Registration Dossier

Administrative data

Description of key information

In animal studies Bisphenol A is not irritating to the skin but irritating to the eye with effects persisted until the end of the study (day 28 postinstillation), consequently, Bisphenol A has the potential to cause serious damage to the eyes. In inhalation studies slight and transient nasal tract epithelial damage was observed in rats exposed to Bisphenol A dust at 170 mg/m3 for 6 hours. Slight local inflammatory effects in the upper respiratory tract were observed in rats exposed to 50 mg/m3 and 150 mg/m3 of Bisphenol A in 2 and 13 week repeat inhalation studies, but were not observed at 10 mg/m3 in the same studies. 

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

The 2003 EU RAR concluded:

"Limited human anecdotal information of uncertain reliability is available from written industry correspondence suggesting that workers handling Bisphenol A have in the past experienced skin, eye and respiratory tract irritation. It cannot be determined whether the reported skin reactions were related to skin sensitisation or irritation. However, a recent well conducted animal study clearly shows that Bisphenol A is not a skin irritant. A recent well conducted animal study shows that Bisphenol A is an eye irritant; effects persisted until the end of the study (day 28 postinstillation) in 1 of 3 rabbits. Overall, taking into account the animal and human evidence, Bisphenol A has the potential to cause serious damage to the eyes. Slight and transient nasal tract epithelial damage was observed in rats exposed to Bisphenol A dust at 170 mg/m3 for 6 hours. Slight local inflammatory effects in the upper respiratory tract were observed in rats exposed to 50 mg/m3 and 150 mg/m3 of Bisphenol A in 2 and 13 week repeat inhalation studies, but were not observed at 10 mg/m3 in the same studies. Taken together with anecdotal human evidence, these data suggest Bisphenol A has a limited respiratory irritation potential."

There is no reliable and significant new information on irritation/corrosion of Bisphenol A in the updated 2008 EU RAR or elsewhere.


Effects on eye irritation: irritating

Effects on respiratory irritation: irritating

Justification for classification or non-classification

Bisphenol A is classified with Eye Dam. 1 (H318) and STOT SE 3 (H335) according to Annex VI of Regulation (EC) No 1272/2008.