Professional Documents
Culture Documents
Trends in Preservatives
Trends in Preservatives
Traditional preservatives
• Parabens
• Isothiazolinones
• Formaldehyde & formaldehyde-donor
• IPBC
• Organic acids
• 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
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
• 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.
Formaldehyde
DMDM hydantoin,
imidazolidinyl urea,
diazolidinyl urea,
2-bromo-2-nitropropane-1,3-diol (bromopol)
PRESERVATIVES – FORMALDEHYDE RELEASERS
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
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
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
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
Changes to the EU Cosmetic Regulation take effect from 16th July 2015.
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
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
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
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
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
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
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
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
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
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 ?
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