Acute and Short Term Toxicity, Alternative Toxicity, Subchronic Toxicity

Studies are designed according to international guidelines, including OECD, EC, OPPTS, ICH or Japanese guidelines.

Acute and Short Term Toxicity

Experimental Testing

Guideline	Study
-	Acute toxicity Route of administration : oral, dermal, intravenous, intraperitoneal, inhalation*
OECD 423	Acute oral toxicity
OECD 425	Acute oral toxicity (LD 50)
OECD 402	Acute dermal toxicity
OECD 403 - OECD 436*	Acute toxicity by inhalation route
OECD 404	Acute skin irritation
OECD 405	Acute eye irritation
OECD 406	Contact sensitization Magnusson & Kligman Buelher
-	Phototoxicity
-	Photoallergy
NF EN ISO 10993.11 Pharm. Eur.8° Ed.	Pyrogen

* With G.L.P. partners in Europe, Asia, USA and India

Alternative Studies

Guideline	Study
OECD 430	Skin corrosion T.E.R (Transcutaneous Electrical Resistance Assay)
OECD 431	In vitro skin corrosion on reconstructed human epidermis
OECD 439	In vitro skin irritation on reconstructed human epidermis
OJRF 26/12/96 OECD 438	Acute eye irritation HET CAM (Hen's Egg Test Chorioallantoïc Membrane) I.C.E (Isolated Chicken Eye)
OECD 429 & 442B	Contact sensitization LLNA (Local Lymph Node Assay) rLLNA (reduced-LLNA)
-	Photoallergy Photo Local Lymph Node Assay
NF EN ISO 10993.5	Cytotoxicity

Experimental Testing

Guideline	Study
OJRF 25/05/93	Local cutaneous tolerance after repeated applications
OJRF 17/06/92	Local tolerance after repeated applications on the cheek pouch
-	14 day oral dose range-finding study
OECD 407	Repeated dose 28 day oral toxicity in rodents *
OECD 408	Repeated dose 90 day oral toxicity in rodents*
OECD 410	**Repeated dose 28 day dermal toxicity in rodents ***

* With G.L.P. partners in Europe, Asia, USA or India