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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted in a manner similar to O.E.C.D. Test Guideline No. 414 with GLP compliance.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- not specified
- 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:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- CD rats [(COBS) CrI:CD (SD)BR] from charles River were housed on Ab-Sorb-Dri cage litter in solid-bottom polypropylene or polycarbonate cages with stainless-steel wire lids and molded filter tops. Feed and deionized/filtered water were available ad libitum throughout the study. Animal rooms were equipped with automatic light cycles (lights on 7:00 AM to 7:00 PM). Temperature and relative humidity were maintained at 21-23"C and approximately 40%, respectively. Air in each animal room was exchanged 12 to 14 times per hour.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- Pregnant animals were dosed by gavage with BPA solutions or corn oil (vehicle) on gestation days (GD) 6 through 15. The volume administered (5.0 ml/kg was based on body weight recorded on each day of the dosing period.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Concentration analysis was conducted by a combination of thin-layer and HPLC, and infared, uv/visible and NMR spectroscopy. For details see George, et. al. 1985 U.S. NTP Final study reports.
- Details on mating procedure:
- A female rat in estrus or proestrus was placed overnight in the home cage of a singly housed male. On the following morning, vaginal
smears were examined for the presence of sperm. - Duration of treatment / exposure:
- From GD 6 to GD 15.
- Frequency of treatment:
- Daily
- Duration of test:
- GD 20
- No. of animals per sex per dose:
- Minimun of 20
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Pregnant animals were assigned to dose groups by the method of stratified randomization so that body weight on GD 0 was not significantly different across dose groups. Rats were weighed on GD 0, 6 through 15. Dams were observed daily during treatment for clinical signs of toxicity. On GD 20, all mated rats were anesthetized with carbon dioxide and sacrificed by cervical dislocation.
Examinations
- Maternal examinations:
- Maternal liver weight, gravid uterine weight, and number of corpora lutea were recorded. The uteri of dams with no apparent implantations were treated with a solution of 10% ammonium sulfide in order to visualize possible implantation sites. Uterine contents (i.e., number of implantation sites, resorptions, dead fetuses, and live fetuses) were evaluated.
- Ovaries and uterine content:
- Uterine contents (i.e., number of implantation sites, resorptions, dead fetuses, and live fetuses) were evaluated, and live fetuses were dissected from the uterus and anesthetized by placing on ice.
- Fetal examinations:
- Each live fetus was weighed and examined for external morphological abnormalities, and the viscera were examined by a fresh tissue technique (Staples, 1974). Half of the fetuses were decapitated prior to dissection and the heads were fixed in Bouin's solution for free-hand sectioning and examination (Wilson, 1965). All fetal carcasses were prepared with Alizarin Red S stain and examined for skeletal malformations, as modified from Peltzer and Schardein (1966) and Crary (1962).
- Statistics:
- Analyses of data were carried out by the General Linear Model (GLM) procedure in the SAS software library (SAS Institute). Dose-response relationships for selected measures were evaluated with a test for linear trend. Analysis of variance (ANOVA) was used to deterine whether significant dose effects had occurred. When ANOVA revealed significant differences among groups, then Williams' multiple comparison test (Williams, 1971,
1972) and Dunnett's test (Dunnett, 1955, 1964) were used to compare BPA-treated groups with the vehicle control group (a level = 0.05). A one-tailed test was used for all parameters except measures of maternal body and organ weight, fetal body weight, and percentage males per litter for which a two-tailed test was used. - Indices:
- For all litters the no. of implantation sites/litter, % resorptions/litter and % litters with resorptions were calculated. For live litters the following the indicies were presented: No. live fetuses/litter, % males/litter, Average fetal body weight/litter, % fetuses with malformations/litter and % litters with malformed fetuses.
- Historical control data:
- Not presented.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Dose-related significant reduction of gruop mean body weight gain at all dose levels. High dose (640 mg/kg/day) mean body weight was reduced approximately 14% by GD 20. During the treatment period (GD 6-15) the high dose mean body weight was reduced approximately 54% relative to the control value at GD 15. At the low dose of 160 mg/kg/day the mean body weight was reduced approximately 35% relative to the untreated control group.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- LOAEL
- Effect level:
- ca. 160 mg/kg diet
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- > 640 mg/kg diet
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects. Remark: upto the high dose level of 640 mg.kg/day.
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 640 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no effects
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Treatment of rat dams with upto a maternally toxic dose level of bisphenol A of 640 mg/kg/day did not induce any evidence of developmental toxicity. This dose level of Bisphenol A resulted in a significant 14% reduction in maternal body weight during the 20 day gestation period. These findings suggest that 2-Acetone polymer with phenol (BPA-Tars) will not be a developmental toxicant to rats due to its structural similarity to the test substance, Bisphenol A.
- Executive summary:
Pregnant rats were assessed for adverse developmental effects in an O.E.C.D. Test Guideline No. 414 Prenatal Developmental Toxicity Study by oral gavage exposure with Bisphenol A doses of: 0, 160, 320 and 640 mg/kg/day. Treatment of rat dams with upto a maternally toxic dose level of Bisphenol A of 640 mg/kg/day did not induce any evidence of developmental toxicity. This dose level of Bisphenol A resulted in a significant 14% reduction in maternal body weight during the 20 day gestation period. These findings suggest that 2-Acetone polymer with phenol (BPA-Tars) will not be a developmental toxicant to rats due to its structural similarity to the test substance, Bisphenol A.
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