Safety&Efficacy

Question 1

Oral toxicity

Answer 1

LD50 in rats- Lethal dose causes 50% of population to die

Question 2

Eye irritation

Answer 2

Draize in rabbits

Individual subjective evaluation of injury to conjunctiva, iris, cornea converted into single numerical score

Question 3

Chamber Scarification test

Answer 3

5 weekday exposures
ranking irritancy of soaps when previous studies failed to do so

scaling/redness/fissuring

Question 4

Facial sting

Answer 4

Nasolabial fold
10% lactic acid
response 0-5 stinging intensity

Question 5

Methods to measure percutaneous absorption

Answer 5

• Tape Stripping
• Franz diffusion cells
• In vivo methods

Question 6

Mutagenicity testing

Answer 6

Ames test: salmonella/microsome alteration test

Question 7

what is meant by carcinogenicity

Answer 7

causes cancer

Question 8

what is meant by teratogenicity

Answer 8

developmental toxins that could cause birth defects

Question 9

Anti-inflammatory testing post UVR

Answer 9

erythema suppression (humans)

Question 10

Anti-inflammatory testing after chemical irritation

Answer 10

erythema grading by chromameter

Question 11

Animal testing for anti-inflammatory

Answer 11

carrageenan foot pad (edema)

Question 12

Critical wavelength for in vitro UVA testing

Answer 12

370 nm

Question 13

antiperspirant efficacy must show

Answer 13

20% sweat reduction minimum

Question 14

Moisturization evaluation

Answer 14

D-squame tape grading
Conductivity/impedance
TEWL
macrophotography (before/after)
skin replicas (image analysis)

Question 15

what does a sebumeter do

Answer 15

measures surface oil by light diffraction

Question 16

what does IR scan measure

Answer 16

skin surface temperature

Question 17

Laser doppler blood flow measures

Answer 17

erythema, vasodilation

Question 18

Vapometer provides measurements of

Answer 18

TEWL
evaporation
permeability

Question 19

21 day moisturization regression study phases

Answer 19

acclimitization (wash-out)
application (3, 7, 14, 21)
Regression (after 21)

Question 20

measure of cell culture viability

Answer 20

mitochondria MTT blue

Question 21

in vitro efficacy testing of skin explants

Answer 21

punch biopsies