Soapmaker Man
Well-Known Member
Thanks goes to member Barb for posting this info.
Preservatives for Personal Care
Cosmetics
Cosmetics are substances especially prepared to improve, beautify and generally increase the attractiveness of the person. The use of cosmetics is an ancient practice and the continued popularity of these products today has made cosmetics a major industry in many parts of the world.
It is probable that cosmetics had their origin in China, but it is necessary to turn to Egypt for the source of the earliest records of cosmetic substances and their application. During the Thinite dynasty (c.3000 BC) it was customary to bury comforts and luxuries with the dead kings. The opening of the tomb of Tutankhamen who ruled c.1350 BC has brought to light many interesting specimens of cosmetics.
At this period it is probable that the priests made most of these compounds and their manufacture was considered a mysterious and much honored art. Cosmetics were used by Egyptian ladies who enhanced their personal beauty by using somewhat crude paints. Such painting reached its peak in the time of Cleopatra. The effects achieved were not unlike some fashions in eye make-up in the late 20th century.
Preservation-The Problem
Preservation of that which is good, pure and unspoiled has in reality been an unattainable goal since Egyptian times. Preservation of cosmetics and toiletries is a problem stated simple enough - a chemical must be identified that is non-toxic, non irritating and able to destroy or inhibit the growth of microorganisms (bacteria, yeast and mold) capable of spoiling the finished product until it is consumed. The problem is compounded when considering factors such as the stability of the preservative over a broad range of pH and temperature conditions together with chemical compatibility demands in the final formulation.
Microbial inhibition itself has not been the problem. There are many products that can inhibit bacterial and fungal growth. It is in the context of allergenicity and irritancy that the difficulties arise - the safety of the consumer is paramount.
The Solution - Sutton Laboratories
Sutton Laboratories, a division of International Specialty Products, are world leaders in preservative technology. Sutton have developed a range of preservatives and preservative systems that are not only non-toxic, compatible with most cosmetic ingredients, and non sensitizing but also provide the ultimate solution-safe microbiological protection. Sutton invented Germall® 115, a preservative introduced to the cosmetic industry that was effective against Gram-negative bacteria, safe for cosmetic use and compatible with other cosmetic ingredients.
The combination of Germall® 115 with parabens rapidly became one of the most widely used preservative systems in the world. Sutton, also invented Germall® II, a superior member of the substituted imidazolidinyl urea family of compounds. Germall® II has a wider spectrum of activity and better performance when compared to Germall® 115. Sutton incorporated Germall® II into a series of products under the Germaben® tradename giving preservative systems that have exceptional convenience in handling and offer significant cost savings.
Sutton continue their vigorous research program of developing safe and effective biocides for the cosmetic industry. A new antimicrobial, Suttocide® A with unique properties has recently been developed particularly for use in haircare formulations.
Sutton Laboratories, producing quality products that solve today's preservation problems.
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GERMALL® 115
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DESCRIPTION
INCI ADOPTED NAME: IMIDAZOLIDINYL UREA
USP/NF DESIGNATION: IMIDUREA, NF
CAS REGISTRY NO: 39236-46-9
MOLECULAR FORMULA: C11H16N8. H2O
MOLECULAR WEIGHT: 406.33
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PROPERTIES
Germall 115 is a white, free-flowing hygroscopic powder that is very soluble in water. It is compatible with essentially all cosmetic ingredients, including surfactants, proteins, and other special ingredients.
Germall 115 is very effective against Gram-negative bacteria, including Pseudomonas aeruginosa.
Germall 115 acts synergistically with other preservatives. With the parabens it provides a broad spectrum of activity against bacteria, yeast and mold. This synergistic activity has made the Germall 115 paraben combination one of the most widely used cosmetic preservative systems in the world.
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PHYSICAL CHARACTERISTICS
(Not Necessarily Specifications)
Color White
30% solution Color not darker than APHA20
30% solution Clarity not more than 6.0 NTU
Odor None or characteristically mild
Appearance Fine, free flowing powder
Nitrogen 26.0-28.0%
pH 6.0-7.5(1% aqueous solution)
Loss on drying 3.0% maximum
Residue on Ignition 3.0% maximum
Heavy Metals 10 ppm maximum
Solubility in 100gms solvent
Water 200 grams
Glycerin 95 grams
Methanol 0.01 grams
Ethanol 0.01 grams
Mineral oil <0.01 grams
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TOXICOLOGICAL DATA
Acute oral toxicity LD50 (rats) 5200 mg/kg
Acute dermal toxicity LD50 (rabbits) >8000 mg/kg
Subacute (90 day) oral toxicity (rats) Essentially non-toxic from 6-600 mg/kg
Subacute (21 day) dermal toxicity (rabbits) No evidence of treatment related effects
Primary skin irritation (rabbits) No irritation (5% or 50% aqueous solution). Score of 3.08 (50% aqueous solution on abraded skin only)
Eye irritation (rabbits) No irritation at up to 20% aqueous solution: mild transient irritation with powder
Teratology (mice) Not teratogenic
Acute inhalation toxicity LC50 (rats) Not toxic at test levels to 5 mg/l
Phototoxicity (guinea pigs) Not phototoxic
Sensitization (guinea pigs) Not a sensitizer
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APPLICATIONS
Germall 115 is permanently listed by the European Union (EU) at levels up to 0.6% without restrictions.
Germall 115 is an effective antibacterial preservative in a wide range of liquid and powder type cosmetic products. In combination with the parabens, Germall 115 provides a versatile and complete antimicrobial preservative system that is active against bacteria, yeast and mold.
Germall 115, because of its high water solubility, can be successfully incorporated into cold mix formulations.
The basic system which has proven successful in personal care products is as follows:
Germall 115 0.30%
Methylparaben 0.20%
Propylparaben 0.10%
It must be emphasized that every cosmetic formulation needs a tailor-made preservative system to meet its specific requirements. Every developed or modified product should be challenge tested to assure preservative efficacy. The following systems are typical of preservative combinations currently being used as % of finished product.
Product Germall II Methylparaben Propylparaben
Creams 0.25 0.20 0.10
Lotions 0.40 0.20 0.10
Shampoos 0.25 0.20 0.10
Conditioners 0.25 0.20 0.10
Suntan lotion 0.25 0.10 0.05
Eyeliners 0.25 0.10 0.10
Mascara 0.25 0.15 0.15
Powders-pressed and loose 0.20 0.15 0.15
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GERMALL® II
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DESCRIPTION
INCI ADOPTED NAME: DIAZOLIDINYL UREA
CAS REGISTRY NO: 78491-02-8
MOLECULAR FORMULA: C8H14N4O7
MOLECULAR WEIGHT: 278.23
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PROPERTIES
Germall II is a white, free-flowing hygroscopic powder that is very water soluble. It is compatible with virtually all cosmetic ingredients.
Germall II provides a wide spectrum of antibacterial activity against Gram-positive and Gram-negative organisms, including Pseudomonas species and troublesome "house" organisms and other mutated types. Germall II also provides some protection against yeast and mold.
Germall II is synergistic with other preservative materials, especially methylparaben and propylparaben. This combination is a complete cosmetic preservative system that is effective at protecting well formulated products from bacterial, yeast and mold contamination during product use.
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PHYSICAL CHARACTERISTICS
(Not Necessarily Specifications)
Color White
Odor None or characteristically mild
Appearance Fine, free flowing powder
Nitrogen 19.0-21.0%
Loss on drying 3.0% maximum
Residue on Ignition 3.0% maximum
Heavy Metals 10 ppm maximum
Solubility-in 100gms solvent
Water 230 grams
Glycerin 57 grams
Methanol 0.05 grams
Ethanol 0.01 grams
Isopropyl palmitate 0.01 grams
Mineral oil <0.01 grams
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TOXICOLOGICAL DATA
Acute oral toxicity LD50 (rats) 2570 mg/kg
Acute dermal toxicity LD50 (rabbits) >2000 mg/kg
Subacute (90 day) oral toxicity (rats) No dose related toxic effects at 100 mg
Primary skin irritation (rabbits) Not a primary skin irritant at 5% aqueous solution
Eye irritation (rabbits) Not an eye irritant at 5% aqueous solution
Teratology dermal (rats) Not teratogenic
Teratology oral (rats) Not teratogenic
Mutagenicity
Ames Not mutagenic
Chinese hamster ovary Not mutagenic
Mouse micronucleus Not mutagenic
Rat Hepatocyte/DNA Repair Not mutagenic
Sensitization (guinea pigs) Landsteiner-Jacobs Not a sensitizer
Repeated Insult Patch Test (humans) Not an irritant or contact sensitizer
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APPLICATIONS
Germall II is permanently listed by the EU at levels up to 0.5% without restrictions.
Germall II is safe for both leave-on and rinse-off products and provides effective protection at low concentration levels (0.1-0.3%).
Germall II is an excellent preservative for shampoos and hair conditioners, either alone or in combination with parabens.
Germall II in combination with parabens retains activity against yeast and mold even when paraben effectiveness has been diminished by interaction with nonionics or proteins, or migration into the oil phase.
Germall II is not inactivated by emulsifiers, proteins or other ingredients that affect other preservative materials.
The basic system which has been proven effective in personal care products is as follows:
Germall II 0.20%
Methylparaben 0.20%
Propylparaben 0.10%
Every cosmetic formulation requires a tailormade preservative system to meet its specific needs. Every developed or modified product should be challenge tested to assure preservative efficacy.
The following systems are typical of preservative combinations currently being used as % of finished product:
Product Germall II Methylparaben Propylparaben
Creams 0.25 0.20 0.10
Lotions 0.20 0.20 0.10
Shampoos 0.20 0.10 0.05
Conditioners 0.20 0.20 0.10
Liquid make-up 0.25 0.20 0.10
Eye area products 0.25 0.20 0.10
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GERMALL® PLUS
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DESCRIPTION
INCI ADOPTED NAME:
DIAZOLIDINYL UREA (and)
IODOPROPYNYL BUTYLCARBAMATE
CAS REGISTRY NO:
78491-02-8 (DIAZOLIDINYL UREA)
55406-53-6 (IODOPROPYNYL BUTYLCARBAMATE)
COMPOSITION:
GERMALL II (DIAZOLIDINYL UREA) 98% MIN.
IODOPROPYNYL BUTYLCARBAMATE 2% MAX.
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PROPERTIES
Germall Plus is the newest addition to the Sutton Laboratories preservative line. It is a white, free-flowing hygroscopic powder which is water soluble and compatible with virtually all cosmetic ingredients.
Germall Plus is a unique and cost effective preservative that provides a high level of antimicrobial activity in a wide variety of cosmetic and personal care formulations. This patented combination of Germall II (diazolidinyl urea) and 3-iodo-2-propynyl butyl carbamate (IPBC) has a dual mode of action that achieves a synergistic preservative effect. This action is highly effective in inhibiting the growth of Gram-positive and Gram-negative bacteria and troublesome house organisms, plus yeasts and molds, without the need of additional auxiliary preservatives.
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PHYSICAL CHARACTERISTICS
(Not Necessarily Specifications)
Color White
Odor None or characteristically mild
Appearance Fine, free flowing powder
Nitrogen 19.0-21.0%
Loss on drying 3.0% Maximum
Residue on Ignition 3.0% Maximum
Heavy Metals 10 ppm Maximum
Iodopropynyl Butylcarbamate 2.0% Maximum
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TOXICOLOGICAL DATA
The toxicity assessment of Germall Plus is based on data generated for Germall II and 3-iodo-2-propynylbutylcarbamate (IPBC). Germall II has been extensively evaluated by the Cosmetic Ingredient Review (CIR). CIR is expected to publish a final monograph on IPBC. Both Germall II and IPBC are low in toxicity. Germall II is not teratogenic or embryotoxic by either the dermal or oral route. IPBC was not teratogenic or embryotoxic at 125 mg/kg administered orally. Neither Germall II nor IPBC is considered to be mutagenic by in vivo or in vitro methods. At 1.0% and 0.5% respectively, IPBC and Germall II did not induce contact sensitization. At use concentrations, Germall Plus should be non-irritating to the skin and eyes.
Ingestion/LD50: Germall II, 2570 mg/kg. IPBC, 1470 mg/kg in rats.
Eye: Germall II, at 5.0%, not an irritant. IPBC, at 0.5% not an irritant.
Skin: Germall II, at 5.0%, not an irritant. IPBC, not an irritant at use concentrations.
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APPLICATIONS
The components of Germall Plus are individually listed by the EU - for Germall II at levels up to 0.5% without restrictions; for IPBC provisionally listed at levels up to 0.1% on a 100% basis.
Germall Plus is highly effective at low concentrations and is fully compatible with cationic, anionic, or nonionic surfactants and emulsifiers, a well as proteins. Normal use levels of 0.05-0.2% will preserve even the most complex systems (0.2% is recommended for systems containing a large amount of protein and/or complex ingredients). Germall Plus is safe for both leave-on and rinse-off products. Germall Plus is water soluble. It is also soluble in the emulsified portion of a cream, conditioner, or lotion from room to elevated temperatures. Add at 50-60°C during the cool down stage of processing. Every cosmetic requires a tailor-made preservative system to meet its specific needs. Every newly developed or modified product should be challenge tested to assure preservative efficacy.
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GERMABEN® II
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INCI Name
Propylene Glycol (and) Diazolidinyl Urea (and) Methylparaben (and) Propylparaben
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DESCRIPTION
Germaben II is a liquid preservative system with the following composition:
GERMALL® II (DIAZOLIDINYL UREA) 30%
METHYLPARABEN 11%
PROPYLPARABEN 3%
PROPYLENE GLYCOL 56%
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PROPERTIES
Germaben II is a clear viscous liquid with a characteristic mild odor. It is readily soluble at a level of 1.0% in both aqueous solutions and oil/water emulsions.
Germaben II is a convenient, ready to-use complete antimicrobial preservative system with a broad spectrum of activity. The solubilized combination of Germall II with methylparaben and propylparaben is effective against Gram-positive and Gram-negative bacteria and against yeast and mold.
Germaben II can be used without additional co-preservatives and is compatible with essentially all cosmetic ingredients, including surfactants and proteins.
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PHYSICAL CHARACTERISTICS
(Not Necessarily Specifications)
Color Pale to light yellow (APHA-100 max.)
Odor Characteristically mild
Appearance Clear viscous liquid
Nitrogen 5.8-6.4%
Specific Gravity 1.1731-1.1839
Total Solids 42.5-45.5%
Residue on Ignition 0.50% maximum
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APPLICATIONS
All the components of Germaben II are permanently listed by the EU.
Germaben II is an ideal preservative system for shampoos, hair conditioners and emulsion products. Germaben II minimizes the problems associated with incorporating solid parabens. It dissolves completely in cosmetic formulations at a 1.0% concentration over a wide pH range.
It can be conveniently incorporated into hot or cold processed shampoos and into creams and lotions during their manufacture. The preferred method of addition of Germaben II is to add it slowly to the product with good stirring just prior to the addition of the fragrance. Germaben II has also been successfully used to preserve troublesome formulations containing nonionic surfactants, proteins, soluble collagen, aloe vera extracts and herbal extracts. The broad spectrum of antimicrobiaI activity obtained by the combination of Germall II with methylparaben and propylparaben provides the preservation protection necessary for sophisticated personal care products.
Germaben II is recommended to be used at a level of up to 1.0%. This level provides to the product: 0.30% Germall II, 0.11% methylparaben, 0.03% propylparaben and 0.56% propylene glycol. Shampoos and liquid soaps generally require less than 1.0% Germaben II. Although Germaben II provides excellent antimicrobial preservation, every developed or modified product should be challenge tested to assure preservative efficacy.
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TOXICOLOGICAL DATA
The toxicity of Germaben II is consistent with the expected average of its component parts. Propylene glycol is low in toxicity, but is known to cause minor eye and skin irritation. Methylparaben and propylparaben, alone or in combination, in concentrations >5.0% in propylene glycol are known to cause severe eye and skin irritation. The irritant effect of the Germall II in this mixture is insignificant.
Toxicity profile of Germaben II:
Acute oral toxicity LD50 (rats) >2000 mg/kg
Acute dermal toxicity LD50 (rabbits) >2000 mg/kg
Primary skin irritation (rabbits) Moderate skin irritant. (However, a 1.0% aqueous solution of Germaben II is not a skin irritant)
Eye irritation (rabbits) Severe eye irritant at full strength. (However, a 1.0% aqueous solution of Germaben II is not an eye irritant)
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GERMABEN® II-E
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INCI Name
Propylene Glycol (and) Diazolidinyl Urea (and) Methylparaben (and) Propylparaben
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DESCRIPTION
Germaben II-E is a liquid preservative system with the following composition:
GERMALL® II (DIAZOLIDINYL UREA) 20%
METHYLPARABEN 10%
PROPYLPARABEN 10%
PROPYLENE GLYCOL 60%
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PROPERTIES
Germaben II-E is a clear viscous liquid preservative system with a characteristic mild odor. It is readily soluble at a level of 1.0% in both water/oil and oil/water emulsions, but not in water alone.
Germaben II-E is a solubilized combination of Germall II with methylparaben and propylparaben in propylene glycol. It is a complete broad spectrum antimicrobial preservative system that is effective against Gram-positive and Gram-negative bacteria and against yeast and mold.
Germaben II-E was developed for creams and lotions that present special preservation problems involving partial inactivation of parabens by ingredients in the formulation. Germaben II-E can be used in problem formulations without the need for additional co-preservatives. It is compatible with almost all cosmetic ingredients, including surfactants and proteins.
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PHYSICAL CHARACTERISTICS
(Not necessarily Specifications)
Color Pale to light yellow (APHA-100 max.)
Odor Characteristically mild
Appearance Clear viscous liquid
Nitrogen 3.8-4.4%
Specific Gravity 1.1353-1.1438
Total Solids 38.5-41.5%
Residue on Ignition 0.50% maximum
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APPLICATIONS
All the components of Germaben II-E are permanently listed by the EU. Germaben II-E is a complete preservative system, in clear liquid form, that was developed especially for cosmetic creams and lotions that present preservation problems caused by the presence of paraben inactivating materials.
Germaben II-E includes a total concentration of 20% parabens predissolved in propylene glycol for easy and convenient addition to cosmetic formulations. It minimizes the difficulties associated with incorporating solid parabens.
Germaben II-E can be conveniently incorporated into hot or cold processed shampoos, creams and lotions during their manufacture. The preferred method of addition is to add it slowly to the cosmetic formulation with good stirring after emulsification and just prior to the addition of fragrance. In fact, some fragrance materials are most effectively incorporated into cosmetics by predissolving them in Germaben II-E and then adding the mixture slowly to the finished formulation.
Germaben II-E is recommended to be used at a level of 1.0%. This level provides to the product: 0.20% Germall II, 0.10% methylparaben, 0.10% propylparaben and 0.60% propylene glycol. Although Germaben II-E provides excellent antimicrobial preservation, every developed or modified product should be challenge tested to assure preservative efficacy.
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TOXICOLOGICAL DATA
The toxicity of Germaben II-E is consistent with the expected average of its component parts. Propylene glycol is low in toxicity, but is known to cause minor eye and skin irritation. Methylparaben and propylparaben, alone or in combination, in concentrations >5.0% in propylene glycol are known to cause severe eye and skin irritation. The irritant affect of the Germall II in this mixture is insignificant. (Refer to the toxicological data for Germaben II, particularly eye and skin irritation.)
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SUTTOCIDE® A
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DESCRIPTION
INCI ADOPTED NAME: SODIUM HYDROXYMETHYLGLYCINATE
CAS REGISTRY NO: 7732-18-5
MOLECULAR FORMULA: C3H6NO3Na
MOLECULAR WEIGHT: 127.10
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PROPERTIES
Suttocide A is sold as a 50% aqueous solution of sodium hydroxymethylglycinate. The solution is a clear alkaline liquid with a mild characteristic odor.
This single preservative is a broad spectrum antimicrobial that is active against Gram-negative and Gram-positive bacteria, yeast and mold, even at low concentrations, providing cost-effective preservation.
Suttocide A remains active at a pH as high as 12, and can be used in acidic conditions as low as pH 3.5, giving the formulator very broad flexibility as well as allowing adequate preservation of alkaline products.
Suttocide A can also be used to neutralize acidic compounds, without any loss of antimicrobial activity.
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PHYSICAL CHARACTERISTICS
(Not necessarily Specifications)
Color Colorless to light yellow
Odor Characteristically mild
Appearance Clear liquid
Nitrogen 5.40-5.75%
Specific Gravity 1.28-1.30
Total Solids 49.0-52.0%
pH 10.0-12.0
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TOXICOLOGICAL DATA
Acute oral toxicity LD50 (rats) 1070 mg/kg (Knudsen and Curtis method)
1410 mg/kg (Litchfield and Wilcoxon method)
Acute dermal toxicity LD50 (rabbits) >2000 mg/kg
Primary skin irritation (rabbits) Suttocide A is not considered to be a primary skin irritant even though it is strongly alkaline
Primary skin irritation (guinea pigs) Not a skin irritant
Repeat exposure skin irritation test(guinea pigs) Not a skin irritant
Eye irritation (rabbits) Moderately irritating at full strength. A 5% test solution followed by a water rinse was non-irritating
Subacute (90 day) oral toxicity (rats) No cumulative toxicity potential when tested up to 160 mg/kg/day
Mutagenicity
Ames Not mutagenic
Mouse micronucleus Not mutagenic
Rat Hepatocyte/DNA Repair Not mutagenic
Sensitization (guinea pigs) Not a contact sensitizer
Modified Buehler topical Not a contact sensitizer at 0.5%
Magnusson-Kligman
maximization Induction at 5% concentration and challenge with 50% Maximization concentration produced erythema. A challenge with a 5% concentration produced very slight erythema. A slight potential for sensitization under these highly exaggerated test conditions
Teratology, oral (rats) Not teratogenic
Repeated Insult Patch Test (humans) Not an irritant or contact sensitizer
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APPLICATIONS
Suttocide A is permanently listed by the EU at levels up to 0.5% active without restrictions.
Suttocide A is a broad spectrum antimicrobial for use in shampoos and conditioners, when used at 0.1-0.2% (as supplied). This provides a safe and cost effective preservative system.
Suttocide A is sold as a pH 10-12 aqueous solution and can be used to react with Stabileze® 06 or to neutralize carbomer to form stable clear gels without losing its antimicrobial activity. Suttocide A is synergistic with other preservatives. Suttocide A in combination with LiquaPar® Oil is particularly effective for preserving complex formulations.
Suttocide A is stable and active up to pH 12 and can also be used in acidic conditions as low as 3.5, giving the formulator very broad pH flexibility as well as being able to adequately preserve alkaline products, e.g. soap bars.
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LIQUAPAR® OIL
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DESCRIPTION
CHEMICAL NAME: A 100% active blend of Isopropyl, Isobutyl and n-Butyl esters of p-Hydroxybenzoic acid
INCI ADOPTED NAME: ISOPROPYLPARABEN (and) ISOBUTYLPARABEN (and) BUTYLPARABEN
CAS REGISTRY NO: 4191-73-5
4247-02-3/94-26-8
EU: Permanently listed up to 0.8% without restriction
JAPAN: Permitted up to a maximum total paraben concentration of 1.0%
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PROPERTIES
LiquaPar Oil is a 100% active, clear, stable, liquid blend of isopropyl, isobutyl and n-butyl esters of para hydroxybenzoic acid. This unique combination of parabens is a very effective preservative against Gram-positive and Gram-negative bacteria, yeast and mold, even at low concentrations. The higher alkyl esters present in LiquaPar Oil, are not only more active, but are also more stable and resistant to hydrolysis than traditional lower alkyl powder parabens.
LiquaPar Oil minimizes problems of grittiness or crystallization often associated with the use of individual powder parabens and it can be readily incorporated into many types of cosmetic formulations without heating. Studies indicate that many fragrances are miscible in LiquaPar Oil thereby facilitating their incorporation into finished products.
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PHYSICAL CHARACTERISTICS
(Not Necessarily Specifications)
Assay (HPLC %) ca 40% Isopropylparaben
ca 30% Isobutylparaben
ca 30% n-Butylparaben
Color (APHA) 250 maximum
Odor Characteristically mild
Appearance Clear viscous yellow liquid
Specific Gravity @ 25°C 1.103
pH (as is) 5-8
Cloud point Remains clear down to -12°C
Boiling point(°C) 268
Saponification Value (mg KOH/g) 292-296
Residue on ignition 0.3%
Refractive Index (@ 25°C) 1.53
Acid value 0.5% maximum
Heavy Metals (UPS Method II) 20 ppm
Viscosity
@ 25°C (Brookfield LVT)
@ 45°C 6450 cps
460 cps
Solubility
SOLVENT LIQUAPAR OIL (%)
Methanol Completely Miscible
Propylene Glycol Completely Miscible
Glycerin 0.8
1,3-Butylene Glycol >1
Castor Oil >1
Soybean Oil >1
C12-16 Alkyl Benzoate >1
Isopropyl Myristate >1
Lanolin Oil >1
Mineral Oil <0.1
Hydrogenated Polybutenes <0.1
Petroleum Distillates <0.1
Water (10°C) <0.1
Water (25°C) <0.1
Water (80°C) <0.1
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TOXICOLOGICAL DATA
Acute oral toxicity >5000 mg/kg
Primary dermal irritation (rabbits) Minimun irritant (l00% active concentration)
Primary eye irritation (rabbits) Severe eye irritant (l00% active concentration)
Delayed Contact Hypersensitivity(guinea pigs) No positive reactions (2% active concentration)
Repeated Insult Patch Test (humans) Not a contact sensitizer (50% emulsion)
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APPLICATIONS
LiquaPar Oil is an active blend of parabens, useful in a wide range of cosmetic formulations including anyhydrous systems. LiquaPar Oil effectively preserves most products when used at concentrations of 0.3-0.6%.
For complex formulations, a dual preservation system consisting of 0.4% LiquaPar Oil in combination with 0.2% EDTA and/or 0.1% Germall II has been found to be particularly effective.
Every cosmetic formulation requires a tailor-made preservative system to meet its specific needs. Therefore every newly developed or modified product should be challenge tested to assure preservative efficacy.
For best results, LiquaPar Oil should be added after emulsification, just prior to the addition of the fragrance.
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LIQUAPAR® PE
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DESCRIPTION
INCI ADOPTED NAME: PHENOXYETHANOL (and)
ISOPROPYLPARABEN (and)
ISOBUTYLPARABEN (and)
BUTYLPARABEN
CAS REGISTRY NO: 122-99-6/4191-73-5/ 4247-02-3/94-26-8
CHEMICAL COMPOSITION: LIQUAPAR OIL
(ISOPROPYLPARABEN, ISOBUTYLPARABEN,
BUTYLPARABEN) 30%
PHENOXYETHANOL 70%
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PROPERTIES
LiquaPar PE is a 100% active, clear, stable, liquid blend of isopropyl, isobutyl, and n-butyl esters of para hydroxybenzoic acid with phenoxyethanol. This combination of parabens and phenoxyethanol is effective against Gram-negative and Gram-positive bacteria, yeast, and mold providing broad spectrum activity for worldwide formulations.
The potentiator effect of phenoxyethanol facilitates use of the LiquaPar Oil technology in nonionic emulsion systems where paraben efficacy might otherwise be compromised.
All LiquaPar PE components are approved for worldwide use thus allowing sale of the same finished formulation in Japan, Europe, Australia and the United States.
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APPLICATIONS
LiquaPar PE is an active blend of parabens and phenoxyethanol useful in a wide range of cosmetic formulations including anhydrous systems. The potentiating effect of phenoxyethanol combined with the highly effective paraben blend provides an effective preservative system for even difficult to preserve nonionic emulsions. In most systems LiquaPar PE should be incorporated at a concentration of 1.0% by weight of the finished formulation.
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PHYSICAL CHARACTERISTICS
(Not necessarily Specifications)
Assay (GC area %) Isopropylparaben 11-13
Isobutylparaben 9-11
Butylparaben 9-11
Phenoxyethanol 65-70
Appearance Clear, colorless to pale yellow liquid
Color (APHA) 200 Maximum
Specific Gravity 1.08-1.12
SOLUBILITY
SOLVENT LIQUAPAR PE (%)
Water <0.1
10% Ethanol/90% Water 0.2
Propylene Glycol Miscible
1.3 Butylene Glycol Miscible
Glycerin 4.0
Isopropyl Myristate Miscible
Octyl Palmitate Miscible
Sesame Oil Miscible
Dimethicone <0.3
Cyclomethicone <0.1
Mineral Oil <0.1
Sodium Lauryl Sulfate (28-30% solids) 1.0
TEA Lauryl Sulfate (40% solids) 1.0
For more complex formulations, a dual preservation system of 1.0% LiquaPar PE in combination with 0.2% ethylenediaminetetra-acetic acid salt (EDTA) has proven effective.
In emulsion systems, LiquaPar PE should be added after emulsification while the product remains at emulsification temperature. For hot mixed systems, add LiquaPar PE early in the process to allow adequate mixing time.
Although phenoxyethanol is slightly volatile, LiquaPar PE is stable at temperatures up to 85°C. For cold mixed systems, add LiquaPar PE early in the process to allow for adequate mixing.
Every cosmetic formulation requires a specific preservative system to meet its individual needs. Therefore, every newly developed or modified product should be challenge tested to assure preservative efficacy.
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TOXICOLOGICAL DATA
The toxicity assessment of LiquaPar PE is based on data generated for LiquaPar Oil (LPO), the individual paraben esters and phenoxyethanol (PE). PE and the paraben esters have been extensively evaluated by the Cosmetic Ingredient Review (CIR). Both LPO and PF are low in toxicity. The undiluted chemicals will be strong eye irritants and moderate skin irritants. In dermal studies, neither the paraben esters nor PE are teratogenic, embryotoxic or mutagenic. PE is not a sensitizer. As a 50% concentration in an emulsion base, LPO did not induce contact sensitization by Repeated Insult Patch Test.
At use levels, LiquaPar PE will be non-irritating to skin and eyes and is not expected to be a sensitizer.
Ingestion/LD50: LP0, >5000 mg/kg. PE, 1300 mg/kg in male rats, 2300 mg/kg in female rats.
Eyes: LPO, at 1.0%, not an irritant. PE, at 2.2%, not an irritant.
Skin: LPO, at 100%, minimal irritation. PE, at 2.0%, a slight irritant.
Preservatives for Personal Care
Cosmetics
Cosmetics are substances especially prepared to improve, beautify and generally increase the attractiveness of the person. The use of cosmetics is an ancient practice and the continued popularity of these products today has made cosmetics a major industry in many parts of the world.
It is probable that cosmetics had their origin in China, but it is necessary to turn to Egypt for the source of the earliest records of cosmetic substances and their application. During the Thinite dynasty (c.3000 BC) it was customary to bury comforts and luxuries with the dead kings. The opening of the tomb of Tutankhamen who ruled c.1350 BC has brought to light many interesting specimens of cosmetics.
At this period it is probable that the priests made most of these compounds and their manufacture was considered a mysterious and much honored art. Cosmetics were used by Egyptian ladies who enhanced their personal beauty by using somewhat crude paints. Such painting reached its peak in the time of Cleopatra. The effects achieved were not unlike some fashions in eye make-up in the late 20th century.
Preservation-The Problem
Preservation of that which is good, pure and unspoiled has in reality been an unattainable goal since Egyptian times. Preservation of cosmetics and toiletries is a problem stated simple enough - a chemical must be identified that is non-toxic, non irritating and able to destroy or inhibit the growth of microorganisms (bacteria, yeast and mold) capable of spoiling the finished product until it is consumed. The problem is compounded when considering factors such as the stability of the preservative over a broad range of pH and temperature conditions together with chemical compatibility demands in the final formulation.
Microbial inhibition itself has not been the problem. There are many products that can inhibit bacterial and fungal growth. It is in the context of allergenicity and irritancy that the difficulties arise - the safety of the consumer is paramount.
The Solution - Sutton Laboratories
Sutton Laboratories, a division of International Specialty Products, are world leaders in preservative technology. Sutton have developed a range of preservatives and preservative systems that are not only non-toxic, compatible with most cosmetic ingredients, and non sensitizing but also provide the ultimate solution-safe microbiological protection. Sutton invented Germall® 115, a preservative introduced to the cosmetic industry that was effective against Gram-negative bacteria, safe for cosmetic use and compatible with other cosmetic ingredients.
The combination of Germall® 115 with parabens rapidly became one of the most widely used preservative systems in the world. Sutton, also invented Germall® II, a superior member of the substituted imidazolidinyl urea family of compounds. Germall® II has a wider spectrum of activity and better performance when compared to Germall® 115. Sutton incorporated Germall® II into a series of products under the Germaben® tradename giving preservative systems that have exceptional convenience in handling and offer significant cost savings.
Sutton continue their vigorous research program of developing safe and effective biocides for the cosmetic industry. A new antimicrobial, Suttocide® A with unique properties has recently been developed particularly for use in haircare formulations.
Sutton Laboratories, producing quality products that solve today's preservation problems.
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GERMALL® 115
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DESCRIPTION
INCI ADOPTED NAME: IMIDAZOLIDINYL UREA
USP/NF DESIGNATION: IMIDUREA, NF
CAS REGISTRY NO: 39236-46-9
MOLECULAR FORMULA: C11H16N8. H2O
MOLECULAR WEIGHT: 406.33
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PROPERTIES
Germall 115 is a white, free-flowing hygroscopic powder that is very soluble in water. It is compatible with essentially all cosmetic ingredients, including surfactants, proteins, and other special ingredients.
Germall 115 is very effective against Gram-negative bacteria, including Pseudomonas aeruginosa.
Germall 115 acts synergistically with other preservatives. With the parabens it provides a broad spectrum of activity against bacteria, yeast and mold. This synergistic activity has made the Germall 115 paraben combination one of the most widely used cosmetic preservative systems in the world.
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PHYSICAL CHARACTERISTICS
(Not Necessarily Specifications)
Color White
30% solution Color not darker than APHA20
30% solution Clarity not more than 6.0 NTU
Odor None or characteristically mild
Appearance Fine, free flowing powder
Nitrogen 26.0-28.0%
pH 6.0-7.5(1% aqueous solution)
Loss on drying 3.0% maximum
Residue on Ignition 3.0% maximum
Heavy Metals 10 ppm maximum
Solubility in 100gms solvent
Water 200 grams
Glycerin 95 grams
Methanol 0.01 grams
Ethanol 0.01 grams
Mineral oil <0.01 grams
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TOXICOLOGICAL DATA
Acute oral toxicity LD50 (rats) 5200 mg/kg
Acute dermal toxicity LD50 (rabbits) >8000 mg/kg
Subacute (90 day) oral toxicity (rats) Essentially non-toxic from 6-600 mg/kg
Subacute (21 day) dermal toxicity (rabbits) No evidence of treatment related effects
Primary skin irritation (rabbits) No irritation (5% or 50% aqueous solution). Score of 3.08 (50% aqueous solution on abraded skin only)
Eye irritation (rabbits) No irritation at up to 20% aqueous solution: mild transient irritation with powder
Teratology (mice) Not teratogenic
Acute inhalation toxicity LC50 (rats) Not toxic at test levels to 5 mg/l
Phototoxicity (guinea pigs) Not phototoxic
Sensitization (guinea pigs) Not a sensitizer
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APPLICATIONS
Germall 115 is permanently listed by the European Union (EU) at levels up to 0.6% without restrictions.
Germall 115 is an effective antibacterial preservative in a wide range of liquid and powder type cosmetic products. In combination with the parabens, Germall 115 provides a versatile and complete antimicrobial preservative system that is active against bacteria, yeast and mold.
Germall 115, because of its high water solubility, can be successfully incorporated into cold mix formulations.
The basic system which has proven successful in personal care products is as follows:
Germall 115 0.30%
Methylparaben 0.20%
Propylparaben 0.10%
It must be emphasized that every cosmetic formulation needs a tailor-made preservative system to meet its specific requirements. Every developed or modified product should be challenge tested to assure preservative efficacy. The following systems are typical of preservative combinations currently being used as % of finished product.
Product Germall II Methylparaben Propylparaben
Creams 0.25 0.20 0.10
Lotions 0.40 0.20 0.10
Shampoos 0.25 0.20 0.10
Conditioners 0.25 0.20 0.10
Suntan lotion 0.25 0.10 0.05
Eyeliners 0.25 0.10 0.10
Mascara 0.25 0.15 0.15
Powders-pressed and loose 0.20 0.15 0.15
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GERMALL® II
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DESCRIPTION
INCI ADOPTED NAME: DIAZOLIDINYL UREA
CAS REGISTRY NO: 78491-02-8
MOLECULAR FORMULA: C8H14N4O7
MOLECULAR WEIGHT: 278.23
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PROPERTIES
Germall II is a white, free-flowing hygroscopic powder that is very water soluble. It is compatible with virtually all cosmetic ingredients.
Germall II provides a wide spectrum of antibacterial activity against Gram-positive and Gram-negative organisms, including Pseudomonas species and troublesome "house" organisms and other mutated types. Germall II also provides some protection against yeast and mold.
Germall II is synergistic with other preservative materials, especially methylparaben and propylparaben. This combination is a complete cosmetic preservative system that is effective at protecting well formulated products from bacterial, yeast and mold contamination during product use.
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PHYSICAL CHARACTERISTICS
(Not Necessarily Specifications)
Color White
Odor None or characteristically mild
Appearance Fine, free flowing powder
Nitrogen 19.0-21.0%
Loss on drying 3.0% maximum
Residue on Ignition 3.0% maximum
Heavy Metals 10 ppm maximum
Solubility-in 100gms solvent
Water 230 grams
Glycerin 57 grams
Methanol 0.05 grams
Ethanol 0.01 grams
Isopropyl palmitate 0.01 grams
Mineral oil <0.01 grams
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TOXICOLOGICAL DATA
Acute oral toxicity LD50 (rats) 2570 mg/kg
Acute dermal toxicity LD50 (rabbits) >2000 mg/kg
Subacute (90 day) oral toxicity (rats) No dose related toxic effects at 100 mg
Primary skin irritation (rabbits) Not a primary skin irritant at 5% aqueous solution
Eye irritation (rabbits) Not an eye irritant at 5% aqueous solution
Teratology dermal (rats) Not teratogenic
Teratology oral (rats) Not teratogenic
Mutagenicity
Ames Not mutagenic
Chinese hamster ovary Not mutagenic
Mouse micronucleus Not mutagenic
Rat Hepatocyte/DNA Repair Not mutagenic
Sensitization (guinea pigs) Landsteiner-Jacobs Not a sensitizer
Repeated Insult Patch Test (humans) Not an irritant or contact sensitizer
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APPLICATIONS
Germall II is permanently listed by the EU at levels up to 0.5% without restrictions.
Germall II is safe for both leave-on and rinse-off products and provides effective protection at low concentration levels (0.1-0.3%).
Germall II is an excellent preservative for shampoos and hair conditioners, either alone or in combination with parabens.
Germall II in combination with parabens retains activity against yeast and mold even when paraben effectiveness has been diminished by interaction with nonionics or proteins, or migration into the oil phase.
Germall II is not inactivated by emulsifiers, proteins or other ingredients that affect other preservative materials.
The basic system which has been proven effective in personal care products is as follows:
Germall II 0.20%
Methylparaben 0.20%
Propylparaben 0.10%
Every cosmetic formulation requires a tailormade preservative system to meet its specific needs. Every developed or modified product should be challenge tested to assure preservative efficacy.
The following systems are typical of preservative combinations currently being used as % of finished product:
Product Germall II Methylparaben Propylparaben
Creams 0.25 0.20 0.10
Lotions 0.20 0.20 0.10
Shampoos 0.20 0.10 0.05
Conditioners 0.20 0.20 0.10
Liquid make-up 0.25 0.20 0.10
Eye area products 0.25 0.20 0.10
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GERMALL® PLUS
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DESCRIPTION
INCI ADOPTED NAME:
DIAZOLIDINYL UREA (and)
IODOPROPYNYL BUTYLCARBAMATE
CAS REGISTRY NO:
78491-02-8 (DIAZOLIDINYL UREA)
55406-53-6 (IODOPROPYNYL BUTYLCARBAMATE)
COMPOSITION:
GERMALL II (DIAZOLIDINYL UREA) 98% MIN.
IODOPROPYNYL BUTYLCARBAMATE 2% MAX.
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PROPERTIES
Germall Plus is the newest addition to the Sutton Laboratories preservative line. It is a white, free-flowing hygroscopic powder which is water soluble and compatible with virtually all cosmetic ingredients.
Germall Plus is a unique and cost effective preservative that provides a high level of antimicrobial activity in a wide variety of cosmetic and personal care formulations. This patented combination of Germall II (diazolidinyl urea) and 3-iodo-2-propynyl butyl carbamate (IPBC) has a dual mode of action that achieves a synergistic preservative effect. This action is highly effective in inhibiting the growth of Gram-positive and Gram-negative bacteria and troublesome house organisms, plus yeasts and molds, without the need of additional auxiliary preservatives.
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PHYSICAL CHARACTERISTICS
(Not Necessarily Specifications)
Color White
Odor None or characteristically mild
Appearance Fine, free flowing powder
Nitrogen 19.0-21.0%
Loss on drying 3.0% Maximum
Residue on Ignition 3.0% Maximum
Heavy Metals 10 ppm Maximum
Iodopropynyl Butylcarbamate 2.0% Maximum
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TOXICOLOGICAL DATA
The toxicity assessment of Germall Plus is based on data generated for Germall II and 3-iodo-2-propynylbutylcarbamate (IPBC). Germall II has been extensively evaluated by the Cosmetic Ingredient Review (CIR). CIR is expected to publish a final monograph on IPBC. Both Germall II and IPBC are low in toxicity. Germall II is not teratogenic or embryotoxic by either the dermal or oral route. IPBC was not teratogenic or embryotoxic at 125 mg/kg administered orally. Neither Germall II nor IPBC is considered to be mutagenic by in vivo or in vitro methods. At 1.0% and 0.5% respectively, IPBC and Germall II did not induce contact sensitization. At use concentrations, Germall Plus should be non-irritating to the skin and eyes.
Ingestion/LD50: Germall II, 2570 mg/kg. IPBC, 1470 mg/kg in rats.
Eye: Germall II, at 5.0%, not an irritant. IPBC, at 0.5% not an irritant.
Skin: Germall II, at 5.0%, not an irritant. IPBC, not an irritant at use concentrations.
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APPLICATIONS
The components of Germall Plus are individually listed by the EU - for Germall II at levels up to 0.5% without restrictions; for IPBC provisionally listed at levels up to 0.1% on a 100% basis.
Germall Plus is highly effective at low concentrations and is fully compatible with cationic, anionic, or nonionic surfactants and emulsifiers, a well as proteins. Normal use levels of 0.05-0.2% will preserve even the most complex systems (0.2% is recommended for systems containing a large amount of protein and/or complex ingredients). Germall Plus is safe for both leave-on and rinse-off products. Germall Plus is water soluble. It is also soluble in the emulsified portion of a cream, conditioner, or lotion from room to elevated temperatures. Add at 50-60°C during the cool down stage of processing. Every cosmetic requires a tailor-made preservative system to meet its specific needs. Every newly developed or modified product should be challenge tested to assure preservative efficacy.
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GERMABEN® II
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INCI Name
Propylene Glycol (and) Diazolidinyl Urea (and) Methylparaben (and) Propylparaben
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DESCRIPTION
Germaben II is a liquid preservative system with the following composition:
GERMALL® II (DIAZOLIDINYL UREA) 30%
METHYLPARABEN 11%
PROPYLPARABEN 3%
PROPYLENE GLYCOL 56%
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PROPERTIES
Germaben II is a clear viscous liquid with a characteristic mild odor. It is readily soluble at a level of 1.0% in both aqueous solutions and oil/water emulsions.
Germaben II is a convenient, ready to-use complete antimicrobial preservative system with a broad spectrum of activity. The solubilized combination of Germall II with methylparaben and propylparaben is effective against Gram-positive and Gram-negative bacteria and against yeast and mold.
Germaben II can be used without additional co-preservatives and is compatible with essentially all cosmetic ingredients, including surfactants and proteins.
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PHYSICAL CHARACTERISTICS
(Not Necessarily Specifications)
Color Pale to light yellow (APHA-100 max.)
Odor Characteristically mild
Appearance Clear viscous liquid
Nitrogen 5.8-6.4%
Specific Gravity 1.1731-1.1839
Total Solids 42.5-45.5%
Residue on Ignition 0.50% maximum
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APPLICATIONS
All the components of Germaben II are permanently listed by the EU.
Germaben II is an ideal preservative system for shampoos, hair conditioners and emulsion products. Germaben II minimizes the problems associated with incorporating solid parabens. It dissolves completely in cosmetic formulations at a 1.0% concentration over a wide pH range.
It can be conveniently incorporated into hot or cold processed shampoos and into creams and lotions during their manufacture. The preferred method of addition of Germaben II is to add it slowly to the product with good stirring just prior to the addition of the fragrance. Germaben II has also been successfully used to preserve troublesome formulations containing nonionic surfactants, proteins, soluble collagen, aloe vera extracts and herbal extracts. The broad spectrum of antimicrobiaI activity obtained by the combination of Germall II with methylparaben and propylparaben provides the preservation protection necessary for sophisticated personal care products.
Germaben II is recommended to be used at a level of up to 1.0%. This level provides to the product: 0.30% Germall II, 0.11% methylparaben, 0.03% propylparaben and 0.56% propylene glycol. Shampoos and liquid soaps generally require less than 1.0% Germaben II. Although Germaben II provides excellent antimicrobial preservation, every developed or modified product should be challenge tested to assure preservative efficacy.
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TOXICOLOGICAL DATA
The toxicity of Germaben II is consistent with the expected average of its component parts. Propylene glycol is low in toxicity, but is known to cause minor eye and skin irritation. Methylparaben and propylparaben, alone or in combination, in concentrations >5.0% in propylene glycol are known to cause severe eye and skin irritation. The irritant effect of the Germall II in this mixture is insignificant.
Toxicity profile of Germaben II:
Acute oral toxicity LD50 (rats) >2000 mg/kg
Acute dermal toxicity LD50 (rabbits) >2000 mg/kg
Primary skin irritation (rabbits) Moderate skin irritant. (However, a 1.0% aqueous solution of Germaben II is not a skin irritant)
Eye irritation (rabbits) Severe eye irritant at full strength. (However, a 1.0% aqueous solution of Germaben II is not an eye irritant)
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GERMABEN® II-E
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INCI Name
Propylene Glycol (and) Diazolidinyl Urea (and) Methylparaben (and) Propylparaben
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DESCRIPTION
Germaben II-E is a liquid preservative system with the following composition:
GERMALL® II (DIAZOLIDINYL UREA) 20%
METHYLPARABEN 10%
PROPYLPARABEN 10%
PROPYLENE GLYCOL 60%
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PROPERTIES
Germaben II-E is a clear viscous liquid preservative system with a characteristic mild odor. It is readily soluble at a level of 1.0% in both water/oil and oil/water emulsions, but not in water alone.
Germaben II-E is a solubilized combination of Germall II with methylparaben and propylparaben in propylene glycol. It is a complete broad spectrum antimicrobial preservative system that is effective against Gram-positive and Gram-negative bacteria and against yeast and mold.
Germaben II-E was developed for creams and lotions that present special preservation problems involving partial inactivation of parabens by ingredients in the formulation. Germaben II-E can be used in problem formulations without the need for additional co-preservatives. It is compatible with almost all cosmetic ingredients, including surfactants and proteins.
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PHYSICAL CHARACTERISTICS
(Not necessarily Specifications)
Color Pale to light yellow (APHA-100 max.)
Odor Characteristically mild
Appearance Clear viscous liquid
Nitrogen 3.8-4.4%
Specific Gravity 1.1353-1.1438
Total Solids 38.5-41.5%
Residue on Ignition 0.50% maximum
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APPLICATIONS
All the components of Germaben II-E are permanently listed by the EU. Germaben II-E is a complete preservative system, in clear liquid form, that was developed especially for cosmetic creams and lotions that present preservation problems caused by the presence of paraben inactivating materials.
Germaben II-E includes a total concentration of 20% parabens predissolved in propylene glycol for easy and convenient addition to cosmetic formulations. It minimizes the difficulties associated with incorporating solid parabens.
Germaben II-E can be conveniently incorporated into hot or cold processed shampoos, creams and lotions during their manufacture. The preferred method of addition is to add it slowly to the cosmetic formulation with good stirring after emulsification and just prior to the addition of fragrance. In fact, some fragrance materials are most effectively incorporated into cosmetics by predissolving them in Germaben II-E and then adding the mixture slowly to the finished formulation.
Germaben II-E is recommended to be used at a level of 1.0%. This level provides to the product: 0.20% Germall II, 0.10% methylparaben, 0.10% propylparaben and 0.60% propylene glycol. Although Germaben II-E provides excellent antimicrobial preservation, every developed or modified product should be challenge tested to assure preservative efficacy.
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TOXICOLOGICAL DATA
The toxicity of Germaben II-E is consistent with the expected average of its component parts. Propylene glycol is low in toxicity, but is known to cause minor eye and skin irritation. Methylparaben and propylparaben, alone or in combination, in concentrations >5.0% in propylene glycol are known to cause severe eye and skin irritation. The irritant affect of the Germall II in this mixture is insignificant. (Refer to the toxicological data for Germaben II, particularly eye and skin irritation.)
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SUTTOCIDE® A
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DESCRIPTION
INCI ADOPTED NAME: SODIUM HYDROXYMETHYLGLYCINATE
CAS REGISTRY NO: 7732-18-5
MOLECULAR FORMULA: C3H6NO3Na
MOLECULAR WEIGHT: 127.10
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PROPERTIES
Suttocide A is sold as a 50% aqueous solution of sodium hydroxymethylglycinate. The solution is a clear alkaline liquid with a mild characteristic odor.
This single preservative is a broad spectrum antimicrobial that is active against Gram-negative and Gram-positive bacteria, yeast and mold, even at low concentrations, providing cost-effective preservation.
Suttocide A remains active at a pH as high as 12, and can be used in acidic conditions as low as pH 3.5, giving the formulator very broad flexibility as well as allowing adequate preservation of alkaline products.
Suttocide A can also be used to neutralize acidic compounds, without any loss of antimicrobial activity.
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PHYSICAL CHARACTERISTICS
(Not necessarily Specifications)
Color Colorless to light yellow
Odor Characteristically mild
Appearance Clear liquid
Nitrogen 5.40-5.75%
Specific Gravity 1.28-1.30
Total Solids 49.0-52.0%
pH 10.0-12.0
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TOXICOLOGICAL DATA
Acute oral toxicity LD50 (rats) 1070 mg/kg (Knudsen and Curtis method)
1410 mg/kg (Litchfield and Wilcoxon method)
Acute dermal toxicity LD50 (rabbits) >2000 mg/kg
Primary skin irritation (rabbits) Suttocide A is not considered to be a primary skin irritant even though it is strongly alkaline
Primary skin irritation (guinea pigs) Not a skin irritant
Repeat exposure skin irritation test(guinea pigs) Not a skin irritant
Eye irritation (rabbits) Moderately irritating at full strength. A 5% test solution followed by a water rinse was non-irritating
Subacute (90 day) oral toxicity (rats) No cumulative toxicity potential when tested up to 160 mg/kg/day
Mutagenicity
Ames Not mutagenic
Mouse micronucleus Not mutagenic
Rat Hepatocyte/DNA Repair Not mutagenic
Sensitization (guinea pigs) Not a contact sensitizer
Modified Buehler topical Not a contact sensitizer at 0.5%
Magnusson-Kligman
maximization Induction at 5% concentration and challenge with 50% Maximization concentration produced erythema. A challenge with a 5% concentration produced very slight erythema. A slight potential for sensitization under these highly exaggerated test conditions
Teratology, oral (rats) Not teratogenic
Repeated Insult Patch Test (humans) Not an irritant or contact sensitizer
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APPLICATIONS
Suttocide A is permanently listed by the EU at levels up to 0.5% active without restrictions.
Suttocide A is a broad spectrum antimicrobial for use in shampoos and conditioners, when used at 0.1-0.2% (as supplied). This provides a safe and cost effective preservative system.
Suttocide A is sold as a pH 10-12 aqueous solution and can be used to react with Stabileze® 06 or to neutralize carbomer to form stable clear gels without losing its antimicrobial activity. Suttocide A is synergistic with other preservatives. Suttocide A in combination with LiquaPar® Oil is particularly effective for preserving complex formulations.
Suttocide A is stable and active up to pH 12 and can also be used in acidic conditions as low as 3.5, giving the formulator very broad pH flexibility as well as being able to adequately preserve alkaline products, e.g. soap bars.
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LIQUAPAR® OIL
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DESCRIPTION
CHEMICAL NAME: A 100% active blend of Isopropyl, Isobutyl and n-Butyl esters of p-Hydroxybenzoic acid
INCI ADOPTED NAME: ISOPROPYLPARABEN (and) ISOBUTYLPARABEN (and) BUTYLPARABEN
CAS REGISTRY NO: 4191-73-5
4247-02-3/94-26-8
EU: Permanently listed up to 0.8% without restriction
JAPAN: Permitted up to a maximum total paraben concentration of 1.0%
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PROPERTIES
LiquaPar Oil is a 100% active, clear, stable, liquid blend of isopropyl, isobutyl and n-butyl esters of para hydroxybenzoic acid. This unique combination of parabens is a very effective preservative against Gram-positive and Gram-negative bacteria, yeast and mold, even at low concentrations. The higher alkyl esters present in LiquaPar Oil, are not only more active, but are also more stable and resistant to hydrolysis than traditional lower alkyl powder parabens.
LiquaPar Oil minimizes problems of grittiness or crystallization often associated with the use of individual powder parabens and it can be readily incorporated into many types of cosmetic formulations without heating. Studies indicate that many fragrances are miscible in LiquaPar Oil thereby facilitating their incorporation into finished products.
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PHYSICAL CHARACTERISTICS
(Not Necessarily Specifications)
Assay (HPLC %) ca 40% Isopropylparaben
ca 30% Isobutylparaben
ca 30% n-Butylparaben
Color (APHA) 250 maximum
Odor Characteristically mild
Appearance Clear viscous yellow liquid
Specific Gravity @ 25°C 1.103
pH (as is) 5-8
Cloud point Remains clear down to -12°C
Boiling point(°C) 268
Saponification Value (mg KOH/g) 292-296
Residue on ignition 0.3%
Refractive Index (@ 25°C) 1.53
Acid value 0.5% maximum
Heavy Metals (UPS Method II) 20 ppm
Viscosity
@ 25°C (Brookfield LVT)
@ 45°C 6450 cps
460 cps
Solubility
SOLVENT LIQUAPAR OIL (%)
Methanol Completely Miscible
Propylene Glycol Completely Miscible
Glycerin 0.8
1,3-Butylene Glycol >1
Castor Oil >1
Soybean Oil >1
C12-16 Alkyl Benzoate >1
Isopropyl Myristate >1
Lanolin Oil >1
Mineral Oil <0.1
Hydrogenated Polybutenes <0.1
Petroleum Distillates <0.1
Water (10°C) <0.1
Water (25°C) <0.1
Water (80°C) <0.1
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TOXICOLOGICAL DATA
Acute oral toxicity >5000 mg/kg
Primary dermal irritation (rabbits) Minimun irritant (l00% active concentration)
Primary eye irritation (rabbits) Severe eye irritant (l00% active concentration)
Delayed Contact Hypersensitivity(guinea pigs) No positive reactions (2% active concentration)
Repeated Insult Patch Test (humans) Not a contact sensitizer (50% emulsion)
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APPLICATIONS
LiquaPar Oil is an active blend of parabens, useful in a wide range of cosmetic formulations including anyhydrous systems. LiquaPar Oil effectively preserves most products when used at concentrations of 0.3-0.6%.
For complex formulations, a dual preservation system consisting of 0.4% LiquaPar Oil in combination with 0.2% EDTA and/or 0.1% Germall II has been found to be particularly effective.
Every cosmetic formulation requires a tailor-made preservative system to meet its specific needs. Therefore every newly developed or modified product should be challenge tested to assure preservative efficacy.
For best results, LiquaPar Oil should be added after emulsification, just prior to the addition of the fragrance.
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LIQUAPAR® PE
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DESCRIPTION
INCI ADOPTED NAME: PHENOXYETHANOL (and)
ISOPROPYLPARABEN (and)
ISOBUTYLPARABEN (and)
BUTYLPARABEN
CAS REGISTRY NO: 122-99-6/4191-73-5/ 4247-02-3/94-26-8
CHEMICAL COMPOSITION: LIQUAPAR OIL
(ISOPROPYLPARABEN, ISOBUTYLPARABEN,
BUTYLPARABEN) 30%
PHENOXYETHANOL 70%
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PROPERTIES
LiquaPar PE is a 100% active, clear, stable, liquid blend of isopropyl, isobutyl, and n-butyl esters of para hydroxybenzoic acid with phenoxyethanol. This combination of parabens and phenoxyethanol is effective against Gram-negative and Gram-positive bacteria, yeast, and mold providing broad spectrum activity for worldwide formulations.
The potentiator effect of phenoxyethanol facilitates use of the LiquaPar Oil technology in nonionic emulsion systems where paraben efficacy might otherwise be compromised.
All LiquaPar PE components are approved for worldwide use thus allowing sale of the same finished formulation in Japan, Europe, Australia and the United States.
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APPLICATIONS
LiquaPar PE is an active blend of parabens and phenoxyethanol useful in a wide range of cosmetic formulations including anhydrous systems. The potentiating effect of phenoxyethanol combined with the highly effective paraben blend provides an effective preservative system for even difficult to preserve nonionic emulsions. In most systems LiquaPar PE should be incorporated at a concentration of 1.0% by weight of the finished formulation.
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PHYSICAL CHARACTERISTICS
(Not necessarily Specifications)
Assay (GC area %) Isopropylparaben 11-13
Isobutylparaben 9-11
Butylparaben 9-11
Phenoxyethanol 65-70
Appearance Clear, colorless to pale yellow liquid
Color (APHA) 200 Maximum
Specific Gravity 1.08-1.12
SOLUBILITY
SOLVENT LIQUAPAR PE (%)
Water <0.1
10% Ethanol/90% Water 0.2
Propylene Glycol Miscible
1.3 Butylene Glycol Miscible
Glycerin 4.0
Isopropyl Myristate Miscible
Octyl Palmitate Miscible
Sesame Oil Miscible
Dimethicone <0.3
Cyclomethicone <0.1
Mineral Oil <0.1
Sodium Lauryl Sulfate (28-30% solids) 1.0
TEA Lauryl Sulfate (40% solids) 1.0
For more complex formulations, a dual preservation system of 1.0% LiquaPar PE in combination with 0.2% ethylenediaminetetra-acetic acid salt (EDTA) has proven effective.
In emulsion systems, LiquaPar PE should be added after emulsification while the product remains at emulsification temperature. For hot mixed systems, add LiquaPar PE early in the process to allow adequate mixing time.
Although phenoxyethanol is slightly volatile, LiquaPar PE is stable at temperatures up to 85°C. For cold mixed systems, add LiquaPar PE early in the process to allow for adequate mixing.
Every cosmetic formulation requires a specific preservative system to meet its individual needs. Therefore, every newly developed or modified product should be challenge tested to assure preservative efficacy.
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TOXICOLOGICAL DATA
The toxicity assessment of LiquaPar PE is based on data generated for LiquaPar Oil (LPO), the individual paraben esters and phenoxyethanol (PE). PE and the paraben esters have been extensively evaluated by the Cosmetic Ingredient Review (CIR). Both LPO and PF are low in toxicity. The undiluted chemicals will be strong eye irritants and moderate skin irritants. In dermal studies, neither the paraben esters nor PE are teratogenic, embryotoxic or mutagenic. PE is not a sensitizer. As a 50% concentration in an emulsion base, LPO did not induce contact sensitization by Repeated Insult Patch Test.
At use levels, LiquaPar PE will be non-irritating to skin and eyes and is not expected to be a sensitizer.
Ingestion/LD50: LP0, >5000 mg/kg. PE, 1300 mg/kg in male rats, 2300 mg/kg in female rats.
Eyes: LPO, at 1.0%, not an irritant. PE, at 2.2%, not an irritant.
Skin: LPO, at 100%, minimal irritation. PE, at 2.0%, a slight irritant.
