Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Duration of treatment / exposure:
24 h
Observation period (in vivo):
1, 24, 48, 72 h
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 1 and 24h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 48 and 48 h
Score:
0
Max. score:
0

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information
Conclusions:
Under the conditions of this study, IN 00078280, was found to be slightly irritating to the eyes of rabbits with a MMTS score of 1.3.
Executive summary:

A. Title Low Volume Primary Eye Irritation Study of IN 00078280 in Rabbits

B. Objective The purpose of this study was to determine the potential irritant and/or corrosive effects of IN 00078280 on eyes of rabbits.

C. Methods The test article, IN 00078280, was instilled onto the corneal surface of the right eye of each of three female New Zealand White rabbits at 10 mg/eye. Upon instillation, each eye was released without forced blinking or manipulation. The left eye was untreated and served as the control. Both eyes of all animals were examined and scored for ocular irritation prior to dose, 1 hour after dose and at 24, 48 and 72 hours post dose.

D. Results Non-positive ocular irritation involving redness of the conjunctivae was observed in the test-treated eyes at 1 and 24 hours post treatment in some animals. No ocular irritation involving the cornea or iris was observed in the test-treated eyes at 1, 24 hours post treatment. No ocular irritation involving the cornea, iris or conjunctivae was observed in the test-treated eyes at 48 or 72 hours post treatment.

E. Conclusion Under the conditions of this study, IN 00078280, was found to be slightly irritating to the eyes of rabbits with a MMTS score of 1.3.