Registration Dossier
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EC number: 201-245-8 | CAS number: 80-05-7 Bisphenol A; BPA
- 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
- 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

Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
The 2003 EU RAR concluded:
"Based on the findings from the most robust animal study, Bisphenol A may possess a skin sensitisation potential, albeit a limited one, and that the available data suggest that Bisphenol A is considered capable of producing skin sensitisation responses in humans."
The 2008 updated EU RAR concluded:
"Overall the new information does not confirm the previously reported evidence of a skin sensitisation potential of Bisphenol A. While the data do not exclude a skin sensitising activity of Bisphenol A at high concentrations (>30%), there is no evidence that this is a concern for workers in current Bisphenol A manufacturing plants (such workers are believed to represent the group most likely to be exposed to Bisphenol A in dust)."
There is no reliable and significant new information on the skin sensitisation of Bisphenol A that was not discussed in the 2003 or 2008 EU RARs.
Migrated from Short description of key information:
The 2008 updated EU RAR reported that reliable and new animal studies do not confirm the previously reported evidence of a skin sensitisation potential of Bisphenol A and concluded: “While the data do not exclude a skin sensitising activity of Bisphenol A at high concentrations (>30%), there is no evidence that this is a concern for workers in current Bisphenol A manufacturing plants (such workers are believed to represent the group most likely to be exposed to Bisphenol A in dust)."
Justification for selection of skin sensitisation endpoint:
No sensitisation was observed in recent animal studies conducted according to guideline.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
The 2003 EU RAR concluded that there are no data from which to evaluate the potential of Bisphenol A to be a respiratory sensitiser.
The 2008 updated EU RAR came to the same conclusion but added: "However, based on the lack of reports of cases of respiratory sensitisation, there are no grounds for concern for this endpoint."
There is no reliable and significant new information on the respiratory sensitisation of Bisphenol A that was not discussed in the 2003 or 2008 EU RARs.
Migrated from Short description of key information:
According to the updated EU RAR 2008 "there are no grounds for concern for this endpoint."
Justification for classification or non-classification
Bisphenol A is classified as Skin Sens. 1 according to Annex VI of Regulation (EC) No 1272/2008.
The 2008 updated EU RAR concluded:
"Overall the new information does not confirm the previously reported evidence of a skin sensitisation potential of Bisphenol A. While the data do not exclude a skin sensitising activity of Bisphenol A at high concentrations (>30%), there is no evidence that this is a concern for workers in current Bisphenol A manufacturing plants (such workers are believed to represent the group most likely to be exposed to Bisphenol A in dust)."
Based on the EU-RAR Bisphenol A is allocated to the moderate hazard band.
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