Safety&Efficacy Flashcards
Oral toxicity
LD50 in rats- Lethal dose causes 50% of population to die
Eye irritation
Draize in rabbits
Individual subjective evaluation of injury to conjunctiva, iris, cornea converted into single numerical score
Chamber Scarification test
5 weekday exposures
ranking irritancy of soaps when previous studies failed to do so
scaling/redness/fissuring
Facial sting
Nasolabial fold
10% lactic acid
response 0-5 stinging intensity
Methods to measure percutaneous absorption
- Tape Stripping
- Franz diffusion cells
- In vivo methods
Mutagenicity testing
Ames test: salmonella/microsome alteration test
what is meant by carcinogenicity
causes cancer
what is meant by teratogenicity
developmental toxins that could cause birth defects
Anti-inflammatory testing post UVR
erythema suppression (humans)
Anti-inflammatory testing after chemical irritation
erythema grading by chromameter
Animal testing for anti-inflammatory
carrageenan foot pad (edema)
Critical wavelength for in vitro UVA testing
370 nm
antiperspirant efficacy must show
20% sweat reduction minimum
Moisturization evaluation
D-squame tape grading Conductivity/impedance TEWL macrophotography (before/after) skin replicas (image analysis)
what does a sebumeter do
measures surface oil by light diffraction
what does IR scan measure
skin surface temperature
Laser doppler blood flow measures
erythema, vasodilation
Vapometer provides measurements of
TEWL
evaporation
permeability
21 day moisturization regression study phases
acclimitization (wash-out)
application (3, 7, 14, 21)
Regression (after 21)
measure of cell culture viability
mitochondria MTT blue
in vitro efficacy testing of skin explants
punch biopsies
