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Diss Factsheets
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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
Toxicity to reproduction
Administrative data
- Endpoint:
- two-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- 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: Well-documented publication which meets basic scientific principles. The justification for the Read Across approach has been attached to the Section 13.
Data source
Referenceopen allclose all
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 014
- Reference Type:
- other: Secondary Source
- Title:
- 2,2’,6,6’-tetrabromo-4,4’-isopropylidenediphenol (tetrabromobisphenol-A or TBBP-A) Part II – human health 4th Priority List, Vol. 63.
- Author:
- ECB - European Chemical Bureau
- Year:
- 2 006
- Bibliographic source:
- Institute for Health and Consumer Protection, European Chemicals Bureau, European Commission Joint Research Centre, Luxembourg
Materials and methods
- Principles of method if other than guideline:
- No available information on method used.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Similar Substance 02
- IUPAC Name:
- Similar Substance 02
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No available data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on exposure:
- F0 generation
♂
Exposition premating period: 10 weeks
Exposition mating period: 2 weeks
♀
Exposition premating period: 10 weeks
Exposition mating period: 2 weeks
Exposition during gestation and lactation: Yes
F1 generation
♂
Exposition premating period: 10 weeks
Exposition mating period: 2 weeks
♀
Exposition premating period: 10 weeks
Exposition mating period: 2 weeks
Exposition during gestation and lactation: Yes - Details on mating procedure:
- The F0 generation was sacrificed after the pups were weaned
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No available data
- Duration of treatment / exposure:
- Premating period: 10 weeks
Mating period: 2 weeks
For female exposition to the test substance during gestation and lactation. - Frequency of treatment:
- Daily
- Details on study schedule:
- No available data
Doses / concentrations
- Remarks:
- Doses / Concentrations:
10 mg/kg bw/day
Basis:
no data
- No. of animals per sex per dose:
- No available data
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- No available data
- Positive control:
- No available data
Examinations
- Parental animals: Observations and examinations:
- No available data
- Oestrous cyclicity (parental animals):
- No available data
- Sperm parameters (parental animals):
- No available data
- Litter observations:
- No available data
- Postmortem examinations (parental animals):
- No available data
- Postmortem examinations (offspring):
- No available data
- Statistics:
- No available data
- Reproductive indices:
- No available data
- Offspring viability indices:
- No available data
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- 1000 mg/kg bw/day group: T4 lower (F0 ♂ ♀); T3 lower (F0 ♂);
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
Effect levels (P0)
- Remarks on result:
- not measured/tested
- Remarks:
- Data no available in the NTP
Results: P1 (second parental generation)
Effect levels (P1)
- Remarks on result:
- not measured/tested
- Remarks:
- Data not available in the NTP.
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- 1000 mg/kg bw/day group: T4 lower (F1 ♂ ♀); 100 mg/kg bw/day group: T4 lower (F1 ♂ ♀)
- Mortality / viability:
- not specified
- Body weight and weight changes:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- no effects observed
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- ca. 1 000 mg/kg bw/day
- Based on:
- not specified
- Sex:
- male/female
- Basis for effect level:
- other: decreased level of T3 (M), T4 (M,F)
Results: F2 generation
Target system / organ toxicity (F2)
- Critical effects observed:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
The F0 generation was sacrificed after the pups were weaned, and decreases in T4 levels were found at the high dose in males and females. In the F1 generation, lower serum T4 concentrations were observed in both sexes at 100 and 1000 mg/kg. T3 serum levels were significantly lower only in F0 males of the 1000 mg/kg group. No changes in serum TSH levels, compared to vehicle control animals, were observed in any of the treated groups.
Applicant's summary and conclusion
- Conclusions:
- NOAEL = 1000 mg/kg bw/day
- Executive summary:
Method
The effects on reproductive performance and fertility were evaluated in a 2 generation study. The substance was administered daily by oral gavage. Sprague Dawley rats were exposed to 10, 100, or 1000 mg/kg bw/day in the F0 generation during 10 weeks premating and during a 2-week mating period. Females were treated also during gestation and lactation. The same treatment regime as in F0 animals was also applied in F1 animals.
Observations
The F0 generation was sacrificed after the pups were weaned, and decreases in T4 levels were found at the high dose in males and females. In the F1 generation, lower serum T4 concentrations were observed in both sexes at 100 and 1000 mg/kg. T3 serum levels were significantly lower only in F0 males of the 1000 mg/kg group. No changes in serum TSH levels, compared to vehicle control animals, were observed in any of the treated groups.
Results
No treatment-related histopathologic changes were observed. The substance has no toxicologically significant effects in fertility or reproductive performance at doses of up to 1000 mg/kg bw/day.
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