/- 20%
- Photoperiod (hrs dark / hrs light): 12 hours daily

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
administered once and left in the eye until first washing 24 h after instillation
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
1
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with isotonic saline at approx. 37°C
- Time after start of exposure: 24hours

TOOL USED TO ASSESS SCORE:
At 24 and 72 hours as well as after 7 and 14 days, the eye was also examined for corneal lesions under UV light after instillation of one drop of a 0.001 % fluorescein-sodium solution. Lesions in cornea, iris or conjunctivea were graded numerically.

READING
The eye was examined 1, 24, 72 hours after administration of the test substance. Since effects were still present in the eye after 72 hours, further examinations were carried out after 7 and 14 days.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.66
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritant / corrosive response data:
One hour up to 14 days after administration the conjunctiva of the animal showed definitely injected blood vessels up to a diffuse beefy red color and an obvious swelling to a swelling with lids half closed to completely closed. 24 hours up to 14 days after administration the iris showed no reaction to light. Diffuse to opalescent areas of the cornea were observed one hour up to 14 days administration. Additionaly, clear-colorless and white-yellow viscous discharge, exfoloation of the conjunctiva and nictating membrane as well as blanched nictating membrane with hemorrhages were noted during the observation period. 14 days after administration the animal showed extreme vascularization.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Under the conditions of the present study the test item Crotonic acid anhydrid is classified as severely irritating to the eye.