SAFETY TESTING OF COSMETIC PRODUCTS

8/7/2019 SAFETY TESTING OF COSMETIC PRODUCTS

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Presented ByVikram Viswajit Mishra,M.Pharm 1st sem

Branch Pharma tech


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` Introduction

` Microbiology in

Cosmetics

` Conditions of use &

exposure

` Clinical consequence

of microorganism

` Preservatives used in

cosmetics` Predicting long term

Preservative Efficacy

` Conclusion

` References


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` The word itself produces glow whenever you

think about it. By its definition, it modifies the look.

But before coming to market it has to go a long

way and after reaching to customer also it has topass many issues.

` Cosmetic products have to be safe for the

consumers and, if relevant, for involved

professionals (i.e. hairdressers, beauticians).


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` A number of adverse effect due to growth of

microorganism is found in cosmetics.

` These includes discolouration of the product,

odour or gas rheological properties of viscousproducts,etc

` Decomposition may occur in such cosmetics after

months

` Yeast growth may also take place in cosmeticpreparations.


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` Organisms commonly isolated from poorly preserved

water-based products include

Enterobacter,Staphylococcus and Bacillus species,

Pseudomonas,

` Gram-negatives are most common and, as they have

very diverse metabolic capabilities, can survive in a

wide range of environments.

` A study of shampoo products 60 % of samples were

contaminated with Gram negatives, 22% of samples ofsun care products in use on a beach contained

Candida species.


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The following parameters have to be considered: Class of cosmetic product(s) in which the ingredient is

used Method of application (e.g. rubbed-in, sprayed, applied and

washed off, etc.) Concentration of ingredient in product Frequency of application Total area of skin contact Site of contact (e.g. mucous membrane, sunburnt skin); Duration of contact (e.g. rinse-off products, leave-on

products) Type of consumers (e.g. children, people with sensitive

skin)


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Skin irritation

Skin Sensitization: Cosmetic products are often

used in areas exposed to environment

Photo Irritation Photo Sensitization: For products applied on the

face or scalp

Eye tolerance


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Potential pathogens have been found in cosmetics

.The more vulnerable members of society

neonates, the elderly, people with debilitating

diseases or those undergoing drug therapy` The eye is particularly vulnerable to infection

E.g.

` Contamination of talc with Clostridium tetani,

` Infection of neonates with P.aeruginosa fromcontaminated cleansing solution


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` The assessment of the safety of any cosmetic product

clearly relates to the manner of use.

` The possible interaction between different ingredients

will usually be evaluated on the basis of experience

(similarities, published data on related compounds,

theoretical considerations, etc.) and may be controlled

using in vitro testing and/or skin compatibility tests.

` In vitro testingmay be carried out to complement

available information with the necessary use ofappropriate benchmarks.


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` Chemical Preservation: These are widely used. These

chemical are used at a conc. of less than 1% e.g.

Benzoic acid, sodium benzoate

`

Manipulation of pH:T

he pH for cosmetics is within therange of 3.5-9.0.Manipulating of pH limits microbiologic

growth

` Limitation of water content: It is commonly used in

cosmetics whose primary components are oils waxes

and contains less water. Water activity should bemaintained below 0.85.


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` Use of hostile raw materials:Materials like

propylene glycol at a conc of 25-50% is used as

hostile agents for microbial growth

` Aseptic Manufacturing:the product should bemanufactured in accordance to GMP

` Packaging Design: the design of a packaging

should be such that it does not allow asny

interaction between the product and theenvironment.


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` It should be free from toxic irritants

` Should be stable to heat and prolonged storage

` Be free from gross incompatibility

` Be effective against a wide range ofmicroorganism

` Be readily soluble at its effective conc.

` Be without odour or colour

` Be able to retain its activity in the presence of

metallic salts


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` Organic acids: Organic acids like benzoic acids

are used as preservatives .compounds having

9,10 or 11carbon atoms like monochloroacetic

acid and propionic acids are used as antifungalactivity.

` Aldehydes: Benzaldehyde and cinnamic aldehyde

are widely used in cosmetics

` Essential oils: Essential oils are used in cosmeticsdue to their antiseptic properties. E.g Sandalwood

oil


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` Phenolic compounds: They are widely used as

antimicrobial agents phenol derivatives are used

like

p-chloro-m-xylenol- used in formulation like

deodrants,shaving creams

O-phenyl phenol- these are used to eliminate

odour, taste and colour grade

Mercury Compounds: It is used to a limited extent

Surface active agent: they are widely used aspreservatives like quaternary ammonium

compounds.


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` By microbial growth under ideal conditions the

efficacy of the preservative system can be

assessed. Methods are as follows

A. Initial microbiological challenge test:These determine the type and the minimum

conc. of the preservatives required. Preliminary

tests are conducted like pH change or colour

changeB. Quick Challenge test: this test is used with

bacteria and fungi for growth inhibition. The

steps involved are


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Preparation of product samples

Preparation of inocula for bacteria and yeast

Preparation of inocula for moulds

C. Repeat Challenge test: This test is conducted topredict the susceptibility of a number of products

to microbial contamination

D. The official Method: It involves involves inoculating

test samples using aratio of inoculum to 20mlE. CTFA Method


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` Shampoos

Skin irritation Test: Consists of Draize Test inRabbits. For shampoos it is for 4hrs.AlternativelyHuman Patch test may be carried out

Skin sensitization test: Magnusson and KligmanGuinea Peg Maximization Test should be carried out

Eye Irritancy Test: Draize Test in rabbits is alsoconducted. Eye irritating potential of a substance is

evaluated on ability to injure cornea.


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` Sunscreen:

Sun Protection Factor(SPF):

It is the ratio between the time needed to achieve

erythematic on protected skin by the time requiredto get it unprotected.

This is applied on human beings. In this method at

least 2 persons are irradiated by medium vapour

lamp generating light as mostly 290-400nm.


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` As a protection to both the cosmetic products and the

cosmetic users, adequate microbiological controls are

an important part of a cosmetic testing .Contamination

of the deionizer water utilized in production can beminimized by ultraviolet radiation..


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1. Dr B.F. Perry, Procter & Gamble TechnicalCentres Ltd.

2. AEAN PIF Guidelines

http://www.hsa.gov.sg/publish/etc/medialib/hsa_library/health_pro

ducts_regulation/cosmetic_products/files_1.Par.34738.File.dat/Gu

idelines%20for%20Product%20Information%20File%20(PIF).pdf

3. Pouchers Perfumes Cosmetics and Soaps.pg 657-659

4. Cosmetics Technology Pg270-298

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SAFETY TESTING OF COSMETIC PRODUCTS