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EC number: 206-462-1 | CAS number: 345-78-8
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on developmental toxicity
Description of key information
In a developmental toxicity test in pregnant rats, developmental effects were observed. However these effects may only occur at maternal toxic doses. In a Frog Embryo Teratogenesis Assay d-Pseudoephedrine is considered to be a weak to moderate teratogen unless there is metabolic breakdown present.
Additional information
Two studies on the developmental toxicity of pseudoephedrine hydrochloride are available.
In a Teratological evaluation study (Freeman1989) pregnant Wistar rats received 240 mg/kg bw of Pseudoephedrine HCl (used as a control substance in the study) on days 6-15 of gestation. At least effects on dams body weight and food consumption and fetal weight and ossification were investigated. An influence of Pseudoephedrine HCl on the dams as well as on the fetuses is reported. Based on the available data, a developmental toxicity effect of the test substance in rats cannot be ruled out, but may only occur at maternal toxic doses.
As part of an validation study (Bantle 1991) d-Pseudoephedrine was tested for developmental toxicity using a 96 hour Frog Embryo Teratogenesis Assay (FETAX). d-Pseudoephedrine was tested both with and without an metabolic activation system in Xenopus Laevis. Without metabolic activation the mean teratogenicity index (TI): (TI = LC50/EC50) of d-Pseudoephedrine was 1.8 meaning that d-pseudoephedrine is a weak to moderate teratogen. When a metabolic activation system is present, the small number of data points did not allow for TI calculation, but all of the mortality and malformation was eliminated following d-Pseudoephedrine exposure. This suggest that d-Pseudoephedrine would not pose any particular problems in in vivo mammalian experiments.
Justification for classification or non-classification
No data is available on the effects of pseudoephedrine hydrochloride on fertility. Therefore classification for effects on fertility in accordance with EU Directive 67/548 (DSD) and EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008 is not possible.
In the available preliminary studies on the developmental toxicity of Pseudoephedrine hydrochloride it can be concluded that pseudoephedrine hydrochloride is not a developmental toxicant. However, the data is not sufficient to classify pseudoephedrine hydrochloride in accordance with EU Directive 67/548 (DSD) and EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008 for developmental toxicity.
Additional information
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