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Description of key information

A LD50 of 350 mg/kg bw has been determined for female rats in an acute oral toxicity study by Stockhaus and Wick (1969).

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
350 mg/kg bw

Additional information

In the study of Stockhaus annd Wick (1969), three groups of five female FW 49/Biberach rats each were exposed to phenylephrine. The LD50 and the confidence limits were calculated according to Litchfield and Wilcoxon. The LD50 was determined to be 350 mg/kg bw (208 -588).

Justification for classification or non-classification

Based on the LD50 value of 350 mg/kg, phenylephrine hydrochloride needs to be classified as Xn:R22 according to the Directive 67/548/EEC and Cat 4:H302 according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.