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Diss Factsheets
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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27th April - 5th June 1981
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Tetrabromo Bisphenol-A, Lot # R6/FD2, was dermally applied to ten guinea pigs for a total of nine six-hour insult periods. A positive control group consisting of 10 guinea pigs was treated with 2 -4 dinitrochlorobenzene.
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The study was conducted before the testing guidelines for LLNA (OECD 429) was available.
Test material
- Details on test material:
- - Name of test material (as cited in study report): Tetrabromo Bisphenol-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: Stable; "there was no apparent change in thephysical state of the test article or control article during adminstration"
- Storage condition of test material: Not reported
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Perfection Breeders, Inc, Douglassville, Penn. USA
- Age at study initiation: Not reported
- Weight at study initiation: 220 to 500 grams
- Housing: Two per cage, in stainless steel 1/2" wire mesh cages
- Diet (e.g. ad libitum): Wayne Guinea Pig Diet, 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
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Moistened with 80% ethanol
- Concentration / amount:
- 500 mg per induction site
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Moistened with 80% ethanol
- Concentration / amount:
- 500 mg per induction site
- No. of animals per dose:
- Ten
- Details on study design:
- RANGE FINDING TESTS: N/A
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: One
- Exposure period: Six hours
- Test groups: One group of 10
- Control group: one group of ten exposed to 2-4 dinitrochlorobenzene
- Site: Dorsal area
- Frequency of applications: See below
- Duration: a total of three weeks
- Concentrations: 500 mg/site
B. CHALLENGE EXPOSURE
- No. of exposures: Eight (not including intial exposure; rotated between application sites, giving a total of three exposures per site )
- Day(s) of challenge: Every Monday, Wednesday, and Friday for three weeks
- Exposure period: Six hours
- Test groups: 10 guinea pigs
- Control group: 10 guinea pigs exposed to 2-4 dinitrochlorobenzene
- Site: Dorsal area (split into three application sites, and dosed on a rotating basis)
- Concentrations: 500 mg/site
- Evaluation (hr after challenge): Treated sites examined 7, 24, and 48 hours after each exposure - Challenge controls:
- 2,4 dinitrochlorobenzene: 1%/mL/site
- Positive control substance(s):
- yes
- Remarks:
- 2,4 dinitrochlorobenzene
Results and discussion
- Positive control results:
- 2,4 dinitrochlorobenzene elicited positive responses at challenges I and II
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 500 mg
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 mg
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No
- Remarks on result:
- not measured/tested
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 1% /ml/site
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Erythema duing induction
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
Table 1: Average Scores at 7, 24, 48 hours following Challenge I and II
|
Challenge I |
Challenge II |
||||||||||
Site I |
Site II |
Site I |
Site II |
|||||||||
Test article |
7 |
24 |
48 |
7 |
24 |
48 |
7 |
24 |
48 |
7 |
24 |
48 |
Tetrabromobisphenol-A (500 mg) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
DNCB (1%) |
1 |
1 |
1 |
1 |
1.5 |
1 |
1 |
1 |
1.2 |
1 |
1 |
2 |
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Tetrabromo Bisphenol-A, Lot #R6-FD2, did not cause delayed hypersensitivity in guinea pigs.
- Executive summary:
Tetrabromobisphenol-A, Lot # R6/FD2, was dermally applied to ten guinea pigs for a total of nine six-hour insult periods. A positive control group consisting of 10 guinea pigs was treated with 2,4 dinitrochlorobenzene. Approximately fourteen days after the last senstizing exposure, the animals were challenged in the same manner at both the site of sensitizing and a second challenge site. 48 hours after the first challenge, a second challenge was made. A positive reposnse was elicited by the animals receiving 2,4 dinitrochlorobenzene at challenges I and II. Erythema was observed during induction at 7 hours post doses 3 and 9, 24 hours post doses 3, 6, and 9, and 48 hours post doses 3, 6, and 9. No irritation was observed during induction or challenge periods with Tetrabromo Bisphenol-A.
Tetrabromo Bisphenol-A, Lot # R6/FD2, did not cause delayed hypersensitivity in guinea pigs.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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