Registration Dossier
Registration Dossier
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EC number: 200-517-3 | CAS number: 61-76-7
Endpoint summary
Administrative data
Description of key information
The structural analogue of phenylephrine hydrochloride: +(-)pseudoephedrin-hydrochloride, is considered to be not irritanting to the skin (OECD 404) and eye (OECD 405).
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
No in vivo skin and eye irritation studies on phenylephrine hydrochloride were available. Article 13 of the REACH legislation states that, in case no appropriate animal studies are available for assessment, information should be generated whenever possible by means other than vertebrate animal tests, i. e. applying alternative methods such as in vitro tests, QSARs, grouping and read-across. Therefore, information from the structural analogue +(-)pseudoephedrin-hydrochloride was used to determine the possible irritating effects of phenylephrine hydrochloride.
In a non-GLP compliant study performed according to OECD Guideline 404, three Vienna White rabbits (2 males and 1 female) were exposed semi-occlusive to 0.5g +(-)pseudoephedrin-hydrochloride in distilled water (BASF 1986). After 4 hours of exposure the patch was removed and the treated area rinsed with lutrol and lutrol/water (1:1). Readings were performed 30-60 minutes after patch removal and 24, 48 and 72 hours after application of the test substance. After the removal of the patch, well defined erythema and slight edema (both beyond the area of exposure) was observed in one male rabbit. In the other rabbits slight erythema was observed and also slight edema was observed in the female rabbit at this time point. All effects were fully reversible as no effects were seen in the rabbits at the other time points. Therefore, +(-)pseudoephedrin-hydrochloride is considered to be not irritating to the skin.
In a non-GLP compliant study, performed according to OECD Guideline 405, three Vienna White rabbits (2 males and 1 female) were exposed to 0.1 mL (about 37 mg of the comminuted +(-)pseudoephedrin-hydrochloride) (BASF AG 1986). The substance was not washed out. Readings were performed 1, 24, 48 and 72 hours after application. One hour after exposure well-defined conjunctival redness was observed in all test animals. In addition, in all treated animals slight chemosis was observed. Twenty-four hours after application of the test substance, in one male rabbit well-defined conjunctival redness and slight chemosis was observed and in the other male rabbit, slight conjunctival redness was observed. Also pupil contraction was observed in these two animals. No effects were observed at later time points and in the female rabbit at the 24 hour time-point after application of the test substance. Therefore,+(-)pseudoephedrin-hydrochloride is considered to be not irritating to the eye.
Justification for classification or non-classification
Based on the findings in the skin irritation and eye irritation studies of (+)-pseudoephedrin-hydrochlorid (a structural analogue of phenylephrine hydrochloride), phenylephrine hydrochloride does not need to be classified as irritating to the skin or eye according to the Directive 67/548/EEC and according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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