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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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28th October 1977 - 16th February 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No GLP data; methodology predates or was not conducted according to standardized guidelines; no analytical verification of test compound concentrations
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Tetrabromobisphenol-A was applied to the shaved skin of male and female rabbits 5 days a week for three weeks at dose levels of 100, 500, and 2500 mg/kg/day.
- GLP compliance:
- not specified
- 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: 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.: 1021-85, received from Velsicol Chemical Corp.
- 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: Not reported
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Sweetwater Farms, Hillsboro, Ohio USA
- Age at study initiation: Not reported
- Weight at study initiation: Male- 1886 to 2284g; Female- 2030 to 2311g
- Fasting period before study: Not reported
- Housing: Individually in hanging wire mesh cages
- Diet (e.g. ad libitum): Purina Rabbit Chow, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Controlled, not specified
- Humidity (%): Controlled, not specified
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Controlled, not specified
Administration / exposure
- Type of coverage:
- open
- Vehicle:
- other: 0.9% physiological saline to form paste
- Details on exposure:
- TEST SITE
- Area of exposure: Dorsal area
- % coverage: 10% of body area
- Type of wrap if used: N/A
- Time intervals for shavings or clipplings: "As necessary"
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Area wiped clean
- Time after start of exposure: Approx 6 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100, 500, 2500 mg/kg/day
- Concentration (if solution): 100, 500, 2500 mg/kg/day
- Constant volume or concentration used: yes/no
- For solids, paste formed: Yes
VEHICLE
- Justification for use and choice of vehicle (if other than water): Saline (physiological)
- Amount(s) applied (volume or weight with unit): 1.5 mL/kg
- Concentration (if solution): 100, 500, 2500 mg/kg/day
USE OF RESTRAINERS FOR PREVENTING INGESTION: Yes, collars - Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- Not performed
- Duration of treatment / exposure:
- 15 exposures of 6 hours each
- Frequency of treatment:
- 5 days a week for three weeks
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100, 500, and 2500
Basis:
nominal per unit body weight
- No. of animals per sex per dose:
- 4 males and 4 females
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Increase of 5x
- Rationale for animal assignment (if not random): Random
- Section schedule rationale (if not random): Random - Positive control:
- None
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Daily
- Cage side observations: signs of overt toxicity, moribundity and mortality
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: At time 0 and at week 3
DERMAL IRRITATION (if dermal study): Yes
- Time schedule for examinations: After each 6-hour exposure
BODY WEIGHT: Yes
- Time schedule for examinations: Weekly
HAEMATOLOGY: Yes
- Time schedule for collection of blood: At time 0 and at week 3
- Anaesthetic used for blood collection: No data
- Animals fasted: Yes, overnight
- How many animals: All
- Parameters examined: hemoglobin, hematocrit, erythrocyte count, leucocyte count
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: At time 0 and at week 3
- Animals fasted:Yes, overnight
- How many animals: all
- Parameters examined: Blood urea nitrogen, fasting glucose, serum alkalie phosphatase, serum glutamic oxalacetic transaminase, serum glutamin pyruvic transaminase, calcium, inorganic phosphorus, total protein and albumin.
URINALYSIS: Yes
- Time schedule for collection of urine: at time 0 and week 3
- Metabolism cages used for collection of urine: No data
- Animals fasted: Yes
- Parameters examined: specific gravity, color and appearance, pH , and qualitative tests for albumin, glucose, ketones, occult blood and bilirubin - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes- spleen, liver, adrenals, testes/ovaries, thyroid/ parathyroid, brain, and kidneys
HISTOPATHOLOGY: Yes (see table) - Statistics:
- One-way ANOVA, Bartlett's test, Dunnett's
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Dermal irritation:
- effects observed, treatment-related
- Description (incidence and severity):
- See table below
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- See explanation below
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- ORGAN WEIGHTS: There was a statistically significant increase in mean absolute brain weight for males in the 500-mg/kg/day group. The biological significance of this variation is not known.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 2 500 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: Mortality
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Table: description of dermal effects observed in rabbits exposed to TBBPA
Treatment level |
Effect |
Degree |
Number affected |
Duration |
100 mg/kg/day |
Erythema |
Very slight |
2 |
Short –term, not specified |
500 mg/kg/day |
Erythema |
Very slight |
8 |
1 to 3 days |
2500 mg/kg/day |
Erythema |
Very slight |
6 |
3+ days |
Applicant's summary and conclusion
- Conclusions:
- There was no mortality in any group. The animals did not show any signs of systemic toxicity or unusual behavior. Very slight erythema was observed in all exposures. No compound induced gross lesions were observed in any of the rabbits at the terminal sacrifice. There were no compound-related microscopic alterations observed in any of the tissues examined.
- Executive summary:
TBBPA was administered to the backs of New Zealand White rabbits,at dosage levels of 100, 500 and 2500 mg/kg/day, 5 days a week, for 3 weeks. Four male and four females rabbits were used at each dosage level and also in a control group. The control rabbits were administered 1.5 ml/kg of 0.9% physiological saline on the same regimen as treated rabbits. The compound was mixed with 0.9% physiological saline to form a paste which was applied. The rabbits were observed daily for signs of overt toxicity, dermal irritation, moribundity and mortality . Body weights were recorded weekly. Hematologic and biochemical studies and urinalyses were conducted during the pretest period and at 3 weeks of study. There was no mortality and no sign of overt toxicity or unusual behavior for the rabbits in any group.
The application of TBBA
on the skin of rabbits at a dosage of 100 mg/kg/day occasionally elicited very slight erythema. The dosage of 500 and 2500 mg/kg/day evoked very slight erythema for almost all rabbits for varying lengths of time. There were no other signs of skin irritation or any signs of toxicity. No changes considered to be related to compound were seen in body weights, hematologic and biochemical parameters and urinalysis. There were no compound induced gross or microscopic lesions in any of the tissues examined. No compound-related organ weight variations occurred.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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