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