Reaction products of tetrabromophthalic anhydride with 2,2'-oxydiethanol and methyloxirane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Performed according to standard guidelines and good laboratory practices.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

up-and-down procedure

Limit test:

yes

Test material

Test material information

1

Reference substance name:

Reaction products of 3,4,5,6-tetrabromobenzene-1,2-dicarboxylate with 2,2'-oxy-diethanol and 2-epoxypropane

EC Number:

616-436-5

Cas Number:

77098-07-8

Molecular formula:

Ester product of C8 H2 Br4 O4 with C4 H10 O3 and C3 H8 O2 and condensation products, thereof.

IUPAC Name:

Reaction products of 3,4,5,6-tetrabromobenzene-1,2-dicarboxylate with 2,2'-oxy-diethanol and 2-epoxypropane

Test animals

Species:

rat

Strain:

other: CD [Crl:DC (SD)IGS BR]

Sex:

female

Details on test animals or test system and environmental conditions:

Rats 7 weeks old on arrival at test laboratory. Housed individually in suspended, stainless steel, wire mesh cages. Acclimated for 7 d prior to test initiation. Weight 166-179 g at randomiization. Identified by microchip implant. Euthanized via CO2 inhalation at end of test. Fed Block Lab Diet (Certified Rodent Diet #5002, PMI Nutrition Internation, Inc). Tap water and diet available ad libitum. Temp 69-74F, Humidity 46-69%.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

Administered as a single dose by oral gavage in corn oil. Observed for 14 daays.

Doses:

2000 mg/Kg

No. of animals per sex per dose:

5

Details on study design:

Initially, one animal was dosed at 2000 mg/kg at a dose volume of 10 ml/Kg. Approximately 3 d later, an additional 4 animals were dosed at 2000 mg/Kg at dose volume of 10 ml/Kg. Each animal was dosed once via oral gavage. The test article formulations were stirred continuously during dosing. Individual doses were based on the most recent body weights. Animals were observed for mortality and toxicity for 14 days post-dosing.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

None.

Clinical signs:

other: No clinical signs of toxicity were observed.

Gross pathology:

No gross macroscopic findings were evident.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

Under the conditions of this study, where female rats were given a single oral (gavage) dose of SAYTEX RB-79 at 2000 mg/KG, no deaths occured and no test article-related signs of toxicity were noted. The LD5 0 was > 2000 mg/kg in female rats.

Executive summary:

Under the conditions of this study, where female rats were given a single oral (gavage) dose of SAYTEX RB-79 at 2000 mg/KG, no deaths occured and no test article-related signs of toxicity were noted. The LD5 0 was > 2000 mg/kg in female rats.