Registration Dossier
Registration Dossier
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EC number: 202-018-6 | CAS number: 90-82-4
Endpoint summary
Administrative data
Description of key information
Acute, oral, rat (OECD TG 401, no GLP): LD50male = ca. 1000 mg/kg bw; LD50female = 464 mg/kg bw
Acute, inhalation, rat (OECD TG 403, no GLP): LC50 > 2 mg/L air
Acute, dermal, rat (OECD TG 402, no GLP): LD50 > 2000 mg/kg bw
Key value for chemical safety assessment
Additional information
Each one study is available for acute toxicity over the oral, dermal, and inhalative route. In an acute oral study on the read-across substance (+)-Pseudoephedrine hydrochloride, (OECD TG 401, non GLP) 5 male and female Wistar rats were dosed with 316, 464, 681, 1000 mg/kg bw. In the highest dose group 3/5 males died and in the 681 mg/kg bw group no mortality occurred, thus the LD50male was ca. 1000 mg/kg bw. In the females no mortality occurred in the lowest dose group. In the 464 mg/kg bw dose group 2/5 animals died, and in the 681 and 1000 mg/kg bw dose group 1/5 animals were found dead. An LD50female of ca. 464 mg/kg bw was deduced. Although no clear dose-response relationship with regard to mortality was obvious, based on the clinical signs the females seemed to be more sensitive compared with the males. While in the 464 mg/kg bw dose group the males were excited, the females showed dyspnea, excitation, staggering and poor general state.
In an acute inhalation study on the read-across substance (+)-Pseudoephedrine hydrochloride (OECD TG 403, no GLP) 5 male and female Wistar rats were exposed (head-nose only) to 2 mg/L test substance for 4 hours. No mortality occurred, but clinical signs as nose discharge (reddish), salivation, accelerated respiration were observed during exposition, and smeared fur (bloody, near head), accelerated/irregular respiration, respiratory sounds, piloerection were observed after exposition. All symptoms were reversible within 5 (males) and 8 (females) days. Thus, an LC50 of >2000 mg/kg bw was deduced for the route.
In an acute dermal toxicity study on the read-across substance (+)-Pseudoephedrine hydrochloride (OECD TG 402, no GLP) 5 male and female Wistar rats were treated semiocclusive with 2000 mg/kg bw test substance for 24 h. No mortality occurred and no abnormalities were observed regarding clinical signs and pathology. Thus, an LD50 of >2000 mg/kg bw was deduced for the dermal route.
Justification for classification or non-classification
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