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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April 14 1981 to April 28 1981
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in accordance with GLP; methodology considered similar to then-current standardized guidelines although no analytical verification of test compound concentrations is reported.

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:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
skin abraded prior to substance application
Principles of method if other than guideline:
Product was administered once to freshly abraded rabbit skin sites and allowed to remain for 24 hours.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

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.: 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
- Storage condition of test material: N/A

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Perfection Breeders. Inc.
- Age at study initiation: Not reported
- Weight at study initiation: 2-3 kg
- Fasting period before study: Not reported
- Housing: Individually in appropriately-sized cages
- Diet (e.g. ad libitum): Wayne Rabbit Ration, ad libitum
- Water (e.g. ad libitum): Tap water fit for human consumption, ad libitum
- Acclimation period: Not reported


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

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: Slightly moistened with physiological saline to produce a paste
Details on dermal exposure:
TEST SITE
- Area of exposure: 10% of dorsal body surface
- % coverage: 10% of dorsal body surface
- Type of wrap if used: Layer of gauze covered with a rubber dam


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


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 g/kg
- Concentration (if solution): N/A
- Constant volume or concentration used: Yes
- For solids, paste formed: Yes


VEHICLE
- Amount(s) applied (volume or weight with unit): Not reported
Duration of exposure:
24hrs
Doses:
2 g/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: 2 and 4 hours after exposure period, and then twice daily for a total of 14 days
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs, body weight
Statistics:
Average and standard deviation calculations

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 other: g/kg
Mortality:
None
Clinical signs:
Slight erythema and edema were observed in one of the ten rabbits on day 1
Body weight:
No significant effect
Gross pathology:
No visible lesion in any of the rabbits
Other findings:
None

Any other information on results incl. tables

Table 1: Mean rabbit body weights (with S.D. and N) following 24hr dermal exposure to Tetrabromobisphenol-A

 

Day 0 weight

Day 7 weight

Day 14 weight

Sex

Avg (g)

S.D.

N

Avg (g)

S.D.

N

Avg (g)

S.D.

N

M

2488

70.38

5

2804

174.04

5

2784

259.36

5

F

2438

201.79

5

2592

43187

5

2643

389.37

5

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal LD50 in rabbits for Tetrabromobisphenol-A is greater than 2 g/kg bw
Executive summary:

In an acute dermal toxicity study conducted to GLP, tetrabromobisphenol-A, Lot #R6/PD2, was applied at 2 g/kg of body weight to ten rabbits (five males and five females). The test article was administered directly on the skin which was abraded within two hours prior to application. All animals survived the 2 g/kg dose for the fourteen day observation period. Slight erythema and edema were observed in one of the ten rabbits on Day 1. No other signs were visible during the fourteen day study. Terminal necropsy revealed no visible lesions in any rabbits on study.

The acute dermal LD50 in rabbits for Tetrabromobisphenol-A is greater than 2 g/kg bw.