Trends In Preservatives 12u1i
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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 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: Final Opinion on Parabens, which is the official statement by the European Union on the unequivocal safety of parabens in skin care, cosmetics and personal care products. This summary of decades of long-term and short-term safety data reinforced the EUs previous decision that parabens are safe in personal care products.
Health Canada, the Canadian FDAequivalent, also finds that, "Currently, there is no evidence to suggest a causal link between parabens and breast cancer.
The American Cancer Society has concluded, based on its research findings, that the scientific and medical research does not a claim that the use of parabens in cosmetics can increase an individual’s risk of developing breast cancer.
The FDA began studying the effects of parabens in response to the outcry of their potential estrogenic effect and link to breast cancer. The FDA found that parabens are safe for use in cosmetics, and it also says that, based on the weight of all the current scientific evidence, there is no reason for consumers to be concerned about the use of products containing parabens.
INTERNATIONAL SAFETY ASSESSMENTS OF PARABENS
Other research has even refuted the long-held belief that parabens are among the more sensitizing preservatives in cosmetics, stating that "...these ubiquitous compounds have withstood four decades of extensive skin testing conducted by a variety of organizations, both North American and European, and now, it seems parabens have shown to be one of the least sensitizing preservatives in commercial use."
Toxicology Letters rr December 2013 that in references to parabens causing health issues "Overall, despite of 20 years of research a human health risk from exposure to low concentrations of exogenous chemical substances with weak hormone-like activities remains an unproven and unlikely hypothesis
.The Personal Care Products Council, a US organization that reviews and assesses the safety of ingredients used in cosmetics in an open, unbiased and expert manner, consolidated more than 265 studies in The Journal of Toxicology that noted a women’s daily cosmetic regimen using products that contain parabens caused no adverse reproductive effects and confirmed the safety of parabe
SL PARABENS & PARABEN BLENDS Sr. Product No. List INCI Name Saligin 1 MP
In use Rins Concent e- Leave- Wet- Liqu soli Handling ration off On wipe id d pH range Temp. •
•
0.1-0.3%
•
3saligin EP Ethyl Paraben
0.1-0.3%
4Saligin BP Butyl Paraben Saligin Sodium Methyl 5 MPS Paraben saligin 6 PPS Sodium propyl Paraben Saligin 7 EPS Sodium Ethyl Paraben Methyl Paraben, Ethyl Paraben, Propyl 8Salisept Paraben Methyl Paraben, Ethyl Paraben, Propyl Paraben, Butyl Paraben, Isobutyl 9Salistat Paraben
0.1-0.3%
Methyl Paraben
0.1-0.3%
2Saligin PP Propyl Paraben
0.1-0.3% 0.1-0.3%
0.1-0.3% 0.050.3%
√ 4.0-8.0
Appox. 80⁰C approx. 0.25%
•
√ 4.0-8.0
Appox. 80⁰C approx. 0.05%
•
•
√ 4.0-8.0
Appox. 80⁰C approx. 0.17%
•
•
√ 4.0-8.0
Appox. 80⁰C approx. 0.02%
•
•
•
•
•
•
•
•
• 0.050.3%
Water Solubility
•
√ 3.0-11.0 Appox. 80⁰C approx. 33% √ 3.0-11.0 Appox. 80⁰C approx. 50%
√ 3.0-11.0 Appox. 80⁰C approx. 50% • √ 4.0-8.0
Appox. 80⁰C
0.20%
√ 4.0-8.0
Appox. 80⁰C
0.14%
•
SL PARABEN BLENDS WITH OTHER PRESERVATIVES In use Concentrat Rinseion off Leave-On Wet-wipe
Product List
INCI Name
1
Salinip
Phenoxyethanol, Methyl Paraben, Propyl Paraben, Ethyl Paraben, Butyl Paraben, Isobutyl Paraben
2
Phenoxyethanol, Methyl Paraben, Propyl Salinip XB Paraben, Ethyl Paraben
3
Phenoxyethanol, Methyl Saliguard paraben, Ethyl paraben, 300 Bronopol 0.3-0.7%
Sr.No.
4
5
6
Methyl Paraben, Propyl Saligerm Paraben, Diazolidinyl G2 Urea, Propylene Glycol Methyl Paraben, Ethyl Saligin Paraben, MEPX Phenoxyethanol
Saligin 300
•
•
•
•
•
•
√
3.0-8.0 max. 40⁰C
√
4.5-8.5 max. 40⁰C Miscible
•
•
0.3-1%
2-Bromo-2Nitropropane-1,3-Diol, Phenoxyethanol, Methyl Paraben, Propyl Paraben 0.3-0.8%
3.0-8.0 max. 40⁰C
•
0.3-1%
•
approx. 0.5%
√
•
0.3-1% •
solid
•
0.25-1%
•
Liquid
Handling Water pH range Temp. Solubility
√
up to 8.0 max. 40⁰C
√
3.0-8.0 max. 40⁰C
√
up to 8.0 max. 40⁰C
•
•
1%
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 • Applications Leave-on, rinse-off • Formulating Tips Highly water soluble Temperature sensitive • pH Range 3-10 pH • Use Level 0.1-0.5 Warning label required in Japan
Comments • Major Types: imidazolidinyl urea, diazolidinyl urea, DMDM Hydantoin, • React with avobenzone • Not well liked in some European countries • Carcinogenicity???
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 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 carcinogen 1B would effectively prohibit its use as a biocidal active ingredient. • Following formaldehydes reclassification, in order to be in accordance with the classification labelling and packaging regulation (EC) No 1272/2008, the relevant classifications (as indicated below) would have to be adhered to for household products
CMR-attribute
Classification of the substance
Classification of the mixture
Mutagenicity
mutagen category 2; H341
Concentration trigger ≥ 1,0%muta. cat 2; H341
Carcinogenicity
carcinogen category 1B; H350
Concentration trigger ≥ 0,1 % carc. cat 1B; H350
SL – FORMALDEHYDE RELEASERS & THREIR BLENDS
Sr.No. 1 2
3
Product List INCI Name Salimid 115
Imidazolidinyl Urea
In use Concentr Leaveation Rinse-off On 0.2-0.5%
Salimall - II Diazolidinyl Urea 0.2-0.5% Saliplus Diazolidinyl Urea, Iodo (Liq. & Propynyl Butyl Powder) Carbamate 0.05-0.2% Methyl Paraben, Propyl Paraben, Diazolidinyl Urea, Propylene Glycol 0.3-1%
5
Saligerm G2 Salidant DHM
6
Salidant DHM Plus DMDM Hydantoin, (Liq. & Iodo Propynyl Butyl Powder) Carbamate
7
Saliccide BR 2-Bromo-2(Bronopol) Nitropropane-1,3-Diol 0.01-0.1%
4
DMDM Hydantoin
0.15-0.4%
•
•
•
•
•
•
Wetwipe
Liquid
√ •
√
3.0-8.5 max. 60⁰C
√
3.0-8.5 max. 40⁰C
√
6.0-7.5 max. 90⁰C
•
•
•
•
•
0.0750.3% •
solid
Handling pH range Temp.
√
up to 8.0 max. 40⁰C
√
4.0-8.0 max. 60⁰C
√
6.0-9.0 max. 90⁰C
√
3.0-8.5 max. 40⁰C
•
PRESERVATIVES – ISOTHIAZOLONES • • • • • • • •
Target Organisms Applications Formulating Tips pH Range Use Level CIR max. EU max. Japan
Bacteria and Fungi Mainly rinse-off Most common blend is CMIT / MIT, Sensitization issues 2-8 pH Typically 1.5% active solution –3:1 blend 15 ppm rinse-off, 7.5 ppm leave-on 15 ppm rinse-off only max. 100 ppm MIT
Comments • Major types: chloromethlyisothiazolinone,methlyisothiazolinone • Not widely accepted in 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) Methylisothiazolinone (3:1) Leave-on Rinse-off
EU Cosmetic Regulation EU Cosmetic Regulation (old) (new) 0.0015%Not permitted 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) Methylisothiazolinone (3:1) Leave-on Rinse-off
EU Cosmetic Regulation EU Cosmetic Regulation (old) (new) 0.01% 0.01% (2) 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
SL – ISOTHIAZOLONES & THEIR BLENDS
Product Sr.No. List INCI Name
2
Salimix MCIIndusrial Grade Salicat MMCosmetic Grade
3
Salicat K 145
1
4
Saicat K727
In use Conce ntratio Rinse- Leav Wetn off e-On wipe
Methylchloroisothiazolinon 0.02e, Methylisothiazolinone 0.15%
Methylchloroisothiazolinon 0.02e, Methylisothiazolinone 0.15% 2-Bromo-2-Nitropropane1,3-Diol, Methylchloroisothiazolinon 0.05e, Methylisothiazolinone 0.3% Methyldibromo Glutaronitrile, Methylchloroisothiazolinon e, Methylisothiazolinone, 0.05Phenoxyethanol 0.6%
Liquid
•
Handling Water Solubility
solid pH range Temp.
√
max. 2.0-9.0 100⁰C
Miscible
√
max. 2.0-9.0 100⁰C
Miscible
√
max. 4.0-9.0 80⁰C
Miscible
√
max. 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
SL – IODOPROPYNYL BUTYL CARBAMATE BLENDS
Produc Sr.No. t List INCI Name
In use Conce ntratio Rinse- Leave- WetpH n off On wipe Liquid solid range
29
Salidant DHM Plus DMDM Hydantoin, (Liq. & Iodo Propynyl Butyl 0.075Powder) Carbamate 0.3%
12
1,2-Hexanediol, 1,2Propanediol, Saliguar Iodopropynl Butyl 0.5d HDZ Carbamate 0.75%
•
• √
•
Water Handlin Solubili g Temp. ty
•
6.0-9.0
max. 90⁰C Miscible
• √
max. 3.0-10.0 80⁰C Miscible
ALCOHOLS • Target Organisms • Applications • Formulating Tips • pH Range • Use Level
Bacteria Rinse-off, leave-on Highly water soluble May have characteristic odor 3-10 pH 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 . Formally approved up to 1.0%, but still some manufacturers have reservations. • Benzyl alcohol listed as a fragrance allergen in Europe
SL – ALCOHOL BLENDS
Sr.No. 1
2
3
4 5 6
7
8 9
Product List INCI Name Saliethano l Phenoxyethanol Phenoxyethanol, Methyl Paraben, Propyl Paraben, Ethyl Paraben, Butyl Salichem Paraben Phenoxyethanol, Methyl Saliguard paraben, Ethyl paraben, 300 Bronopol Benzoic Acid, Saliguard Dehydroacetic Acid, BDP Phenoxyethanol Saliguard PCG Saiguard PG
In use Concent Rinseration off 0.5-1%
LeaveOn
Wetwipe
•
•
•
•
•
•
0.25-1% •
•
•
•
•
•
•
•
•
•
•
•
• •
• •
3.0-8.0 max. 80⁰C
√
4.5-8.5 max. 40⁰C Miscible
√
up to 6.0 max.60⁰C Miscible
√
3.0-10.0 max.60⁰C
>95%
•
0.2-1.2%
Phenoxyethanol, Caprylyl Glycol, Propylene Glycol 0.5-1% Phenoxyethanol, Caprylyl Glycol 0.5-1% Caprylyl Glycol, Saliguard Chlorphenesin, COS Phenoxyethanol 0.75-1.5% Undecylenic Acid, Saliguard Caprylyl glycol, U Phenoxyethanol 0.75-1% Saliguard Ethylhexylglycerin, EHGP Phenoxyethanol 0.5-1%
√
solid pH range Temp.
•
0.3-0.7% •
√
Handling Water Solubility highly 3.0-8.5 max. 80⁰C soluble
Liquid
√
Immiscibl e Immiscibl 3.0-10.0 max.60⁰C e
√
3.0-8.0
max.80⁰C Miscible
√
3.0-6.5
max.80⁰C Miscible
√
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”
SL - GLYCOLS & THEIR BLENDS
Sr.No. Product List INCI Name 1
2
3 4
5 6
Salicap G
Caprylyl Glycol 1,3-Propanediol (Corn derived), Salidiol G Glycerin Phenoxyethanol, Caprylyl Glycol, Saliguard PCG Propylene Glycol Phenoxyethanol, Saiguard PG Caprylyl Glycol Caprylyl Glycol, Chlorphenesin, Saliguard COS Phenoxyethanol Caprylyl Glycol, Saliguard CGZ 1,3-Propane Diol
In use Concen Rinse- Leavetration off On
Wetwipe
•
•
•
•
•
•
1-2%
Liquid √
√ •
•
•
0.5-1% 0.5-1%
0.751.5% 0.751.25%
√ •
•
•
•
•
•
√
√ •
•
•
√
pH Handlin Water solid range g Temp. Solubility 3.0- max.90 12.0 ⁰C Miscible max.90 ⁰C Miscible 3.0- max.60 10.0 ⁰C Immiscible 3.0- max.60 10.0 ⁰C Immiscible
max.80 3.0-8.0 ⁰C Miscible 3.0- max.80 10.0 ⁰C Immiscible
SL - GLYCOLS & THEIR BLENDS
Sr.No. Product List INCI Name 7
8
9
Saliguard MIZ
Saliguard HDZ
Saliguard HDC
10
Saliguard UZB
11
Saliguard U
Methylisothiazolinone , 1,3-Propanediol 1,2-Hexanediol, 1,2Propanediol, Iodopropynl Butyl Carbamate 1,2-Hexanediol, Phenoxyethanol, chlorphenesin
In use Concen Rinse- Leave- Wettration off On wipe 0.751.5%
0.50.75% 0.751.5%
Undecylenic Acid, 1,3Propanediol (Corn Derived), Benzyl Alcohol 0.75-1% Undecylenic Acid, Caprylyl glycol, Phenoxyethanol 0.75-1%
•
•
Saliguard EZ
Ethylhexylglycerin, 1,3-Propanediol
0.5-2%
√ •
• √
•
•
•
•
•
•
•
•
max.80⁰ 3.0-10.0 C Miscible
√
max.80⁰ Partially 3.0-10.0 C miscible Limited solubility in water, highly miscible in max.40⁰ organic 3.0-6.5 C solvent
√
3.0-6.5
√
• 12
Liquid
Handling Water solid pH range Temp. Solubility max.80⁰ 3.0-9.0 C Immiscible
•
•
• √
max.80⁰ C Miscible Limited solubility in water, highly miscible in max.80⁰ organic 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
SL - ETHYL HEXYL GLYCERIN BASED PRESERVATIVES
Product Sr.No. List
INCI Name
In use Conce Handli ntrati Rinse- Leave- WetpH ng Water on off On wipe Liquid solid range Temp. Solubility •
1 2
3
Saliguard EHG Saliguard EHGP
Ethylhexylglycerin 0.3-1% Ethylhexylglycerin , Phenoxyethanol 0.5-1%
• √
•
•
•
•
•
•
Ethylhexylglycerin Saliguard EU , Undecylenic acid 0.5-2%
Ethylhexylglycerin Saliguard EZ , 1,3-Propanediol 0.5-2%
√
√
• 4
•
•
• √
Limited solubility in water, highly 2.0- max.80 miscible in 12.0 ⁰C organic solvent 2.0- max.80 12.0 ⁰C >0.1% Limited solubility in water, highly max.80 miscible in 3.0-7.0 ⁰C organic solvent Limited solubility in water, highly max.80 miscible in 3.0-7.0 ⁰C organic solvent
GLYCOLS – CHLOPHENESIN • • • •
Target Organisms Applications pH Range Use Level
Fungi Rinse-off, leave-on Best at acid pH 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
SL – CHLOPHENESIN BASED PRESERVATIVES
Product Sr.No. List 1
2
3
INCI Name
Saliphenesin Chlorphenesin
In use Concen Rinse- Leave- WetpH Handling Water tration off On wipe Liquid solid range Temp. Solubility 0.1-0.3%
Saliguard COS
Caprylyl Glycol, Chlorphenesin, Phenoxyethanol
0.751.5%
Saliguard HDC
1,2-Hexanediol, Phenoxyethanol, chlorphenesin
0.751.5%
max.50⁰ C
Miscible
√
max.80⁰ 3.0-8.0 C
Miscible
√
3.010.0
Partially miscible
•
•
•
√
•
•
•
• max.80⁰ C
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
SL - ORGANIC ACIDS ACID BASED PRESERVATIVES
Sr.No. Product List INCI Name 1
Salicylic Acid
2
Salicylic Acid Methyl Salicylate
3
4 5 6
7
8
9
2-Hydroxybenzoic Acid 2-Hydroxybenzoic Acid
Methyl Salicylate Benzoic Acid, Dehydroacetic Acid, Saliguard BDP Phenoxyethanol Benzyl Alcohol, Saliguard BDHA Dehydroacetic acid Sodium Benzoat, Saliguard SP Potassium Sorbate Undecylenic Acid, 1,3-Propanediol (Corn Derived), Saliguard UZB Benzyl Alcohol Undecylenic Acid, Caprylyl glycol, Saliguard U Phenoxyethanol
Saliguard EU
Ethylhexylglycerin, Undecylenic acid
In use Concen Rinse- Leave- WetpH tration off On wipe Liquid solid range 0.1-0.5% 0.1-0.5% 0.1-0.5%
•
•
√
2 g/l
•
•
√
2 g/l
•
•
•
•
•
0.5-1.5%
√
3.0-6.5
√
3.0-7.0
•
•
•
√
•
•
•
√
•
•
•
0.75-1% •
•
•
•
up to 6.0
•
0.75-1%
0.5-2%
√
max.60⁰ C Miscible max.80⁰ up to 6.5 C Miscible max.80⁰ up to 5.5 C Miscible Limited solubility in water, highly max.40⁰ miscible in 3.0-6.5 C organic solvent
√
0.2-1.2% 0.2-0.8%
Handlin g Temp. Water Solubility
•
max.80⁰ C Miscible Limited solubility in water, highly max.80⁰ miscible in C organic solvent
SL – OTHER PRESEVATIVES & ACTIVES
Product Sr.No. List
INCI Name
In use Conce ntratio Rinse- Leave WetpH Handlin Water n off -On wipe Liquid solid range g Temp. Solubility
3
5-Bromo-5Nitropropane1,3-Dioxane, 0.05Brosalidox L Propylene Glycol 0.3% Dimethyl Salibide DMI Isosorbide 1-8% 0.1Salisan Triclosan 0.3%
4
Salidruff
1 2
Zinc Pyrithione
0.5-2%
• √ •
•
•
√
•
√
•
√
•
5
Salitoin
0.10.4%
6
Chlorohexidine 0.25Salidine 20% Digluconate 20% 1.5%
•
Allantoin
5.08.0
•
4.09.5
Slight max.50 soluble in ⁰C water
• √
•
•
√
max. 50⁰C max 0.5% max.90 ⁰C Miscible max.80 ⁰C 0.001%
5.08.0
>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
SL - NATURAL PRESEVATIVES Natural Presrvatives - Ecocertified Sr. No. Product Salinatural 1 CCL Salinatural 2 BCLS
salinatural 3 TCLS Salinatural 4 OLG
Salinatural 5 MIN
Salinatural 6 CIN Salinatural 7 KJ
In use Concentrati pH Handling on Rinse-off Leave-On Wet-wipe Liquid solid range Temp. Water Solubility
INCI Name Curry Leaf Oil, Cinnamon leaf Oil, Sesame Oil 0.75-1.2% Basil Extract, Clove Bud Oil, Lemongrass Oil, Sesame Oil 1-2% Turmeric Oil, Clove Bud Oil, Lemonrass Oil, Sesame Oil 1-2% Orange Oil, Lemongrass Oil, Sesame Oil 1-2% Peppermint Oil, spearmint Oil, Clove Oil, Neem Leaf Extraact, Rosemary Oil 1.5-2% Clove Oil, Cinnamon Bark Oil, Neem Leaf Extract, Rosemary Oil, Eucalyptus Oil 1.5-2% Pongamia Glabra Seed Oil 3-5%
√
3.07.0 max. 60⁰C Immiscible
√
3.07.0 max. 50⁰C Immiscible
√
3.07.0 max. 50⁰C Immiscible 3.07.0 max. 50⁰C Immiscible
√
3.07.0 max. 50⁰C Immiscible
√
√ √
3.07.0 max. 50⁰C Immiscible 3.07.0 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
Staphylococcus aureus Escherichia coli Pseudomonas aeruginosa Salmonella typhi Aspergillus niger Candida albicans **Test material sparingly soluble in water, solvent used
MIC%
<0.0001 0.001 0.001 0.0005 0.1 0.05
SALIBACT RATE TIME KILL TEST FOR FORMULATION 1 (TRICLOSAN) AND 2 (SALIBACT) Test Product
Test Organism
Esch. Coli 0.3% Salisan (Triclosan) (form:1) Staph. Aureus
Esch. Coli 0.1% SALIBACT (SALIBACT)(Form:2) Staph. Aureus
Exposure Time 30 Secs. 60 Secs. 2 Min. 30 Secs. 60 Secs. 2 Min. 30 Secs. 60 Secs. 2 Min. 30 Secs. 60 Secs. 2 Min.
Anti Microbial Activity % reduction 99.97 >99.99 >99.99 >99.99 >99.99 >99.99 >99.99 >99.99 >99.99 >99.99 >99.99 >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 Dr. Rakesh Ratnam
Ms. Krishna Sarviaya
Director- Technical Marketing
Vice Presidednt
SALICYLATES & CHEMICALS PVT. LTD
SALICYLATES & CHEMICALS PVT. LTD
rr@salicylates .net +91 945761744 Bangalore,India
5/44 Tardeo Air conditioned Market, Mumbai- 400 034, India Phone: +91-22-23514413 Mob :+91 9821211274
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 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: Final Opinion on Parabens, which is the official statement by the European Union on the unequivocal safety of parabens in skin care, cosmetics and personal care products. This summary of decades of long-term and short-term safety data reinforced the EUs previous decision that parabens are safe in personal care products.
Health Canada, the Canadian FDAequivalent, also finds that, "Currently, there is no evidence to suggest a causal link between parabens and breast cancer.
The American Cancer Society has concluded, based on its research findings, that the scientific and medical research does not a claim that the use of parabens in cosmetics can increase an individual’s risk of developing breast cancer.
The FDA began studying the effects of parabens in response to the outcry of their potential estrogenic effect and link to breast cancer. The FDA found that parabens are safe for use in cosmetics, and it also says that, based on the weight of all the current scientific evidence, there is no reason for consumers to be concerned about the use of products containing parabens.
INTERNATIONAL SAFETY ASSESSMENTS OF PARABENS
Other research has even refuted the long-held belief that parabens are among the more sensitizing preservatives in cosmetics, stating that "...these ubiquitous compounds have withstood four decades of extensive skin testing conducted by a variety of organizations, both North American and European, and now, it seems parabens have shown to be one of the least sensitizing preservatives in commercial use."
Toxicology Letters rr December 2013 that in references to parabens causing health issues "Overall, despite of 20 years of research a human health risk from exposure to low concentrations of exogenous chemical substances with weak hormone-like activities remains an unproven and unlikely hypothesis
.The Personal Care Products Council, a US organization that reviews and assesses the safety of ingredients used in cosmetics in an open, unbiased and expert manner, consolidated more than 265 studies in The Journal of Toxicology that noted a women’s daily cosmetic regimen using products that contain parabens caused no adverse reproductive effects and confirmed the safety of parabe
SL PARABENS & PARABEN BLENDS Sr. Product No. List INCI Name Saligin 1 MP
In use Rins Concent e- Leave- Wet- Liqu soli Handling ration off On wipe id d pH range Temp. •
•
0.1-0.3%
•
3saligin EP Ethyl Paraben
0.1-0.3%
4Saligin BP Butyl Paraben Saligin Sodium Methyl 5 MPS Paraben saligin 6 PPS Sodium propyl Paraben Saligin 7 EPS Sodium Ethyl Paraben Methyl Paraben, Ethyl Paraben, Propyl 8Salisept Paraben Methyl Paraben, Ethyl Paraben, Propyl Paraben, Butyl Paraben, Isobutyl 9Salistat Paraben
0.1-0.3%
Methyl Paraben
0.1-0.3%
2Saligin PP Propyl Paraben
0.1-0.3% 0.1-0.3%
0.1-0.3% 0.050.3%
√ 4.0-8.0
Appox. 80⁰C approx. 0.25%
•
√ 4.0-8.0
Appox. 80⁰C approx. 0.05%
•
•
√ 4.0-8.0
Appox. 80⁰C approx. 0.17%
•
•
√ 4.0-8.0
Appox. 80⁰C approx. 0.02%
•
•
•
•
•
•
•
•
• 0.050.3%
Water Solubility
•
√ 3.0-11.0 Appox. 80⁰C approx. 33% √ 3.0-11.0 Appox. 80⁰C approx. 50%
√ 3.0-11.0 Appox. 80⁰C approx. 50% • √ 4.0-8.0
Appox. 80⁰C
0.20%
√ 4.0-8.0
Appox. 80⁰C
0.14%
•
SL PARABEN BLENDS WITH OTHER PRESERVATIVES In use Concentrat Rinseion off Leave-On Wet-wipe
Product List
INCI Name
1
Salinip
Phenoxyethanol, Methyl Paraben, Propyl Paraben, Ethyl Paraben, Butyl Paraben, Isobutyl Paraben
2
Phenoxyethanol, Methyl Paraben, Propyl Salinip XB Paraben, Ethyl Paraben
3
Phenoxyethanol, Methyl Saliguard paraben, Ethyl paraben, 300 Bronopol 0.3-0.7%
Sr.No.
4
5
6
Methyl Paraben, Propyl Saligerm Paraben, Diazolidinyl G2 Urea, Propylene Glycol Methyl Paraben, Ethyl Saligin Paraben, MEPX Phenoxyethanol
Saligin 300
•
•
•
•
•
•
√
3.0-8.0 max. 40⁰C
√
4.5-8.5 max. 40⁰C Miscible
•
•
0.3-1%
2-Bromo-2Nitropropane-1,3-Diol, Phenoxyethanol, Methyl Paraben, Propyl Paraben 0.3-0.8%
3.0-8.0 max. 40⁰C
•
0.3-1%
•
approx. 0.5%
√
•
0.3-1% •
solid
•
0.25-1%
•
Liquid
Handling Water pH range Temp. Solubility
√
up to 8.0 max. 40⁰C
√
3.0-8.0 max. 40⁰C
√
up to 8.0 max. 40⁰C
•
•
1%
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 • Applications Leave-on, rinse-off • Formulating Tips Highly water soluble Temperature sensitive • pH Range 3-10 pH • Use Level 0.1-0.5 Warning label required in Japan
Comments • Major Types: imidazolidinyl urea, diazolidinyl urea, DMDM Hydantoin, • React with avobenzone • Not well liked in some European countries • Carcinogenicity???
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 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 carcinogen 1B would effectively prohibit its use as a biocidal active ingredient. • Following formaldehydes reclassification, in order to be in accordance with the classification labelling and packaging regulation (EC) No 1272/2008, the relevant classifications (as indicated below) would have to be adhered to for household products
CMR-attribute
Classification of the substance
Classification of the mixture
Mutagenicity
mutagen category 2; H341
Concentration trigger ≥ 1,0%muta. cat 2; H341
Carcinogenicity
carcinogen category 1B; H350
Concentration trigger ≥ 0,1 % carc. cat 1B; H350
SL – FORMALDEHYDE RELEASERS & THREIR BLENDS
Sr.No. 1 2
3
Product List INCI Name Salimid 115
Imidazolidinyl Urea
In use Concentr Leaveation Rinse-off On 0.2-0.5%
Salimall - II Diazolidinyl Urea 0.2-0.5% Saliplus Diazolidinyl Urea, Iodo (Liq. & Propynyl Butyl Powder) Carbamate 0.05-0.2% Methyl Paraben, Propyl Paraben, Diazolidinyl Urea, Propylene Glycol 0.3-1%
5
Saligerm G2 Salidant DHM
6
Salidant DHM Plus DMDM Hydantoin, (Liq. & Iodo Propynyl Butyl Powder) Carbamate
7
Saliccide BR 2-Bromo-2(Bronopol) Nitropropane-1,3-Diol 0.01-0.1%
4
DMDM Hydantoin
0.15-0.4%
•
•
•
•
•
•
Wetwipe
Liquid
√ •
√
3.0-8.5 max. 60⁰C
√
3.0-8.5 max. 40⁰C
√
6.0-7.5 max. 90⁰C
•
•
•
•
•
0.0750.3% •
solid
Handling pH range Temp.
√
up to 8.0 max. 40⁰C
√
4.0-8.0 max. 60⁰C
√
6.0-9.0 max. 90⁰C
√
3.0-8.5 max. 40⁰C
•
PRESERVATIVES – ISOTHIAZOLONES • • • • • • • •
Target Organisms Applications Formulating Tips pH Range Use Level CIR max. EU max. Japan
Bacteria and Fungi Mainly rinse-off Most common blend is CMIT / MIT, Sensitization issues 2-8 pH Typically 1.5% active solution –3:1 blend 15 ppm rinse-off, 7.5 ppm leave-on 15 ppm rinse-off only max. 100 ppm MIT
Comments • Major types: chloromethlyisothiazolinone,methlyisothiazolinone • Not widely accepted in 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) Methylisothiazolinone (3:1) Leave-on Rinse-off
EU Cosmetic Regulation EU Cosmetic Regulation (old) (new) 0.0015%Not permitted 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) Methylisothiazolinone (3:1) Leave-on Rinse-off
EU Cosmetic Regulation EU Cosmetic Regulation (old) (new) 0.01% 0.01% (2) 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
SL – ISOTHIAZOLONES & THEIR BLENDS
Product Sr.No. List INCI Name
2
Salimix MCIIndusrial Grade Salicat MMCosmetic Grade
3
Salicat K 145
1
4
Saicat K727
In use Conce ntratio Rinse- Leav Wetn off e-On wipe
Methylchloroisothiazolinon 0.02e, Methylisothiazolinone 0.15%
Methylchloroisothiazolinon 0.02e, Methylisothiazolinone 0.15% 2-Bromo-2-Nitropropane1,3-Diol, Methylchloroisothiazolinon 0.05e, Methylisothiazolinone 0.3% Methyldibromo Glutaronitrile, Methylchloroisothiazolinon e, Methylisothiazolinone, 0.05Phenoxyethanol 0.6%
Liquid
•
Handling Water Solubility
solid pH range Temp.
√
max. 2.0-9.0 100⁰C
Miscible
√
max. 2.0-9.0 100⁰C
Miscible
√
max. 4.0-9.0 80⁰C
Miscible
√
max. 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
SL – IODOPROPYNYL BUTYL CARBAMATE BLENDS
Produc Sr.No. t List INCI Name
In use Conce ntratio Rinse- Leave- WetpH n off On wipe Liquid solid range
29
Salidant DHM Plus DMDM Hydantoin, (Liq. & Iodo Propynyl Butyl 0.075Powder) Carbamate 0.3%
12
1,2-Hexanediol, 1,2Propanediol, Saliguar Iodopropynl Butyl 0.5d HDZ Carbamate 0.75%
•
• √
•
Water Handlin Solubili g Temp. ty
•
6.0-9.0
max. 90⁰C Miscible
• √
max. 3.0-10.0 80⁰C Miscible
ALCOHOLS • Target Organisms • Applications • Formulating Tips • pH Range • Use Level
Bacteria Rinse-off, leave-on Highly water soluble May have characteristic odor 3-10 pH 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 . Formally approved up to 1.0%, but still some manufacturers have reservations. • Benzyl alcohol listed as a fragrance allergen in Europe
SL – ALCOHOL BLENDS
Sr.No. 1
2
3
4 5 6
7
8 9
Product List INCI Name Saliethano l Phenoxyethanol Phenoxyethanol, Methyl Paraben, Propyl Paraben, Ethyl Paraben, Butyl Salichem Paraben Phenoxyethanol, Methyl Saliguard paraben, Ethyl paraben, 300 Bronopol Benzoic Acid, Saliguard Dehydroacetic Acid, BDP Phenoxyethanol Saliguard PCG Saiguard PG
In use Concent Rinseration off 0.5-1%
LeaveOn
Wetwipe
•
•
•
•
•
•
0.25-1% •
•
•
•
•
•
•
•
•
•
•
•
• •
• •
3.0-8.0 max. 80⁰C
√
4.5-8.5 max. 40⁰C Miscible
√
up to 6.0 max.60⁰C Miscible
√
3.0-10.0 max.60⁰C
>95%
•
0.2-1.2%
Phenoxyethanol, Caprylyl Glycol, Propylene Glycol 0.5-1% Phenoxyethanol, Caprylyl Glycol 0.5-1% Caprylyl Glycol, Saliguard Chlorphenesin, COS Phenoxyethanol 0.75-1.5% Undecylenic Acid, Saliguard Caprylyl glycol, U Phenoxyethanol 0.75-1% Saliguard Ethylhexylglycerin, EHGP Phenoxyethanol 0.5-1%
√
solid pH range Temp.
•
0.3-0.7% •
√
Handling Water Solubility highly 3.0-8.5 max. 80⁰C soluble
Liquid
√
Immiscibl e Immiscibl 3.0-10.0 max.60⁰C e
√
3.0-8.0
max.80⁰C Miscible
√
3.0-6.5
max.80⁰C Miscible
√
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”
SL - GLYCOLS & THEIR BLENDS
Sr.No. Product List INCI Name 1
2
3 4
5 6
Salicap G
Caprylyl Glycol 1,3-Propanediol (Corn derived), Salidiol G Glycerin Phenoxyethanol, Caprylyl Glycol, Saliguard PCG Propylene Glycol Phenoxyethanol, Saiguard PG Caprylyl Glycol Caprylyl Glycol, Chlorphenesin, Saliguard COS Phenoxyethanol Caprylyl Glycol, Saliguard CGZ 1,3-Propane Diol
In use Concen Rinse- Leavetration off On
Wetwipe
•
•
•
•
•
•
1-2%
Liquid √
√ •
•
•
0.5-1% 0.5-1%
0.751.5% 0.751.25%
√ •
•
•
•
•
•
√
√ •
•
•
√
pH Handlin Water solid range g Temp. Solubility 3.0- max.90 12.0 ⁰C Miscible max.90 ⁰C Miscible 3.0- max.60 10.0 ⁰C Immiscible 3.0- max.60 10.0 ⁰C Immiscible
max.80 3.0-8.0 ⁰C Miscible 3.0- max.80 10.0 ⁰C Immiscible
SL - GLYCOLS & THEIR BLENDS
Sr.No. Product List INCI Name 7
8
9
Saliguard MIZ
Saliguard HDZ
Saliguard HDC
10
Saliguard UZB
11
Saliguard U
Methylisothiazolinone , 1,3-Propanediol 1,2-Hexanediol, 1,2Propanediol, Iodopropynl Butyl Carbamate 1,2-Hexanediol, Phenoxyethanol, chlorphenesin
In use Concen Rinse- Leave- Wettration off On wipe 0.751.5%
0.50.75% 0.751.5%
Undecylenic Acid, 1,3Propanediol (Corn Derived), Benzyl Alcohol 0.75-1% Undecylenic Acid, Caprylyl glycol, Phenoxyethanol 0.75-1%
•
•
Saliguard EZ
Ethylhexylglycerin, 1,3-Propanediol
0.5-2%
√ •
• √
•
•
•
•
•
•
•
•
max.80⁰ 3.0-10.0 C Miscible
√
max.80⁰ Partially 3.0-10.0 C miscible Limited solubility in water, highly miscible in max.40⁰ organic 3.0-6.5 C solvent
√
3.0-6.5
√
• 12
Liquid
Handling Water solid pH range Temp. Solubility max.80⁰ 3.0-9.0 C Immiscible
•
•
• √
max.80⁰ C Miscible Limited solubility in water, highly miscible in max.80⁰ organic 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
SL - ETHYL HEXYL GLYCERIN BASED PRESERVATIVES
Product Sr.No. List
INCI Name
In use Conce Handli ntrati Rinse- Leave- WetpH ng Water on off On wipe Liquid solid range Temp. Solubility •
1 2
3
Saliguard EHG Saliguard EHGP
Ethylhexylglycerin 0.3-1% Ethylhexylglycerin , Phenoxyethanol 0.5-1%
• √
•
•
•
•
•
•
Ethylhexylglycerin Saliguard EU , Undecylenic acid 0.5-2%
Ethylhexylglycerin Saliguard EZ , 1,3-Propanediol 0.5-2%
√
√
• 4
•
•
• √
Limited solubility in water, highly 2.0- max.80 miscible in 12.0 ⁰C organic solvent 2.0- max.80 12.0 ⁰C >0.1% Limited solubility in water, highly max.80 miscible in 3.0-7.0 ⁰C organic solvent Limited solubility in water, highly max.80 miscible in 3.0-7.0 ⁰C organic solvent
GLYCOLS – CHLOPHENESIN • • • •
Target Organisms Applications pH Range Use Level
Fungi Rinse-off, leave-on Best at acid pH 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
SL – CHLOPHENESIN BASED PRESERVATIVES
Product Sr.No. List 1
2
3
INCI Name
Saliphenesin Chlorphenesin
In use Concen Rinse- Leave- WetpH Handling Water tration off On wipe Liquid solid range Temp. Solubility 0.1-0.3%
Saliguard COS
Caprylyl Glycol, Chlorphenesin, Phenoxyethanol
0.751.5%
Saliguard HDC
1,2-Hexanediol, Phenoxyethanol, chlorphenesin
0.751.5%
max.50⁰ C
Miscible
√
max.80⁰ 3.0-8.0 C
Miscible
√
3.010.0
Partially miscible
•
•
•
√
•
•
•
• max.80⁰ C
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
SL - ORGANIC ACIDS ACID BASED PRESERVATIVES
Sr.No. Product List INCI Name 1
Salicylic Acid
2
Salicylic Acid Methyl Salicylate
3
4 5 6
7
8
9
2-Hydroxybenzoic Acid 2-Hydroxybenzoic Acid
Methyl Salicylate Benzoic Acid, Dehydroacetic Acid, Saliguard BDP Phenoxyethanol Benzyl Alcohol, Saliguard BDHA Dehydroacetic acid Sodium Benzoat, Saliguard SP Potassium Sorbate Undecylenic Acid, 1,3-Propanediol (Corn Derived), Saliguard UZB Benzyl Alcohol Undecylenic Acid, Caprylyl glycol, Saliguard U Phenoxyethanol
Saliguard EU
Ethylhexylglycerin, Undecylenic acid
In use Concen Rinse- Leave- WetpH tration off On wipe Liquid solid range 0.1-0.5% 0.1-0.5% 0.1-0.5%
•
•
√
2 g/l
•
•
√
2 g/l
•
•
•
•
•
0.5-1.5%
√
3.0-6.5
√
3.0-7.0
•
•
•
√
•
•
•
√
•
•
•
0.75-1% •
•
•
•
up to 6.0
•
0.75-1%
0.5-2%
√
max.60⁰ C Miscible max.80⁰ up to 6.5 C Miscible max.80⁰ up to 5.5 C Miscible Limited solubility in water, highly max.40⁰ miscible in 3.0-6.5 C organic solvent
√
0.2-1.2% 0.2-0.8%
Handlin g Temp. Water Solubility
•
max.80⁰ C Miscible Limited solubility in water, highly max.80⁰ miscible in C organic solvent
SL – OTHER PRESEVATIVES & ACTIVES
Product Sr.No. List
INCI Name
In use Conce ntratio Rinse- Leave WetpH Handlin Water n off -On wipe Liquid solid range g Temp. Solubility
3
5-Bromo-5Nitropropane1,3-Dioxane, 0.05Brosalidox L Propylene Glycol 0.3% Dimethyl Salibide DMI Isosorbide 1-8% 0.1Salisan Triclosan 0.3%
4
Salidruff
1 2
Zinc Pyrithione
0.5-2%
• √ •
•
•
√
•
√
•
√
•
5
Salitoin
0.10.4%
6
Chlorohexidine 0.25Salidine 20% Digluconate 20% 1.5%
•
Allantoin
5.08.0
•
4.09.5
Slight max.50 soluble in ⁰C water
• √
•
•
√
max. 50⁰C max 0.5% max.90 ⁰C Miscible max.80 ⁰C 0.001%
5.08.0
>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
SL - NATURAL PRESEVATIVES Natural Presrvatives - Ecocertified Sr. No. Product Salinatural 1 CCL Salinatural 2 BCLS
salinatural 3 TCLS Salinatural 4 OLG
Salinatural 5 MIN
Salinatural 6 CIN Salinatural 7 KJ
In use Concentrati pH Handling on Rinse-off Leave-On Wet-wipe Liquid solid range Temp. Water Solubility
INCI Name Curry Leaf Oil, Cinnamon leaf Oil, Sesame Oil 0.75-1.2% Basil Extract, Clove Bud Oil, Lemongrass Oil, Sesame Oil 1-2% Turmeric Oil, Clove Bud Oil, Lemonrass Oil, Sesame Oil 1-2% Orange Oil, Lemongrass Oil, Sesame Oil 1-2% Peppermint Oil, spearmint Oil, Clove Oil, Neem Leaf Extraact, Rosemary Oil 1.5-2% Clove Oil, Cinnamon Bark Oil, Neem Leaf Extract, Rosemary Oil, Eucalyptus Oil 1.5-2% Pongamia Glabra Seed Oil 3-5%
√
3.07.0 max. 60⁰C Immiscible
√
3.07.0 max. 50⁰C Immiscible
√
3.07.0 max. 50⁰C Immiscible 3.07.0 max. 50⁰C Immiscible
√
3.07.0 max. 50⁰C Immiscible
√
√ √
3.07.0 max. 50⁰C Immiscible 3.07.0 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
Staphylococcus aureus Escherichia coli Pseudomonas aeruginosa Salmonella typhi Aspergillus niger Candida albicans **Test material sparingly soluble in water, solvent used
MIC%
<0.0001 0.001 0.001 0.0005 0.1 0.05
SALIBACT RATE TIME KILL TEST FOR FORMULATION 1 (TRICLOSAN) AND 2 (SALIBACT) Test Product
Test Organism
Esch. Coli 0.3% Salisan (Triclosan) (form:1) Staph. Aureus
Esch. Coli 0.1% SALIBACT (SALIBACT)(Form:2) Staph. Aureus
Exposure Time 30 Secs. 60 Secs. 2 Min. 30 Secs. 60 Secs. 2 Min. 30 Secs. 60 Secs. 2 Min. 30 Secs. 60 Secs. 2 Min.
Anti Microbial Activity % reduction 99.97 >99.99 >99.99 >99.99 >99.99 >99.99 >99.99 >99.99 >99.99 >99.99 >99.99 >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 Dr. Rakesh Ratnam
Ms. Krishna Sarviaya
Director- Technical Marketing
Vice Presidednt
SALICYLATES & CHEMICALS PVT. LTD
SALICYLATES & CHEMICALS PVT. LTD
rr@salicylates .net +91 945761744 Bangalore,India
5/44 Tardeo Air conditioned Market, Mumbai- 400 034, India Phone: +91-22-23514413 Mob :+91 9821211274
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