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Administrative data

Description of key information

Key value for chemical safety assessment

Additional information

Source: National Toxicological Program, Technical Report Series No. 322. Toxicology and carcinogenesis studies of phenylephrine hydrochloride (CAS No. 61-76-7) in F344/N rats and B6C3F1 mice (feed studies).

Using an unspecified strain and sex of rat, Stockhaus and Wiek (1969) reported an oral LD50 value of 350 mg/kg.

Justification for classification or non-classification

Based on an LD50 value of 350 mg/kg, phenylephedrine hydrochloride (CAS No. 61-76-7) needs to be classified acute oral toxicity Cat. 4 and Xn R22, according to Regulation (EU) 1272/2008 and Directive 67/548/EEC, respectively.