Safety verification for polysorbate 20, pharmaceutical excipient for intramuscular administration, in Sprague-Dawley rats and New Zealand White rabbits
Fig 2
Histopathological section of the administration site in the four-week repeated intramuscular dose toxicity study in Sprague-Dawley (SD) rats.
Hematoxylin and eosin stained histopathological section (original magnification 100x) of the gastrocnemius muscle of the SD rats: a) Control group, male; b) Control group, female; c) Polysorbate 20–0.02 mg/kg, male; d) Polysorbate 20–0.02 mg/kg, female; e) Polysorbate 20–0.1 mg/kg, male; f) Polysorbate 20–0.1 mg/kg, female; g) Polysorbate 20–0.4 mg/kg, male; h) Polysorbate 20–0.4 mg/kg, female; i) Human serum albumin-0.06 mg/kg, male; j) Human serum albumin-0.06 mg/kg, female; k) Human serum albumin-0.12 mg/kg, male; l) Human serum albumin-0.12 mg/kg, female. Mild macrophage infiltration, neovascularization, inflammatory cells infiltration, and fat infiltration were observed with a similar degree and frequency in all administered groups. An arrow pointing up (↑) indicated macrophage infiltration and an arrow pointing down (↓) indicated neovascularization.