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EC number: 500-086-4 | CAS number: 35238-34-7
- 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:
- multi-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:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to a U.S. National toxicology Program (NTP) study protocol with GLP compliance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- According to Fertility Assessment by Continuous Breeding in the mouse developed by the U.S. National Toxicology Program (NIEHS).
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 4,4'-isopropylidenediphenol
- EC Number:
- 201-245-8
- EC Name:
- 4,4'-isopropylidenediphenol
- Cas Number:
- 80-05-7
- Molecular formula:
- C15H16O2
- IUPAC Name:
- 2,2-bis(4-hydroxyphenyl)propane
- Reference substance name:
- 4,4’-isopropylidenediphenol
- IUPAC Name:
- 4,4’-isopropylidenediphenol
- Reference substance name:
- Phenol, 4,4’-(1-methylethylidene)bis-
- IUPAC Name:
- Phenol, 4,4’-(1-methylethylidene)bis-
- Reference substance name:
- Bisphenol A.
- IUPAC Name:
- Bisphenol A.
- Details on test material:
- As per IUCLID5 Sections 1.1. - 1.4. for Bisphenol A.
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- COBS® CD-l®, (ICR)BR outbred albino mice supplied by the Charles River Breeding Laboratories, Inc. (Kingston, NY). were used for the study. The males and females were 6 weeks of age at the time of arrival at the laboratory. Males and females were group housed (ten per cage by sex) in solid bottom polypropylene or polycarbonate cages (6" x 19" x 10 1/2") with stainless steel wire lids. Deionized/filtered water and NIH-07 open formula ground rodent chow was available to the animals ad libitum. Temperature was maintained at 70 +/- 2 degrees F in the animal room. Air in each animal room was 12 to 14 times per hour.
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- Dose-feed ad libitium.
- Details on mating procedure:
- Females and males from the same treatment group were paired and cohabited for 98 days (14 weeks), one breeding pair per cage (40 breeding pairs per vehicle control group and 20 breeding pairs per dose group). Thereafter each male and female will be housed individually for a period of 21 days.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Following methanol extraction of the feed samples and dilution with methanol the Bisphenol A content was measured by gas chromatography with the following conditions: Instrument: Varian 3700 Gas Chromatograph wich AutoSampler and Varian CDS 111-C integrator; Column - 3% OV-17 on 100/120 mesh Supelcoport, 1.3 m x 2 rom ID, glass, silanized; Detection - Flame ionization; Temperature -: Inlet, 250°C,Oven, 210°C, Detector, 300°C; Carrier Gas - Nitrogen; Flow Rate - 35 cc/min. Volume of Solution Injected ~ed: 4.5 uL; Retention Times - Bisphenol A - 8.0 min. Triphenylmethane (Internal Standard) - 4.0 min. Validation was by Bisphenol a spiked feed samples. Actual concentrations ranged from 93% to 113% of nominal.
- Duration of treatment / exposure:
- Continuous
- Frequency of treatment:
- Daily in the feed.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 0.25, 0.5 and 1.0% or approximately 0, 437.5, 875 and 1759 mg/kg/day.
Basis:
nominal in diet
Concentration range was 93% to 113% based on analysis.
- No. of animals per sex per dose:
- 40 for untreated diet, 20 animals per Bisphenol a dose.
- Control animals:
- yes, plain diet
- Positive control:
- no
Examinations
- Parental animals: Observations and examinations:
- Clinical signs and body weights
- Oestrous cyclicity (parental animals):
- Yes
- Sperm parameters (parental animals):
- Yes
- Litter observations:
- Yes
- Postmortem examinations (parental animals):
- Selected organ weights and histopathology.
- Postmortem examinations (offspring):
- Selected organ weights and histopathology.
- Statistics:
- Yes
- Reproductive indices:
- Yes
- Offspring viability indices:
- Yes
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- High dose (1.0%) females only.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- High dose (1.0%) females only.
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Liver and kidney males and females, high dose only.
- Other effects:
- not examined
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- effects observed, treatment-related
- Description (incidence and severity):
- Mean seminal vesicle and sperm motility were significantly reduced at 1.05 in the feed.
- Reproductive performance:
- effects observed, treatment-related
- Description (incidence and severity):
- At 1.0% Bisphenol A in the diet there was a significant reduction in: number of litters produced/pair, number of live pups/litter and proportion of pups born alive.
Details on results (P0)
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 0.25 other: 0.25% wt/wt or approximately 437.5 mg/kg/day.
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Based on the observation of adverse target organ findings including histopathology and reproductive parameters in adult (F0) and F1 generation mice at o.5% and 1.0% in the feed.
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Mortality / viability:
- mortality observed, treatment-related
- Description (incidence and severity):
- Significant at the high dose of 1.0%.
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Significant at the high dose.
- Gross pathological findings:
- not examined
- Histopathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- High dose liver and kidney.
Details on results (F1)
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The No-Observed-Adverse-Effect-Level (NOAEL) for systemic effects in both the parental (F0) and F1 generations was 0.5% Bisphenol A in the diet (~875 mg/kg/day). The NOAEL for adverse reproductive findings was 0.25% in the diet (~ 437.5 mg/kg/day). Significant evidence of reproductive toxicity included: Significantly reduced group mean litters produced /breeding pair, number of live pups/litter, seminal vesicle weight, sperm motility and F1 pup survival at the two hghest does levels of Bisphenol A. The results of cross-over mating studies at 1.0% Bispheniol A suggested that the testr substance had a greater adveres impact on the female reproductive system. These findings for Bisphenol A suggest that 2-Acetone polymer with phenol (BPA-Tars) will also be a rodent reproductive toxicant under similar experimental and exposure conditons.
- Executive summary:
Bisphenol A, a structural analog for 2 -Acetone polymer with phenol (BPA-Tars) was assessed for adverse effects on reproduction in a U.S. National Toxicology Program "Fertility Assessment by Continuous Breeding" study protocol conducted in mice by dietary exposure. The study was conducted under the GLP regulations at dietary dose levels of: 0, 0.25%, 0.5% and 1.0% or approximately, 0, 437.5, 875, and 1750 mg/kg/day respectively. The No-Observed-Adverse-Effect-Level (NOAEL) for systemic effects in both the parental (F0) and F1 generations was 0.5% Bisphenol A in the diet (~875 mg/kg/day). The NOAEL for adverse reproductive findings was 0.25% in the diet (~ 437.5 mg/kg/day). Significant evidence of reproductive toxicity included: Significantly reduced group mean litters produced /breeding pair, number of live pups/litter, seminal vesicle weight, sperm motility and F1 pup survival at the two hghest does levels of Bisphenol A. The results of cross-over mating studies at 1.0% Bispheniol A suggested that the test substance had a greater adveres impact on the female reproductive system. These findings for Bisphenol A suggest that BPA-Tars will also be a rodent reproductive toxicant under similar experimental and exposure conditons.
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