2,2',6,6'-tetrabromo-4,4'-isopropylidenediphenol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15 April 1981 to 29 April 1981

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Conducted according to GLP standards; predates or was not conducted according to standardized guidelines; no analytical verification of test compound concentrations

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report): Tetrabromo Bisphenol-A
- Molecular formula (if other than submission substance): N/A
- Molecular weight (if other than submission substance): N/A
- Smiles notation (if other than submission substance): N/A
- InChl (if other than submission substance): N/A
- Structural formula attached as image file (if other than submission substance): see Fig. N/A
- Substance type: Monoconstituent
- Physical state: Solid, white powder
- Analytical purity: Not reported
- Impurities (identity and concentrations): Not reported
- Composition of test material, percentage of components: Not reported
- Isomers composition: Not reported
- Purity test date: Not reported
- Lot/batch No.: # R6/FD2
- Expiration date of the lot/batch: Not reported
- Radiochemical purity (if radiolabelling): N/A
- Specific activity (if radiolabelling): N/A
- Locations of the label (if radiolabelling): N/A
- Expiration date of radiochemical substance (if radiolabelling): N/A
- Stability under test conditions: There was no apparent change in the physical state of the test article during administration; stable
- Storage condition of test material: Not reported

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Brreding Laboratories
- Age at study initiation: Adult
- Weight at study initiation: 180 to 280 grams (after fasting)
- Fasting period before study: 18 hours
- Housing: Individually in stainless steel 1/2" wire mesh cages
- Diet (e.g. ad libitum): Wayne Lab Blox, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Not reported


ENVIRONMENTAL CONDITIONS
- Temperature (°F): 75 +/-5F
- Humidity (%): Ambient
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 10hrs light: 14hrs dark

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

VEHICLE
- Concentration in vehicle: Unclear
- Amount of vehicle (if gavage): Unclear


MAXIMUM DOSE VOLUME APPLIED: Unclear

Doses:

5000 mg/kg

No. of animals per sex per dose:

FIve males and five females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observed at 2, 4, and 24 hours post-exposure, and then daily for a total of 14 days
- Necropsy of survivors performed: Yes
- Other examinations performed: body weight

Statistics:

None (no positive response)

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: None

Gross pathology:

Clear fluid discovered in the uterus of one rat; no other evidence of lesions, etc, in other rats.

Other findings:

None reported

Any other information on results incl. tables

Table 1: Rat body weights following oral exposure to 5000 mg/kg Tetrabromo Bisphenol-A

Animal #	Sex	Day 0 Body weight	Day 14 Body weight
3411	M	207	284
3412	M	212	310
3413	M	203	266
3414	M	233	293
3415	M	200	268
3416	F	188	227
3417	F	204	244
3418	F	180	216
3419	F	188	226
3420	F	195	234

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The estimated acute oral LD50 in rats for Tetrabromo Bisphenol-A Lot # R6/FD2, is greater than 5 g/kg.

Executive summary:

In an acute toxicology study conducted to GLP, Tetrabromo Bisphenol-A, Lot # R6/FD2, was administered orally to one group of ten rats at 5 g/kg. None of the animals died on study. No signs of toxicity were evident during the fourteen day study. Terminal necropsy revealed clear fluid in the uterus of one rate, no visible lesions were evident in the remaining animals. The estimated acute oral LD50 in rats for Tetrabromo Bisphenol-A Lot # R6/FD2, is greater than 5 g/kg.