SUMMARY

The test article. AES Capsule. Multi Gate Korea Co., Ltd.; AES P-6551-KL, was extracted in 0.9% Sodium Chloride Injection. USP and Cottonseed Oil, NF. These extracts were evaluated for systemic toxicity in accordance with the guidelines of the current USP.

A single dose of the appropriate test article extract was injected into five mice per extract by either the intravenous or intraperitoneal route. Similarly, five mice were dosed with each corresponding blank vehicle. The animals were observed immediately and at 4, 24, 48, and 72 hours after systemic injection.

Under the conditions of this study, there was no mortality or evidence of significant systemic toxicity from the extracts. Each test article extract met the USP requirements.

Study and Supervisory Personnel:	Chris Weeks, B.S. Daphne Berry, B.S., LAT Jane Herriges, B.A., ALAT Parviz Ronaghi, B.S. Abel Hernandez Enrique Vazquez David Vergil
Approved by		11-19-96
	Daphne Berry, B.S., LAT Section Manager, Testing Services Toxicology	Report Date

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