| GHS-Einstufung | WarningH302 (100%): Harmful if swallowed [Warning Acute toxicity, oral]H315 (17.2%): Causes skin irritation [Warning Skin corrosion/irritation]H317 (73.9%): May cause an allergic skin reaction [Warning Sensitization, Skin]H319 (17.2%): Causes serious eye irritation [Warning Serious eye damage/eye irritation]H335 (46%): May cause respiratory irritation [Warning Specific target organ toxicity, single exposureRespiratory tract irritation]P261, P264, P264+P265, P270, P271, P272, P280, P301+P317, P302+P352, P304+P340, P305+P351+P338, P319, P321, P330, P332+P317, P333+P317, P337+P317, P362+P364, P403+P233, P405, and P501 (click each P-code to see the statement)Aggregated GHS information provided per 261 reports by companies from 24 notifications to the ECHA C&L Inventory. Each notification may be associated with multiple companies.Information may vary between notifications depending on impurities, additives, and other factors. The percentage value in parenthesis indicates the notified classification ratio from companies that provide hazard codes. Only hazard codes with percentage values above 10% are shown. For more detailed information, please visit ECHA C&L website. |
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| Regulatorische Informationen | Status: Active Update: 17-06-2015 https://echa.europa.eu/registration-dossier/-/registered-dossier/12556Pseudoephedrine hydrochloride: Does not have an individual approval but may be used under an appropriate group standard |
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| Weitere Sicherheitsinformationen | IMAP assessments - Benzenemethanol, .alpha.-[1-(methylamino)ethyl]-,hydrochloride, [S-(R*,R*)]-: Environment tier I assessmentIMAP assessments - Benzenemethanol, .alpha.-[1-(methylamino)ethyl]-,hydrochloride, [S-(R*,R*)]-: Human health tier I assessment |
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| Hazard Classes and Categories | Acute Tox. 4 (100%)Skin Irrit. 2 (17.2%)Skin Sens. 1 (73.9%)Eye Irrit. 2 (17.2%)STOT SE 3 (46%) |
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| Expositionspfade | Pseudoephedrine is readily and almost completely absorbed from the GI tract and there is no evidence of first-pass metabolism. |
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| Toxizitätsübersicht | Pseudoephedrine acts directly on both alpha- and, to a lesser degree, beta-adrenergic receptors. Through direct action on alpha-adrenergic receptors in the mucosa of the respiratory tract, pseudoephedrine produces vasoconstriction. Pseudoephedrine relaxes bronchial smooth muscle by stimulating beta2-adrenergic receptors. Like ephedrine, pseudoephedrine releasing norepinephrine from its storage sites, an indirect effect. This is its main and direct mechanism of action. The displaced noradrenaline is released into the neuronal synapse where it is free to activate the postsynaptic adrenergic receptors. |
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| Signs and Symptoms | Common adverse reactions include nervousness, restlessness, and insomnia. Rare adverse reactions include difficult/painful urination, dizziness/lightheadedness, heart palpitations, headache, increased sweating, nausea/vomiting, trembling, troubled breathing, unusual paleness, and weakness. |
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| Carcinogen Classification | No indication of carcinogenicity to humans (not listed by IARC). |
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| Drug Induced Liver Injury | Drug Induced Liver Injury Rank (DILIrank 2.0)Pseudoephedrine hydrochloridevNo-DILI-concernNo matchDOI:10.1016/j.drudis.2016.02.015 |
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