Pseudoephedrine

Endpoint summary

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

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.