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
Objective end point
U
Utilizes less test substance
U
HUMAN ASSAYS
I
A single induction single challenge patch test
Schwartz-Peck Test
J
Human Repeated Insult Patch Test (HRIPT)
U
Human Maximization Test
U
The performance of the different tests
depends on a number of factors
U
Ten induction patches are applied on different skin
sites for 24 hr every other day
H
After 2 weeks of the last induction patch a
challenge patch is applied for 24 hr
U
CONCERNS REGARDING THE USE OF HUMANS IN SENSITIZATION TESTING
H
Human sensitization tests are …. consuming and
very …
,
Ingredients identified as sensitizers in animal
studies …. tested in humans
L
The volunteers are at risk of developing adverse
effects
J
The animal tests used to evaluate the cutaneous
sensitization potential is reliable for a …
.
The animal assays performance may not be as
reliable for a …..
.
PROBLEMS ASSOCIATED WITH THE USE OF COSMETICS AND SKIN CARE PRODUCTS
K
The reactions depend on the condition of the skin ….
L
Contact Dermatitis
,
Contact Urticarial Syndrome
L
is a general term that describes an
inflammation of the skin
L
results from direct contact
with one of many irritants or allergens
K
The most common skin irritants include
K
Acids
I
alkalies
J
detergents
U
solvents
J
bath soap
I
make-up removers,
I
shampoos
J
antiperspirants
J
permanent hair-
waving solutions.
I
Repeated exposure to weak irritants (water,
detergents, abrasive dusts etc.) can have
cumulative effect and can cause….
L
is caused by reaction between the
body’s immune system and the allergen.
K
It takes …….for the body to become
sensitized after the initial exposure to the
allergen.
M
This explains why some individuals can become
allergic to a substance after using for weeks
without problems.
K
COMMON CAUSES OF ALLERGIC CONTACT DERMATITIS
K
Fragrances
K
Cinnamic alcohol,
K
cinnamic aldehyde,
J
musk
J
isoeuogenol
J
increased pigmentation of
the affected skin, photodermatitis, or contact
dermatitis
M
Unscented doesn’t mean…..
.
Those who are allergic to fragrance should look
for “fragrance-free” o….
.
Advise individuals to apply perfumes to their
clothes not to their …
.
Advise individuals not to apply ….
perfumes to their skin on sunny days
.
Preservatives
L
An individual who react to one preservative
doesn’t necessary react to other preservatives
L
Parabens
M
quarternium 15,
I
diazolidinyl urea,
I
imidazolidynyl urea
K
Toothpaste and mouthwashes
M
Bleaching or freckle cream
J
Sunscreen containing PABA
J
Face powders r
J
Lipsticks contain waxes and fats
J
cocoa butter
J
SYNTHETIC COSMETIC INGREDIENTS TO AVOID
K
Imidazolidnyl Urea and Diazolidinyl Urea
K
Methyl, ethyl, propyl, and butyl parabens
K
Petrolatum
K
Propylene glycol
K
Polyvinylpyrrolidone (PVP)/polyvinyl acetate (PVA)
copolymer
J
Sodium lauryl sulphate
K
…… lauryl sulphate is not carcinogenic, but it is
usually combined with TEA, and DEA which are
carcinogenic. So, it is recommended to add antioxidants
Vit C, or Vit A to products containing TEA, or DEA.
M
Synthetic colors
K
Colors used should be ….
L
FD&C Red No.40 (Orange-red)
K
DIAGNOSIS OF CONTACT DERMATITIS CAUSED BY COSMETIC PRODUCTS
K
This is usually done by ….
J
Chemicals are applied to the back in small
chambers or in circle of filter paper fixed with
adhesive tape
J
Patches are left for ….
K
SYMPTOMS
L
erythema, mild edema,
desquamation, papules)
L
TREATMENT
L
In acute dermatitis, gauze dipped in water and
applied to the lesion for soothing and cooling effect.
Apply for ….
.
…. can be drained but the top should not be
removed.
P
In severe cases, oral corticosteroids (prednisone 60
mg/day) ….. (if not
contraindicated)
K
……….. are not effective in the acute
phase, but after the acute phase corticosteroid cream
or ointment can be applied ……..
L
…….. are not effective in the allergic
contact dermatitis, but it helps in ….
,
Individuals with ICU may require antihistamines
and s.c. epinephrine in severe cases.
M
Antihistamines: H1 histamine receptor
antagonist.
K
Vasopressors: e.g. epinephrine to treat
anaphylactoid reaction
J
