Registration Dossier

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.