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EC number: 947-368-7 | CAS number: -
- 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 mammalian screening – in vivo (level 3)
Administrative data
- Endpoint:
- endocrine disrupter mammalian screening – in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2016
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- The study design is similar to pubertal assay of OECD GD 150
Data source
Reference
- Reference Type:
- publication
- Title:
- Gestational and lactational exposure to bisphenol AF in maternal rats increases testosterone levels in 23-day-old male offspring
- Author:
- Li et al
- Year:
- 2 016
- Bibliographic source:
- Chemosphere 163 (2016) 552-561
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 890.1450 (Pubertal Development and Thyroid Function in Intact Juvenile/Peripubertal Female Rats
- Version / remarks:
- Non-guidline study in female rats similar to the pubertal assay
- Deviations:
- not specified
- GLP compliance:
- not specified
- Test type:
- in vivo
- Limit test:
- no
Test material
- Reference substance name:
- 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol
- Cas Number:
- 1478-61-1
- Molecular formula:
- C15H10F6O2
- IUPAC Name:
- 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Not reported
- Stability under test conditions: Not reported
- Solubility and stability of the test substance in the solvent/vehicle: Dissolved in corn oil
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: Not reported
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Dissolved in corn oil
- Preliminary purification step (if any): n/a
- Final dilution of a dissolved solid, stock liquid or gel: Not reported
- Final preparation of a solid: n/a
FORM AS APPLIED IN THE TEST (if different from that of starting material): Applied as a liquid.
OTHER SPECIFICS: n/a
Administration / exposure
- Route of administration:
- oral: gavage
- Details on route of administration:
- Oral gavage
- Vehicle:
- corn oil
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Geastationday (GD) 3 to gestation day (GD) 19 and postnatal period (PD 3 to PD 190
- Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 30
- Control animals:
- yes
- Details on study design:
- The test item dissolved in corn oil was adminsitered daily via oral gavage to femle rats from gestational day (GD) 3 to GD 19. During the gestational period, 30 females from the control group and 30 females from the treatment group were treated daily at doses of 0 or 100 mg BPAF/kg of body weight, respectively. Litters born to treated and control dams were cross-fostered, resulting in the following groups: unexposed control (CC group), pups exposed prenatally (TC group), pups exposed postnatally (CT group), and pups exposed both prenatally and postnatally (TT group). During the postnatal period (PD 3 to PD 19), cross-fostered mothers were given BPAF dissolved in corn oil orally at doses of either 0 (CC and TC) or 100 mg/kg/day BPAF (CT and TT), respectively. The mothers were weighed every 3 day and the pups were weighed every 6 day. All animals were weighed and euthanized at PD 23. Blood was collected and centrifuged at 3000 rpm at 4 C. The serum was then collected and stored at - 80 C until further analysis. Testes and epididymides were isolated and weighed. Testes were frozen in liquid nitrogen and stored at - 80 C for RNA isolation and protein extraction.
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Body weights of the GD 9 to GD 18 treatment group mothers and pups showed significant decrease.
- Food consumption and compound intake (if feeding study):
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Significant increase in testis testosterone levels
Significant decrease in testis inhibin B (INHB) levels
279 genes were significantly differentially expressed in the testes of pups exposed - Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
Any other information on results incl. tables
BPAF concentration in serum and testis
The concentrations of free and total BPAF in serum and testis were detected in all groups via LC-MS/MS. The concentrations of free BPAF in serum were 0.21, 0.34, 9.32, and 29.38 ng/mL, and the concentrations of total BPAF were 0.76, 1.32, 27.60, and 127.00 ng/mL in the CC, TC, CT, and TT groups, respectively. Free andt otal BPAF levels in serum were ranked as TT group > CT group > TC group > CC group. The content of free and total BPAF in the TC and CT groups indicated that BPAF was transferred to infants via gestation and lactation, although the concentration of BPAF in cord blood and breast milk was not measured directly. Furthermore, BPAF in the serumwas more easily eliminated than that in the testis during exposure.
Hormone levels in serum and testis
No significant differences were observed in the levels of serum estradiol, luteinizing hormone, or follicle-stimulating hormone among the four groups, except for a decrease in the TC and CT group compared with the TT group. Serum anti-Müllerian hormone (AMH) levels in the TT group were lower than those of the CC, TC and CT group, respectively (p < 0.05). Only the TT group serum and testis testosterone levels showed significant increase compared with those of the CC group (p < 0.05, Fig. 2). The levels of INHB in the serum of the TC and TT groups decreased compared with those of the CC group (p < 0.05), while the content of INHB in the testis of all treated groups decreased significantly compared with that of the control group (p < 0.01).
Applicant's summary and conclusion
- Conclusions:
- Pups exposed to BPAF both prenatally and postnatally showed a significant increase in testis testosterone levels compared with that of the control, while all pups exposed to BPAF showed a significant decrease in testis inhibin B (INHB) levels. Compared with the control, RNA-seq revealed that 279 genes were significantly differentially expressed in the testes of pups exposed to BPAF both prenatally and postnatally, including genes involved in cell differentiation and meiosis. These results indicate that gestational and lactational exposure to BPAF in the mother can impair reproductive function in male offspring.
This test was not conducted in accordance with International guidance and has significant methological deficincies when compared to OECD reproductive toxicity tests. - Executive summary:
In this non-guideline test, female rats from gestational day (GD) 3-19 were exposed to 100 mg BPAF/kg/day by oral gavage. On the day of birth (postnatal day (PD) 0), cross-fostering took place between treated and control litters, and cross-fostered mother rats were given BPAF 100 mg/kg/day during the postnatal period (PD 3 to PD 19).
HPLC-MS/MS analysis showed that BPAF was transferred via cord blood and lactation, finally bioaccumulating in the offspring testes.
Body weights of the GD 9 to GD 18 treatment group mothers showed significant decrease.
No effect on the absolute and relative weights of the testis and the absolute weights of the epididymis in pups.
Free and total BPAF levels in serum was high in all treatment group i.e. material and pup, indicating that BPAF was transferred to infants via gestation and lactation. Free and total BPAF levels in testis was detected in all treatment groups. Testis testosterone levels showed significant increase in pups exposed to pre/postnatal and there was significant decrease in testis inhibin B (INHB) levels.
Compared with the control, RNA-seq revealed that 279 genes were significantly differentially expressed in the testes of pups exposed to BPAF both prenatally and postnatally. The protein levels of genes involved in steroidogenesis (P450scc and StAR) in the male rat testis increased in pre/post-natal exposure group, including genes involved in cell differentiation and meiosis.
These results indicate that gestational and loctational exposure to BPAF in the mother can impair reproductive function in male offspring.
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