Anda di halaman 1dari 48

TRENDS IN PRESERVATIVES

AND ANTIMICROBIAL ACTIVES

We make preservatives that preserve your reputation


PRESERVATIVES

• Preservatives - substances added to dosage forms to protect them from microbiological


growth or from microorganisms that are introduced inadvertently during or subsequent
to the manufacturing process .

• Preservatives -commonly used in food, cosmetic, and pharmaceutical industries to


prevent microbial growth from contaminating finished products

• Preservatives - not a substitute for cGMP

• Use of a mixture of preservatives can potentially have synergistic effects .

• A perfect preservative is a “colourless, odourless, water soluble, nontoxic, non-allergenic,


non-irritating chemical capable of inhibiting the growth of a broad spectrum bacteria and
fungi”
CATOGERIES OF PRESERVATIVES

Traditional preservatives
• Parabens
• Isothiazolinones
• Formaldehyde & formaldehyde-donor
• IPBC
• Organic acids

Non-traditional preservation methods


• Glycols
• Ethylhexylglycerin
• Chlorphenisin
• Natural preservative
PRESERVATIVES - PARABENS

• Parabens are the Para benzoic acid salts/esters

• The most common preservatives found in many


skincare and cosmetic products

• Most widely used preservatives- over 50 years


with an excellent safety record

• Also used in Pharmaceutical and food applications.

• Cosmetics that may contain parabens include makeup,


moisturizers, hair care; products, and shaving products.

• Most major brands of deodorants and antiperspirants do


not currently contain parabens.
PARABENS

• Target Organisms Fungi


• Applications Rinse-off, leave-on
• Formulating Tips Low water solubility, Inactivated by nonionics, ethoxylates
• pH Range 3.5-6.5 pH (optimal), Can be used up to pH 8
• Use Level 0.1-0.8%
• Approved in Japan up to 1.0%, EU and Brazil up to 0.8% total paraben;
additional restrictions for single parabens
PARABENS

• In September 2005, the CIR decided to re-open the safety assessment for parabens to
request exposure estimates and a risk assessment for cosmetic uses.

• In December 2005, after considering the margins of safety for exposure to women and
infants, the Panel determined that there was no need to change its original conclusion
that parabens are safe as used in cosmetics. (The CIR is an industry-sponsored
organization that reviews cosmetic ingredient safety and publishes its results in open,
peer-reviewed literature. FDA participates in the CIR in a non-voting capacity.)

• The study left several questions unanswered. For example, the study did not show that
parabens cause cancer, or that they are harmful in any way, and the study did not look at
possible paraben levels in normal tissue. FDA is aware that estrogenic activity in the body
is associated with certain forms of breast cancer.
INTERNATIONAL SAFETY ASSESSMENTS OF PARABENS

The Scientific
Committee on
Consumer Safety: The FDA began studying
Final Opinion on the effects of parabens in
The American Cancer response to the outcry of
Parabens, which is the
Society has concluded, their potential estrogenic
official statement by Health Canada, based on its research effect and link to breast
the European Union on the Canadian FDA- findings, that the cancer. The FDA found
the unequivocal equivalent, also finds scientific and medical that parabens are safe
safety of parabens in that, "Currently, there is research does not for use in cosmetics, and
skin care, cosmetics no evidence to suggest support a claim that the it also says that, based
and personal a causal link between use of parabens in on the weight of all the
care products. This parabens and breast cosmetics can increase current scientific
summary of decades of cancer. an individual’s risk of evidence, there is no
developing breast reason for consumers to
long-term
cancer. be concerned about the
and short-term safety use of products
data reinforced the EUs containing parabens.
previous decision that
parabens are safe in
personal care
products.
INTERNATIONAL SAFETY ASSESSMENTS OF PARABENS

Other research has even refuted .The Personal Care Products


the long-held belief that parabens Council, a US organization that
Toxicology Letters rr December
are among the more sensitizing reviews and assesses the safety of
2013 that in references to
preservatives in cosmetics, stating ingredients used in cosmetics in an
parabens causing health issues
that "...these ubiquitous open, unbiased and expert
"Overall, despite of 20 years of
compounds have withstood four manner, consolidated more than
research a human health risk from
decades of extensive skin testing 265 studies in The Journal of
exposure to low concentrations of
conducted by a variety of Toxicology that noted a women’s
exogenous chemical substances
organizations, both North daily cosmetic regimen using
with weak hormone-like activities
American and European, and now, products that contain parabens
remains an unproven and unlikely
it seems parabens have shown to caused no adverse reproductive
hypothesis
be one of the least sensitizing effects and confirmed the safety
preservatives in commercial use." of parabe
SCPL PARABENS & PARABEN BLENDS

In use Rins
Sr. Product Concent e- Leave- Wet- Liqu soli Handling
No. List INCI Name ration off On wipe id d pH range Temp. Water Solubility
Saligin
• •
1 MP Methyl Paraben 0.1-0.3% √ 4.0-8.0 Appox. 80⁰C approx. 0.25%
2Saligin PP Propyl Paraben 0.1-0.3% • • √ 4.0-8.0 Appox. 80⁰C approx. 0.05%
3saligin EP Ethyl Paraben 0.1-0.3% • • √ 4.0-8.0 Appox. 80⁰C approx. 0.17%
4Saligin BP Butyl Paraben 0.1-0.3% • • √ 4.0-8.0 Appox. 80⁰C approx. 0.02%
Saligin Sodium Methyl
• •
5 MPS Paraben 0.1-0.3% √ 3.0-11.0 Appox. 80⁰C approx. 33%
saligin
• •
6 PPS Sodium propyl Paraben 0.1-0.3% √ 3.0-11.0 Appox. 80⁰C approx. 50%
Saligin
• •
7 EPS Sodium Ethyl Paraben 0.1-0.3% √ 3.0-11.0 Appox. 80⁰C approx. 50%
Methyl Paraben, Ethyl
Paraben, Propyl 0.05- • • •
8Salisept Paraben 0.3% √ 4.0-8.0 Appox. 80⁰C 0.20%
Methyl Paraben, Ethyl
Paraben, Propyl
Paraben, Butyl • • •
Paraben, Isobutyl 0.05-
9Salistat Paraben 0.3% √ 4.0-8.0 Appox. 80⁰C 0.14%
SCPL PARABEN BLENDS WITH OTHER PRESERVATIVES

In use
Product Concentrat Rinse- Handling Water
Sr.No. List INCI Name ion off Leave-On Wet-wipe Liquid solid pH range Temp. Solubility
Phenoxyethanol, Methyl
Paraben, Propyl
Paraben, Ethyl Paraben, • • •
Butyl Paraben, Isobutyl approx.
1 Salinip Paraben 0.25-1% √ 3.0-8.0 max. 40⁰C 0.5%

Phenoxyethanol, Methyl
• • •
Paraben, Propyl
2 Salinip XB Paraben, Ethyl Paraben 0.3-1% √ 3.0-8.0 max. 40⁰C
Phenoxyethanol, Methyl
Saliguard paraben, Ethyl paraben, • • •
3 300 Bronopol 0.3-0.7% √ 4.5-8.5 max. 40⁰C Miscible
Methyl Paraben, Propyl
Saligerm Paraben, Diazolidinyl • •
4 G2 Urea, Propylene Glycol 0.3-1% √ up to 8.0 max. 40⁰C 1%
Methyl Paraben, Ethyl
Saligin Paraben, • • •
5 MEPX Phenoxyethanol 0.3-1% √ 3.0-8.0 max. 40⁰C

2-Bromo-2-
Nitropropane-1,3-Diol, • •
Saligin Phenoxyethanol, Methyl
6 300 Paraben, Propyl Paraben 0.3-0.8% √ up to 8.0 max. 40⁰C
PRESERVATIVES – FORMALDEHYDE RELEASERS

• Formaldehyde and formaldehyde-releasing preservatives (FRPs) are used in many


personal care products, which help prevent microbes from growing in water-based
products.

• Absorbed through the skin and have been linked to cancer and allergic skin reactions.

• FOUND IN: Nail polish, nail glue, eyelash glue, hair gel, hair-smoothing products,
baby shampoo, body soap, body wash, color cosmetics.

• Frequently used FRPs

Formaldehyde
DMDM hydantoin,
 imidazolidinyl urea,
 diazolidinyl urea,
2-bromo-2-nitropropane-1,3-diol (bromopol)
PRESERVATIVES – FORMALDEHYDE RELEASERS

Target Organisms Bacteria Comments


• Applications Leave-on, rinse-off • Major Types: imidazolidinyl urea,
• Formulating Tips Highly water soluble diazolidinyl urea, DMDM Hydantoin,
Temperature sensitive • React with avobenzone
• pH Range 3-10 pH • Not well liked in some European countries
• Use Level 0.1-0.5 Warning label • Carcinogenicity???
required in Japan

Carcinogenicity
• Formaldehyde gas shown to be carcinogenic by inhalation (construction industry)
• “Prior editions of the RoC had listed formaldehyde as reasonably anticipated to be
a human carcinogen, and following a rigorous scientific review, formaldehyde is
now reassigned to the category known to be a human carcinogen.” – National
Toxicology Program, US Dept. HHS, Addendum to the 12th Report on Carcinogens
PRESERVATIVES – FORMALDEHYDE RELEASERS

• DMDM Hydantoin is found in lotion, sunscreen and make-up remover and is one of the
least sensitizing of the FRPs
• 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
• Diazolidinyl urea releases the most formaldehyde of any FRP
• Bronopol is found in nail polish, makeup remover, moisturizer and body wash. Bronopol
is considered safe in concentrations less than 0.1%, but cannot be found in formulations
with the FRP amine. Mixing bronopol and amines produce nitrosamines (Link to same
chemical in nitrosamines) which have been found to penetrate the skin and cause cancer
• Bronopol is found in conditioner, lotion, nail polish and nail treatment. CIR Expert Panel
has declared that glyoxal is a skin allergen.

13
PRESERVATIVES – FORMALDEHYDE RELEASERS

• HEALTH CONCERNS
Cancer, skin irritation . In anionic shampoos, the amount of formaldehyde released by
such donors increases in the order: imidazolidinyl urea < DMDM hydantoin <
diazolidinyl urea

• VULNERABLE POPULATIONS:
Infants, hair salon workers, nail salon workers.

• 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.

• J&J has removed the formaldehyde-releasing preservative from its baby shampoo in
several countries.
PRESERVATIVES – FORMALDEHYDE RELEASERS

Regulation (EU) No. 91/2015.


• The reclassification of formaldehyde as a Classification
Classification
carcinogen 1B would effectively prohibit CMR-attribute of the
of the mixture
its use as a biocidal active ingredient. substance

Concentration
• Following formaldehydes reclassification, mutagen
in order to be in accordance with the trigger
Mutagenicity category 2;
classification labelling and packaging ≥ 1,0%muta.
H341
regulation (EC) No 1272/2008, the cat 2; H341
relevant classifications (as indicated
Concentration
below) would have to be adhered to carcinogen
trigger
for household products Carcinogenicity category 1B;
≥ 0,1 % carc.
H350
cat 1B; H350
SCPL – FORMALDEHYDE RELEASERS & THREIR BLENDS

In use
Product Concentr Leave- Wet- Handling
Sr.No. List INCI Name ation Rinse-off On wipe Liquid solid pH range Temp.
Salimid -
• •
1 115 Imidazolidinyl Urea 0.2-0.5% √ 3.0-8.5 max. 60⁰C
• •
2 Salimall - II Diazolidinyl Urea 0.2-0.5% √ 3.0-8.5 max. 40⁰C
Saliplus Diazolidinyl Urea, Iodo
(Liq. & Propynyl Butyl • •
3 Powder) Carbamate 0.05-0.2% √ √ 6.0-7.5 max. 90⁰C

Methyl Paraben, Propyl


• •
Saligerm Paraben, Diazolidinyl
4 G2 Urea, Propylene Glycol 0.3-1% √ up to 8.0 max. 40⁰C
Salidant
• •
5 DHM DMDM Hydantoin 0.15-0.4% √ 4.0-8.0 max. 60⁰C

Salidant
DHM Plus DMDM Hydantoin, • •
(Liq. & Iodo Propynyl Butyl 0.075-
6 Powder) Carbamate 0.3% √ 6.0-9.0 max. 90⁰C

Saliccide
• •
BR 2-Bromo-2-
7 (Bronopol) Nitropropane-1,3-Diol 0.01-0.1% √ 3.0-8.5 max. 40⁰C
PRESERVATIVES – ISOTHIAZOLONES

• Target Organisms - Bacteria and Fungi


• Applications - Mainly rinse-off
• Formulating Tips - Most common blend is CMIT / MIT, Sensitization issues
• pH Range 2-8 pH
• Use Level Typically 1.5% active solution –3:1 blend
• CIR max. 15 ppm rinse-off, 7.5 ppm leave-on
• EU max. 15 ppm
• Japan rinse-off only max. 100 ppm MIT

Comments
• Major types: chloromethlyisothiazolinone,methlyisothiazolinone
• Not widely accepted in Germany and Scandinavia
• CMI`T/MIT approved for use in Japan for rinse-off only
• MIT approved for use in Japan for leave-on and rinse-off, except mucous membrane
PRESERVATIVES – ISOTHIAZOLONES

• Broad spectrum effectiveness


• Best for Rinse – off products
• Effective over the entire pH range normally encountered in
cosmetics
• Toxicological data has shown them to be non-carcinogenic
• May cause skin irritation for some consumers
PRESERVATIVES – ISOTHIAZOLONES REGULATIONS

Changes to the EU Cosmetic Regulation take effect from 16th July 2015.

Methylchloroisothiazolinone (and) EU Cosmetic Regulation


Methylisothiazolinone (3:1) EU Cosmetic Regulation (old) (new)
Leave-on 0.0015%Not permitted
Rinse-off 0.0015%0.0015%(1)
Methylisothiazolinone is also regulated in entry 57 of Annex V. The two entries are mutually
exclusive: the use of the mixture of Methylchloroisothiazolinone (and) Methylisothiazolinone is
incompatible with the use of Methylisothiazolinone alone in the same product

Methylchloroisothiazolinone (and) EU Cosmetic Regulation


Methylisothiazolinone (3:1) EU Cosmetic Regulation (old) (new)
Leave-on 0.01% 0.01% (2)
Rinse-off 0.01% 0.01%(2)
Methylisothiazolinone is also regulated in entry 39 (of Annex V) in a mixture with
Methylchloroisothiazolinone. The two entries are mutually exclusive: the use of the mixture of
Methylchloroisothiazolinone (and) Methylisothiazolinone is incompatible with the use of
Methylisothiazolinone alone in the same product.
PRESERVATIVES – REGULATIONS

• In-use concentrations for Methylisothiazolinone remains unchanged at 0.01 %,


but is now recognised as being mutually exclusive, whereby it can no longer be
used in combination with Methylchloroisothiazolinone (and)
Methylisothiazolinone in the same product in any proportion.

• Methylchloroisothiazolinone (and) Methylisothiazolinone can no longer be used


in Leave-on pro
SCPL – ISOTHIAZOLONES & THEIR BLENDS

In use
Conce
Product ntratio Rinse- Leav Wet- Handling Water
Sr.No. List INCI Name n off e-On wipe Liquid solid pH range Temp. Solubility
Salimix
MCI-

Indusrial Methylchloroisothiazolinon 0.02- max.
1 Grade e, Methylisothiazolinone 0.15% √ 2.0-9.0 100⁰C Miscible
Salicat
MM-

Cosmetic Methylchloroisothiazolinon 0.02- max.
2 Grade e, Methylisothiazolinone 0.15% √ 2.0-9.0 100⁰C Miscible
2-Bromo-2-Nitropropane-
1,3-Diol,

Salicat K Methylchloroisothiazolinon 0.05- max.
3 145 e, Methylisothiazolinone 0.3% √ 4.0-9.0 80⁰C Miscible
Methyldibromo
Glutaronitrile,
Methylchloroisothiazolinon •
Saicat K- e, Methylisothiazolinone, 0.05- max.
4 727 Phenoxyethanol 0.6% √ 4.0-8.0 50⁰C
PRESERVATIVE – IODOPROPYNYLBUTYL CARBAMATE

• Target Organisms Fungi


• Applications Rinse-off, leave-on
• Formulating Tips Low water solubility, Inactivated by reducing agents,
• alkaline pH’s
• pH Range Up to 9 pH
• Use Level 0.05-0.1% as active , Approved in Japan to 200 ppm
Restriction on use in EU

Comments
• Available in surfactant, water or bicarbonate solid
• 100% active not often sold due to discoloration and clumping
• Solutions may darken over time and/or at elevated temperature
PRESERVATIVES – IPBC REGUALTIONS

European Union Restrictions


• Not to be used in oral and lip products
• Rinse-off products up to 0.02%
• Not to be used in products for children under 3 years of age, except in bath
products/ shower gels and shampoo
• Leave-on products up to 0.01%
• Not to be used in body lotion and body cream
• Not to be used in products for children under 3 years of age
• Deodorants & Antiperspirants up to 0.0075%

REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL


SCPL – IODOPROPYNYL BUTYL CARBAMATE BLENDS

In use
Conce Water
Produc ntratio Rinse- Leave- Wet- pH Handlin Solubili
Sr.No. t List INCI Name n off On wipe Liquid solid range g Temp. ty
Salidant
DHM
Plus DMDM Hydantoin, • •
(Liq. & Iodo Propynyl Butyl 0.075- max.
29 Powder) Carbamate 0.3% √ 6.0-9.0 90⁰C Miscible

1,2-Hexanediol, 1,2-
Propanediol, • • •
Saliguar Iodopropynl Butyl 0.5- max.
12 d HDZ Carbamate 0.75% √ 3.0-10.0 80⁰C Miscible
ALCOHOLS

• Target Organisms Bacteria


• Applications Rinse-off, leave-on
• Formulating Tips Highly water soluble
May have characteristic odor
• pH Range 3-10 pH
• Use Level 0.5-1.0%
Approved globally, including Japan
Structure Example
General alcohol functionality

Comments
• Major Types: phenoxyethanol, benzyl alcohol,ethyl alcohol
• Phenoxyethanol had been of concern in France. Formally approved up to 1.0%,
but still some manufacturers have reservations.
• Benzyl alcohol listed as a fragrance allergen in Europe
SCPL – ALCOHOL BLENDS

In use
Product Concent Rinse- Leave- Wet- Handling Water
Sr.No. List INCI Name ration off On wipe Liquid solid pH range Temp. Solubility
Saliethano highly
• • •
1 l Phenoxyethanol 0.5-1% √ 3.0-8.5 max. 80⁰C soluble
Phenoxyethanol, Methyl
Paraben, Propyl Paraben,
• • •
Ethyl Paraben, Butyl
2 Salichem Paraben 0.25-1% √ 3.0-8.0 max. 80⁰C >95%
Phenoxyethanol, Methyl
Saliguard paraben, Ethyl paraben, • • •
3 300 Bronopol 0.3-0.7% √ 4.5-8.5 max. 40⁰C Miscible
Benzoic Acid,
Saliguard Dehydroacetic Acid, • • •
4 BDP Phenoxyethanol 0.2-1.2% √ up to 6.0 max.60⁰C Miscible
Saliguard Phenoxyethanol, Caprylyl • • • Immiscibl
5 PCG Glycol, Propylene Glycol 0.5-1% √ 3.0-10.0 max.60⁰C e
Saiguard Phenoxyethanol, Caprylyl Immiscibl
• • •
6 PG Glycol 0.5-1% √ 3.0-10.0 max.60⁰C e
Caprylyl Glycol,
Saliguard Chlorphenesin, • • •
7 COS Phenoxyethanol 0.75-1.5% √ 3.0-8.0 max.80⁰C Miscible
Undecylenic Acid,
Saliguard Caprylyl glycol, • • •
8 UCP Phenoxyethanol 0.75-1% √ 3.0-6.5 max.80⁰C Miscible
Saliguard Ethylhexylglycerin,
• • •
9 EHGP Phenoxyethanol 0.5-1% √ 2.0-12.0 max.80⁰C >0.1%
GLYCOLS – CAPRYL GLYCOL

• Target Organisms Bacteria, weak against fungi


• Applications Rinse-off, leave-on
• pH Range 2-10 pH
• Use Level 1-5%
Approved globally, including Japan

Comments
• Limiting factor - water solubility
• Caprylyl glycol – recent CIR review “Safe as used”
SCPL - GLYCOLS & THEIR BLENDS

In use
Concen Rinse- Leave- Wet- pH Handlin Water
Sr.No. Product List INCI Name tration off On wipe Liquid solid range g Temp. Solubility
3.0- max.90
• • •
1 Salicap G Caprylyl Glycol 1-2% √ 12.0 ⁰C Miscible
1,3-Propanediol
(Corn derived), • • • max.90
2 Salidiol G Glycerin √ ⁰C Miscible
Phenoxyethanol,
Caprylyl Glycol, • • • 3.0- max.60
3 Saliguard PCG Propylene Glycol 0.5-1% √ 10.0 ⁰C Immiscible
Phenoxyethanol, 3.0- max.60
• • •
4 Saiguard PG Caprylyl Glycol 0.5-1% √ 10.0 ⁰C Immiscible
Caprylyl Glycol,
Chlorphenesin, 0.75- • • • max.80
5 Saliguard COS Phenoxyethanol 1.5% √ 3.0-8.0 ⁰C Miscible
Caprylyl Glycol, 0.75- 3.0- max.80
• • •
6 Saliguard CGZ 1,3-Propane Diol 1.25% √ 10.0 ⁰C Immiscible
SCPL - GLYCOLS & THEIR BLENDS

In use
Concen Rinse- Leave- Wet- Handling Water
Sr.No. Product List INCI Name tration off On wipe Liquid solid pH range Temp. Solubility
Methylisothiazolinone 0.75- max.80⁰

7 Saliguard MIZ , 1,3-Propanediol 1.5% √ 3.0-9.0 C Immiscible
1,2-Hexanediol, 1,2-
Propanediol,
• • •
Iodopropynl Butyl 0.5- max.80⁰
8 Saliguard HDZ Carbamate 0.75% √ 3.0-10.0 C Miscible
1,2-Hexanediol,
Phenoxyethanol, 0.75- • • • max.80⁰ Partially
9 Saliguard HDC chlorphenesin 1.5% √ 3.0-10.0 C miscible
Limited
solubility in
Undecylenic Acid, 1,3- water, highly
• • •
Propanediol (Corn miscible in
Derived), Benzyl max.40⁰ organic
10 Saliguard UZB Alcohol 0.75-1% √ 3.0-6.5 C solvent
Undecylenic Acid,
Caprylyl glycol, • • • max.80⁰
11 Saliguard UCP Phenoxyethanol 0.75-1% √ 3.0-6.5 C Miscible
Limited
solubility in
water, highly
• • •
miscible in
Ethylhexylglycerin, max.80⁰ organic
12 Saliguard EZ 1,3-Propanediol 0.5-2% √ 3.0-7.0 C solvent
GLYCOLS – ETHYL HEXYL GLYCERIN

• Target Organisms Gram positive bacteria; yeast & mold at higher use levels
• Applications Leave-on, some rinse-off
• Formulating Tips Limited water solubility, Booster for traditional and
Nontraditional preservatives , HLB 7.5
• pH Range 2-12 pH
• Use Level 0.1-1%
Approved globally, including Japan

Comments
• Deodorant active
• Can destabilize emulsions - HLB
• Eye area stinging if used with high levels of glycols
• Emollient
• Determined “Safe-as-Used” by CIR
SCPL - ETHYL HEXYL GLYCERIN BASED PRESERVATIVES

In use
Conce Handli
Product ntrati Rinse- Leave- Wet- pH ng Water
Sr.No. List INCI Name on off On wipe Liquid solid range Temp. Solubility
Limited
solubility in
• • • water, highly
Saliguard 2.0- max.80 miscible in
1 EHG Ethylhexylglycerin 0.3-1% √ 12.0 ⁰C organic solvent
Saliguard Ethylhexylglycerin 2.0- max.80
• • •
2 EHGP , Phenoxyethanol 0.5-1% √ 12.0 ⁰C >0.1%
Limited
solubility in
• • • water, highly
Ethylhexylglycerin max.80 miscible in
3 Saliguard EU , Undecylenic acid 0.5-2% √ 3.0-7.0 ⁰C organic solvent
Limited
solubility in
• • • water, highly
Ethylhexylglycerin max.80 miscible in
4 Saliguard EZ , 1,3-Propanediol 0.5-2% √ 3.0-7.0 ⁰C organic solvent
GLYCOLS – CHLOPHENESIN

• Target Organisms Fungi


• Applications Rinse-off, leave-on
• pH Range Best at acid pH
• Use Level Up to 0.3%
Approved globally, including Japan
Limited to 0.3% in EU, Japan and Brazil
Not permitted for mucous membrane in Japan

Comments
• Mainly used to boost traditional and nontraditional preservation systems
• Powder, easiest to dissolve in glycerin, glycol or >50° water
SCPL – CHLOPHENESIN BASED PRESERVATIVES

In use
Product Concen Rinse- Leave- Wet- pH Handling Water
Sr.No. List INCI Name tration off On wipe Liquid solid range Temp. Solubility
max.50⁰

1 Saliphenesin Chlorphenesin 0.1-0.3% √ C Miscible

Caprylyl Glycol, • • •
Saliguard Chlorphenesin, 0.75- max.80⁰
2 COS Phenoxyethanol 1.5% √ 3.0-8.0 C Miscible

1,2-Hexanediol, • • •
Saliguard Phenoxyethanol, 0.75- 3.0- max.80⁰ Partially
3 HDC chlorphenesin 1.5% √ 10.0 C miscible
ORGANIC ACIDS

Target Organisms Fungi


• Applications Rinse-off, leave-on
• Formulating Tips Acid forms have low water solubility
Only the free acids active
Use in combinations
• pH Range <6 pH or lower depending on acid
• Use Level Typically, up to 0.5% as the free acids
Approved globally, including Japan

Comments
• Main types: sorbic, benzoic, salicylic, dehydroacetic, citric
• Salts often used for better water solubility
• Extremely pH dependant
SCPL - ORGANIC ACIDS ACID BASED PRESERVATIVES

In use
Concen Rinse- Leave- Wet- pH Handlin
Sr.No. Product List INCI Name tration off On wipe Liquid solid range g Temp. Water Solubility
2-Hydroxybenzoic
• •
1 Salicylic Acid Acid 0.1-0.5% √ 2 g/l
2-Hydroxybenzoic
• •
2 Salicylic Acid Acid 0.1-0.5% √ 2 g/l
Methyl
• •
3 Salicylate Methyl Salicylate 0.1-0.5%
Benzoic Acid,
Dehydroacetic Acid, • • • max.60⁰
4 Saliguard BDP Phenoxyethanol 0.2-1.2% √ up to 6.0 C Miscible
Benzyl Alcohol, max.80⁰
• • •
5 Saliguard BDHA Dehydroacetic acid 0.2-0.8% √ up to 6.5 C Miscible
Sodium Benzoat, max.80⁰
• • •
6 Saliguard SP Potassium Sorbate 0.5-1.5% √ up to 5.5 C Miscible
Undecylenic Acid, Limited solubility
1,3-Propanediol in water, highly
• • •
(Corn Derived), max.40⁰ miscible in
7 Saliguard UZB Benzyl Alcohol 0.75-1% √ 3.0-6.5 C organic solvent
Undecylenic Acid,
Caprylyl glycol, • • • max.80⁰
8 Saliguard UCP Phenoxyethanol 0.75-1% √ 3.0-6.5 C Miscible
Limited solubility
in water, highly
• • •
Ethylhexylglycerin, max.80⁰ miscible in
9 Saliguard EU Undecylenic acid 0.5-2% √ 3.0-7.0 C organic solvent
SCPL – OTHER PRESEVATIVES & ACTIVES

In use
Conce
Product ntratio Rinse- Leave Wet- pH Handlin Water
Sr.No. List INCI Name n off -On wipe Liquid solid range g Temp. Solubility

5-Bromo-5-
Nitropropane- •
1,3-Dioxane, 0.05- 5.0- max.
1 Brosalidox L Propylene Glycol 0.3% √ 8.0 50⁰C max 0.5%
Dimethyl max.90
• • •
2 Salibide DMI Isosorbide 1-8% √ ⁰C Miscible
0.1- 4.0- max.80

3 Salisan Triclosan 0.3% √ 9.5 ⁰C 0.001%
4 Salidruff Zinc Pyrithione 0.5-2% • √
Slight
0.1- • • • max.50 soluble in
5 Salitoin Allantoin 0.4% √ ⁰C water
Chlorohexidine 0.25- • • • 5.0-
6 Salidine 20% Digluconate 20% 1.5% √ 8.0 >70⁰C Miscible
NATURAL PRESEVATIVES

• Applications Rinse-off, leave-on


• Formulating Tips Need to be blended for broad spectrum effect
• pH Range Varied
• Use Level Usually high use level to be effective

Comments
• Often strong odor and/or color at effective use levels
• May have high level of irritation or sensitization at use level
• Some listed on EU Allergens List
SCPL - NATURAL PRESEVATIVES

Natural Presrvatives - Ecocertified


In use
Sr. Concentrati pH Handling
No. Product INCI Name on Rinse-off Leave-On Wet-wipe Liquid solid range Temp. Water Solubility
Curry Leaf Oil,
Salinatural Cinnamon leaf Oil, 3.0-
1 CCL Sesame Oil 0.75-1.2% √ 7.0 max. 60⁰C Immiscible
Basil Extract, Clove Bud
Salinatural Oil, Lemongrass Oil, 3.0-
2 BCLS Sesame Oil 1-2% √ 7.0 max. 50⁰C Immiscible
Turmeric Oil, Clove Bud
salinatural Oil, Lemonrass Oil, 3.0-
3 TCLS Sesame Oil 1-2% √ 7.0 max. 50⁰C Immiscible
Salinatural Orange Oil, Lemongrass 3.0-
4 OLG Oil, Sesame Oil 1-2% √ 7.0 max. 50⁰C Immiscible
Peppermint Oil,
spearmint Oil, Clove Oil,
Salinatural Neem Leaf Extraact, 3.0-
5 MIN Rosemary Oil 1.5-2% √ 7.0 max. 50⁰C Immiscible
Clove Oil, Cinnamon
Bark Oil, Neem Leaf
Salinatural Extract, Rosemary Oil, 3.0-
6 CIN Eucalyptus Oil 1.5-2% √ 7.0 max. 50⁰C Immiscible
Salinatural Pongamia Glabra Seed 3.0-
7 KJ Oil 3-5% √ 7.0 max. 50⁰C Immiscible
SALIBACT
BROAD SPECTRUM ANTIMICROBIAL

We make preservatives that preserve your reputation


SALIBACT (CHLORHEXIDINE UNDECYLENATE) ANTIMICROBIAL

• A PATENTED broad spectrum antimicrobial active.

• A novel chlorhexidine salt isolated and characterized.

• Chlorhexidine and its salts are reported as being used in


Personal care/pharma formulation as an active ingredient
to give the desired antimicrobial effect.
SALIBACT
• Need for an environment friendly, biodegradable broad spectrum antimicrobial active.
• To be used across Pharma; Personal care, Home care and Neutraceutical formulations.

Many well know antimicrobial in Market today have issues with regards to
• Range of health and environmental effects,
• Skin irritation, allergy susceptibility,
• Bacterial and compounded antibiotic resistant
• Dioxin contamination
• Destruction of fragile aquatic ecosystems

Consumers are concerned about the recent studies that have prompted further FDA and EPA
review of many antimicrobials”.
“For formulators seeking alternatives, there is a need to provide a suitable replacement with
similar efficacy”.
Ref: American Medical Association. 2000.
Use of Antimicrobials in Consumer Products Report 2 of the Council on Scientific Affairs (A-00).
SALIBACT
NAME : SALIBACT

CAS NO. : 1884575-91-0


CA INDEX NAME : 10 Undecenoic acid; compoud with N1, N14 bis
(4-chlorophenyl) – 3,12 diimmino – 2,4,11,13 –
tetraazatetradecanediimidamide(2:1)

MOLECULAR FORMULA : C44H70Cl2N10O4

MOLECULAR WEIGHT : 873

PHYSICAL NATURE : White colored solid

PROPERTIES : An Active antifungal, Anti Bacterial ingredient.

Also Effective against yeast and moulds.


SALIBACT
MINIMUM INHIBITORY CONCENTRATION TEST
Test Method:
ASM: Manual of Microbiology Methods

Test Organism MIC%


Staphylococcus aureus <0.0001
Escherichia coli 0.001
Pseudomonas aeruginosa 0.001
Salmonella typhi 0.0005
Aspergillus niger 0.1
Candida albicans 0.05
**Test material sparingly soluble in water, solvent used
SALIBACT
RATE TIME KILL TEST FOR
FORMULATION 1 (TRICLOSAN) AND 2 (SALIBACT)
Anti Microbial
Test Product Test Organism Exposure Time
Activity % reduction
30 Secs. 99.97
Esch. Coli 60 Secs. >99.99
0.3% Salisan (Triclosan) 2 Min. >99.99
(form:1) 30 Secs. >99.99
Staph. Aureus 60 Secs. >99.99
2 Min. >99.99
30 Secs. >99.99
Esch. Coli 60 Secs. >99.99
0.1% SALIBACT 2 Min. >99.99
(SALIBACT)(Form:2) 30 Secs. >99.99
Staph. Aureus 60 Secs. >99.99
2 Min. >99.99

Conclusion:
By above test result shows 0.1% SALIBACT is more effectively working against microorganisms
SALIBACT
CONCLUSION
• Acute Dermal Toxicity Study in Rabbits
LD50 (rabbit): GREATER THAN 2000 MG/KG BODY WEIGHT
• Acute Oral Toxicity Study in Rats
LD50 (rat): GREATER THAN 2000 MG/KG BODY WEIGHT

• AIMS TEST: SALIBACT did not induce gene mutations either by base pair
substitution or by frame shifts in the genome of the strains.
SALIBACT
WHY USE SALIBACT ?

• Broad spectrum activity


• Near zero probability of bacterial resistance
• Biocompatibility
• Low environmental concern
• Biodegradable
SALIBACT

FOR ADDITIONAL INFORMATION


CONTACT

Dr. Rakesh Ratnam Ms. Krishna Sarviaya


Director- Technical Marketing Vice Presidednt

SALICYLATES & CHEMICALS PVT. LTD SALICYLATES & CHEMICALS PVT. LTD
rr@salicylates .net 5/44 Tardeo Air conditioned Market,
+91 945761744 Mumbai- 400 034, India
Bangalore,India Phone: +91-22-23514413
Mob :+91 9821211274

Anda mungkin juga menyukai