2,2',6,6'-tetrabromo-4,4'-isopropylidenediphenol

Acute Toxicity: dermal

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

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Reference 2

Reference Type:

publication

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

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

Test material information

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.: 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 or test system 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:

other: Slight erythema and edema were observed in one of the ten rabbits on day 1

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.