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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16th - 19th April 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP study conducted according to older guidelines; no analytical verification of test concentrations

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981
Reference Type:
publication
Title:
RISK ASSESSMENT of 2,2’,6,6’-TETRABROMO-4,4’-ISOPROPYLIDENE DIPHENOL.
Author:
EU risk assessment: United Kingdom (TBBPA)
Year:
2008
Bibliographic source:
Environment Agency Chemicals Assessment Section United Kingdom
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Tetrabromobisphenol-A was moistened with saline and applied to the abraded skin of six rabbits.
GLP compliance:
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 ("The purity of the test article was the responsibility of the sponsor")
- 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: Not reported
- Storage condition of test material: Not reported

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Perfection Breeders, Inc. Douglassville, Penn US
- Age at study initiation: Adult
- Weight at study initiation: 2-3kg
- Housing: Individually in cages
- Diet (e.g. ad libitum): Wayne Rabbit Ration, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Seven day period

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 72 +/- 5F
- Humidity (%): Ambient
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 10 hours light: 14 hours dark

Test system

Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
physiological saline
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
- Concentration (if solution): N/A

VEHICLE
- Amount(s) applied (volume or weight with unit): Small amount, enough to form a paste
Duration of treatment / exposure:
24 hr exposure
Observation period:
48 hours
Number of animals:
Six
Details on study design:
TEST SITE
- Area of exposure: One square inch shaved abraded/intact surface
- % coverage: Not reported
- Type of wrap if used: Square of gauze, covered with rubber dental dam

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Area wiped clean
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize Evaluation of Dermal Irritation

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: No effects observed
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: No effects observed
Irritant / corrosive response data:
No response; not an irritant

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: Draize Evaluation of Dermal Irritation
Conclusions:
Based on the observations made in the Primary Dermal Irritation Study in rabbits, Tetrabromo Bisphenol-A Lot #R6/FD2 is considered to be a non-dermal irritant.
Executive summary:

Tetrabromobisphenol-A was applied to two intact and two abraded skin sites on each of six rabbits (three males and three females). No signs of erythema or edema were visible in any rabbits at the 24 or 72 hour observation periods.

Based upon the observations made in the Primary Dermal Irritation Study in Rabbits, Tetrabromobisphenol-A is considered to be a non-dermal irritant.