Melafresh™ T96 Melafresh™ T10-Ws Melafresh™ T10-slr

Activeingredients

Melafresh™ T96Melafresh™ T10-WsMelafresh™ T10-slr

Terpinen-4-ol to the rescue!

Standardized Tea Tree extract containing 96% terpinen-4-ol-Multifunctional soothing and powerful antimicrobial-Preservation boosting agent

technical file

Technical File Melafresh™ T96

Lucas Meyer Cosmetics

www.lucasmeyercosmetics.com 1

SUMMARY

INCI NAME

CAS

EINECS

4-Terpineol (1)

562-74-3 (1)

209-235-5 (1)

ORIGIN Melafresh™ T96 is a highly pure form of terpinen-4-ol, the active ingredient naturally present in tea tree (Melaleuca alternifola) oil, concentrated at 96%.

COSMETIC PROPERTIES • Potent antimicrobial activity • Strong anti-inflammatory activity • May act as a preservative booster

SKIN BENEFITS /

POTENTIAL CLAIMS • Helps to reduce UV-induced erythema • Improves and soothes acne-prone skin • Helps reduce dandruff and soothes itchy and irritated scalp • Helps reduce fungal foot related problems

APPLICATIONS • Skin Care • Acne-prone skin • Sensitive skin • After-sun • Hair Care • Anti-dandruff

• Irritated scalp • Feminine wash • Deodorant • Foot Care • Oral Care • Preservative booster

RECOMMENDED

DOSAGE 0.2 - 1%

USAGE PH RANGE 4.0-9.5

INCORPORATION Incorporate at the end of the process <40°C

INCOMPATIBILITIES None known




INTRODUCTION Over the last 20 years, the use of essential oils in the cosmetic industry has been rapidly gaining popularity due to their biological activities and their fragrance. One of the most commercialized essential oil has been the tea tree oil, largely employed in many cosmetic and personal care formulations for its interesting antimicrobial, antifungal and anti-inflammatory activities.

Inspired by the powerful properties of the native Australian tea tree oil, (Melaleuca alternifola) Melafresh™ T96 is the highly pure concentrated form of terpinen-4-ol standardized at 96% which is the active ingredient naturally present in tea tree oil. Melafresh™ T96 is reduced in color compared to the Australian tea tree oil. It is specifically designed to soothe and protect the skin against infection, to balance the excess oily hair, to incorporate in anti-dandruff and athlete’s foot products cares and to use as a preservative booster.

Also available in different versions:

• Melafresh™ T10 WS: (10% Melafresh™ T96 in aqueous micro-emulsion); • Melafresh™ T10 SLR: (cyclodextrin powder complex 10% Melafresh™ T96).

Australian tea tree: An outstanding tree with powerful properties

Origin of the Australian tea tree

The genus Melaleuca belongs to the myrtle family (Myrtaceae) and includes about 250 species. Most of the Melaleuca species are restricted to Australia. Melaleuca alternifolia is native only to the East coast. It is an evergreen shrub growing to 6m high by 4m wide. It grows along streams and on swampy flats, and is often the dominant species where it occurs. The flowering season is from spring to early summer. The narrow leaves of Melaleuca alternifolia help to distinguish it from similar species.

Traditional usage of tea tree

Tea tree essential oil has been used for a thousand years in Australia for its antiseptic and anti-inflammatory actions. The earliest report on the traditional use was by the Bundjalung Aborigines of northern New South Wales. Crushed leaves were inhaled to treat coughs and cold or used on wounds. Tea tree leaves were also soaked to make an infusion to treat sore throats. The oral stories also relate about mystic “healing lakes”




which were lagoons into which tea tree leaves had fallen providing healing and cleansing powers. Legend has it that the oil with its medicinal benefits was considered so important that Australian soldiers were supplied with tea tree oil in the Wold War II military kit. The use of the tea tree oil became common practice after Penfold published the first reports of its antimicrobial activity in a series of papers in the 1920s.

Composition

Terpinen-4-ol is the principal active compound in tea tree oil responsible for the antimicrobial and anti-inflammatory activities. This active compound is present in the essential oil at around 40%, but Melafresh™ T96 is standardized at 96% of terpinen-4-ol in the same chiral ratio as occurs naturally in tea tree oil.

While tea tree oil is used in ranges of cosmetics, personal care products and over-the-counter (OTC) pharmaceuticals around the world for its antibacterial, anti-fungal and anti-inflammatory properties, there is no doubt that its utilization has been limited because of the strong medicinal odor of the oil. Melafresh™ T96 is a tea tree derivative which is more potent than the tea tree oil and significantly lower odor. Thus, Melafresh™ T96 allows formulators of skin care products to achieve highly active products with greatly reduced odor.

Highly standardised

Melafresh™ T96 is highly standardized from batch to batch in terms of efficacy, odor and taste. In comparison, tea tree oil contains over 60 components and even the tightest specification for pharmaceutical grade tea tree oil will still result in significant variations in odor and taste.

Melafresh™ T96 is 2x more concentrated in terpinen-4-ol than tea tree oil.

COMPOUNDS %

(+)-Terpinen-4-ol 65

(-)-Terpinen-4-ol 35

Chiral ratio: (+:-) 2:1

GC PROFILE (FID) PHARMA GRADE TEA TREE OIL

MELAFRESH™ T96

α-Pinene 1.0-6.0%

Sabinene Trace-3.5%

α-Terpinene 5.0-13.0%

p-Cymene 0.5-4.0%

Limonene 0.5-1.4%

1,8-Cineole 0.0-5.0%

γ-Terpinene 10.0-28.0%

α-Terpinolene 1.5-5.0%

Terpinen-4-ol 37.0-45.0% 96.0%

α-Terpineol 1.5-8.0%

Aromadendrene Trace-7.0%

δ-Cadinene Trace-8.0%

Globulol Trace-3.0%

Viridiflorol Trace-1.5%




EFFICACY DATA




BIO-ACTIVE PROPERTIES

The bio-active properties of Melafresh™ T96 include:

1. Anti-inflammatory 1.1. Anti-irritant 1.2. Reduces UV-induced erythema 1.3. Anti-itch 1.4. Prevents formation of free radicals 1.5. Reduction of pro-inflammatory cytokines

2. Broad-spectrum antimicrobial 2.1. Mode of Action 2.2. Antibacterial & Anti-fungal Activity 2.3. Preservative capabilities

1. ANTI-INFLAMMATORY ACTIVITY

1.1 ANTI-IRRITANT

Superoxide is a common reactive form of oxygen that is formed when molecular oxygen gains a single electron. It is present in numerous biological oxidation reactions and is deployed by the immune system to protect against microorganisms. In the skin, an overproduction of superoxide can cause irritation. Melafresh™ T96 acts as an anti-irritant by suppressing the release of superoxide from neutrophils, eosinophils and leukocytes3.

1.2 REDUCTION OF UV-INDUCED ERYTHEMA

Sunburn is the commonly experienced cutaneous inflammation that occurs in response to acute over-exposure of the skin to ultraviolet radiation (UV). The classical characteristics of inflammation are erythema, oedema, increased tissue temperature and very marked increased of skin sensitivities to both thermal and mechanical stimuli emerge in response to ultraviolet radiation within the burn and are typically present for several days.

The Australian Photobiology Testing Facility at Sydney University compared the anti-inflammatory effectiveness of terpinen-4-ol (from tea tree oil), natural (-) α-bisabolol and indomethicin by determining their ability to reduce skin erythemal response induced by solar simulated UV on the dorsal skin of 31 subjects. They concluded that:

• 1% terpinen-4-ol is nearly as effective as 1% indomethacin in reducing UV-induced erythema33; • 0.5% terpinen-4-ol is equivalent to 0.5% natural (-) α-bisabolol in reducing UV-induced erythema33.




1.3 ANTI-ITCH

The itch is an irritating cutaneous sensation that produces a desire to scratch. Itchy skin can cause discomfort, embarrassment and distraction from the task at hand, and can result in complications, such as skin infections, if the condition becomes severe. Histamine is one of the main components that induces itching by exciting cutaneous sensory neurons. It is released from mast cells when tissues are inflamed or stimulated by allergens.

Melafresh™ T96 is a potent anti-inching agent which inhibits histamine release from mast cells32.

1.4 PREVENTION OF FREE RADICAL FORMATION

There are considerable evidences that free radicals induce oxidative damage to biomolecules. These damages accelerate aging, causes inflammation and loss in hydration as well as severe other conditions. Antioxidants, which scavenge free radicals, are known to possess an important role in preventing these free radical scavenging conditions.

Melafresh™ T96 prevents formation of free radicals by suppressing the release of superoxide from neutrophils, eosinophils and leukocytes3.

1.5 REDUCTION OF PROINFLAMMATORY CYTOKINES

Skin inflammation is linked to various skin problems including pruritus, dermatitis and infection. Less known, inflammation also caused premature aging by enhancing the expression of metalloprotease (MMP) in the dermis responsible to increase the collagen degradation.

Melafresh™ T96 prevents inflammation induced-skin aging by reducing the production of pro-inflammatory cytokines: TNF-α, IL-1β, IL-8 and PGE229,49.




2. ANTIMICROBIAL ACTIVITY

MECHANISM OF ACTION

It is known that tea tree oil works as an antimicrobial through several mechanisms, thereby reducing the possibility of developing resistance. These include13,14:

• Disruption of cell membrane; • Formation of extracellular blebs on membrane surface and leakage of

cytoplasm; • Inhibition of respiration.

This is an electron micro-graph on an E. coli cell magnified 7100X. It shows the physical effect TTO on the cell membrane. In particular the formation of the extracellular bleb with is later accompanied by leakage of cytoplasm21. Interestingly, recent evidences suggest that other components in Tea Tree Oil may actually reduce the effectiveness of Terpinen-4-ol against some microorganisms, at least in in vitro experiments14.

2.1 ANTIBACTERIAL & ANTI-FUNGAL ACTIVITY

Tea tree oil is effective in controlling bacteria, yeast and fungi that cause a variety of dermal conditions in skin care 1,20,22,28,45. In Table 1 below are the Minimum Inhibitory Concentrations (MIC) for Melafresh™ T96 versus pharmaceutical grade tea tree oil (TTO-PG).

Table 1. MINIMUM INHIBITORY CONCENTRATIONS (MIC) FOR MELAFRESH™ T96

Micro-organism TTO-PG Melafresh™ T96

Improved Efficacy

Application

Propionibacterium acne 0.50% 0.10% 5 X Anti-acne, skin care

Staphylococcus epidermidis 0.50% 0.25% 2 X Body odor

Malassezia furfur (P.ovales) 0.20% 0.05% 4 X Anti-dandruff, itchy scalp

Trichophyton mentagrophytes 0.40% 0.05% 8 X Anti-fungal, athlete's foot

Trichophyton rubrum 1.00% 0.05% 20 X Anti-fungal, nail care




Melafresh™ T96 is a broad-spectrum antimicrobial effective against a wide range of bacteria, yeast and fungi that cause a spoilage in product preservation. Table 2 below lists the Minimum Inhibitory Concentrations (MIC) for Melafresh™ T96 against the main microorganisms that are specified in the British Pharmacopeia preserve challenge test.

Table 2. – MIC RESULTS FOR MELAFRESH™ T96 FOR NATURAL PRESERVATIVE

When Melafresh™ T96 is incorporated at 0.1-0.2%, it would be expected to act as a preservation booster with anti-irritant effect, therefore allowing the formulator to reduce the usage levels of synthetic preservatives (e.g. parabens). The use of Melafresh™ T96 at dosage of >0.5% allows preservative free formulation.




DELIVERY SYSTEMS FOR MELAFRESH™ T96

Being lipophilic, there are limitations on the type of formulations Melafresh™ T96 can be used in. To address this, Southern Cross Botanicals has developed a range of delivery systems to meet the requirements of certain applications. The range of derivatives is as follows:

TRADE-NAME DESCRIPTION SPECIFICATION

PROPERTIES

Melafresh™ T96

CONCENTRATED low odor, highly active fraction of tea tree oil with antibacterial, anti-fungal and anti-irritant activity

Terpinen-4-ol 96% minimum.

Colorless mobile liquid

Oil soluble

Mild odor

Antimicrobial

Anti-inflammatory

Melafresh™ T10-SLR

with a slow-release delivery system

SLOW RELEASE cyclodextrin powder complex of 10% Melafresh™ T96


White powder

Not soluble in water or oil, solid in suspension

Virtually odorless

Antimicrobial

Anti-inflammatory

Melafresh™ T10-WS

WATER SOLUBLE 10% Melafresh™ T96 in aqueous micro-emulsion for clear gels, liquids and cleansers


Water soluble

Mild odor

Clear on dilution

Antimicrobial

Anti-inflammatory




CONCLUSION

Melafresh™ T96 is a universal and natural anti-inflammatory and antimicrobial active ingredient for cosmetics and personal care products. It is a safe natural active ingredient, which imparts an anti-irritant effect making it suitable for sensitive skin in either leave-on or rinse-off products. Applications include anti-aging, anti-acne, anti-dandruff, after-sun and deodorants. A range of derivatives offering water-soluble, Melafresh™ T10-WS, or slow-release delivery system, Melafresh™ T10-SLR, are available to suit the formulation.

COSMETIC APPLICATIONS

• Skin Care • Acne-prone skin • Sensitive skin • After-sun • Hair Care • Anti-dandruff • Anti-aging

• Irritated scalp • Sun care • Feminine wash • Deodorant • Foot Care • Oral Care • Preservative booster

RECOMMENDATION FOR USE

Melafresh™ T96 is recommended to be incorporated at the end of the process, at a temperature below 40⁰C.

RECOMMENDED DOSAGE:

0.2-1%




ADDITIONAL

INFORMATION




Melafresh™ T10-WS

INCI NAME

CAS

EINECS

Water (1) (and) PEG 40 Hydrogenated Castor Oil (2) (and) Polysorbate 20 (3) (and) 4-Terpineol (4)

7732-18-5 (1), 61788-85-0 (2), 9005-64-5 (3), 562-74-3 (4)

231-791-2 (1), 500-147-5 (2), 500-018-3 (3), 209-235-5 (4)

ORIGIN Melafresh™ T10-WS is a water soluble version of a pure form of terpinen-4-ol, the active ingredient naturally present in tea tree (Melaleuca alternifola) oil, concentrated at 10%.

COSMETIC PROPERTIES • Strong antimicrobial activity • Strong anti-inflammatory activity

SKIN BENEFITS /



• Irritated scalp • Feminine wash • Foot Care • Oral Care • Preservative booster

RECOMMENDED

DOSAGE 2-5 %







Melafresh™ T10-SLR

INCI NAME

CAS

EINECS

Cyclodextrin (1) (and) 4-Terpineol (2)

7585-39-9 (1), 562-74-3 (2)

231-493-2 (1), 209-235-5 (2)

ORIGIN Melafresh™ T10-SLR is a pure form of terpinen-4-ol, the active ingredient naturally present in tea tree (Melaleuca alternifola) oil, concentrated at 10% and encapsulated in cyclodextrin which allows a slow release of the active ingredient for longer action.

COSMETIC PROPERTIES • Strong antimicrobial activity • Strong anti-inflammatory activity

SKIN BENEFITS /



• Irritated scalp • Feminine wash • Foot Care • Oral Care • Preservative booster

RECOMMENDED

DOSAGE 1-5%







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