Registration Dossier

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).

Phenylephrine hydrochloride was reported not to cause significant edema to the intacte corneal tissue of rabbits. No information are known of irritating effects on the skin.

Justification for classification or non-classification

Based on the information given above, there are not sufficient indications which would warrant classification of phenylephrine hydrochloride for skin and eye irritation, according to Regulation (EU) 1272/2008 and Directive 67/548/EEC, respectively.