Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Respiratory sensitisation

Endpoint conclusion
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).

Several instances of contact dermatitis were reported in humans who used eyedrops containing phenylephrine hydrochloride (Barber, 1983; Camarasa, 1984). Moreover, the structurally similar pseudoephedrine (CAS 90 -82 -4) was identified as skin sensitizer in an experiment conducted according to OECD TG 442 B (BASF, 2012).

Justification for classification or non-classification

Based on the results of the read across substance pseudoephedrine hydrochloride (CAS 90 -82 -4) and the reported cases of human dermatitis after exposure to phenylephrine hydrochloride (CAS 61 -76 -7), classification as skin sensitizer Cat 1B and R43 ist warranted, according to Regulation (EU) 1272/2008 and Directive 67/548/EEC, respectively.