Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study consisted of an andequate number of animals adminstered a limit dose. The methodology is consistent with current guidelines. The study was performed prior to established guidelines and GLPs.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: Section 1500.42 - Hazardous Substances and Articles, Administration and Enforcement Regulations, U.S. Federal Register, 38(187)P 27019, 27 Sept 1973
Qualifier:
equivalent or similar to
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
Principles of method if other than guideline:
0.1 g instilled in one eye of each of 6 rabbits. test material not washed from eye. observed 1, 24, 48 & 72 h & 5 and 7 d post treatment.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified

Test animals / tissue source

Species:
rabbit
Strain:
other: albino rabbits

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: each animal served as own control
Amount / concentration applied:
0.1 gm in one eye of each rabbit
Duration of treatment / exposure:
test material not washed from eye
Observation period (in vivo):
observed 1, 24, 48 & 72 h & 5 and 7 d post treatment.
Number of animals or in vitro replicates:
6

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: all time points
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: all scores at all time points were 0

Any other information on results incl. tables

Eyes observed for corneal opacity, iris, conjunctival redness and chemosis, and discharge.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
EBTBP is not an eye irritatnt.
Executive summary:

EBTBP (100 mg) was instilled in the right eye of six albino rabbits. The treated eyes were observed at 1, 24, 48 and 72 hours and 5 and 7 days post treatment. No effects were observed at any time point in any animal with respect to the cornea, iris, or conjunctiva. The test article was not an eye irritant.