Testing Cosmetic Flashcards
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
Closed patch test
J
Single and repeated exposure tests
I
The choice of the test is based on the
J
This test involves application of the ingredient
(diluted or undiluted) under investigation on the
يشب هيطغا ام و هطحا
skin (without occlusion) for a period between 15
min to 24 hr
M
This test involves application of the ingredient
under investigation (diluted or undiluted) under
occlusive chamber for 24 - 48 hr
H
The test involves repeated application of the
ingredient under investigation to the same area of
the skin 1 - 7 times a week for 1-5 weeks (based
مادختسلا ةتقيرط بسح ىلع
on the expected use pattern)
J
EVALUATION OF THE IRRITATION
M
Newer techniques such as measuring the
J
….. develops after exposure of a sensitized individual to a contact allergen
K
Contact allergen (haptens, low MW molecules) bind to skin component
J
The hapten-protein conjugate function as an …
H
This antigen is presented to the B-cells to
I
When a sensitized individual (with antibodies
against the hapten) is exposed to the hapten
again, ……is developed.
N
ANIMAL ASSAYS FOR SENSITIZING ACTION
I
Guinea pig assay
M
The animal are treated with the test
substance (by intra-dermal injection or patch )
J
The animal develop specific sensitization in the
following …… if the substance is sensitizer
K
After a period, the animal is
challenged with a …. of
the test substance. more response
K
If the animal develops a response to the
challenge, the animal is considered……
L
The Guinea Pig Maximization Test
K
The Buehler Test
I
It includes both intra-dermal and topical induction
and closed challenge
J
Highly sensitive method Widely used ( give valid result )
K
It uses repeated closed topical induction and
closed challenge
U
Less sensitive test
J
THE MOUSE ASSAY
J
The Local Lymph Node Assay (LLNA):
U
alternative method to the Guinea pig test
U
involves application of the test substance on the
ear of the mouse.
U
The response is measured by the degree of
…..
K
Shorter test duration
U
