controversial ingredient ,What exactly are paraben preservatives

1. Presented by:
Sishant Rav Divya
M.Pharm First Year ( Pharmaceutics )
BBAU Lucknow
2017-19

2. Controversial Ingredients
• Paraben
• formaldehyde liberator
• DIOXANE

3. Paraben
Parabens are widely
used preservatives in cosmetic and pharmaceutical products.
they are a series of parahydroxybenzoates or esters of
parahydroxybenzoic acid (also known as 4-hydroxybenzoic acid).
Parabens are effective preservatives in many types of formulas.
parabens are found in shampoos, commercial moisturizers, shaving
gels, personal lubricants, topical/parenteral pharmaceuticals, spray
tanning solution, makeup, and toothpaste. They are also used as food
additives

4. Chemistry
• Parabens are esters of para-hydroxybenzoic acid, from which the
name is derived. Common parabens include methylparaben (E
number E218), ethylparaben (E214), propylparaben(E216), butylparab
en and heptylparaben (E209). Less common parabens
include isobutylparaben, isopropylparaben, benzylparaben and their
sodium salts.
( para-hydroxybenzoate)
where R = an alkyl group

5. Synthesis
• All commercially used parabens are synthetically produced, although
some are identical to those found in nature.
• They are produced by the esterification of para-hydroxybenzoic acid
with the appropriate alcohol, such as methanol, ethanol, or n-
propanol

6. Mode of action
• Parabens are active against a broad spectrum of microorganisms.
• but their antibacterial mode of action is not well understood
• Parabens inhibiting synthesis of DNA and RNA or of some key
enzymes

7. Why parabens are contraversial
• Most of the available paraben toxicity data are from single-exposure
studies, meaning one type of paraben in one type of product.
• According to paraben research this is relatively safe, posing only a
negligible risk to the endocrine system

8. American Cancer Society and FDA
• Allergic reactions
In individuals with normal skin, parabens are, mostly non-irritating and non-
sensitizing. But Parabens can, cause skin irritation and contact
dermatitis and rosacea in individuals with paraben allergies, a small percentage
of the general population.
• Breast cancer
No evidence shows that application of comatic products containing parabens
cause cancer.Investigations by the American Cancer Society and FDA found that
current levels of parabens in cosmatic products were not dangerous

9. Estrogenic activity
Animal experiments have shown that parabens have
weak estrogenic activity, acting as xenoestrogens.In an in vivo study,
The estrogenic activity of parabens increaseswith lenth of alkyl group.

10. Sun exposure
Studies indicate that methylparaben applied on the skin may react
with UVB leading to increased skin aging and DNA damage

11. What Are the Dangers of Parabens in Skin Care?
• Parabens are synthetic preservatives used in foods, pharmaceuticals,
cosmetics and personal care products such as deodorants,
moisturizers and shampoos.
• Common parabens include methylparaben, ethylparaben,
propylparaben and butylparaben.
• they also enter your body through your skin when you use these
products. According to Mercola, the body can absorb as much as five
pounds of cosmetic chemicals every year.
• Parabens can mimic hormones in the body and disrupt functions of
the endocrine system

12. Breast Cancer
• Colby College’s reports that parabens can mimic estrogen and disrupt
the body’s hormone system
• Cornell University reports that a high lifelong exposure to estrogen
can increase breast cancer risk.
• Estrogen, and synthetic chemicals act like estrogen, play a role in
stimulating the division of breast cells and affect other hormones that
stimulate breast cell division.
• Your body does not easily break down synthetic estrogen

13. • The paraben accumulate in fat cells,
• including breast tissue.
• In 2004, a study by the University of Reading in the United Kingdom
found concentrations of parabens, particularly methylparaben, in
human breast tumors.

14. Early Puberty
• The ability of parabens to mimic other hormones makes them
endocrine disruptors,
• substances that adversely affect the endocrine system.
• The endocrine system releases hormones into the bloodstream and is
involved in a number of functions related to
• reproduction,
• waste elimination,
• digestion and metabolism.
• Endocrine disruptors such as parabens can lead to early puberty in
adolescent girls and boys

15. Decreased Sperm Levels
• Parabens can also affect the male reproductive system. In a study by
the Tokyo Metropolitan Research Laboratory of Public Health,
researchers administered parabens to three-week-old rats. After four
weeks, researchers examined the rats and found their sperm
production significantly decreased in relation to the amount of
parabens they had received. The rats who received the highest dose
of parabens, which was consistent with the daily acceptable intake of
parabens in Europe and Japan, showed a significant decrease in
sperm concentration

16. Regulation
The European Scientific Committee on Consumer Safety (SCCS)
reiterated (agains) in 2013 that methylparaben and ethylparaben are
safe at the maximum authorized concentrations (up to 0.4% for one
ester or 0.8% when used in combination).
The SCCS concluded that the use of butylparaben and propylparaben as
preservatives in finished cosmetic products is safe to the consumer,

17. formaldehyde liberators

18. FORMALDEHYDE AND FORMALDEHYDE-RELEASING
PRESERVATIVES
• Formaldehyde and formaldehyde-releasing preservatives (FRPs) are
used in many personal care products,particularly in shampoos and
liquid baby soaps.
• These chemicals, which help prevent microbes from growing in water-
based products, can be absorbed through the skin and have been
causes to cancer and allergic skin reactions

19. FORMALDEHYDE-RELEASING
• FOUND IN: Nail polish, nail glue, eyelash glue, hair gel, hair-
smoothing products, baby shampoo, body soap, body wash, color
cosmetics.
• WHAT TO LOOK FOR ON THE LABEL: Formaldehyde, quaternium-15,
DMDM hydantoin, imidazolidinyl urea, diazolidinyl urea,
polyoxymethylene urea, sodium hydroxymethylglycinate, 2-bromo-2-
nitropropane-1,3-diol (bromopol) and glyoxal.
• WHAT IS FORMALDEHYDE? Formaldehyde is a colorless, strong-
smelling gas used in a wide range of industries and products including
building materials, walls, cabinets furniture and personal care
products.

20. CHEMICALs THAT RELEASE FORMALDEHYDE
 quaternium-15,
DMDM hydantoin,
imidazolidinyl urea,
diazolidinyl urea,
 polyoxymethylene urea,
sodium hydroxymethylglycinate,
bromopol and glyoxal.

21. Quaternium-15
• Quaternium-15 is a quaternary ammonium salt used as a surfactant
and preservative in many cosmetics and pharmaceutical product.
• Synthesis
• Quaternium-15 can be prepared by reacting hexamethylene
tetramine with 1,3-dichloropropene to produce the product as a
mixture of cis and trans isomers.
• Quaternium-15 is the most sensitizing of FRPs and is found in blush,
mascara, lotion and shampoo.

22. DMDM Hydantoin
• DMDM hydantoin is an antimicrobial formaldehyde
releaser preservative with the trade name Glydant.
• DMDM hydantoin is an organic compound belonging to a class of
compounds known as hydantoins.
• DMDM hydantoin works as a preservative because the
released formaldehyde makes the environment less favorable to
the microorganisms.
• DMDM Hydantoin is found in lotion, sunscreen and make-up remover
and is one of the least sensitizing of the FRPs.

23. Imidazolidinyl urea, diazolidinyl urea, and
polyoxymethylene urea
Imidazolidinyl urea, diazolidinyl urea, and polyoxymethylene urea,
• are found in shampoo, conditioner, blush, eye shadow, and lotion and
are all known human allergens.
• Imidazolidinyl urea is one of the most common antimicrobial agents
used in personal care products and is often combined with parabens
to provide a broad spectrum preservative system

24. • Sodium hydroxymethylglycinate is found in shampoo, moisturizer,
conditioner, and lotion.
• IN Animal studies have shown that sodium hydroxymethylglycinate has the
potential for sensitization and dermatitis.
• Bromopol is found in nail polish, makeup remover, moisturizer and body
wash.
• Bromopol is safe in concentrations less than 0.1%, but cannot be found in
formulations with the FRP amine.
• Mixing bromopol and amines produce nitrosamines (Link to same chemical
in nitrosamines) which have been found to penetrate the skin and cause
cancer.

25. Glyoxal
• Glyoxal is an organic compound
• It is a yellow-colored liquid that evaporates to give a green-colored
gas.
• Glyoxal is the smallest dialdehyde (two aldehyde groups).
• Glyoxal is found in conditioner, lotion, nail polish and nail treatment.
CIR Expert Panel has declared that glyoxal is a skin allergen.

26. HEALTH CONCERNS:
Cancer,
skin irritation
VULNERABLE POPULATIONS:
Infants,
hair salon workers,
nail salon workers.

27. • Cancer: Formaldehyde is considered a known human carcinogen by
many expert and government bodies, including the United States
National Toxicology Program
• A 2014 study found that formaldehyde initiates and promotes tumor
formation.
• When formaldehyde is present in personal care products, people can
be exposed by inhaling the formaldehyde that couses cancer.
• Animal studies indicate that formaldehyde can be absorbed through
the skin when formaldehyde-containing personal care products,
including formaldehyde-releasing preservatives, are applied.

28. Irritation:
• Formaldehyde is the 2015 American Contact Dermatitis Society
Contact Allergen of the Year
• 2015 study determined that up to 11.9% of the population is allergic
to formaldehyde when exposed to a 2.0% formaldehyde patch test
• Formaldehyde sensitivity may develop over time from repeated low-
level exposures

29. REGULATIONS:
• Banned from use in cosmetics and toiletries in Japan and Sweden
• in the EU, restricted in personal care products, and labeling is
required in products that do contain these chemicals
• concentration restrictions in Canada.
• The EU allows the use of Quaternium-15 up to 0.2% as a preservative
in cosmetic products.

30. HOW TO AVOID:
• Read labels and avoid products containing the following ingredients:
Formaldehyde, quaternium-15, dimethyl-dimethyl (DMDM)
hydantoin, imidazolidinyl urea, diazolidinyl urea, sodium
hydroxymethylglycinate, 2-bromo-2-nitropropane-1,3-diol
(bromopol). In addition, choose nail products that are labeled
formaldehyde-free or “toxic-trio-free” (formaldehyde, toluene and
DBP).
• Skip hair-smoothing products—especially those sold in salons, as
salon-based products are exempt from labeling laws.
• Don’t use expired cosmetic products or store cosmetic products in
the sun because this can cause more formaldehyde to be released

31. 1,4-DIOXANE
• It is a biproduct of PEG, polyethylene,polyoxyethylene.
• During the manufacturing the dioxane produse from them.
• Limit less than 10ppm dioxane safe for human.
• It is evaporate rapidly

32. • 1,4-dioxane, a carcinogen linked to organ toxicity, may be found in as
many as 22 percent of the more than 25,000 cosmetics products in
the Skin Deep database ,
• but you won’t find it on ingredient labels. because 1,4-dioxane is a
contaminant when common ingredients react to form the compound.

33. • FOUND IN: Products that create suds (such as shampoo, liquid soap,
bubble bath), hair relaxers, others
• WHAT TO LOOK FOR ON THE LABEL:
• Sodium laureth sulfate,
• PEG compounds,
• chemicals that include the clauses xynol,
• ceteareth and oleth

34. WHAT IS 1,4 DIOXANE?
• 1,4-dioxane is generated through a process called ethoxylation, in
which ethylene oxide, a known breast carcinogen, is added to other
chemicals to make them less harsh.
• This process creates 1,4-dioxane. For example, sodium laurel sulfate,
a chemical that is harsh on the skin, is often converted to the less-
harsh chemical sodium laureth sulfate .
• The conversion process can lead to contamination of this ingredient
with 1,4-dioxane.
• Other common ingredients that may be contaminated by 1,4-dioxane
include PEG compounds and chemicals that include the clauses
“xynol,” “ceteareth” and “oleth”.

35. • Most commonly, 1,4-dioxane is found in products that create suds,
like shampoo, liquid soap and bubble bath.
• Environmental Working Group’s analysis suggests that 97 percent of
hair relaxers, 57 percent of baby soaps and 22 percent of all products
in Skin Deep may be contaminated with 1,4-dioxane.
• Independent lab tests co-released by the Campaign for Safe
Cosmetics in 2007 showed that popular brands of children’s bubble
bath and body wash contained 1,4-dioxane.

36. • HEALTH CONCERNS: Cancer
Cancer: Research shows that 1,4-dioxane readily penetrates the skin. 1,4-
dioxane is considered a probable human carcinogen by the U.S.
Environmental Protection Agency and is listed as an animal carcinogen by
the National Toxicology Program .
It is included on California’s Proposition 65 list of chemicals known or
suspected to cause cancer or birth defects.
• VULNERABLE POPULATIONS:
Pregnant women,
infants,
 teenagers
• REGULATIONS: Banned/found unsafe for use in cosmetics in Canada

37. HOW TO AVOID
• The FDA does not require 1,4-dioxane to be listed as an ingredient on product
labels because the chemical is a contaminant produced during manufacturing.
• Without labeling, there is no way to know for certain whether a product contains
1,4,-dioxane, making it difficult for consumers to avoid it.
•
Alternative processes to ethoxylation do exist, but many companies don’t take
advantage of them.
• Vacuum-stripping can remove 1,4-dioxane from an ethoxylated product, or
manufacturers can skip ethoxylation entirely by using less-harsh ingredients to
begin with.
• Organic standards do not allow ethoxylation and some conventional companies,
such as Johnson & Johnson, have agreed to alter the process that results in this
contamination.

38. • A study by the Organic Consumers Association shows that 1,4-dioxane
is nonexistent in a variety of cosmetics certified under the USDA
National Organic Program.
• Therefore a good way to avoid exposure to this chemical is to buy
products that have been certified under this program.
• Additionally, consumers can avoid products that contain sodium
laureth sulfate, PEG compounds, and chemicals that include the
clauses xynol, ceteareth and oleth.