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Diss Factsheets
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EC number: 926-571-4 | CAS number: 1187203-96-8
- 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:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Secondary literature: EU Risk Assessment Report Bisphenol A (review)
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- 4,4'-Isopropylidenediphenol (Bisphenol A) (CAS-No. 108-95-2)
- Author:
- European Chemicals Bureau (ECB)
- Year:
- 2 003
- Bibliographic source:
- EU Risk Assessment Report, 3rd Priority List, Volume 37
- Reference Type:
- publication
- Title:
- 4,4´-Isopropylidenediphenol (bisphenol-A)
- Author:
- European Chemicals Bureau (ECB)
- Year:
- 2 008
- Bibliographic source:
- EU Risk Assessment Report, Human Health Addendum of April 2008 (to be read in conjunction with published EU RAR of BPA, 2003)
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
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
Constituent 1
Results and discussion
Results (fetuses)
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Executive summary:
The 2003 EU RAR concluded:
"No human data on reproductive toxicity of BPA are available. BPA has been shown to have endocrine modulating activity in a number of screening assays, with a potency that generally ranged from 3 to 5 orders of magnitude less than that of oestradiol. The effects of BPA on fertility and reproductive performance have been investigated in two-generation and multi-generation studies in the rat and a continuous breeding study in mice. Effects were seen in both species at approximately the same dose level and it is considered that the NOAEL of 50 mg/kg/day identified in the rat multi-generation study is also likely to produce no adverse effects in mice for which there is only a LOAEL of 300 mg/kg/day for a small decrease in epididymal weight in F1 males. The NOAEL of 50 mg/kg/day from the multi-generation study will be used for risk characterisation purposes, in relation to effects on fertility."
The 2008 updated EU RAR concluded:
"A new two-generation study in mice by Tyl et al. (published in 2008) provides a comprehensive and definitive investigation on the effects of BPA on reproduction at exposure levels spanning the low (ug/kg/day) to high (mg/kg/day) ranges. This study showed that BPA causes adverse effects on pregnancy and the offspring at 600 mg/kg/day, an exposure level that also caused mild parental toxicity. Fertility was not affected by BPA exposure. A NOAEL for reproductive toxicity of 50 mg/kd/day was identified and should be used in the risk assessment."
There is no reliable and significant new information on the reproductive or developmental toxicity of Bisphenol A.
The 2003 EU RAR concluded that in standard developmental studies in rodents, there is no convincing evidence that Bisphenol A is a developmental toxicant. Available and apparently conflicting data from studies conducted using low doses raise uncertainties that the Competent Authorities required to be resolved through further testing. A provisional NOAEL of 50 mg/kg/day for developmental effects, derived from a rat multi-generation study, should be used in the risk characterisation in the interim while awaiting the outcome of further testing.
The 2008 updated EU RAR concluded that no conclusions could be drawn from new developmental toxicity studies or from a human study investigating recurrent miscarriage and Bisphenol A exposure, so these studies do not influence the conclusions of the original risk assessment report.
There is no significant and reliable new information on the reproductive or developmental toxicity of Bisphenol A that was not discussed in the 2003 or 2008 EU RARs.
Bisphenol A is classified Repr. Cat.3; R62 according to Annex 1 of Regulation 67/548/EEC and Repr. 2 according to Annex VI of Regulation (EC) No 1272/2008.
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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