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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No GLP data; methodology predates or was not conducted according to standardized guidelines; no analytical verification of test compound concentrations

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1967
Report Date:
1967
Reference Type:
publication
Title:
Unnamed
Year:
1995

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Wistar rats, NDMI mice, and guinea pigs were exposed to aersolised tetrabromobisphenol-A for eight hours, followed by a 48 hour observation period and necropsy.
GLP compliance:
not specified
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): Tetrabromobisphenol-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.: Not reported; received from Great Lakes Chemical Corp.
- 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: Not reported
- Storage condition of test material: Not reported

Test animals

Species:
other: 1) Rat; 2) Mouse; 3) Guinea pig
Strain:
other: 1) Wistar; 2) NMDI; 3) Not reported
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Not reported (in-house cultures)
- Age at study initiation: Adult?
- Weight at study initiation: Not reported
- Fasting period before study: Not reported
- Housing: Stainless steel inhalation chambers
- Diet (e.g. ad libitum): Standard laboratory diet, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: One week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22C
- Humidity (%): 50-60%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported, ambient?

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Stainless steel inhalation chamber
- Exposure chamber volume: Not reported
- Method of holding animals in test chamber: Whole animal placed in chamber
- Source and rate of air: Continuous airflow, flow rate not reported
- Method of conditioning air: Not reported
- System of generating particulates/aerosols: Draeger/Lubeck aerosol apparatus
- Method of particle size determination: Not reported
- Treatment of exhaust air: Not reported
- Temperature, humidity, pressure in air chamber: 22C, 50-50%, Not reported

TEST ATMOSPHERE
- Brief description of analytical method used: No analysis performed
- Samples taken from breathing zone: N/A, no analysis performed


TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: No analysis performed
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): No analysis performed
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
24 h
Concentrations:
0.5 mg/l air
No. of animals per sex per dose:
Five males and five females per species
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 48 hours
- Frequency of observations and weighing: Not reported
- Necropsy of survivors performed: Yes
Statistics:
None reported

Results and discussion

Preliminary study:
None
Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LC50
Effect level:
>= 0.5 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
8 h
Remarks on result:
other: rat
Sex:
male/female
Dose descriptor:
LC50
Effect level:
>= 0.5 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
8 h
Remarks on result:
other: mouse
Sex:
male/female
Dose descriptor:
LC50
Effect level:
>= 0.5 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
8 h
Remarks on result:
other: guinea pig
Mortality:
None
Clinical signs:
None
Body weight:
Not measured as an endpoint
Gross pathology:
No significant findings or pathologic lesions
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
TBBPA was not acutely toxic by inhalation in rats, mice or guinea pigs.
Executive summary:

Groups of 10 Wistar rats, 10 NMDI-mice, and 10 guinea pigs (five of each sex/group) were exposed for 8 h to a concentration of 0.5 mg TBBPA/L air, and observed for 48 h after exposure. None of the animals showed symptoms of local or systemic toxicity. No gross pathological findings were observed on necropsy. The 8 h LC50 in three mammalian species was >0.5 mg/L air.