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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000-01-10 to 2000-03-14
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
updated guideline, adopted: February 24, 1987
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
443-010-4
EC Name:
-
Cas Number:
53641-10-4
Molecular formula:
C14H15ClN2O4
IUPAC Name:
N-[3-chloro-4-(3-oxobutanamido)phenyl]-3-oxobutanamide
Test material form:
solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
-Species: New Zealand albino rabbit
-Sex: female
- Origin: Charles River Deutschland GmbH, 88353 Kißlegg
- Weight at study initiation: 2.9 – 3.4 kg
- Housing: in fully air-conditioned rooms in separate cages arranged in a battery
- Diet (e.g. ad libitum): ssniff K-H (V2333), ad libitum; and hay (approx. 15 g daily)
- Water (e.g. ad libitum): water from automatic water dispensers, ad libitum
- Acclimation period: at least seven days
- Animal identification: numbered ear tags

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 50 +/- 20%
- Lighting time: 12 hours daily

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
100 mg per eye
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
The eyes were examined 1, 24, 48 and 72 hours after administration of the test substance. At 24 and 72 hours, the eyes were further examined for corneal lesions under UV light after instillation of one drop of a 0.01% fluorescein-sodium solution. Lesions in cornea, iris or conjunctivae were graded numerically. All other changes or toxic effects were recorded when apparent.
Number of animals or in vitro replicates:
3
Details on study design:
About 24 hours before the start of the study the test eyes of all animals were examined under UV light for corneal lesions after instillation of one drop of a 0.01% fluorescein-sodium solution. Only animals without ocular abnormalities were used for the study.

100 mg of the test item was administered once to the conjunctival sac of the left eye of three rabbits. In each case the untreated eyes served as a control.

24 hours after administration the treated eyes were washed out thoroughly with isotonic saline at approximately 37°C. The eyes were also washed out at designated examination times at which discharge was observed or a corneal examination with fluorescein was performed.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: Not applicable
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: Not applicable
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: Not applicable
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 3 days
Other effects:
Colorless, serous eye discharge different from normal up to discharge with moistening of the lids and hairs just adjacent to the lids was noted only one hour after administration.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Testing of the test item for primary eye irritation in the rabbit showed that the substance is not irritating to eyes.
Conclusions:
Testing of the test item for primary eye irritation in the rabbit showed that the substance is not irritating to eyes.
Executive summary:

One hour up to 48 hours after administration the animals showed some definitely hyperamic blood vessels up to diffuse crimson color and any swelling above normal up to obvious swellings with partial eversion of lids. Additionally, colorless, serous eye discharge different from normal up to discharge with moistening of the lids and hairs just adjacent to the lids was noted only one hour after administration. At day four of study all sings of irritation were reversible.