Safety Performance Test
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Transcript of Safety Performance Test
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PATCH TESTINGPATCH TESTING
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Points to be studied
Principle behind patch test
Types of patch testing
Open & prophetic patch test
Constraints in patch test
Report of patch test
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What is patch testing?
Patch testing is a way of identifying whether asubstance that comes in contact with the skin
is causing inflammation of the skin (contact
dermatitis). There are two types of contact dermatitis:
irritant contact dermatitis and
allergic contact dermatitis.
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Allergic contact dermatitis
An allergic reaction is specific to the individual and toa substance (or a group of related substances) called
an allergen.
Allergy is a hypersensitivity to a particular substance,and always involves the immune system.
All areas of skin that are in contact with the allergen
develop the rash.
The rash will disappear if you avoid contact with the
substance.
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Purpose of Patch Testing Patch testing can help to differentiate between the
two.
The test involves the application of various test
substances to the skin under adhesive tape that are
then left in place for 48 hours.
The skin is then examined further 48 hours later for
any response.
This can help the doctor/ cosmetic chemist, to decide
which allergens you are allergic to and identify thosethat could be aggravating your dermatitis.
The doctor will then be able to advise how you can
avoid the allergens.
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Types of patch test
Diagnostic patch test Prophetic patch test
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Diagnostic patch test
The cosmetic which used, has causeddermatitis and if cosmetic is known, the
in redient which h s c used it.
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Prophetic patch test
For new cosmetic products.
Whether new product should place in
market or not.
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General procedure
Place 0.1 to 0.3 gm of cosmetic to be tested on a piece of
cotton or flannel (2-3 cm2)
Apply to the skin of arms, thighs or back.
This patch is covered with the patch of cellophane (5 cm2) and
sealed with adhesive plaster (40 cm2
) Apply several patches at one time.
Some patches: similar cosmetics with other brand but known
not to cause any harm to the skin.
Other similar cosmetics: Controls
Allowed to remain that patches for 24 72 hrs.
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If there is no reaction, the same patch shouldreapplied to the same place or fresh patch of the
same material may be made & applied.
This may be continued till: either a reaction is produced under one or more patches, or
investigator is confirmed that no reaction will occur.
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Reading & grading of patches: experienced dermatologist. Sites of the patches, examined after 30 minutes of removal of
patch.
removal.
Skin under adhesive tape: inflamed,
Skin under cellophane tape: clear
Skin under test patch: no reaction or reactions like erythema,erythema with papules, papulory vascular reaction or ulceration or
neurosis.
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Erythema: redness of the skin caused by capillarycongestion.
Erythema with papules: elevated, solid lesion, less
than 1 cm. Papulory vascular reaction: injury to blood vessels.
Ulceration: inflammatory or more seriously, infective
condition of the cornea involving disruption of its
epithelial layer.
Necrosis: premature death of cells and living tissues.
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Sr. No Description of observation Symbol1 No reaction -
2 Erythema only +
3 Erythema with papules ++
4 Papilovascular +++
5 Ulceration or Necrosis ++++
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If no reactions are observed, the subjectsshould be observed for next 3 to 5 days bcoz
some ingredients show late reaction.
The skin is exposed to sunlight and find out, itcauses any photosensitization.
For particular ingredients:
Eighteen patches can placed on one subject:
Three on each arm & thigh and
Six on the back.
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OPEN PATCH TEST Used for cosmetics containing higher % of potential irritants like
hair dyes, shampoos, hair tonics. Sealing of patches does not simulate actual use so patches are
kept open and performed on sensitive part of skin e.g. bend of
elbow o liteal s ace of the skin behind the ears.
Cosmetics applied on 1 cm2 area.
Control patches of similar cosmetic but well known brand applied.
Site of patch inspected after 24 hrs.
If no reaction: repeated once more on same site upto three times.
If no reaction after third time: not hypersensitive
If reaction occurs: hypersensitive.
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PROPHETIC PATCH TEST Before performing this test, investigator should confirm that the
material is not the primary irritant. Careful about the sign of the subjects for the waiver of damage
and money matter.
.
One to five days for observation, three more days for late
reaction.
After 7 to 10 days, patches are reapplied for the same test if not
shown any positive response in first. If there are no reactions or one or two reactions out of 200, new
product can be placed for trial sale in a community of about
10,000 persons.
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Prophetic test may be open or covered. Safe cosmetics: if more than 2 in 10,000
.
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Constraints in Patch test
Concentration of ingredient Solid: mild than liquid or semisolid
Individual basis: some ma roduce reaction ver
soon than others.
Seasonal changes: Summer season due to pricks
formation around the area of test due to occlusion
Volatile subs. may acts as primary irritants
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Report of Patch Test
Concentration of chemical / agent,
Amount used,
Site of application,
No. of days patch was left on the skin, Period after the removal of patch when observations
were made.
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DRAWBACKS OF PROPHETICTEST
Quick absorption of potential skin irritant thr skin Rapid evaporation of volatile skin irritants from patch
Small amount of test sub. is used as com ared to
large qty. actually used
Small area of skin is used as compared to actual S.A.
of skin
Short exposure of skin to cosmetic than the exposure
actual in use.
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Various tests to be performed forsafety
Cosmetics .potential for adverse reactionEx.
Skin irritation
Allergic sensitization Contact urticaria
Stinging
Photo toxicity Photo allergy
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Skin irritation
Irritation: state of inflammation or painful reaction toallergy or cell-lining damage.
inflammatory responses such as erythema, oedema or
vesiculation Irritants: Substances that damage the skin by toxic
reaction
Primary irritants Secondary irritants
How to perform the test?
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Tests for cosmetics
Test Type of product1.Skin irritation test
2.Oral toxicity limit test
Skin, hair and lip products
Dentrifrices, mouth wash and
3.Mucous membraneirritancy test
a. Eye irritancy andmucous membraneirritancy
b. Oral mucousirritancy
lip products
Hair care and eye area
cosmetics
Dentrifrices and mouth wash
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Sensitivity testing
Draize patch test
Area: hairless, 10 cm2, 2-3 cm apart, 4
patches
Applicant: 12 ply surgical gauze on polythenesheet on surgical adhesive plaster
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Draize patch test
Quantity: 0.5 ml - liquids0.5gm - solids/semisolids
Positive control: sodium laur l sul hate 2-20%
Position maintaining: wrapping whole trunk with
cloth/canvas bandage
Duration of exposure- 24hrs/4hrs
Duration of response- 24/48/72 hrs
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Draize patch evaluation
Erythema / eschar formation ScoreNo erythema
0
Well defined erythema
Moderate to severe erythema
Severe erythema and slight eschar
formation
2
3
4
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Draize patch evaluation
Oedema formation Score
No oedema
0
Very slight oedemaSlight oedema (defined edges)
Moderate oedema(1 mm raising)
Severe oedema(1 mm raising beyondarea of exposure)
12
3
4
Oedema: abnormal accumulation of fluid beneath
the skin, or in one or more cavities of the body.
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Draize patch scoring
Average of 6 animals= a
Primary irritancy index= a/12
0.00 No irritation
0.04 0.99 Irritation barely perceptible
1.00 1.99 Slight irritation
2.00 2.99 Mild irritation
3.00 5.99 Moderate irritation
6.00 8.00 Severe irritation
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IRRITATION TEST
Indian standards Patch test
Guinea i s/rabbits
No. of animals: 10
Patch Area : 2 cm2
Area: without hairs
No use of bandage
Cosmetic used as such
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IRRITATION TEST
Base is painted on skin If no reaction. Test carried out in 10
Application on forearm
No reactionsafe
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REPEATED INSULT TEST Described by Draize so called Draize test.
Apply same conc. found in product in strong base.
Strong base may be saline solution to such nonirritating,
nonsensitizing organic solvent like dimethyl phthalate.
0.5gm/0.5 ml of sample
Site: back/upper arm skin
Duration: 24 hours
Observation: 15-20 min after patch removal
24 hours rest periodsecond patch different site
10 consecutive exposure10-14 days rest period
retest application
Comparison of reactions of retest and original application
Selection of test subjects
200 test subjects
Ideally initially 10 animals10 human volunteer
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PHOTOPATCH TEST
Some substances are not harmful by themselves butbecome harmful when exposed to sun light
Wavelength 300- 800 nm
Substance applied in duplicate in a manner same forstandard patch test
After 24 hrs one patch is exposed to sunlight / uv light
for 30 min
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Exposed patch covered again One adjoining area of skin expose to sunlight
After 24 hrs. examination of patches
No reaction no phototoxicity
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TEST FOR SENSITIZING
POTENTIAL
Standard patch test with same chemical / cosmetic.in 200 volunteers after an interval of 10-14 days
Persons showing reactions.sensitizing potential of
the substance Provocative patch test
Weak sensitizing agents
10-15 applications of a substance on alternate days
on same spot in 10 volunteers
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TEST FOR SENSITIZING
POTENTIAL
Standard patch test performed after 10
days of last application
Test will give idea about developing
sensitizing potential In case of unknown chemicals, ideally
performed on animals like gunia
pigs/rabbits
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USE TEST
Cosmetic to used and adverse effects areobserved
.
No adverse reactions released for trials
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RESTRICTED CONSUMER
TEST
After passing tests for irritant potential andsensitivity potential
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In case of any adverse reactions, further
testing with appropriate methods
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Stability of cream & lotion
Storage test:
- 200 C for 24 hrs. (thaw)
- 50 C for 1 week (thaw),
n ar p ace or mon s, es eac mon ,
400C for 3 months, test each month,
500C for 1 week, test at 1, 3 & 7th day.
Thaw: to pass or change from a frozen to a
liquid or semi liquid state
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Temperature swing test: Freeze & thaw cycles during six weeks,
- 0 .
24 hrs. at 400C
Judge & interpret the result
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Centrifugation test:
Performed at AT:
Either for 10 mins. At 10,000 rpm or
.
Specific value is considered and scale the rating as follow:
Stable,
Slight inhomogenity,
Beginning of separation,
Marked separation,
Complete separation
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Questions ?????
What is the purpose of testing the cosmetic onanimal? Enlist various tests to be performed for
safety. Write in brief about patch test.
Write principle behind irritancy test of cosmetics?Explain in brief irritancy test?
Write a note on safety of cosmetic products.
Write a note on stability of cosmetic products.