Assessment of Proposed Cyclohexanone Limits for Containers.

Autor: Cammack, Jon N., White, Randy D., Wilson, Daniel M., Gonder, Janet C., Hoet, Patrick
Zdroj: International Journal of Toxicology (Sage); Mar1999, Vol. 18 Issue 2, p157-158, 2p
Abstrakt: A limit of 5 mg was recently proposed as the European Pharmacopoeia limit for residual cyclohexanone in plastic containers for parenteral medical use with a nominal volume greater than 250 ml. Comparison of the proposed limit to published toxicological end-points and current governmental regulations was used to assess the potential risk following exposure. Based on the comparison, no adverse effects would be predicted from clinical exposures to 5 mg residual cyclohexanone in containers with a nominal volume of greater than 250 ml. [ABSTRACT FROM PUBLISHER]
Databáze: Complementary Index