Testing Cosmetic Flashcards
(139 cards)
SAFETY OF THE COSMETIC PRODUCTS
.
Cosmetics should not ….. affect the human
health
.
toxicological testing is needed
/
EXAMPLES OF REGULATORY REQUIREMENTS FOR THE USE OF HUMANS IN RESEARCH
/
The Declaration of Helsinki (1964).
J
Good Clinical Practice (GCP) for trials on medicinal products in the EU.
J
National regulations regarding human studies.
J
The health and welfare of subjects has the priority and must be highly protected.
J
Historically most toxicological
data are generated by testing
on …
.
Safety in animals does not
mean safety in humans
J
Toxicity in animals does not
mean toxicity in humans
J
…… testing may have limited predictive value
.
vitro techniques, cell culture, tissue culture etc. )
M
…. studies (and alternative techniques) are used to show that the substance being tested is expected to have high degree of safety
.
Confirmatory safety testing in …. may be necessary
.
Confirmatory tests in humans should not be expected to cause ….. toxicity
.
TESTING FOR IRRITANT ACTION
• Two steps are followed:
.
EVALUATION OF IRRITATION
L
Consumer market surveillance
L
Ingredient or mixture should be tested at ….. concentration
.
Animals and in vitro techniques are used to prove
the ….. irritation potential
.
Skin tolerability of the ingredient can be
confirmed by testing in …
.
TESTS USED TO EVALUATE IRRITATION
Type:
.
Open patch test
I