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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
Endocrine disrupter testing in aquatic vertebrates – in vivo
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- amphibian: other
- Remarks:
- Larval Amphibian Growth and Development Assay with the African Clawed Frog (Xenopus laevis)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2019-2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD TG 241 (The Larval Amphibian Growth and Development Assay (LAGDA))
- Version / remarks:
- Adopte 28 July 2015
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: U.S. EPA OCSPP 890.2300
- Version / remarks:
- 2015
- Deviations:
- no
- Guideline:
- other: according to the Decision on Substance Evaluation letter for TBBPA
- Deviations:
- no
- Principles of method if other than guideline:
- In addition to the guidlines specified, he following endpoints ere measured: triiodothyronine (T3) and L-thyroxine (T4) concentrations in plasma and tissue homogenate
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): 3,3’,5,5’-Tetrabromo-bisphenol-A (TBBPA)
- Name of additional materials (as cited in study report): 3,3’,5,5’-Tetrabromo-bisphenol-A-monomethylether (TBBPA-MME) and 3,3’,5,5’-Tetrabromo-bisphenol-A-dimethylether (TBBPA-DME)
- Radiolabelled material: 3,3’,5,5’-Tetrabromo-bisphenol-A (ring-13C12)
Constituent 1
- Specific details on test material used for the study:
- The test substance, a solid, was identified as Tetrabromobisphenol A; Batch number 651170360. The test substance contained >99% active ingredient and had an expiration date of 26 December 2020
Sampling and analysis
- Analytical monitoring:
- yes
Test solutions
- Vehicle:
- yes
- Remarks:
- UV sterilized well water
Test organisms
- Aquatic vertebrate type:
- frog
- Test organisms (species):
- Xenopus laevis
- Details on test organisms:
- Test Organism
African clawed frogs (Xenopus laevis) were used in this test. This species was selected as this was the recommended species for the test (1,2). Larvae were obtained from cultures maintained by Eurofins Easton. Adult frogs for the culture were obtained from Xenopus Express, Inc. of Brooksville, Florida, and were maintained under flow-through conditions at a target temperature of 22ºC for approximately 1.5 years for the purpose of providing tadpoles for the test. The photoperiod for adult frogs was 12 hours of light and 12 hours of dark per day, with a 30-minute transition period. The frogs were fed an adult Xenopus diet supplied by Zeigler Brothers, Inc. of Gardners, Pennsylvania at a rate sufficient to maintain the health of the culture. The culture frogs showed no sign of disease or stress prior to the test. Adult frogs used to supply embryos for use on test were confirmed to produce genetically identifiable offspring during non-GLP preliminary trials.
Study design
- Test type:
- flow-through
- Water media type:
- well water
- Limit test:
- no
- Total exposure duration:
- 133 d
Test conditions
- Nominal and measured concentrations:
- TEST CONCENTRATIONS: Nominal Mean Measured
Negative Control < LOQ
5.7 µg/L 5.9 µg/L
18 µg/L 19 µg/L
59 µg/L 60 µg/L
188 µg/L 1 86 µg/L
600 µg/L 609 µg/L
50 mg/L PTU 51 mg/L PTU
1.0 µg/L T4 1.3 µg/L T4 - Details on test conditions:
- See table below
- Reference substance (positive control):
- yes
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 133 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 609 µg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other:
- Remarks:
- overall
- Remarks on result:
- other:
- Remarks:
- Highest concentration measured
- Key result
- Duration:
- 133 d
- Dose descriptor:
- LOEC
- Effect conc.:
- > 609 µg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: Overall
- Remarks on result:
- other:
- Remarks:
- Highest concentration measured
- Details on results:
- The LAGDA study was designed to evaluate a chemical’s ability to affect the hypothalamus, pituitary, and thyroid axis (HPT) and the hypothalamus, pituitary, and gonadal axis (HPG). In evaluations of the HPT axis there were no effects in thyroid histology, developmental morphology, time-to-reach Stage 62 at any of the TBBPA concentrations tested. There were slight increases and decreases in T3 and T4 measurements that occurred in the two highest treatment groups, but they were inconsistent with no observed effects on thyroid histology, developmental morphology, and time-to-reach Stage 62 that were observed at all TBBPA concentrations tested. In the evaluation of the HPG axis there were no effects on genetic sex, histology, and vitellogenin (VTG) at any of the TBBPA concentrations tested. The positive control responses were as expected with PTU showing the characteristic responses of delayed a thyroid hormone antagonist resulting in delayed development and a T4 responding as a thyroid hormone agonist characterized by accelerated development. The responses observed in the TBBPA groups were closer to the negative control than either of the positive controls which support no effects on thyroid endpoints.
Endpoints NOEC LOEC
Survival 609 µg/L >609 µg/L
NF Stage 58 Growth 609 µg/L >609 µg/L
NF Stage 62 Growth 609 µg/L >609 µg/L
Time to NF Stage 62 609 µg/L >609 µg/L
Juvenile Growth 609 µg/L >609 µg/L
Liversomatic Index 609 µg/L >609 µg/L
Histopathology 609 µg/L >609 µg/L
Sex Ratio 609 µg/L >609 µg/L
The overall NOEC was 609 µg/L and the overall LOEC was > 609 µg/L, the highest concentration tested. - Results with reference substance (positive control):
- The positive control responses were as expected with PTU showing the characteristic responses of delayed a thyroid hormone antagonist resulting in delayed development and a T4 responding as a thyroid hormone agonist characterized by accelerated development
Any other information on results incl. tables
Endpoints |
NOEC |
LOEC |
Survival |
609 µg/L |
>609 µg/L |
NF Stage 58 Growth |
609 µg/L |
>609 µg/L |
NF Stage 62 Growth |
609 µg/L |
>609 µg/L |
Time to NF Stage 62 |
609 µg/L |
>609 µg/L |
Juvenile Growth |
609 µg/L |
>609 µg/L |
Liversomatic Index |
609 µg/L |
>609 µg/L |
Histopathology |
609 µg/L |
>609 µg/L |
Sex Ratio |
609 µg/L |
>609 µg/L |
The overall NOEC was 609 µg/L and the overall LOEC was > 609 µg/L, the highest concentration tested.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- CONCLUSIONS
African clawed frogs (Xenopus laevis) were exposed to five test concentrations of TBBPA, a negative (dilution water) control, one concentration of L-thyroxine (T4) and one concentration of 6 n propyl-2-thiouracil (PTU) under flow-through conditions from embryo-larval development through metamorphosis, and then through early juvenile development. The five concentrations selected were 5.7, 18, 59, 188 and 600 µg TBBPA/L. The LAGDA study was designed to evaluate a chemical’s ability to affect the hypothalamus, pituitary, and thyroid axis (HPT) and the hypothalamus, pituitary, and gonadal axis (HPG). In evaluations of the HPT axis there were no effects in thyroid histology, developmental morphology, time-to-reach Stage 62 at any of the TBBPA concentrations tested. There were slight increases and decreases in T3 and T4 measurements that occurred in the two highest treatment groups, but they were inconsistent with no observed effects on thyroid histology, developmental morphology, and time-to-reach Stage 62 that were observed at all TBBPA concentrations tested. In the evaluation of the HPG axis there were no effects on genetic sex, histology, and vitellogenin (VTG) at any of the TBBPA concentrations tested. The positive control responses were as expected with PTU showing the characteristic responses of delayed a thyroid hormone antagonist resulting in delayed development and a T4 responding as a thyroid hormone agonist characterized by accelerated development. The responses observed in the TBBPA groups were closer to the negative control than either of the positive controls which support no effects on thyroid endpoints. The overall NOEC was 609 µg/L and the overall LOEC was > 609 µg/L, the highest concentration tested. - Executive summary:
SUMMARY
African clawed frogs (Xenopus laevis)were exposed to five test concentrations of, a negative (dilution water) control, one concentration of L-thyroxine (T4) and one concentration of 6‑n‑propyl-2-thiouracil (PTU) under flow-through conditions from embryo-larval development through metamorphosis, and then through early juvenile development. The five concentrations selected were5.7, 18, 59, 188 and 600 µg TBBPA/L.
LENGTH OF EXPOSURE: 132/133 Days
AGE OF TEST ORGANISMS: Tadpoles (NF Stage 8)
TEST ENDPOINTS: Stage of development, growth (wet weight,snout-to-vent and hind-limb length), liver somatic index (LSI), genetic/phenotypic sex ratios, as well as histology of the thyroid, gonad, reproductive duct, kidney and liver, plasma vitellogenin (VTG),triiodothyronine (T3) and L-thyroxine (T4) concentrations in plasma and tissue homogenateas well as general observations of health.
RESULTS:
The LAGDA study was designed to evaluate a chemical’s ability to affect the hypothalamus, pituitary, and thyroid axis (HPT) and the hypothalamus, pituitary, and gonadal axis (HPG). In evaluations of the HPT axis there were no effects in thyroid histology, developmental morphology, time-to-reach Stage 62 at any of the TBBPA concentrations tested. There were slight increases and decreases in T3 and T4 measurements that occurred in the two highest treatment groups, but they were inconsistent with no observed effectson thyroid histology, developmental morphology, and time-to-reach Stage 62 that were observed at all TBBPA concentrations tested. In the evaluation of the HPG axis there were no effectsongenetic sex, histology, and vitellogenin (VTG) at any of the TBBPA concentrations tested. The positive control responses were as expected with PTU showing the characteristic responses of delayed a thyroid hormone antagonist resulting in delayed development and a T4 responding as a thyroid hormone agonist characterized by accelerated development. The responses observed in the TBBPA groups were closer to the negative control than either of the positive controls which support no effects on thyroid endpoints.
Endpoints
NOEC
LOEC
Survival
609 µg/L
>609 µg/L
NF Stage 58 Growth
609 µg/L
>609 µg/L
NF Stage 62 Growth
609 µg/L
>609 µg/L
Time to NF Stage 62
609 µg/L
>609 µg/L
Juvenile Growth
609 µg/L
>609 µg/L
Liversomatic Index
609 µg/L
>609 µg/L
Histopathology
609 µg/L
>609 µg/L
Sex Ratio
609 µg/L
>609 µg/L
The overall NOEC was 609 µg/L and the overall LOEC was > 609 µg/L, the highest concentration tested.
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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