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EC number: 206-462-1 | CAS number: 345-78-8
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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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