N,N'-ethylenebis(3,4,5,6-tetrabromophthalimide)

Eye irritation

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: Section 1500.42 - Hazardous Substances and Articles, Administration and Enforcement Regulations, U.S. Federal Register, 38(187)P 27019, 27 Sept 1973

Test guideline 2

Qualifier:

equivalent or similar to guideline

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

Test material information

Constituent 1

Reference substance name:

N,N'-ethylenebis(3,4,5,6-tetrabromophthalimide)

EC Number:

251-118-6

EC Name:

N,N'-ethylenebis(3,4,5,6-tetrabromophthalimide)

Cas Number:

32588-76-4

Molecular formula:

C18H4Br8N2O4

IUPAC Name:

N,N'-ethylenebis(3,4,5,6-tetrabromophthalimide)

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.