Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on developmental toxicity

Additional information

Source: National Toxicological Program, Technical Report Series No. 322. Toxicology and carcinogenesis studies of phenylephrine hydrochloride (CAS No. 61 -76 -7) in F344/N rats and B6C3F1 mice (feed studies).

Phenylephrine hydrochloride given to pregnant rabbits during the last third of gestation produced fetal growth retardation and the onset of early labor (Shabanah et al., 1969). The use of medications containing phenylephrine hydrochloride during the first 4 months of pregnancy was associated with a greater than expected number of eye, ear, and other minor malformations in humans (Heinonen et al., 1977). Two other epidemiologie studies found no association between congenital disorders and use of phenylephrine hydrochloride during pregnancy (Jick et al., 1981; Colley et al., 1982). ß-Sympathomimetic agents consistently caused external and cardiac malformations when administered to chick embryos, but phenylephrine hydrochloride did not cause similar defects (Hodach et al., 1975; Bruyere et al., 1983).

Toxicity to reproduction: other studies

Additional information

The briefly presented data above indicate some evidence of phenylephrine hydrochloride to be a contributory factor of fetal growth retardation and premature labor. However, due tu the restricted data presented in the underlying NTP document, no classification for developmental toxicity is proposed for phenylephrine hydrochloride.

No information is available of possible impairment of fertility through phenylephrine hydrochloride.

Justification for classification or non-classification

Based on the above presented data, no classification for reprotoxicity of phenylephrine hydrochloride is warranted.