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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was performed prior to international gudielines and good laboratory practices. It used a micronized form of the commerical product. Micronization may impact (e.g. increase) the potential for toxicity.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974

Materials and methods

Principles of method if other than guideline:
Rats were exposed to a single concentration of the test material for 4 hours and observed for 14 days afterward.
GLP compliance:
no
Test type:
fixed concentration procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
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
Details on test material:
A micronized form of the test material was used.

Test animals

Species:
rat
Strain:
other: Spartan
Sex:
male/female
Details on test animals or test system and environmental conditions:
Five male and five female rats were used. The rats were housed by sex in groups of 5 in metal cages above the droppings in temperature and humnidity contolled quarters. Purina Laboratory Chow and water were available ad libitum.

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
"The group of 10 rats was placed in a sealed 59.1 liter glass chamber and exposed for 4 hours to a dynamic atmosphere containing the dust of the test material. In order to prevent "piling up" during the exposure, the rats were separated into 4 units of 2 or 3 rats each. Addition of the test compound to the test chamber atmosphere was controlled by a Wright Dust Feeder. Dried and filtered air was passed through the mechanism and directly into the exposure chamber. Airflow was regulated by means of a flowmeter (Gelman Insturment Company, Ann Arbor, Michigan, Model No. 8221). The calculated atmospheric concentration administered was approximately 10.92 mg/L* of FM PHT4 (micronized), Lot N0. 6332-B.
*The physical properties of the test compound precluded administration of the test material at a higher atmospheric concentration."
Duration of exposure:
4 h
Concentrations:
10.92 mg/L
No. of animals per sex per dose:
5M/5F
Control animals:
no
Details on study design:
The rats were observed continuously during and immediately after the 4 hr exposure. All rats which died on study were necropsied. All surviving animals were necropsied at the end of the 14 d observation period.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 10.92 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
4 h
Mortality:
None.
Clinical signs:
other: During exposure: decreased activity, eye squint, slight dyspnea, erythema. At 24 hr: 1 rat with nasal "porphyrin" discharge. At 10-14 days: several rats with diarrhea.
Body weight:
All rats exhibited normal body weight gain during the study.
Gross pathology:
No compound-related gross lesions were observed.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The 4 hr LC50 in rats was > 10.92 mg/L.