Product Fact Sheet

NIPASOL® M

Preservative for the cosmetic industry

Chemical Name Propyl 4-Hydroxybenzoate CLARIANT INTERNATIONAL LTD

Rothausstrasse 61
INCI designation Propylparaben 4132 Muttenz
Chemical structure Switzerland

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1
PRODUCT PROPERTIES

Appearance (20 °C) White, almost white crystalline powder.

Chemical and physical data

Melting point 96 - 98 °C
Assayacc. BP/PH.Eur 98.0 - 102.0 %

Uses
Nipasol® M is a broad spectrum antimicrobial agent designed for preservation of
a wide range of cosmetics, toiletries and topical pharmaceuticals. Nipasol® M is
suitable to preserve both rinse-off and leave-on formulations.

Applications
Typical use concentrations of Nipasol® M is 0.1 – 0.3 %. Combinations of p-
Hydroxybenzoic acid esters, e.g. with Nipagin® M, Nipagin® A or Nipabutyl®
exhibit increased activity compared with individual esters.

Regulatory status
Europe: maximum concentration 0.4 % (acid) for 1 ester, and 0.8 % (acid) for
mixtures of esters, no restrictions, Annex VI, 76/768/EEC.

Japan: maximum concentration 1 % in cosmetic product, no restrictions.

USA: considered safe as used by Cosmetic Ingredient Review (2006),

Propylparaben up to 0.4 % if used alone (paraben mixes up to 0.8 %).

1 These characteristics are for guidance only and not to be taken as product specifications. The
tolerances are given in the product specification sheet. For further product properties, specifications,
safety and ecological data, please refer to the MSDS.

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Incorporation
Nipasol® M is freely soluble in most oils, waxes, fatty alcohols, but have
relatively low solubility in water.

The low aqueous solubility does not affect the microbiological efficacy of the CLARIANT INTERNATIONAL LTD
esters.
Rothausstrasse 61
4132 Muttenz
Most formulations requiring preservation contain a significant amount of water.
Switzerland
This may mean that Nipasol® M cannot readily be added directly to the BUSINESS UNIT INDUSTRIAL &
formulation. CONSUMER SPECIALTIES

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Other methods of incorporation are quite straightforward however, and are www.clariant.com
listed below.

Dissolving in water
The solubility of Nipasol® M increases greatly as the temperature of the water
rises. Therefore a concentrate may be made up by heating an appropriate
quantity of water to 60- 100 °C prior to addition of Nipasol® M. This concentrate
may then be added to the formulation, provided that the ester concentration
does not exceed its solubility in the formulation at normal ambient
temperatures.

Dissolving in organic solvents

Nipasol® M is readily soluble in polar organic solvents. Where such a solvent is
already part of a formulation, a Nipasol® M concentrate may be made up prior to
addition. If a suitable solvent is not already part of the formulation, a highly
concentrated solution may be made up e.g. 32 % in Ethanol, which would give
insignificant residual levels of ethanol in the end product.

Solubilisation in oils, emulsifiers etc.

Nipasol® M is readily soluble in lipophilic ingredients and may be introduced to
a formulation by adding to the oil phase with some warming before any
emulsification stage. In multiphase systems, such as emulsions, it is often
advisable to use a combination of aqueous dissolution with either of the other
methods to ensure adequate preservation. The ester may be incorporated in the
water to its maximum solubility and any further quantities may be dissolved in
the oil phase, or solvent, as appropriate.

pH stability
Nipasol® M remains fully stable over a wide pH range from 4- 8. In general the
lower the pH of the formulation, the more active is Nipasol® M. That can result
in a lower use concentration when the pH of the formulation is more acidic.

Temperature stability
Nipasol® M is stable up to 80 °C.

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Solubility
The solubility of Nipasol® M in different solvents is illustrated in the following
table.

Solvent % (w/w)
Water 10 °C 0.018
Water 25 °C 0.04
Water 80 °C 0.45
Water 100 °C 0.7 CLARIANT INTERNATIONAL LTD
Acetone 51
Rothausstrasse 61
Methanol 50 4132 Muttenz
Ethanol 50 Switzerland
Propylene Glycol 29
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Vegetable oils (arachis) 1.4
Liquid paraffin 0.033 www.ics.clariant.com
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Microbial activity
Nipasol® M exhibits microbiostatic activity against a wide range of bacteria,
yeast and mould. This is illustrated by the following table which shows the
minimum inhibitory concentration (MIC) of Nipasol® M against examples of
different groups of microorganisms.

Microorganisms MIC level (%)

Gram Negative Bacteria
Pseudomonas aeruginosa 0.08
Escherichia coli 0.04
Klebsiella aerogenes 0.04
Klebsiella pneumoniae 0.025
Serratia marcescens 0.04
Proteus vulgaris 0.025
Salmonella enteritidis 0.04
Salmonella typhi 0.06
Gram Positive Bacteria
Stpahylococcus aureus 0.04
Streptococcus haemolyticus 0.04
Bacillus cereus 0.025
Bacillus subtilis 0.025
Lactobacillus buchneri 0.025
Yeasts
Candida albicans 0.013
Saccharomyces cerevisiae 0.013
Moulds
Aspergillus brasiliensis 0.02
Penicillium digitatum 0.006
Rhizopus nigricans 0.013

Page 3 of 4 NIPASOL® M May 2013

Storage instructions
The product must be stored in tighly closed container in a cool, well- ventilated,
dry place.
Further information on handling, storage and dispatch is given in the EC safety
data sheet.

CLARIANT INTERNATIONAL LTD

Rothausstrasse 61
4132 Muttenz
Switzerland

BUSINESS UNIT INDUSTRIAL &

CONSUMER SPECIALTIES

www.ics.clariant.com
www.clariant.com

This information corresponds to the present state of our knowledge For sales to customers located within the United States and Canada
and is intended as a general description of our products and their the following applies in addition:
possible applications. Clariant makes no warranties, express or NO EXPRESS OR IMPLIED WARRANTY IS MADE OF THE
implied, as to the information’s accuracy, adequacy, sufficiency or MERCHANTABILITY, SUITABILITY, FITNESS FOR A PARTICULAR
freedom from defect and assumes no liability in connection with any PURPOSE OR OTHERWISE OF ANY PRODUCT OR SERVICE.
use of this information. Any user of this product is responsible for
determining the suitability of Clariant’s products for its particula
application. * Nothing included in this information waives any of ® Trademark of Clariant registered in many countries
Clariant’s General Terms and Conditions of Sale, which control © 2012 Clariant International Ltd
unless it agrees otherwise in writing. Any existing
intellectual/industrial property rights must be observed. Due to
possible changes in our products and applicable national and
international regulations and laws, the status of our products could
change. Material Safety Data Sheets providing safety precautions,
that should be observed when handling or storing Clariant products,
are available upon request and are provided in compliance with
applicable law. You should obtain and review the applicable Material
Safety Data Sheet information before handling any of these products.
For additional information, please contact Clariant.

Page 4 of 4 NIPASOL® M May 2013