Tetrabromophthalic anhydride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1964

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The information on this study is in the form of a letter report. It was conducted prior to international guidelines and good laboratory practice standards. The study appears to be robust.

Data source

Reference

Reference Type:

other: Letter Report

Title:

Unnamed

Year:

1964

Materials and methods

Principles of method if other than guideline:

Conducted generally as modern studies - a single gavage dose to six groups of rats with observation for 14 days followed by sacrifice with gross necropsies.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Tetrabromophthalic anhydride

EC Number:

211-185-4

EC Name:

Tetrabromophthalic anhydride

Cas Number:

632-79-1

Molecular formula:

C8Br4O3

IUPAC Name:

tetrabromo-1,3-dihydro-2-benzofuran-1,3-dione

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

The test material was administered as a 50% weight/volume suspension in water.

Doses:

0, 215, 464, 1000, 2150, 4640 and 10000 mg/kg bw

No. of animals per sex per dose:

5 M/dose

Control animals:

yes

Details on study design:

The test material was administered orally by stomach tube to 6 groups, each composed of 5 male albino rats (Dublin Sprague-Dawley strain, 201-291 g in weight). The test material was administered as a 50% weight/volume suspension in water. Food was withheld for approximately 18 hr prior to dosing. Food (commercial pellets) and water was then available ad libitum. The rats were housed in groups in wire mesh cages suspended above the droppings. All animals were observed closely for gross signs of systemic toxicity and mortality several times during the day of dosage, and at frequent intervals thereafter for a total of 14 days. At the end of the 14 d observation period, rats were weighed, sacrificed by cerebral concussion, and gross necropsies performed.

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Mortality:

None due to test article toxicity. One death at 464 mg/kg due to gavage error.

Clinical signs:

other: other: none

Gross pathology:

see remarks

Any other information on results incl. tables

One rat at the 464 mg/kg dose was found dead on the third experimental day. Necropsy findings indicated the death was due to gavage error (e.g. intratracheal). No other mortalities occurred during the 14-day observation. The oral LD50 was determined to be > 10000 mg/kg bw. The average body weight gain in each group was reported as within the normal limits for rats of the age, sex and strain employed in the study. At gross necropsy on termination, slight congestion of the kidney was observed in rats at the lower dose levels, and moderate to marked congestion of the kidneys were observed at the highest dose level. 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Criteria used for interpretation of results: expert judgment