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
Additional information
Two reliable in vitro and one reliable in vivo study are available investigating the genotoxicity of phenylephrine hydrochloride.
In the study of Zieger et al (1987), four Salmonella typhimurium strains (TA98, TA100, TA1535, and TA1537) were exposed to the test substance (0, 100, 333, 1000, 3333, and 10000 µg/plate) in the presence or absence of Aroclor 1254-induced rat or hamster liver S9. In this bacterial reverse mutation assay, phenylephrine hydrochloride was considered to be not mutagenic.
In the study by Anderson et al (1990), chinese hamster ovary cells were exposed to the test substance to determine chromosomal aberrations. The cells were exposed to 0, 1500, 2000 and 2500 µg/ml without metabolic activation and 0, 9000, 9500 and 10000 µg/ml with metabolic activation. Chromosome aberrations were not induced by phenylephrine hydrochloride.
In an in vivo micronucleus test, phenylephrine hydrochloride was administered intraperitoneally daily for three consecutive days (0, 4, 8, 17, 35 mg/kg) to male F344 rats. Exposure of 17 and 35 mg/kg resulted in the death of all animals. No increase in micronuclei was observed in the polychromatic erythrocytes of the surviving rats.
Short description of key information:
Phenylephrine hydrochloride was not mutagenic in bacteria with or without metabolic activation. Furthermore, phenylephrine hydrochloride did not induce chromosome abberations in chinese hamster ovary cells in the absence and presence of metabolic activation and in the in vivo micronucleus test no genotoxicity was observed.
Endpoint Conclusion:
Justification for classification or non-classification
Based on the negative results in the Ames test, the in vitro chromosome abberation test and the in vivo micronucleus test, classification for genetic toxicity is not warranted in accordance with the Directive 67/548/EEC and according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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