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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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

Constituent 1
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 or test system 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:
other: 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.