Safety verification for polysorbate 20, pharmaceutical excipient for intramuscular administration, in Sprague-Dawley rats and New Zealand White rabbits
Fig 1
Body weight changes in a four-week repeated intramuscular dose toxicity study in Sprague-Dawley (SD) rats and an intradermal irritation study in New Zealand White (NZW) rabbits.
Body weight changes measured once a week in a) SD rats and b) NZW rabbits, for a total of five times during the study period. In SD rats, all substances were injected once every two weeks for four weeks (total three times; days 1, 15, 29) into one site of the gastrocnemius muscle of the right hindlimb. Neither male nor female rat groups showed significant differences in body weight on days 8, 15, 22, and 29 (Kruskal-Wallis test). In NZW rabbits, all substances were injected once into five sites of the back skin (total one time; day 1). There was no significant difference in body weight on days 8, 15, 22, and 29 in all groups (Kruskal-Wallis test).