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Toxicological information

Acute Toxicity: oral

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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:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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 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:
None
Body weight:
No effects
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.