Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

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.