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EC number: 201-236-9 | CAS number: 79-94-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05 January 2005 to 20 April 2005 (experimental phase)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Methodology conducted according to OECD guidelines under GLP principles
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 428 (Skin Absorption: In Vitro Method)
- GLP compliance:
- yes
Test material
- Details on test material:
- - Name of test material (as cited in study report): Tetrabromobisphenol-A (TBBPA)
- 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: Radiolabelled test item- dissolved in ethanol; Non-radiolabelled- white powder
- Analytical purity: Radiolabelled= 99.6%; Non-radiolabelled=99.20%
- Impurities (identity and concentrations): Not reported
- Composition of test material, percentage of components:
Non-radiolabelled= 99.20% TBBPA, 0.02% Tribromophenol, 0.75% TriBPA, 0.03% o,p-TBBPA
- Isomers composition: Not reported
- Purity test date: Not reported
- Lot/batch No.: Radiolabelled= No. CFQ14174; Non-radiolabelled= #TS6404
- Expiration date of the lot/batch: Not reported
- Radiochemical purity (if radiolabelling): 99.6% (determined by HPLC)
- Specific activity (if radiolabelling): 1.0mCi/mL in ethanol; 56mCi/mmol when undissolved
- Locations of the label (if radiolabelling): Not reported
- Expiration date of radiochemical substance (if radiolabelling): Not reported
- Stability under test conditions: Not reported
- Storage condition of test material: Radiolabelled test item: at -20C in the dark; Non-radiolabelled test item: at ambient temperature in the dark
- Other:
Constituent 1
- Radiolabelling:
- yes
Test animals
- Species:
- human
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST SKIN
- Source: Skin washing experiment: obtained from female surgery patients aged 19 to 49 years old; Absorbtion experiment: obtained from female surgery patients aged 25 to 57 years old
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Stored at -20C, and thawed prior to use
- Humidity (%): Not reported
- Air flow rate: about 1.5 mL/h
- Photoperiod (hrs dark / hrs light): Not reported
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- acetone
- Duration of exposure:
- Single dose applied to skin surface, with vehicle evaporation and observations for 24hours post-application.
- Doses:
- - Nominal doses: 1.9 mg/cm2
- Actual doses: 2.0 mg/cm2
- Actual doses calculated as follows: Absorbed dose was 0.73% of the applied dose; Dermal delivery was 1.60% of the applied dose
- Dose volume: 6.4 uL
- Rationale for dose selection: None given - No. of animals per group:
- 10 samples of human skin
- Control animals:
- no
- Details on study design:
- DOSE PREPARATION
- Method for preparation of dose suspensions:
- Method of storage:
APPLICATION OF DOSE:
VEHICLE
- Justification for use and choice of vehicle (if other than water): Solubility of TBBPA in acetone is greater than water, and acetone evaporates faster
- Amount(s) applied (volume or weight with unit): 6.4 uL
- Concentration (if solution): 1246 ug/6.4 uL
TEST SITE
- Preparation of test site: Skin placed in a flow-through diffusion cell
- Area of exposure: 0.64 cm2
- % coverage: total?
- Type of cover / wrap if used: N/A
- Time intervals for shavings or clippings: N/A
REMOVAL OF TEST SUBSTANCE
- Removal of protecting device: N/A
- Washing procedures and type of cleansing agent: 50 uL of Radox Supersoap
- Time after start of exposure: 8hr after exposure
ANALYSIS
- Method type(s) for identification: Liquid scintillation counting
- Liquid scintillation counting results (cpm) converted to dpm as follows: Not reported
- Validation of analytical procedure: Not reported
- Limits of detection and quantification: Not reported - Details on in vitro test system (if applicable):
- SKIN PREPARATION
- Source of skin: Plastic surgery patients
- Ethical approval if human skin: Yes
- Type of skin: Breast and upper arm
- Preparative technique: placed in flow-through cell and acetone vehicle evaporated
- Thickness of skin (in mm): Full thickness (690 to 1550 um)
- Membrane integrity check: yes
- Storage conditions: at -20C until use
- Justification of species, anatomical site and preparative technique:
PRINCIPLES OF ASSAY
- Diffusion cell: Flow-through
- Receptor fluid: Ethanol and water, 1:1 v/v
- Solubility of test substance in receptor fluid: water solubility = 1.26 ppm and ethanol solubility = 80% w/w
- Static system: No
- Flow-through system: Yes
- Test temperature: 32C
- Humidity: Not reported
- Occlusion: Yes
- Reference substance(s): None
Results and discussion
- Signs and symptoms of toxicity:
- not specified
- Dermal irritation:
- not specified
- Absorption in different matrices:
- - Non-occlusive cover + enclosure rinse:
- Skin wash: 24.97% of applied dose when washed 8h after exposure
- Skin test site: 24hr mean total unabsorbed dose= 102.26% of radioactivity
- Skin, untreated site: 0.25% of radioactivity
- Blood: N/A
- Carcass: N/A
- Urine: N/A
- Expired air (if applicable): N/A
- Serial non-detects in excreta at termination: N/A
- Receptor fluid, receptor chamber, donor chamber (in vitro test system): ranged from 0.30% to 1.74% of applied dose
- Skin preparation (in vitro test system): See table below
- Stratum corneum (in vitro test system): The bulk of the radioactivity (9.47%) was recovered in the outermost 5 tape strips - Total recovery:
- Total recovery ranged from 99.27 to 108.8%
- Conversion factor human vs. animal skin:
- N/A
Any other information on results incl. tables
Table 1: Distribution of Radioactivity (% Applied Dose) at 24 h Post Dose Following Topical Application of TBBPA in Acetone Vehicle to Human Split‑Thickness Skin
|
Cell Number and Donor Number |
|
|
|||||||||
|
Cell 40 |
Cell 41 |
Cell 42 |
Cell 43 |
Cell 44 |
Cell 54 |
Cell 55 |
Cell 57 |
Cell 58 |
Cell 59 |
|
|
|
0095 |
0100 |
0109 |
0112 |
0113 |
0100 |
0109 |
0113 |
0112 |
0098 |
Mean |
SD |
Skin Wash 8 h |
27.95 |
28.61 |
17.45 |
39.54 |
28.69 |
27.08 |
12.70 |
19.57 |
17.31 |
10.89 |
24.97 |
8.76 |
Tissue Swab 8 h |
0.84 |
2.89 |
5.09 |
0.11 |
3.20 |
3.18 |
4.58 |
0.29 |
2.00 |
3.44 |
2.38 |
1.77 |
Pipette Tips 8 h |
0.08 |
0.05 |
0.01 |
0.31 |
0.05 |
0.09 |
0.04 |
0.14 |
0.43 |
0.05 |
0.10 |
0.09 |
Total Q-Tips |
31.19 |
36.04 |
27.96 |
60.37 |
37.64 |
32.21 |
37.77 |
29.89 |
46.73 |
17.33 |
34.08 |
12.28 |
Dislodgeable Dose 8 h |
60.05 |
67.59 |
50.51 |
100.32 |
69.57 |
62.55 |
55.08 |
49.89 |
66.47 |
31.71 |
61.52 |
19.84 |
Tissue Swab 24 h |
1.49 |
1.34 |
1.52 |
0.15 |
0.87 |
1.02 |
2.39 |
1.70 |
6.24 |
1.28 |
1.17 |
0.49 |
Cell Wash |
26.85 |
18.52 |
33.36 |
0.95 |
22.06 |
31.07 |
32.97 |
26.54 |
17.09 |
55.38 |
26.84 |
15.30 |
Total Dislodgeable Dose |
88.39 |
87.45 |
85.39 |
101.42 |
92.49 |
94.64 |
90.45 |
78.13 |
89.80 |
88.37 |
89.53 |
6.87 |
Stratum Corneum 1-5 |
6.78 |
8.69 |
9.34 |
1.41 |
8.06 |
5.45 |
7.37 |
21.11 |
10.54 |
14.88 |
9.47 |
6.04 |
Stratum Corneum 6-10 |
0.85 |
1.73 |
1.46 |
0.15 |
0.97 |
0.73 |
2.05 |
4.96 |
1.51 |
1.32 |
1.52 |
1.47 |
Stratum Corneum 11-15 |
0.39 |
0.43 |
0.95 |
0.06 |
0.99 |
0.40 |
1.44 |
2.44 |
0.48 |
1.23 |
0.86 |
0.75 |
Stratum Corneum 16-20 |
0.42 |
0.37 |
0.61 |
0.05 |
0.15 |
0.24 |
0.46 |
0.54 |
0.32 |
0.91 |
0.41 |
0.27 |
Stratum Corneum 21-25 |
0.21 |
0.48 |
0.22 |
0.01 |
0.01 |
0.32 |
0.54 |
0.18 |
0.25 |
0.29 |
0.22 |
0.16 |
Total Stratum Corneum |
8.65 |
11.71 |
12.59 |
1.69 |
10.19 |
7.14 |
11.86 |
29.22 |
13.09 |
18.62 |
12.48 |
8.31 |
Unexposed Skin |
0.09 |
0.16 |
0.27 |
0.06 |
0.05 |
0.13 |
0.09 |
0.08 |
0.11 |
1.16 |
0.25 |
0.37 |
Total Unabsorbed |
97.12 |
99.31 |
98.24 |
103.17 |
102.74 |
101.91 |
102.40 |
107.43 |
103.00 |
108.16 |
102.26 |
4.03 |
Exposed Skin |
1.14 |
0.87 |
1.49 |
0.26 |
0.78 |
1.63 |
4.22 |
0.63 |
2.02 |
0.16 |
0.87 |
0.53 |
Receptor Fluid |
1.00 |
0.84 |
1.74 |
0.49 |
0.30 |
0.39 |
0.75 |
0.44 |
3.61 |
0.54 |
0.72 |
0.48 |
Receptor Rinse |
0.01 |
0.01 |
0.02 |
0.00 |
0.00 |
0.01 |
0.02 |
0.01 |
0.18 |
0.02 |
0.01 |
0.01 |
Total Absorbed |
1.01 |
0.85 |
1.76 |
0.50 |
0.31 |
0.40 |
0.76 |
0.46 |
3.79 |
0.56 |
0.73 |
0.48 |
Dermal Delivery |
2.15 |
1.71 |
3.25 |
0.76 |
1.09 |
2.03 |
4.98 |
1.09 |
5.81 |
0.72 |
1.60 |
0.86 |
Mass Balance |
99.27 |
101.02 |
101.49 |
103.92 |
103.83 |
103.94 |
107.38 |
108.51 |
108.81 |
108.88 |
103.86 |
3.41 |
Table 2: Distribution of [14C]‑TBBPA (µg equiv./cm2) at 24 h Post Dose Following Topical Application of TBBPA in Acetone Vehicle to Human Split‑Thickness Skin
|
Cell Number and Donor Number |
|
|
|||||||||
|
Cell 40 |
Cell 41 |
Cell 42 |
Cell 43 |
Cell 44 |
Cell 54 |
Cell 55 |
Cell 57 |
Cell 58 |
Cell 59 |
|
|
|
0095 |
0100 |
0109 |
0112 |
0113 |
0100 |
0109 |
0113 |
0112 |
0098 |
Mean |
SD |
Dislodgeable Dose 8 h |
1202.93 |
1353.96 |
1011.84 |
2009.68 |
1393.62 |
1253.09 |
1103.44 |
999.34 |
1331.44 |
635.30 |
1232.47 |
397.44 |
Total Dislodgeable Dose |
1770.57 |
1751.82 |
1710.45 |
2031.63 |
1852.86 |
1895.77 |
1811.87 |
1565.05 |
1798.82 |
1770.29 |
1793.56 |
137.62 |
Stratum Corneum |
173.19 |
234.49 |
252.13 |
33.80 |
204.14 |
143.11 |
237.62 |
585.39 |
262.30 |
373.06 |
249.91 |
166.49 |
Total Unabsorbed |
1945.48 |
1989.41 |
1967.95 |
2066.63 |
2058.08 |
2041.57 |
2051.27 |
2151.97 |
2063.38 |
2166.61 |
2048.46 |
80.82 |
Total Absorbed |
20.18 |
16.95 |
35.34 |
9.94 |
6.11 |
7.95 |
15.29 |
9.12 |
75.85 |
11.23 |
14.60 |
9.61 |
Dermal Delivery |
43.06 |
34.30 |
65.17 |
15.21 |
21.84 |
40.61 |
99.72 |
21.76 |
116.38 |
14.48 |
32.05 |
17.32 |
Total Recovery |
1988.53 |
2023.72 |
2033.12 |
2081.84 |
2079.91 |
2082.18 |
2151.00 |
2173.73 |
2179.75 |
2181.09 |
2080.52 |
68.39 |
Cell 55 was rejected from mean + SD as this was an outlier for dermal delivery
Cell 58 was rejected from mean + SD as this was damaged during the 8 h washing process
Applicant's summary and conclusion
- Conclusions:
- in vitro skin permeability study in human (split thickness) skin of 14C-TBBPA: < 1% of dose absorbed. The stratum corneum was an efficient barrier to [14C]-TBBPA penetration.
- Executive summary:
In an In Vitro percutaneous absorption study of radiolabelled tetrabromobisphenol A (TBBPA) through human skin conducted to GLP in accordance with OECD Guideline 428, radiolabelled [14C]‑TBBPA was applied in vitro in an acetone vehicle at 10 µL/cm2 to human split‑thickness skin membranes mounted using flow‑through diffusion cells. The acetone evaporated rapidly from the skin surface leaving behind the [14C]‑TBBPA (1.9 mg/cm2).
Following this topical application of [14C]-TBBPA to human split‑thickness skin in vitro, the absorbed dose and dermal delivery were 0.73% (14.60 µg.equiv./cm2) and 1.60% (32.05 µg.equiv./cm2) of the applied dose, respectively.
At 8 h post dose, the dislodgeable dose was 61.52% of the applied dose. At 24 h post dose, a further 28.01% was dislodged from the skin. Therefore, the total dislodgeable dose was 89.53% of the applied dose.
The stratum corneum contained a further 12.48% of the applied dose. The bulk of this (9.47%) was recovered in the first 5 tape strips. Since the bulk of the stratum corneum associated material was found in the first 5 tapes strips, this indicated that the [14C]‑TBBPA was on the surface of the skin and that the stratum corneum was an efficient barrier to [14C]-TBBPA penetration.
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