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| Study name | Short Description | Data Owner |
|---|---|---|
| Toxicological | Eye irritation | Right to refer to study -- Title: Transcutol. Ocular irritation and reversibility test on the rabbit | Author: Mercier O. | Year: 1996 | Guideline: 405 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study | GLP: Y. | Gattefossé |
| Toxicological | in vitro gene mutation study in bacteria (Ames) | Right to refer to study -- Title: Transcutol P -Bacterial reverse mutation test (plate incorporation) | Author: Aujoulat M. | Year: 1999 | Guideline: 471 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study | GLP: Y. | Gattefossé |
| Toxicological | Genetic toxicity in vivo | Right to refer to study -- Title: Transcutol: Measurement of unscheduled DNA synthesis in rat liver using an in vivo/in vitro procedure | Author: Clare C. | Year: 1996 | Guideline: 486 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study | GLP: Y. | Gattefossé (+Vetoquinol) |
| Toxicological | Acute toxicity: oral | Right to refer to study -- Title: Acute toxicity following a single oral administration (limit test) in the rat | Author: Cantor S. | Year: 1994 | Guideline: 401 | Klimisch score: 2 - Reliable with restrictions | Adequacy: supporting study. | Gattefossé |
| Toxicological | Basic toxicokinetics | Right to refer to study -- Title: Plasma kinetics, absorption and tissue distribution of 14C-diethylene glycol monoethylether administered by intravenous and oral route to the male and female Sprague-Dawley rats and BDIX rats. | Author: Marsili-Guidicelli M.D. | Year: 2002 | Guideline: 417 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study | GLP: Y. | Gattefossé |
| Toxicological | Basic toxicokinetics | Right to refer to study -- Title: Metabolite determination of 14C-diethylene glycol monoethylenether administered by oral route to the male Sprague-Dawley rats | Author: Le Gal A. | Year: 2003 | Klimisch score: 1 - Reliable without restriction | Adequacy: supporting study | GLP: N. | Gattefossé |
| Toxicological | Basic toxicokinetics | Right to refer to study -- Title: Metabolism study of diethylene glycol monoethylether administered by oral route to male Sprague-Dawley rats | Author: Le Gal A. | Year: 2003 | Guideline: 417 | Klimisch score: 1 - Reliable without restriction | Adequacy: supporting study | GLP: Y. | Gattefossé |
| Toxicological | Repeated dose toxicity: oral | Right to refer to study -- Title: A 13-week oral (gavage) toxicity study of Transcutol HP in Beagle dogs | Author: Padgett E.L. | Year: 2007 | Guideline: 409 | Klimisch score: 1 - Reliable without restriction | Adequacy: key study | GLP: Y. | Gattefossé |
| Toxicological | Repeated dose toxicity: dermal | Right to refer to study -- Title: 28-Day repeat dose dermal toxicity study: rabbits | Author: Wnorowski G. | Year: 1995 | Guideline: 410 | Klimisch score: 2 - Reliable with restrictions | Adequacy: key study | GLP: Y. | Gattefossé |
| Toxicological | Developmental toxicity/teratogenicity | Right to refer to study -- Title: Transcutol HP- Embryo toxicity study by the oral route (gavage) in the rat (Segment II) | Author: Rogissart A. | Year: 2002 | Guideline: 414 | Klimisch score: 2 - Reliable with restrictions | Adequacy: key study | GLP: Y. | Gattefossé |
| Toxicological | Toxicity to reproduction | Right to refer to study -- Title: Reproduction/Development Toxicity Test: Fertility Study - Segment I | Author: Rogissart A. | Year: 2001 | Klimisch score: 2 - Reliable with restrictions | Adequacy: supporting study | GLP: Y. | Gattefossé |
| Toxicological | Sensitisation data (humans) | Right to refer to study -- Title: Clinical study for the evaluation of the irritating and sensitizing potentials of several cosmetic test articles by repeated cutaneous 48 hours applications under occlusive patch test in 25 healthy adult volunteers (Marzulli and Maibach's method) | Author: Colin L. | Year: 1993 | Klimisch score: 2 - Reliable with restrictions | Adequacy: key study | GLP: N. | Gattefossé |
| Toxicological | Exposure-related observations in humans: other data | Right to refer to study -- Title: Single patch test: Verification of the good epicutaneous local tolerance of several test articles after a single application to the skin of the back and under occlusive patch test for 48h in 10 healthy adult volunteers | Author: Boidin C. | Year: 1992 | Klimisch score: 2 - Reliable with restrictions | Adequacy: supporting study | GLP: Y. | Gattefossé |
| Toxicological | Exposure-related observations in humans: other data | Right to refer to study -- Title: Single patch test: Verification of the good epicutaneous local tolerance of several test articles after a single application to the skin of the back and under occlusive patch test for 48h in 10 healthy adult volunteers | Author: Boidin C. | Year: 1992 | Klimisch score: 2 - Reliable with restrictions | Adequacy: supporting study | GLP: Y. | Gattefossé |