Registration Dossier
Registration Dossier
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EC number: 206-080-5 | CAS number: 299-42-3
Endpoint summary
Administrative data
Description of key information
In an acute oral toxicity study (similar to OECD 401), the LD50 was determined to be ca. 681 mg/kg bw. In an acute inhalation toxicity study (similar to OECD 403), the LC50 was determined to be >5.4 mg/L.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 681 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute oral toxicity
Five Sprague-Dawley rats per sex per dose were exposed in a study similar to OECD 401 to 215, 316, 464, 681 or 1000 mg/kg bw of the test substance, dissolved in 0.5% aqueous carboxymetyl cellulose solution, via oral gavage. After an observation period of 14 days the surviving animals were necropsied. Several clinical signs were observed such as dyspnea, apathy, agitation, lying in an abnormal position, staggering, atony, trembling, twitching, rough fur, exsiccosis, salivation, blood in saliva, difficulty breathing, and a poor general state. Acute hyperemia of the heart and lung effects were observed in animals that died. No abnormalities were detect in sacrificed animals. The LD50 was determined to be ca. 681 mg/kg bw.
Acute inhalation toxicity
Ten Sprague-Dawley rats per sex were exposed in a study performed according to OECD 403 study by inhalation to 5.4 mg/L air dust aerosols of the substance for 4 hours. After an observation period of 14 days surviving animals were necropsied. No mortality or treatment related effects were observed during and after exposure. The LC50 was determined to be >5.4 mg/L air.
Justification for selection of acute toxicity – oral endpoint
One acute oral toxicity study is available. This study is adequate for covering this endpoint.
Justification for selection of acute toxicity – inhalation endpoint
One acute inhalation toxicity study is available. This study is adequate for covering this endpoint.
Justification for classification or non-classification
Based on oral LD50 in rats of 681 mg/kg bw, ephedrine has to be classified for Acute toxicity Cat 4:H302: Harmful if swallowed in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008 and Xn R22: Harmful is swallowed in accordance with EU Directive 67/548 (DSD).
Based on inhalation LC50 of >5.4 mg/L air classification for acute inhalation is not warranted in accordance with EU Directive 67/548 (DSD) and EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.
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