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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
8th - 15th April 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP study conducted according to non-standardized guidelines; no analytical verification

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:
Test article placed, undiluted, into the right eyes of three males and three female rabbits, which were observed for 7 days post-instillation.
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: "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: Stable: "there was no apparent change in the physical state of the the article during administration"
- Storage condition of test material: Not reported

Test animals / tissue source

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

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

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
- Concentration (if solution): N/A

VEHICLE: no vehicle used
Duration of treatment / exposure:
Administered once, and then subjects observed for seven days
Observation period (in vivo):
Seven days
Number of animals or in vitro replicates:
Six: three males and three females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not washed
- Time after start of exposure: N/A

SCORING SYSTEM: According to Draize (1965)

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
Four of the rabbits exhibited a slight redness at the one hour observation period. These signs were not present at the 24 hour observation. No other ocular reactions to the test material were observed during the study.
Other effects:
None reported

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: US CPSC / US FDA
Conclusions:
None of the rabbits exhibited a positive reaction to the test article. Therefore, tetrabromobisphenol-A is considered to be a non-irritant.
Executive summary:

Tetrabromobisphenol-A was instilled in the right eye of six rabbits (three males and three females). The untreated left eye served as the negative control.

Four rabbits exhibited slight redness at the one hour observation period. No other ocular reactions were observed during the study.

Based upon the observations made in the Acute Eye Irritation Test, Tetrabromobisphenol-A is considered to be a non-eye irrritant.