Registration Dossier
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EC number: 306-832-3 | CAS number: 97416-84-7
- 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

Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro DNA damage and/or repair study
- Remarks:
- Type of genotoxicity: DNA damage and/or repair
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given. The summary report is taken from IPCS Environmental Health Criteria 172 (WHO), which is a relayble internationally accepted sorce. The justification for the Read Across approach has been attached to the Section 13
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Tetrabromobisphenol A and Derivatived (Environmental health criteria ; 172).
- Author:
- G.J. van Esch
- Year:
- 1 995
- Bibliographic source:
- World Health Organization; IPCS
- Reference Type:
- other: Secondary Source
- Title:
- In vitro sister chromatid exchange in Chinese hamster ovary cells with GLCC 785-104C
- Author:
- Cavagnaro J & Cortina TA
- Year:
- 1 984
- Bibliographic source:
- Vienna, Virginia, Hazleton Biotechnologies Corporation
Materials and methods
- Principles of method if other than guideline:
- No available information on method used.
- GLP compliance:
- not specified
- Type of assay:
- sister chromatid exchange assay in mammalian cells
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Details on mammalian cell type (if applicable):
- No data available
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- No data available
- Test concentrations with justification for top dose:
- 5, 17, 50, 170, and 500 µg/ml
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- not specified
- Details on test system and experimental conditions:
- DURATION
- Exposure duration: 2 hours
- Expression time (cells in growth medium): 24 hours
Results and discussion
Test results
- Species / strain:
- not specified
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- No statistically significant increases in the number of exchanges per chromosome or the number of exchanges per cell were seen at any of the levels tested, either with, or without, metabolic activation.
Any other information on results incl. tables
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Not Mutagenic - Executive summary:
References
The evaluation of Genetic toxicity reported from Cavagnaro J & Cortina TA (1984)[1] in the WHO publication[2] has been considered in order to complete the assessment.
Method and observations
Chinese hamster ovary cells (CHO, K-1, number CCL61) were exposed to 5 concentrations of the substance in DMSO (5, 17, 50, 170, and 500 µg/ml) for 2 h in the presence, or absence, of metabolic activation followed by a 24 h expression period in comparison with solvent and positive controls. At dosing, it was noted that the culture medium became cloudy at 170 µg/ml and that the compound precipitated at 500 µg/ml.
Results
No statistically significant increases in the number of exchanges per chromosome or the number of exchanges per cell were seen at any of the levels tested, either with, or without, metabolic activation. The substance is considered to be negative in this system
[1]Cavagnaro J & Cortina TA (1984) In vitrosister chromatid exchange in Chinese hamster ovary cells with GLCC 785-104C (Final report). Vienna, Virginia, Hazleton Biotechnologies Corporation (Report to Great Lakes Chemical Corporation, West Lafayette, submitted to WHO by the Brominated Flame Retardant Industry Panel).
[2]World Health Organization (WHO, Geneva, 1995); Dr. G.J. van Esch “Tetrabromobisphenol A and Derivatived” (Environmental health criteria; 172)
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