Registration Dossier

Administrative data

Description of key information

Bisphenol A is of low acute toxicity by all routes of exposure relevant to human health. Oral LD50 values beyond 2,000 mg/kg are reported in rodents, and dermal LD50 values above 2,000 mg/kg are indicated in the rabbit. For inhalation, a 6-hour exposure to 170 mg/m3 (the highest attainable concentration) produced no death in rats; slight and transient slight nasal tract epithelial damage was observed.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
4 100 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
discriminating conc.
170 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
3 000 mg/kg bw

Additional information

The 2003 EU RAR concluded:

"No useful information is available on the effects of single exposure to Bisphenol A in humans. Oral LD50 values beyond 2,000 mg/kg are indicated in the rat and mouse, and dermal LD50 values above 2,000 mg/kg are indicated in the rabbit. Few details exist of the toxic signs observed or of target organs. For inhalation, a 6-hour exposure to 170 mg/m3 (the highest attainable concentration) produced no death in rats; slight and transient slight nasal tract epithelial damage was observed. These data indicate that Bisphenol A is of low acute toxicity by all routes of exposure relevant to human health."

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


Justification for selection of acute toxicity – oral endpoint
Jones 1985 reported LD50 >2000; NTP reported 4100 mg/kg as the lowest LD50.

Justification for classification or non-classification

Bisphenol A is included in Annex 1 of Regulation 67/548/EEC and Annex VI of Regulation (EC) No 1272/2008.

No classification regarding acute toxicity is required.