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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:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature

Data source

Reference
Reference Type:
secondary source
Title:
APPROVAL PACKAGE FOR: APPLICATION NUMBER 20-825. Pharmacology Review(s).
Bibliographic source:
Food and Drug Administration - Center for Drug Evaluation and research.
Report Date:
2000

Materials and methods

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
44.9 mg
Observation period (in vivo):
4 days

Results and discussion

Any other information on results incl. tables

No signs of ocular irritation were detected in cornea, iris, or conjunctivae. However, according to the text, the following were noted: (1) redness of the conjunctiva in the treated eye of each rabbit, (2) iritis and "slight circumcorneal reddening" in the eye of one rabbit; in this rabbit. By 48 hrs, all treated eyes appeared normal. Again, as in the dermal study, no positive controls were included in the study; also, no inert substance was tested to control for mechanical irritation effects.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No signs of ocular irritation were detected in cornea, iris, or conjunctivae.