safety performance test

8/12/2019 Safety Performance Test

1/42

PATCH TESTINGPATCH TESTING


2/42

Points to be studied

Principle behind patch test

Types of patch testing

Open & prophetic patch test

Constraints in patch test

Report of patch test


3/42

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.


4/42


5/42

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.


6/42

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.


7/42

Types of patch test

Diagnostic patch test Prophetic patch test


8/42

Diagnostic patch test

The cosmetic which used, has causeddermatitis and if cosmetic is known, the

in redient which h s c used it.


9/42

Prophetic patch test

For new cosmetic products.

Whether new product should place in

market or not.


10/42

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.


11/42

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.


12/42

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.


13/42

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.


14/42

Sr. No Description of observation Symbol1 No reaction -

2 Erythema only +

3 Erythema with papules ++

4 Papilovascular +++

5 Ulceration or Necrosis ++++


15/42

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.


16/42

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.


17/42

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.


18/42

Prophetic test may be open or covered. Safe cosmetics: if more than 2 in 10,000

.


19/42

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


20/42

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.


21/42

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.


22/42

Various tests to be performed forsafety

Cosmetics .potential for adverse reactionEx.

Skin irritation

Allergic sensitization Contact urticaria

Stinging

Photo toxicity Photo allergy


23/42

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?


24/42

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


25/42

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


26/42

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


27/42

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


28/42

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.


29/42

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


30/42

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


31/42

IRRITATION TEST

Base is painted on skin If no reaction. Test carried out in 10

Application on forearm

No reactionsafe


32/42

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


33/42

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


34/42

Exposed patch covered again One adjoining area of skin expose to sunlight

After 24 hrs. examination of patches

No reaction no phototoxicity


35/42

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


36/42

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


37/42

USE TEST

Cosmetic to used and adverse effects areobserved

.

No adverse reactions released for trials


38/42

RESTRICTED CONSUMER

TEST

After passing tests for irritant potential andsensitivity potential

-

In case of any adverse reactions, further

testing with appropriate methods


39/42

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


40/42

Temperature swing test: Freeze & thaw cycles during six weeks,

- 0 .

24 hrs. at 400C

Judge & interpret the result


41/42

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


42/42

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.

safety performance test

Documents