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A new preservative for high pH systems: Rohm and Haas offers an alternative to formaldehyde in household and I&I applications.

FOR FORMULATORS OF household and I&I products, high pH formulations have typically been more difficult to preserve than low pH formulas. Many common preservatives are less effective or less stable at alkaline pHs. (1) Rohm and Haas Company has addressed this issue by developing a technically innovative preservative that is specifically designed for use in hard-to-preserve, high pH formulations in household and I&I applications. Based on isothiazolinone chemistry, new Neolone M-10 preservative is a highly stable, safe and effective, broad-spectrum preservative that is particularly suitable as a replacement for formaldehyde and formaldehyde donors in a wide range of applications, including liquid laundry products, all-purpose cleaners, furniture and floor care products and surfactants and other aqueous raw materials.

The introduction of Neolone M-10 preservative reflects Rohm and Haas Company's position as one of the world's leading suppliers of preservative technology and its 30-year history as a developer of innovative products for applications in the household and I&I markets. In these applications, Neolone M-10 preservative complements Kathon CG/ICP preservative, which is most effective in less alkaline formulations.

Ncolone M-10 preservative is 9.5% methylisothiazolinone in water. It is miscible in water, lower alcohols and glycols and has low solubility in hydrocarbons. The recommended use levels for Neolone M-10 preservative is 0.053-0.158% as supplied (50-150 ppm of active ingredient).

Chemical Stability

Neolone M-10 preservative shows excellent stability in household and I&I formulations with aqueous raw materials. Neolone M-10 preservative is stable over a wide range of pH and temperature conditions and is compatible with a variety of surfactants. The active ingredient is stable in surfactants and household products, such as laundry products, floor care products and all-purpose cleaners. The active ingredient was measured by high-performance liquid chromatography (HPLC) in a variety of household products and raw materials.

Figures 1-3 demonstrate these formulation advantages.

[FIGURE 1 OMITTED]

Preservative Efficacy

Neolone M-10 preservative exhibits strong antimicrobial activity, inhibiting a wide range of Gram-positive and Gram-negative bacteria. Figure 4 provides the minimum inhibitory concentration (MIC) values in parts per" million active ingredient methylisothiazolinone, which inhibited the growth of various microorganisms in broth tests.

Long-term microbiological protection is obtained by employing use levels of up to 0.158% Neolone M-10 preservative as supplied. Typical use levels for most household and I&I products are in the range of 0.053% to 0.158% (50-150 ppm active ingredient). Efficacy of Neolone M-10 was evaluated in surfactants and household and I&I products using standard protocols. (2) Figures 5 and 6 illustrate that Neolone M-10 preservative is effective at low use levels in a variety of household and I&I products.

Bacterial and fungal efficacy of Neolone M-10 preservative was evaluated in sodium lauryl ethoxy sulfate (Figure 5) and a liquid laundry detergent (Figure 6). Samples were inoculated with [10.sup.6] to [10.sup.7] organisms/g and monitored for viable microorganisms at appropriate time intervals using standard plating methods. Bacterial samples were stored at 30[degrees]C and fungal samples at 25[degrees]C for the duration of the test. The preservative was deemed effective if no microorganisms survived in the samples.

Test results shown in Figures 5 and 6 clearly demonstrate that Neolone M-10 preservative is effective at low use levels in household and l&I products.

Environmental Profile

Neolone M-10 preservative is recognized as being extremely safe for the environment. It has low use levels, rapidly biodegrades to non-toxic substances, does not persist in the environment and is halogen-free. In addition, Neolone M-10 preservative does not affect the performance of waste-water treatment plants and does not bioaccumulate. Also, the predicted environmental concentration (PEC) of Neolone M-10 preservative will be significantly less than the toxic threshold, and thus will have minimal environmental impact.

The toxicology of methylisothiazolinone, the active ingredient of Neolone M-10 preservative, has been assessed in an extensive battery of non-clinical and clinical testing. Results of these studies prove that Neolone M-10 preservative does not present a mutagenic, teratogenic, reproductive or carcinogenic risk to humans. Use of Neolone M-10 preservative at recommended use levels is safe. This is supported by our" extensive toxicological and clinical databases, our work with dermatologists worldwide and more than 20 years of experience with safe use of isothiazolinone chemistry in a large number of household and I&I products around the world.

A Formaldehyde-Free Solution

Today's preservatives are formulated in household and I&I products principally to protect them from chance microbial contamination during production, storage and final customer use. High pH formulations of these products are frequently difficult to preserve. Neolone M-10 preservative--stable over a range of pH and temperatures, highly effective and safe--provides formulators of household and I&I products with a proven formaldehyde-free solution for high pH formulations.

For additional information on new Neolone M-10 preservative, visit http://www.rhcis.com.

Kathon and Neolone are registered trademarks of Rohm and Haas Company.
Fig. 2: Neolone M-10 preservative is stable in surfactants

% Active Ingredient (AI) Remaining at Four Weeks:

Matrix 25[degrees]C 42[degrees]C 50[degrees]C

Sodium alkyl benzene
 sulfate 100 100 Not Tested
Sodium lauryl ethoxy
 sulfate 100 100 100
Sodium [C.sub.14-16]
 olefin sulfonate 100 93 79
Sodium lauryl sulfate 100 100 100
Sodium lauroyl sarcosinate 84 (52 weeks at 25[degrees]C)
Fig. 3: Neolone M-10 preservative is stable in household and I&I
products

 Temperature Time % AI
Matrix pH [degrees]C Weeks Remaining

Laundry Products
 Fabric wash concentrate 8 45 4 96
 Laundry detergent 9 25 12 80
Floor Care Products
 Floor finish 9 45 4 90
 Floor polish 8 40 12 100
Liquid Cleaners
 Shower cleaner 9 40 12 100
 Dish detergent 8 40 12 100
 Scrub product 8 40 12 100
Fig. 4. Neolone M-10 preservative inhibits a range of bacteria at
low levels
 MIC
Microorganism ATCC # ppm AI

Enterobacter aerogenes 15038 30
Pseudomonas aeruginosa 15442 40
Burkholderia cepacia 17765 20
Pseudomonas oleovorans 8062 30
Pseudomonas putida 795 20
Staphylococcus aureus 6538 40
Serratia marcescens Isolate 30

Test parameters: Nutrient Broth, 30[degrees]C / pH 7; 24-hour
contact time
Fig. 5: Neolone M-10 preservative efficacy in

 Concentration CFU/g after day:

Preservative % AI 7 14 28

Bacteria
U11preserved 0 [10.sup.8] [10.sup.7] [10.sup.7]
Neolone M-10 0.0050 <10 <10 <10

Fungi
Unpreserved 0 [10.sup.7] [10.sup.7] [10.sup.7]
Neolone M-10 0.0050 <10 <10 <10
Fig. 6: Neolone M-10 preservative efficacy in a liquid laundry
detergent

 Concentration CFU/g after day:

Preservative % AI 7 14 28

Bacteria
Unpreserved 0 [10.sup.6] [10.sup.6] [10.sup.6]
Neolone M-10 0.0050 <10 <10 <10

Fungi
Unpreserved 0 [10.sup.6] [10.sup.6] [10.sup.6]
Neolone M-10 0.0075 <10 <10 <10


References

(1.) Steinberg, D.C. 1996. Preservatives for Cosmetics. Cosmetics and Toiletries.

(2.) Curry, Anita S, Joyce F. Graf, and G. N. McEwen Jr., eds. 1993. Determining the Preservative Adequacy in Cosmetic Formulations. CTFA Microbiology Guidelines.
Megan A. Diehl
Applications Scientist,
Preservatives
Consumer & Industrial
Specialties Business
Rohm and Haas Company
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Author:Diehl, Megan A.
Publication:Household & Personal Products Industry
Date:Aug 1, 2002
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