Registration Dossier
Registration Dossier
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EC number: 200-517-3 | CAS number: 61-76-7
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on developmental toxicity
Description of key information
In a study by Shabanah et al. (1969) treatment of pregnant rabbits with phenylephrine hydrochloride (3 subcutaneous injections of 1 mg per day from the twenty-second day of gestation until delivery) caused fetal growth retardation and premature labor. It is not known whether these effects occurred in the presence or absence of maternal toxicity.
Additional information
In a study by Shabanah et al., (1969), the effect of phenylephrine hydrochloride on fetal growth and the onset of labor was studied during the second half of pregnancy in New Zealand White rabbits. Three groups of rabbits were subcutaneously injected with 1 milligram of phenylephrine hydrochloride in 1 milliliter of saline solution. Two groups consisted of 10 animals of which, respectively 7 and 5 rabbits were treated three times a day from the twenty-second day of gestation and daily thereafter until delivery. The third group consisted of two rabbits treated with phenylephrine from the sixteenth day on. After delivery, pups were weighed and counted. The placentas of the two rabbits in group 3 were sectioned for histologic study of the placental vessels; placental weights were also recorded. Urine samples of the two rabbits in group 3 and of two of the controls in each of groups 1 and 2 were tested for sugar, three times a day as of the fourth day of treatment. The results obtained suggests that phenylephrine given to pregnant rabbits during gestation produced fetal growth retardation and the onset of early labor. The authors do not indicate wether these effects occurred in the presence or absence of maternal effects.
Toxicity to reproduction: other studies
Additional information
Based on the absence of information on the potential of phenylephrine hydrochloride to affect fertility and since it is unknown whether the effects observed in the developmental study occurred in the presence or absence of maternal toxicity, it is not possible to classify the substance for reproduction toxicity according to Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
Justification for classification or non-classification
Additional information
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