TABLE XIV

Summary of Safety Evaluation of a New Excipient Used in Injection

Tests	Injectable Route^*
Baseline toxicity data
Acute oral toxicity	Required
Acute dermal toxicity	Required
Acute inhalation toxicity	Conditional
Eye irritation	Required
Skin irritation	Required
Skin sensitization	Required
Acute injectable toxicity	Required
Application site evaluation	Required
Phototoxicity/photoallergy	Required
Genotoxicity assays	Required
ADME/PK-intended route	Required
28 day toxicity (2 species) intended route	Required
Additional data: Short- or intermediate-term repeated use
90 day toxicity (most appropriate species)	Required
Embryo-fetal toxicology	Required
Additional assays	Conditional
Genotoxicity assays	Required
Immunosuppression assays	Required
Additional data: Intermittent long-term or chronic use
Chronic toxicity (rodent, nonrodent)	Conditional
Reproductive toxicity	Required
Photocarcinogenicity	Conditional
Carcinogenicity	Conditional