Abstract
The mutagenicity of protamine sulfate has been clarified based on chromosomal aberration of cultured chinese hamster lung cells (cell line) in direct and metabolic activation methods and microbial mutagenesis (Ames test). In chromosomal aberration test, protamine sulfate caused cytotoxicity in the high doses (2500 and 5000 μg/ml) in the presence of rat liver homogenates (S-9). But very negligible or no cytotoxicity occurred in direct method at high dose (5000 μg/ml). Structural aberration of chromosome was not occurred in either of the methods. In microbial mutagenesis study, protamine sulfate did not show any cytotoxicity to microbes up to the dose of 5000 μg per plate. Furthermore, it did not have any effect in microbes like mutagens or like some toxic agent. The study reveals that protamine sulfate is not mutagen.
