Table 1. Study design of four-week repeated intramuscular dose toxicity study in Sprague-Dawley rats and intradermal irritation study in New Zealand white rabbits.

Study	Species	Group	Substance	Dose volume	Dose	Route and Frequency of administration	Number of animals (male/female)
Four-week repeated intramuscular dose toxicity study	Sprague-Dawley Rats	G1	Control (0.9% saline)	0.2 mL/kg	0 mg/kg	Intramuscular injection (Gastrocnemius muscle) Once per 2 weeks (Total 3 times)	11 (6/5)
		G2	Polysorbate 20		0.02 mg/kg		11 (6/5)
		G3	Polysorbate 20		0.1 mg/kg		11 (6/5)
		G4	Polysorbate 20		0.4 mg/kg		11 (6/5)
		G5	Human serum albumin		0.06 mg/kg		11 (6/5)
		G6	Human serum albumin		0.12 mg/kg		11 (6/5)
		Total					66 (36/30)
Intradermal irritation study	New Zealand White rabbits	G1	Control (0.9% saline)	0.4 mL/site (Total 5 sites)	0 mg/kg/site	Intradermal injection (Dorsal back skin) Once (Total 1 time)	3 (3/0)
		G2	Polysorbate 20		0.02 mg/kg/site		3 (3/0)
		G3	Polysorbate 20		0.1 mg/kg/site		3 (3/0)
		G4	Polysorbate 20		0.4 mg/kg/site		3 (3/0)
		G5	Human serum albumin		0.06 mg/kg/site		3 (3/0)
		G6	Human serum albumin		0.12 mg/kg/site		3 (3/0)
		Total					18 (18/0)