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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26th January 2001 - 20th September 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted according to standardized OECD/EPA guidelines, with analytical verification of test compound concentrations administered
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.3700 (Prenatal Developmental Toxicity Study)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- 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: 98.91%
- Impurities (identity and concentrations):
Tetrabromobisphenol-A: 98.91%
o,p- tetrabromobisphenol-A: 0.05%
2,4,6-Tribromophenol: <0.01%
Tribromobisphenol-A: 1.04%
- Composition of test material, percentage of components: See Above
- Isomers composition: Not reported
- Purity test date: 4 and 5 January and 9 May 2001
- Lot/batch No.: 5381
- 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: Not reported
- Storage condition of test material: Room temperature, dessiccated, in a dry well-ventilated area
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Portgage MI USA
- Age at study initiation: 10 weeks old at study initiation
- Weight at study initiation: 203 to 274 g
- Fasting period before study: Not reported
- Housing: Individually in hanging wire cages
- Diet (e.g. ad libitum): Rodent Chow #5002, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 2 weeks prior to mating
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 26C
- Humidity (%): 38 to 63%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12 hours light: 12 hours dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Measured weights of TBBPA added pre-determined quantities of corn oil
DIET PREPARATION
- Rate of preparation of diet (frequency): Weekly
- Mixing appropriate amounts with (Type of food): Corn oil, for gavage
- Storage temperature of food: Refrigerated
VEHICLE
- Justification for use and choice of vehicle (if other than water): Not given, standard vehicle
- Concentration in vehicle: Sufficient to give 100, 300, and 1000 mg/kg/day
- Amount of vehicle (if gavage): 5mL per kg
- Lot/batch no. (if required): PU0041, PO0173
- Purity: Not reported - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Prior to initiation oftest article administration, test batches ofthe test article suspensions at the low and high concentrations used in the study (20 and 200 mg/mL, respectively) were prepared to assess the homogeneity of the test preparations employing the same method and batch size to be used during the study.
Validation was performed by HPLC with UV detection, with an internal standard operating procedure. LLOQ = 0.0100 mg/mL
Column: Phenomenex Luna C i 8, (250 mm x 4.6 mm), 5 urn
Guard Column: 0.45 urn ¡nline filter canridge
Column Temp: Ambient
Mobile Phase: A: 10 mM Phosphate buffer (pH = 4) B: Acetonitrle - Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1:1
- Length of cohabitation: Not reported
- Further matings after two unsuccessful attempts: Not reported
- Verification of same strain and source of both sexes: Yes
- Proof of pregnancy Not reported, referred to as day 0 of pregnancy
- Any other deviations from standard protocol: None reported - Duration of treatment / exposure:
- Exposed to 100, 300, and 1000 mg/kg/day from Day 0 of gestation to Day 19
- Frequency of treatment:
- Daily
- Duration of test:
- 20 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100, 300, 1000 mg/kg/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 25 females per dose plus control
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Based on available data from previous studies
- Rationale for animal assignment (if not random): Random
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Twice daily, seven days a week for morbidity, mortality, and signs of injury
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Daily
BODY WEIGHT: Yes
- Time schedule for examinations: On Days 0, 3,6, 9, 12, 15, 18, and 20 of gestation.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day #20
- Organs examined: uterus, placenta, standard gross necropsy on maternal rats, fetal examinations - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: half per litter
- Skeletal examinations: Yes: half per litter
- Head examinations: No data - Statistics:
- Group Pair-Wise Comparisons; Fisher's Exact Test; Arcsin-Square-Root transformation; Covariate analysis; Descriptive
- Indices:
- Fertility indices
- Historical control data:
- See table below
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
One mortality determined to be result of dosing injury; salivation effects determined to be sporadic and not related to dose
Effect levels (maternal animals)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
The few external findings (malformations and variations) seen in the treated groups occurred with low incidence on both a per fetus and per litter basis and were considered unrelated to treatment. The litter incidences for these findings for the treated groups did not differ statistically from controls.
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: All measured endpoints
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- In this oral developmental toxicity study in rats with Tetrabromobisphenol A, the NOAEL (No Observable Adverse Effect Level) for maternal and developmental toxicity was 1000 mg/kg/day, the highest dose level evaluated.
- Executive summary:
The objective of this study was to provide general information concerning the effects of oral treatment of the pregnant rat with Tetrabromobisphenol A (TBBP A) on the developing organism. This included death, structural abnormalities or altered growth, and assessment of maternal effects. Female CD rats were mated in-house and received the TBBPA at dose levels of 0, 100, 300, and 1000 mg/kg/day at a constant volume of 5 mL/kg. The test article was administered orally by gavage as a single daily dose.
Observations of the dams included clinical signs, gestational body weights, and food consumption. Females were euthanized on Day 20 of gestation and given a postmortem macroscopic examination. All fetuses were given a gross external examination for malformations and variations. Approximately one-half of the fetuses in each litter were fixed in Bouin's solution, and the remaining fetuses were skinned and preserved in alcohol.
Pretest analyses confirmed that the suspensions as prepared were homogeneous and stable for at least 14 days when stored refrgerated. Periodic analysis of dosing suspensions used on study ranged from 88 to 113% of nominal and confirmed that animals were receiving the appropriate dose levels.
No treatment-related mortality was seen. The death of 1 animal in the 300 mg/kg/day group on Gestation Day 5 was attributed to an intubation injury. All other animals survived to scheduled euthanasia.
Salivation was seen among the TBBPA-treated animals, occurring most frequently at the 300 and 1000 mg/kg/day dose levels, Because of its sporadic occurrence, this was not considered to represent a direct effect of treatment with TBBPA, but more likely was in response to the taste of residual amounts oftest article on the dosing catheter. No other effects of treatment were seen from the clinical examinations, and no effect of treatment was evident from gestational parameters (body weight, body weight gain, or food consumption), uterine implantation data, liver weights, or necropsy findings, Likewise, no effect of treatment was evident from fetal body weights, fetal sex distribution, or from fetal external, visceral, or skeletal examinations.
Thus, in this oral developmental toxicity study in rats with TBBPA, the NOAEL (No Observable Adverse Effect Level) for maternal and developmental toxicity was 1000 mg/kg/day, the highest dose level evaluated.
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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