Registration Dossier

Administrative data

Description of key information

A reliable acute oral toxicity study was conducted in SD rat using Nonylphenol in liquid paraffin. LD50 values were reported for males = 1246 mg/kg bw; females = 1648 mg/kg bw and combined = 1412 mg/kg bw.

The study is supported by an OECD 401 study conducted in Wistar rats using Iso-Nonylphenol with an LD50 of 1900 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
1 246 mg/kg bw

Additional information

Both acute oral toxicity studies are classified as acceptable. They are comparable or do satisfy the guideline requirement for an acute oral study in the rat.

Nonylphenol is classified as corrosive. According REACH regulation Annex VIII acute toxicity studies do not generally need to be conducted if the substance is classified as corrosive to the skin. Hence, it is not necessary to provide data for a second route of exposure.

Justification for classification or non-classification

Nonylphenol is of acute oral toxicity category 4 based on a LD50(rat) according Regulation (EC) No 1272/2008, Table 3.1.1, Oral (mg/kg bodyweight): 300 < ATE ≤ 2000