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Technical Information
Irgacare® MP
March 2011
04_101002e-00/Page 1 of 8
® = Registered trademark of BASF group
Medical grade for oral care applications
Personal Care
04_101002e-00 March 2011
Characterization Page 2 of 8
Irgacare MP
Irgacare MP is a highly efficient broad-spectrum antimicrobial based on Triclosan.
The product shows activity against gram-negative and gram-positive bacteria
as well as yeast and fungi. Triclosan is widely used in personal care and human
hygiene applications.
Irgacare MP is a medical grade especially designed for incorporation into oral care
applications.
Chemical Name
The active ingredient of Irgacare MP is 2,4,4’-trichloro-2’-hydroxy-diphenyl-ether
Structural formula
Cl
OH
O
Cl
PRD-No.*
Cl
30480531
* BASF’s commercial product numbers.
INCI Name
Triclosan
Applications
Oral Care, e.g. tooth paste, mouth rinses.
Features / benefits
Irgacare MP is effective at low concentrations against a broad spectrum of unwanted
and pathogenic microorganisms being involved in plaque formation and malodor.
Irgacare MP shows good substantivity to the dental enamel and mucosa leading
to a long-lasting effect.
In addition Irgacare MP provides an anti-inflammatory benefit.
Guidelines for use
Application
Typical Use Level of Irgacare MP
Tooth paste
up to 0.3%
Mouth rinse
0.03 – 0.1%
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Benefits
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Irgacare MP
There are both production and formulation benefits associated with Irgacare MP.
A number of these benefits are highlighted below:
Products Benefit
Impact to Application
Broad-Spectrum Activity
Broad-spectrum antibacterial activity claims can be
made as the antimicrobial active works against aerobic
and anaerobic gram-positive and gram-negative
bacteria, and yeasts.
Long-lasting activity on,
teeth and mucosa
Tests have shown effective long-lasting antibacterial
activity in oral care applications.
Anti-inflammatory effect
The anti-inflammatory activity of Irgacare on skin and
mucosa membranes is well documented. This property
of the active results in reduction of gingivitis and skin
inflammation.
Use of IrgacareMP can help reduce the irritation of
other raw materials in a formulation (e.g. Sodium
Lauryl Sulphate).
Compatibility
Highly compatible with other personal care ingredients
Toxicology Favorable toxicological profile Stability
Triclosan displays a high thermal and chemical stability
as well as photostability.
Purity
Irgacare MP is produced under GMP and has a
superior quality meeting the specification of the U.S.
Pharmacopoeia
Solubility
The product is soluble in many solvents used in personal care formulations, but is only sparingly soluble
in water.
Irgacare MP shows bacteriostatic and bactericidal activity depending on the
concentrations applied.
The active has various modes of action with the main site of action being the
cytoplasmatic membrane and the cytoplasm.
Physical Properties
Form
Powder
Color
White
Odor
Trace aromatic
Identity
Conform to Standard Spectrum
Melting Point:
56 – 58 °C
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Minimum Inhibitory Concentration
(MIC) of Irgacare MP
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Irgacare MP
Irgacare MP against oral microorganisms.
Bacteria
MIC * (ppm)
Gram-positive species
Actinomyces naeslundii
20
Actinomyces viscosus
20
Actinomyces odontolyticus
20
Actinomyces israelii
10
Peptococcus asaccharolyticus
10
Peptococcus saccharolyticus
10
Peptococcus magnus
50
Peptostreptococcus anaerobius
50
Streptococcus mutans
10
Streptococcus sanguis
10
Gram-negative species
Actinobacillus actinomycetemcomitans
5
Bacteroides melaninogenicus
10
Bacteroides intermedius
10
Bacteroides endodontalis
50
Bacteroides oralis
10
Bacteroides distasonis
50
Fusobacterium nucleatum
50
Leptotrichia buccalis
20
Porphyromonas (Bacteroides) gingivalis
50
Veillonella parvula
20
Yeasts
Candida albicans
10
*ref: Journal of Clinical Periodontology Vol. 18 No. 16 July 1991
04_101002e-00 March 2011
Activity in toothpaste
– biocidal activity
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Irgacare MP
With its excellent bactericidal activity Irgacare MP prevents the colonization of dental
surfaces and the formation of plaque. To demonstrate this efficacy a test was
designed which uses hydroxyapatite discs (HAP) as a dental model.
Bactericidal activity of Irgacare MP on HAP disc
1 000 000 000
cell count [cfu/ml]
100 000 000
10 000 000
1 000 000
100 000
10 000
1 000
100
10
0
6
12
18
24
time [h]
Toothpaste + 0.3% Irgacare MP
Control
The HAP discs were incubated in artificial saliva for 4 hrs (under stirring), rinsed
with 10 ml NaCl, dried over night, and finally incubated in 10 ml of a toothpaste
solution containing 500 ppm Irgacare MP for 30 min. Afterwards, all treated discs
were put in 12 well Nunclon surface titre plates (one disc per well), and 4 ml Caso
Broth inoculated with A. viscosus ATCC 43146 (ca.105 cfu / ml) were added.
The titre plates were incubated at 37 °C, samples were taken after 6 and 24 hrs
and the colony count was determined.
Irgacare MP also reduces already existing plaque caused by bacteria on the dental
surface due to its good substantivity to the dental enamel.
Reduction of dental plaque bacteria in a biofilm model on HAP disc
1 000 000 000
99.9
%m
100 000 000
10 000 000
icro
orga
nism
redu
ctio
n
1 000 000
100 000
10 000
1000
100
Control
0.1% Irgacare MP
0.3% Irgacare MP
Biofilm formation
Hydroxyapatite (HAP) discs are pretreated with human saliva (pellicle formation)
and exposed to a mixed culture of different oral bacteria containing early and late
colonizers (Streptococcus sobrinus OMZ 918, Veilonella dispar OMZ 493, Fuso­
bacterium nucleatum OMZ 598, Streptococcus oralis OMZ 607, Acinomyces
naeslundii OMZ 745, Candida albicans OMZ 110).
Treatment
Discs are dipped 6 times during 2 days into 30% dentifrice suspension for 60 sec.
Afterwards the discs were incubated anaerobically for 24 h at 37 °C. The biofilms
are harvested and the number of bacteria on the HAP discs is determined.
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Anti-inflammatory effect
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Irgacare MP
Irgacare MP was proven to be a potent inhibitor of cyclo-oxygenases and
lipoxygenases, which are key enzymes of the arachidonic acid metabolism, resulting
in a reduced formation of pro-inflammatory metabolites such as prostaglandine
E2 and leukotriene B4 (A. Gaffar et al.: Journal of Clin. Periodontol. 480-484, 1995).
Proposed mechanism of the anti-inflammatory activity of Irgacare MP.
Arachidonic acid
S
e
TC
e
yg
x
ipo
s
na
L
Leukotriene A
TC
Cy
S
(= clo
c
o
Pr om xyg
o p
Sy sta on ena
nt gla ent se
he n
ta din of
se
)
Endoperoxides
Leukotriene B-E
Thromboxans
Prostaglandins
Findings that the active ingredient is capable of reducing cytotoxic effects of sodium
lauryl sulphate on human gingival fibroplasts (E.J. Coleman at al: J. Dent. Res. 72
IADR abstracts, abstract no 1837, 1993) and on the oral mucosa (S.M. Waaler et
al.: Scandinavian Journal of Dental Research 101, 192-195, 1993; A.B. Skaare
et al.: J. Clin. Periodontol. 23, 1010-1013, 1996) further substantiate the anti-irritant
and anti-inflammatory effects of Irgacare MP.
Health & Safety
Irgacare MP is safe for humans and the environment as multiple studies and 35
years of application without adverse effects demonstrate.
Irgacare MP is not accumulated in humans and the environment but readily
degraded in wastewater treatment plants and surface waters.
A recent assessment (December 2010) by the expert panel of the US Cosmetics
Ingredients Review (CIR) has reconfirmed that Triclosan is safe as used.
In manufacturing, processing, or repackaging of pure product skin and eye irritation
have to be prevented. Contact with eyes, skin and clothing should be avoided and
containers kept closed. The products are for industrial use only.
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Registration
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Irgacare MP
Detailed information on product safety and the registration status is available on
request.
Cosmetic / Drug Registration Status of Irgacare MP
Country
Status / Restrictions
Europe
Approved for use in all cosmetics according to European
Cosmetic Directive 76/768/EEC, Annex VI, Part 1.
As preservative maximum allowed concentration in cosmetic
end products: 0.3%.
USA
Topical antimicrobial drug products for over-the-counter (OTC)
human use; Tentative final monograph for first aid antiseptic
drug products max.1.0%.
Topical antimicrobial drug products for over-the-counter (OTC)
human use; Tentative final monograph for antimicrobial antiseptic
hand wash products: max. 1.0%.
Drug Master File (DMF) and over-the-counter (OTC) public
docket data supporting NDA’s and IND’s (Investigational New
Drug Application) for oral and dermal uses.
Japan
“Japanese Cosmetic deregulation” included in Japanese
positive list for cosmetic ingredients as preservative in all
cosmetic end-products ( max 0.1%) – “ Japanese Quasi-Drug
Regulation” : following precedent uses for Triclosan as a QD
active:
1. Medicated soaps, deo-soaps (solid) max. 0.5%
2. Liquid hand soaps max. 0.3%
3. Deodorants max. 0.2%
4. Toothpastes / mouth rinses max. 0.1%
South Korea
Approved as antiseptic / preservative up to 1% for use in all
cosmetics.
China
“Chinese Cosmetic Regulation”, max 2% for skin applications,
0.35% for mucous membrane applications.
Triclosan listed in the Chinese Standard of Toothpaste with max.
of 0.3%.
Australia
No limit on Triclosan concentrations for therapeutics or for
cosmetics as long as the safety aspects are controlled and
the concentration is justified by product efficacy.
Philippines
Antimicrobial agent: Deodorants – Maximum concentration in
the finished product: 2%.
As preservative in other cosmetic products: max 0.3% in
finished product.
Canada
Dentifrice Concentration not to exceed 0.3%. Labelling must
be submitted along with analytical methods and data on
PCDD/PCDF impurities.
Mouthwash. Concentration not to exceed 0.03%. Labelling
must be submitted along with analytical methods and data on
PCDD/PCDF impurities.
Switzerland
Approved for use in all cosmetics.
Maximum allowed concentration in cosmetic end products: 0.3%.
India
Approved as preservative with a maximum allowed concentration
in cosmetic end products: 0.3%.
Israel
Approved for use in all cosmetics. According to Goods and
Services Ordinance, as preservative maximum allowed concentration in all cosmetic end products: 0.3%.
04_101002e-00 March 2011
Note
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Irgacare MP
Taiwan
Law for the control of cosmetic hygiene:
Medicated Cosmetics (antibacterial agent), Used in soap,
shampoo, shave cream, facial cream, emulsions, and tonic
waters as anti-bacterial agent. 0.3% (max 0.3% of Triclosan
as preservatives in general cosmetics = no claim).
Malaysia
Approved for use in all cosmetics. According to Control of Drugs
and Cosmetics, as preservative maximum allowed concentration
in all cosmetics: 0.3%.
South Africa
Antimicrobial agent: Oral hygiene Products : max 0.2% – 0.35%
m/m (label: Contains Triclosan ).
Preservative in cosmetic products: max 0.3%.
Argentina
Approved for use in all cosmetics.
As preservative maximum allowed concentration in all types
of products: 0.3%.
Brazil
Approved for use in all cosmetics.
As preservative maximum allowed concentration in all types
of products: 0.3%.
Chile
As antimicrobial agent: Liquid and solid deodorant soap;
0.50 g – 2.00 g. %.
As antimicrobial agent : Underarm deodorants; 0.10 g – 0.20 g %.
Mexico
Approved for use in all cosmetics.
As preservative maximum 0.3% in all types of products. Other
uses up to 0.5% in all types of products.
Norway
Preservatives in cosmetic products max 0.3%
Soaps and products which are rinsed off after use 0.5%; other
products: max. 0.3%.
Turkey
Approved for use in all cosmetics.
As preservative maximum allowed concentration in all types
of products: 0.3%.
Iceland
Approved for use in all cosmetics.
As preservative maximum allowed concentration in cosmetics:
0.3%.
This document, or any answers or information provided herein by BASF, does
not constitute a legally binding obligation of BASF. While the descriptions, designs,
data and information contained herein are presented in good faith and believed
to be accurate, it is provided for your guidance only. Because many factors may
affect processing or application/use, we recommend that you make tests to
determine the suitability of a product for your particular purpose prior to use. It
does not relieve our customers from the obligation to perform a full inspection of
the products upon delivery or any other obligation. NO WARRANTIES OF ANY KIND,
EITHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY
OR FITNESS FOR A PARTICULAR PURPOSE, ARE MADE REGARDING PRODUCTS
DESCRIBED OR DESIGNS, DATA OR INFORMATION SET FORTH, OR THAT THE
PRODUCTS, DESIGNS, DATA OR INFORMATION MAY BE USED WITHOUT
INFRINGING THE INTELLECTUAL PROPERTY RIGHTS OF OTHERS. IN NO CASE
SHALL THE DESCRIPTIONS, INFORMATION, DATA OR DESIGNS PROVIDED BE
CONSIDERED A PART OF OUR TERMS AND CONDITIONS OF SALE.
March 2011
BASF SE - Care Chemicals Division - Personal Care - 67056 Ludwigshafen - www.personal-care.basf.com