Registration Dossier
Registration Dossier
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EC number: 200-424-8 | CAS number: 59-42-7
Endpoint summary
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.
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