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CAMPO RESEARCH PTE LTD Level 30, 6 Battery Road, Singapore 049909 Tel: (65) 63833203 / 202 / 63833631 Direct Fax (65) 63833632 / 63834034 Email: [email protected] Website: http///www.campo-research.com Internet-Video-Phone Teleconferencing: [email protected] For Technical Assistance CAMPO® Multi-Purpose Cosmetic Base Chemicals & Active Ingredients CAMPO® Novel Functional Active Cosmetic Ingredient & Raw Materials Novel functional ingredients for multi-purpose formulations

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Page 1: Novel functional ingredients for multi-purpose …...CAMPO® Novel Functional Active Cosmetic Ingredient & Raw Materials Novel functional ingredients for multi-purpose formulations

CAMPO RESEARCH PTE LTD

Level 30, 6 Battery Road, Singapore 049909

Tel: (65) 63833203 / 202 / 63833631 Direct Fax (65) 63833632 / 63834034

Email: [email protected] Website: http///www.campo-research.com Internet-Video-Phone Teleconferencing: [email protected] For Technical Assistance

CAMPO® Multi-Purpose Cosmetic Base Chemicals & Active Ingredients

CAMPO® Novel Functional Active Cosmetic Ingredient & Raw Materials

Novel functional ingredients for

multi-purpose formulations

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Campo Biotechnological Herbal Vegetal Cholesterol Extract

CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 2

Ask about our Herbal Natural Products Chemistry Consultancy Services -Product Registration EEC/UK New Drug Development (NDA-US); Quasi-Drug Topicals (MOHW_Japan); Development of Standards, Analysis & Profiles of Phytochemicals; Literature searches, Cultivation of Medicinal Plants, Clinical-Trials, Development of new uses for Phytochemicals and Extracts; Contract Research and Development Work in Natural Products for Novel Drugs, New Cosmetic Active Ingredients for Active Topica/OTC Cosmetic with functionality and Consumer-preceivable immediate-results, New Food Ingredients for Nutraceuticals & Functional Foods.

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Campo Biotechnological Herbal Vegetal Cholesterol Extract

CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 3

PRODUCT INFORMATION

CAMPO MUTHU THULASI CHOLESTEROL 10

CAMPO MUTHU THULASI CHOLESTEROL 10 SE

VEGETAL CHOLESTEROL (FROM BIOTECHNOLOGICAL OLIVE FRUIT CELLS)

A PRODUCT INFORMATION BRIEF-

(these ingredients ex-olive fruits cells are available on request)

VEGETAL LANOLIN - AN INTRODUCTION

An Overview of the present position of vegetable derived Lanolin with regard to its

physical quality, purity, allergenicity, and effectiveness in comparision to the animal-

derived lanolin.

VEGETAL LANOLIN- COSMETIC GRADES

Cosmetic Grade A and Cosmetic Grade B

Lanolin, vegetal

Isopropyl Myristate

Isopropyl palmitate

Campo HERB-ACELAN LD Campo Herb Acelan SD TOXICOLOGICAL & ECOTOXICOLOGICAL DATA

The MATREX

VEGETAL LANOLIN & BIOTECHNOLOGICAL VEGETAL ISOPROPYL

ESTERS (BIOTECHNOLOGICAL VEGETAL CHOLESTEROL ESTERS) BLEND

(Campolan 1, Campolan 2, and Campolan 3).

SOLUBILISED ACETYLATED VEGETAL LANOLIN ALCOHOL DERIVATIVE -

Liquid (Campo Herb-Acelan LD)

ACETYLATED VEGETAL LANOLIN-Soft Solid

(Campo Acelan SD)

Matrix In-Vivo Toxicity Testing Systems

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Campo Biotechnological Herbal Vegetal Cholesterol Extract

CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 4

Biotechnologic herbs’ eextracts for alternative animal-identical & human-

skin identical functionally active - cosmetic ingredients as true non-cruelty

replacement for cruel animal-based cosmetic ingredients & raw materials.

Product Information

BIOTECHNOLOGIC HERBS and Plants are novel State-of-Art Plants and Herbs, which

are genetically manipulated with DNA and viable Genes from sources in Animal Kingdom.

The resultant Biotechnologic hybrids are identical to the normal species of plants, but

certain parts of these Biotechnologic species exhibits the required necessary properties and

functions which are previously possibly obtained only from 'cruelty to animal-sources' such

as placental, Hyaluronic acid, lipids, collagens, foetal extracts, and many others.

Biotechnologic Herbs Extract as an Alternative Animal-Identical and Human-Skin Identical

Cosmetic Ingredients are a true novel replacement and cruelty-free alternative to the

"Animal-Cruelty" sourced functional cosmetic ingredients.

Campo Vegetal CHOLESTEROL Extracts which is VCE in short is extracted from

Mexican Skin-Tree inner-bark cells which are genetically manipulated with BOVINE-

WOOI-WAX & LIPIDS forming Cells’- DNA scripts (from genetic material that is

responsible for the formation of the sterol).

As Mexican Skin-Tree (Mimosa ternuiflora) as a skin-and hair-regeneration traditional

remedy is well known in catastrophic events of Mexican Gas Explosion in 1984 and Mexico

City Earthquake in 1987. When in both cases, a million burn victims were treated for severe

to light burn skin-conditions, as medical supplies were non- existent, in these 2 national

disasters, with the Mexican Tepescohuite, which in Spanish simply means Skin-Tree.

The Biotechnologic Mexican Skin-Tree cells are novelty which are more prolific and

enhanced in its activity of re-generation of the cellular structures and contains a cocktail of

sterols - high molecular weight alcohol characterised structurally by the presence of a

saturated phenanthrene ring systems, having an additional five membered ring fused at the

1,2 position.

The principal sterol being Cholesterol occurring in its free state and or as fatty acid esters,

identical, in cholesterol formation and functions as to that presently found viable and

exclusively only in the animal sources.

In general, these vegetal cholesterol are identical in its moisturising and emulsified water

retention to the skin functions and in its many other characteristics as the animal sourced

cholesterol; which functions by holding emulsified water to the skin as a moisturiser in

similar manner as the human-skin lipids.

Vegetal Cholesterol has the unique character to impart its property as above mention, to

other waxes and fats in a formulary; apart from this moisturising, Vegetal Cholesterol aids

in modifying the occlusiveness of the fatty and oily films, as the natural human-skin

cholesterol functions does.

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Campo Biotechnological Herbal Vegetal Cholesterol Extract

CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 5

Vegetal Cholesterol is positively as known from various tests and assays is a natural

Animal-Cruelty-Free and Human skin-identical natural emollient and moisturiser of the

skin.

Vegetal Cholesterol is water in oil emulsifying agent, which may be used as a primary

emulsifier in water in oil ointment, creams and lotions.

Vegetal Cholesterol is a primary non-irritation and can be safely recommended for reducing

the irritation and defatting action of soaps and detergents. Tests have shown that Vegetal

Cholesterol in the soap lather in the emulsified form can readily penetrates the epidermis

and imparts suppleness.

Vegetal Cholesterol can be used in "All Cruelty Free" skincare preparation, as an emollient

moisturising additive, which exhibit unique surface activity, emollience, superfatting

properties and can be incorporated in as a functional additive for medicated and non-

medicated shampoos, cleansing, cold, nourishing, moisturising hair preparation and other

skin preparations for skin-softening and improving skin textures.

Therefore, the functional Alternative Animal-Identical and Human-Skin-identical

Biotechnological vegetal sourced novel active cosmetic ingredients presents a uniquely

viable marketing strategy in an era of Anti-Animal Vissisection & Cruelty-Free and Vegan -

& Green consciousness. VCE as active ingredients which are uniquely functional and active

in formulations:

Anti-cellulite, body contour reflex, treatment of body-zones with weak connective tissues,

massage formulations, facial skin re-generation, skin & bruises rapid healing, after-

shaves, after-sun, anti-acne treatment, day & night moisturisers, insect-bite-anti-

irritation; snow & sun chapped irritated skin, regeneration & reversing of aged skin; and

baby-skin formulas.

Other non-specific functions are decrease in the water evaporation and increase in moisture-

absorbency/retention rate of corny layer which is re-adjusted to a silky smooth surface

instead hard, corny, unregulated, and uneven surface of the skin.

VCE can be manufactured to USPXXVII (NMMII) specification on custom-request.

CAMPO R&D BIOTECHNOLOGICAL Cosmetic Ingredients Div.

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Campo Biotechnological Herbal Vegetal Cholesterol Extract

CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 6

Biotechnological herbs’ eextracts for alternative animal-identical & human-

skin identical functionally active - cosmetic ingredients as true non-cruelty

replacement for cruel animal-based cosmetic ingredients & raw materials.

VCE Product Specification

USPXXII/NFXVII Specification

Product Name: Campo Muthu-Thulasi

Cholesterol 10

(USP/NF Equivalent)

Syn. Name: Vegetal Cholesterol Extract (Bovine-Identical)

CTFA/INCI Name: (proposed) Cholesterol Extract

Product #: Biotechnologic Cholesterol 10 equal USP/NF

Appearance (25C) white crystalline powder

Solubility (1% in ETOH) no deposit or turbidity after solubilising

Melting point 147-150C

(By capillary)

Specific rotation -38 to -34 deg.

(2% in dioxane)

Acidity 0.3 ml max

(0.5M sulfuric)

Loss on drying (1g) 0.3%

Sulfated ash 0.1%

Microbiological characteristic

Total aerobic bacteria 100 opg max

Yeasts & moulds 100 opg max

Gram-negative bacteria not detected/nil

Shelf life: approx. > 24 months

CAMPO R&D

BIOTECHNOLOGIC Cosmetic Ingredients Div.

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Campo Biotechnological Herbal Vegetal Cholesterol Extract

CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 7

Biotechnologic herbs’ eextracts for alternative animal-identical & human-

skin identical functionally active - cosmetic ingredients as true non-cruelty

replacement for cruel animal-based cosmetic ingredients & raw materials.

VCE Product Specification

Specification

Product Name: Campo Muthu-Thulasi Cholesterol 10 SE

Syn. Name: Vegetal Cholesterol Extract (Bovine-Identical)

Product #: Biotechnologic Cholesterol 10 SE

CTFA/ INCI Name (proposed) Cholesterol Extract

CAS #

EINECS NAME

EINECS #

Appearance (25C) yellow viscous liquid

Odor (physical) slight characteristic

Color (gardener) 2.5 max

Acid value (BS 684) 0.05 max

Saponification value 85 - 107.0

(BS684 at 4 hours)

Hydroxyl value 5.00 max

Iodine value (WIJ’s) 20.00 - 36.00

Volatile (%) 0.30% max

(5g 105C at 1 hour)

Ash % 0.100 % max

Heavy metal (PPM) 20 max

Arsenic (PPM) 2 max

Water content 1-% max

(Karl Fisher)

Shelf life: approx. > 24 months

CAMPO R&D

BIOTECHNOLOGICAL Cosmetic Ingredients Div.

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Campo Biotechnological Herbal Vegetal Cholesterol Extract

CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 8

Mexican Skin Tree -Tepescohuites (a Biotechnologic version grown as Bonsai)

More Vegetal Cholesterol FROM BIOTECHNOLOGIC OLIVE FRUIT CELLS Are Also Available n Request

Vegetal Cholesterol (isolated from Biotechnologic olive fruit cells)

Vegetal Cholesterol CAM-1 (USP equivalent), vegetal Cholesterol CAM-2 (Grade A) and

Vegetal Cholesterol CAM-3 are three grades available of Vegetal Cholesterol range. CAM-

1 and CAM-2 are white crystalline powders and CAM-3 (50% cholesterol) is a hard yellow

wax, melting at approximately 50C. CAM-2 and CAM-3 are acceptable for most cosmetic

applications. The CAM-1 grade can be used in pharmaceutical compositions and where only

the purest of raw materials are acceptable.

Vegetal Cholesterol is identical to the most common animal derived sterol-“cholesterol”. In

animals, it occurs in its free state or as fatty acid esters in all animal tissues where it

participates in the skin’s protective mechanism. The importance of animal cholesterol in

cosmetics is related to this mechanism where it functions as a natural moisturizing agent.

Vegetal Cholesterol confers this mechanism and its moisturizing effect on other fats and

waxes making it possible to formulate products which stimulate the natural properties of

skin in lipids, Vegetal Cholesterol is a powerful water in oil emulsifying agent. In oil in

water creams it functions as an auxiliary emulsifier. The super fatting properties of vegetal

cholesterol are identical as animal cholesterol and can be important in counteracting the

degreasing effect of detergents or solvent compositions.

Vegetal Cholesterol is recommended for use in all skin care cosmetics. In addition, it can be

claimed to be effective conditioner in hair and scalp treatment as that claimed for animal

derived cholesterol.

Contact Campo Research email: [email protected]

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Campo Biotechnological Herbal Vegetal Cholesterol Extract

CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 9

VEGETAL LANOLIN - THE FUTURE ??? An overview of the present position of vegetable derived lanolin with regard to its physical quality, purity, allergenicity and effectiveness in comparison to animal-derived lanolin Introduction Vegetable Lanolin is not described nor specified in any national or intra-regional or international pharmacopoeias. However these non-specifications for vegetal lanolin or vegetable lanolin in pharmacopoeias give very little insight into the advanced materials - (Vegetable Lanolin also referred to as Vegetal Lanolin) produced by modern biotechnological advances in mass-tissue-culture of Biotechnologic olive fruit cells. While the specifications for animal-derived Lanolin contained within official standards such as BP, PhEur, USP, JP etc have changed very little in the last twenty-five years. On the other hand, the demand for 'true green and natural' with safer; with ever better quality and purity, channels the demand and availability of competitive Biotechnologic vegetal-origin materials, that are 'easy on the collective conscious mind of green consumer's; have resulted in considerable developments in Biotechnologic vegetable lanolin technology. These changes were stimulated by the exclusive close relationship between vegetable lanolin manufacturer - Campo and the cosmetics & pharmaceutical industry. Because pharmacopoeial review is very slow process, many of these quality enhancements are not yet integrated into the pharmacopoeias - some probably never will be in the present century. Accordingly, formulators who are not conversant with the situation will be given a false impression of modern vegetable lanolin if the vegetable lanolin and its specification are not quoted in these 'official' sources are regarded as definitive 'negative' status. Color and Odor For animal derived lanolin, neither of these parameters (color and odor) are quantitatively defined in the pharmacopoeias. Color is usually described as 'yellow' and the odor defined as 'characteristic'. These descriptions are quite meaningless to the formulator and do not provide an acceptable threshold of acceptability. This allows for a variety of qualities of animal derived lanolin to be available within the marketplace and on balance, gives a poor impression of the very high qualities of vegetable lanolin which are now available. ln order to establish a quantitative definition of color, vegetable lanolin users (most of Campo's Clients) agree on the use of the Gardner color scale as the most practical method of color control. Most manufacturers of animal lanolin are quite capable of providing material with Gardner colors of 8,9 or 10. These are typical of the cosmetic and pharmaceutical grades used over the last 25 years. However, to the contrary, in vegetable lanolin production, lower color intensity level of 8,7, 6, 5, 4, 3 and specialty vegetal lanolin with colors of much lower levels are available. In regard to odor, the modern vegetable lanolin standard is essentially odorless. Animal lanolin manufacture requires automatically to incorporate a de-odorisation step which results in toxic chemicals waste streams which are environmentally undesirable and lack of odor is a prerequisite for almost all lanolin users (animal derived and vegetable derived) users. The traditional principle of a 'characteristic' odor is simply not acceptable. Now, more with the advent of the novel vegetable-derived animal-identical lanolin of Biotechnologic means, odorless has become the standard for even for animal lanolin. The quantitation of odor using electronic sensing devices is seen to be the logical next step and we at Campo has arrived at its threshold and are working closely with the Japanese partner- a world leader in such technology. Purity Like many other natural derivatives and the animal derived lanolin; to which the vegetable derived lanolin has been compared with; and criticized over possible contamination with

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CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 10

traces of pesticides. The animal derived lanolin market has today established a standard of purity which, in broad terms, equates with the regulations covering foodstuffs. Indeed, naturally the purity of modern vegetable lanolin astronomically exceeds the standards required in the food area and animal-derived lanolin's' area and is rigorously tested using the most sophisticated analytical techniques to support its (vegetal lanolin) "as no pesticides used". Pesticides are not required in tissue culture callus cultivation of the olive fruit cells. On the other hand, for animal-derived lanolin, the need for pesticide residue purity has recently been recognized by the United States Pharmacopoeia (USP) and a revised specification is now in place and which provides appropriate assurances on pesticide residues. Indeed, two new specifications have been issued for animal-derived lanolin. The one covering pharmaceutical/medical applications ('Modified Lanolin USP') contains a residual pesticide specification of 3 PPM maximum total for all pesticide component substances and no individual substance shall exceed 1 PPM. The European Pharmacopoeia (PhEur) has issued a revised specification for animal-derived lanolin during 1996. The residual pesticide (PhEur) specification will equate with the 3/1-PPM limits of USP. In the vegetable lanolin arena, pesticide residual do not exists and is considered an antiquated past to screen for pesticide for modern vegetable lanolin's available from Campo. Allergy Sulzberger in New York conducted the first scientific study into the allergenicity of animal derived lanolin during the early 50's. The study involved over one thousand people who were regularly attending New York University Hospital, Skin and Cancer Unit. All patients were suffering from eczematous skin conditions. Animal derived lanolin based creams had been used for many years to treat these conditions and most patients improved through its use. However, the study showed that 1.14-% of these particular patients showed an adverse reaction to lanolin. Sulzberger presented his findings in two reports dated 1950 and 1953 (1,2). The cosmetics/pharmaceutical press published the results, and concluded that over 1% of the general population of New York were allergic to animal-derived lanolin! The following 30 years, animal lanolin was known to be an allergen. The result - Specific lanolin allergy, (3) and the manufacture of so called hypoallergenic animal lanolin has been established to provide for these situations. Hypoallergenic animal-derived lanolin is material containing a reduced level of free lanolin alcohols, the component believed to contain the allergenic factor-excessive free lanolin alcohols (4). The USP has acknowledged the value of such an animal-derived lanolin grade and incorporated the relevant parameters into the 'Modified Lanolin' monograph (as limit of maximum 6% free lanolin alcohol). In the case of vegetable-derived lanolin, as the free lanolin alcohol is totally non-existent and nil, as the Biotechnologic olive fruit cells' genetic makeup are inhibited from producing any free lanolin alcohols in the complex mechanism to produce vegetal lanolins. Effectiveness Vegetable lanolin is a truly multifunctional material, though its supreme emolliency is perhaps its best-known property. Its ability to moisturize the skin as true human-identical moisturizing factor is no doubt related to its water binding capacity and its skin-substantive enzymatic functions. Campo-manufactured vegetable lanolins can meet the aspect is that is legislated for animal lanolin by the water absorption tests demanded by BP and PhEur. Most grades of animal derived lanolin and lanolin derivatives have inferior water holding capacity and will therefore be less effective moisturizers like that of animal-derived lanolin BP /PhEur.

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CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 11

The supreme emolliency of vegetable lanolin as equal to animal Lanolin BP/PhEur was quantified through a series of studies undertaken by Campo in 1990-93. These involved Skin Profilometry, Intracomeal Cohesography and Skin Elasticity. These evaluation assays prove, beyond doubt, the effectiveness of vegetable lanolin as a skin conditioner. Copies of these extensive reports (5) are available on request. Availability Vegetable Derived Lanolins (Campo Vegetal Lanolins) which fully comply with the quality parameters discussed above are available from Campo. We are able to provide material, which conforms to all pharmacopoeial requirements or indeed, to our clients' special needs and requirements References 1 Sulzberger M B, Lazar M P:A study of the allergenic constituents of lanolin (wool

fat) : J Invest Dermatol: 15:453-458:1950 2 Sulzberger M B, Warshaw T, Herrmann F : Studies of skin-hypersensitivity to lanolin

: J Invest Dermatol : 20:33-43:1953 3 Clark E W: Estimation of the general incidence of specific lanolin allergy : J Soc

Cosmet Chem 26:323-335;1975 4 Clark E W, Blondeel A, Cronin E, Olefte J A, Wilkinson D S : Lanolin of reduced

sensitisation potential : Contact Dermatitise: 7:80-83:1981 5 Campo Eisai In-house literature (12,000 pages): The Emollient properties of Vegetal

Lanolin of Biotechnologic olive fruit cells origins (In Japanese) 1991-1993

VEGETAL LANOLIN

STRUCTURE- MICROSCOPE PICTOGRAPH

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CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 12

Product Information A novel natural green cosmetic active ingredient ' Vegetal Lanolin, cosmetic grade' that is manufactured to match all the specifications of the USP and BP for the animal-derived lanolin except the melting point which was Biotechnologically designed to have a slightly higher melting point. As

this increase of melting point (41 C - 50 C) is a desirable property in all cosmetic formulations based on vegetal lanolins, as known empirically but was not achieved previously for animal-derived lanolin. Vegetal lanolin CG functions as a wetting/dispersing agent in lipophilic media, as a co-solvent, plasticiser, powerful but gentle water in oil emulsifier as well as stabilizer for both oil in water and water in oil emulsions- (which both types of emulsions' stability are improved with this vegetal lanolin as additive), super fatting, emollient, moisturizing and conditioning agent. Vegetal lanolin CG can be safely used in virtually all-cosmetic preparations, as it is a superb emollient, making the skin soft and supple Product Name: Vegetal Lanolin, Cosmetic Grade A Vegetal Lanolin CGB Other Syn. Names Vegetable Lanolin, cosmetic grade A Vegetable Lanolin, CG B Vegetal Lanolin CG A Vegetal Lanolin CG B Product Code# VLCG 1993-010-02-01A VLCG 1993-010-02-02A CTFA/ INCI Name Lanolin Lanolin CAS# 8006-54-0 8006-54-0 EINECS Name Lanolin, vegetal Lanolin, vegetal EINECS# 232-348-6 232-348-6

Plant Parts used Biotechnologic Olive Fruit cells line#10-02 Technical Specification

Appearance (25 C) Yellow stiffed mass Yellow soft mass Appearance (molten) Clear Clear Color (Gardener) 8 max. GARDENER 8 max Acid value (BS684) 1 max MG KOH/G 1 max Saponification value 85-109 MG KOH/G 85 - 109 (BS648 - 4hours) Peroxide value 20 max 20 max Volatile content 10G 0.5 % max 0.5 % max (BS648) Ash Content (BS648) 0.05% max 0.15%

Mettler Drop Point 41 - 50 C 38 - 44C (For vegetal lanolins) Pesticide Content (OC/OP) Nil Nil Campo Vegetal Lanolin CG A and Campo Vegetal Lanolin CG B are now well-established as cosmetic and pharmaceutical raw material and was used as an exclusive additive in several major international brands (cosmetics, pharmaceutical OTC) as a raw material with no special hazards. Campo Research Eisai biotech labs.1994-10-02 vegetal lanolin cosmetic grade

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CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 13

Product Information Campolan (Liquid Vegetal Lanolin and Biotechnologic vegetal isopropyl esters blend)

This one of its kind novel cosmetic active ingredient combines the emollient effect of vegetal lanolin

with solvency of Biotechnologic vegetal isopropyl esters (vegetal cholesterol and its derivative

cholesterol esters) in a clear liquid form.

Campo develop three Campolan vegetal lanolin grades based on the astronomically demand for

these vegetable -derivatives, which are presently used in various many internationally popular

cosmetic brands' formulations.

Campolan 1 containing approximately a ratio of 1:1 vegetal lanolin CG*: Biotechnologic vegetal

isopropyl esters. (Approx. 50% 0f each material)

Campolan 2 containing approximately a ratio of 1:2.5 vegetal lanolin CG*: Biotechnologic vegetal

isopropyl esters. (Approx. 30% of vegetal lanolin CG & 70% IPE)

Campolan 3 containing approximately a ratio of 1:3 vegetal lanolin CG*: Biotechnologic vegetal

isopropyl esters. (Approx. 20-25% of vegetal lanolin CG & 75-80% Isopropyl esters)

CG * = Vegetal Lanolin, Cosmetic Grade (see specification elsewhere)

Features 1. greaseless emollience 2. solvents/plasticisers 3. high lanolin content 4. compatible with most fats and waxes used in cosmetics

Campolans are extremely effective greaseless emollients and co-solvents, imparting a soft,

soothing effect to the skin,

Campolans contains Biotechnologic vegetable-derived cholesterol and its esters (as Biotechnologic

vegetal isopropyl esters) as oil-soluble liquid and combine the advantageous properties of both

vegetal-derived materials (vegetal lanolin and vegetal cholesterols)

Applications

1 baby oils and lotions

2 hair and skin care applications

3 Shaving creams

4 nail lacquer removers

5 Lipsticks

6 bath-oils

Campolans enable the formulation of cosmetics with superior spreading characteristics which

deposits a molecular size thin, highly water-resistant, non-greasy emollients film on the skin.

Addition of Campolan into cosmetic formulations allows the production of clear, liquid, non-sticky

highly emollient preparations.

CTFA/INCI NAME (proposed)

CAMPOLAN 1 - ISOPROPYL MYRISTATE (AND) LANOLIN OIL

CAMPOLAN 2 - ISOPROPYL MYRISTATE (AND) LANOLIN OIL

CAMPOLAN 3 - ISOPROPYL PALMITATE (AND) LANOLIN OIL

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CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 14

Lanolin, vegetal

CAS# 8006-54-0

EINECS Name Lanolin, vegetal

EINECS# 232-348-6

Isopropyl Myristate

CAS# 110-27-4

EINECS Name Isopropyl Myristate

EINECS # 203-751-4

Isopropyl palmitate

CAS# 142-91-6

EINECS Name Isopropyl palmitate

EINECS # 205-571-1

Specifications

Campolan 1 Campolan 2 Campolan 3 Appearance Yellow, clear liquid Yellow, clear liquid Yellow, clear liquid Color (Gardner) 7 max 6 max 7 max Saponification value 150 - 163 168 - 182 142 - 166 Acid value 2 max 2 max 2 max

Cloud point 10 C 10 C 13 C

Pour point -1C -1C -1C

Campolans are well established (1994-97) in various many well-known brands' formulations

under exclusivity, and generally now considered as cosmetic ingredients that presents no special

hazards.

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CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 15

Product information

Campo HERB-ACELAN LD (Solubilised acetylated vegetal lanolin alcohol derivative)

Campo Herb-Acelan LD is a multi-functional vegetable-derived surface active emollient, which can

be employed in almost all types of cosmetic preparations.

Product Name Campo Herb Acelan LD Other Syn. Name Solubilised acetylated vegetal lanolin alcohol derivative)

Product # VLSA-1993-0190-03 ACELAN LD

Plant Parts used for extraction of Vegetal Lanolin :

Biotechnologic Mexican Skin Tree (Mimosa terniflora) bark cells line#10-02ace var.# 95

CTFA/INCI Nomenclature (proposed)

Campo Herb Acelan LD - polysorbate 80 (and) Acetate (and) Acetylated Lanolin Alcohols

Features

emollient

conditioner

emulsifier

solubiliser

plasticiser

wetting agent

Applications Campo Herb-Acelan LD is soluble in both ethanol and water, a useful emollient in aqueous,

aqueous- alcoholic and alcoholic compositions, in which, its functions are also a solubiliser

for perfumes and other in-soluble matter.

Campo Herb-Acelan LD can be used as emollient systems, which will not tolerate lipophilic

materials (e.g. Detergent systems).

HAIR CARE

In alcoholic hair-styling preparations, both aerosol and non-aerosol, Campo Herb-Acelan LD

functions as resin modifier or plasticiser, improving the overall gloss and reducing the

flaking of resin on the hair.

In aqueous and aqueous-alcoholic lotions, sprays and gel, in addition to its role as a film

modifier; Campo Herb-Acelan LD will also acts a perfume solubiliser ensuring a crystal clear

solution/preparation.

In aerosol styling mousses Campo Herb Acelan LD will improve foam stability and

emulsification of the propellant into the concentrate.

When used as a conditioner agent in shampoo, Campo Herb Acelan LD improves sheen and

handling of the hair. This novel ingredient helps to reduce static build-up and imparts a

general improvement in manageability and appearance. In this role, this ingredient does not

interfere with foam volume or stability.

Campo Herb Acelan LD may be included in hair conditioning cream rinses to modify

emulsion texture and viscosity. In clear conditioning rinses it functions as a water-soluble

super-fatting conditioner and perfume solubiliser.

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SKIN CARE PREPARATIONS

Campo Herb Acelan LD is frequently now used in a variety of make up composition including

facial foundation creams/lotion, facemask and eye -liners.

In these types of preparations, Campo Herb Acelan LD functions as primary or secondary oil

in water emulsifier or solubiliser pigment wetting aid, of plasticiser in preparations

containing polymers.

Campo Herb Acelan LD can be incorporated into nail varnish removers as a superfatting

agent to help prevent dryness and whitening of the skin surrounding the nail.

Campo Herb Acelan LD; in perfumery compositions for formulations such as body

fresheners or colognes; be employed as solubiliser and an aqueous-alcoholic emollient.

In skin creams and lotions including sunscreen and after-sun preparations.

Campo Herb Acelan LD functions as the primary or secondary emulsifier, to aid improved

emulsion stability.

In toiletry preparations such as foam baths, liquid soaps, facial cleanser, shower shampoo

and anti-perspirants; Campo Herb Acelan LD functions as both an emulsifier and an

emollient.

Specification

Appearance Yellow, clear liquid

Color (Gardener) 8 max

Acid value 1.5 max

Saponification value 63 - 73

Iodine value 16 - 22

Viscosity 25 C (cPs) 300 - 400

Hydroxyl value 55 - 75

Odor Mild, olive fruit characteristic

Physiological data

Campo Herb Acelan LD is know established (1993-96 under exclusive use) in various

international popular brands' cosmetic preparations and in general now consider as a

cosmetic raw material with no special hazard.

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Product Information

Campo Herb Acelan SD (Acetylated Vegetal Lanolin- soft solid)

A novel natural green cosmetic active ingredient ' Campo Herb Acelan SD - Acetylated Vegetal

Lanolin -a soft solid, which is a more hydrophobic than the animal-derived version. Yet Campo

Herb Acelan SD - Acetylated Vegetal Lanolin retains the protective and conditioning properties of all

manufactured animal-derived lanolin in the specifications of the USP and BP.

Biotechnologically designed Acetylated Vegetal Lanolin (Campo Herb Acelan SD) is an ideal

component of anhydrous systems for both hair and skin care preparations.

Campo Herb Acelan SD, in protective composition such as baby creams and oils; repels urine, water

and water borne irritants.

Acetylated Vegetal lanolin SD can be safely used in virtually all-cosmetic preparations, as it is a

superb emollient, making the skin soft and supple

Product Name: Campo Herb Acelan SD

Other Syn. Names Acetylated Vegetable Lanolin, cosmetic grade

Acetylated Vegetal Lanolin CG

Acetylated Vegetal Lanolin SD, Cosmetic Grade

Product Code# VLCG 1993-010-02-01OO SDA

CTFA/INCI Nomenclature (proposed)

Campo Herb Acelan SD - Acetylated Lanolin Alcohol

CAS# 8006-54-0 8006-54-0

EINECS Name Lanolin, vegetal Lanolin, vegetal

EINECS# 232-348-6 232-348-6

Plant Parts used Biotechnologic Mexican Skin Tree bark cells

line#10-02ace var.

Technical Specification

Appearance (25 C) Yellow soft mass

Appearance (molten) Clear

Color (Gardener) 8 max. GARDENER

Acid value (BS684) 3 max MG KOH/G

Saponification value 110 - 145 MG KOH/G

(BS648 - 4hours)

Hydroxyl value 20 max MG/KOH/G

Ash Content (BS648) 0.05% max

Melting Point 41 - 50 C

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Pesticide Content (OC/OP) Nil

Campo Herb Acelan SD Acetylated Vegetal Lanolin are now well-established (1994-1196) as

cosmetic and pharmaceutical raw material and was used as an exclusive additive in several major

international brands (cosmetics, pharmaceutical OTC) and now considered as a raw material with no

special hazards.

Campo Research Eisai biotech labs.

Acetylated vegetal lanolin cosmetic grade

Mexican Skin Tree - a Biotechnologic dwarf version cultivated as a Japanese bonsai Art

Mimosa terniflora L., (spanish: Tepescohuites)

VEGETAL CHOLESTROL STRUCTURE – MICROSCOPE PICTOGRAPH

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CAMPOLAN 1

THE ACTIVE NOVEL DRUG FOR THE COSMETIC FORMULATION

TOXICOLOGICAL & ECOTOXICOLOGICAL DATA

TOLERANCE As to ensure a good level of innocuity CAMPOLAN 1 was tested in in-vitro as follows:

*Irritation potential of the chorio-allantoic membrane of an egg.

When tested on the chorio-allantoic membrane of a chicken egg, according to the technique developed by

LUEPKE** in a 90% liposoluble solution, CAMPOLAN 1 is classified as non irritant.

**LUEPKE, N.P., Hen’s egg chorio-allantoic membrane test for irritation potentiation. Fd. Chem. 1986, 24, 6-

7, 495-496.

* Cytotoxicity on human fibroblasts.

When tested on human fibroblasts using a method patented by BIOGIR (which can be applied to both

hydrosoluble as well as liposoluble products). CAMPOLAN 1 in a 50% active aqueous phase or oily phase,

does not show any signs of toxicity towards fibroblasts in culture.

* Eyetex According to this technique, in a 75% active solution, CAMPOLAN 1 is classified non-irritant.

* Skintex

According to this technique, in a 50% active solution, CAMPOLAN 1 is non irritant. This tolerance data is

confirmed by the tests carried out in vivo on health humans.

* Test on healthy humans

When patch tests were carried out at increasing concentrations (0.5%, 1.1%, 2.2%, 4.7%, 10% & 100%) on 10

subjects, CAMPOLAN 1 did not show any significant irritant reaction at all. Its tolerance is total satisfactory.

COMEDOGENESIS CAMPOLAN 1 was tested in a 100% active concentrate solution on human volunteers, according to the usual

protocols has proven to be free of comedogenic effect.

Because of its good level of innocuity. CAMPOLAN 1 has proved to be first class skin moisturizer and

transepidermal water loss barrier for very many skin moisturizing formulae where tolerance is imperative (

skin moisturizing cream, moisturizing lotion, etc.).

BIODEGRADABILITY

The ultimate aerobic biodegradability of CAMPOLAN 1 is measured according to STRUM TEST (OCDE 301

B, guideline EEC 84/449, Annex V. Method C5).

Under these conditions, a level of biodegradability of CAMPOLAN 1 is 100% in 28 days at 50 mg/ml.

The level of biodegradability of CAMPOLAN 1 is considered to be excellent.

Campo Research Singapore

May 10th

1997

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CAMPOLAN 2

THE ACTIVE NOVEL DRUG FOR THE COSMETIC FORMULATION

TOXICOLOGICAL & ECOTOXICOLOGICAL DATA

TOLERANCE As to ensure a good level of innocuity CAMPOLAN 2 was tested in in-vitro as follows:

*Irritation potential of the chorio-allantoic membrane of an egg.

When tested on the chorio-allantoic membrane of a chicken egg, according to the technique developed by

LUEPKE** in a 50% liposoluble solution, CAMPOLAN 2 is classified as non irritant.

**LUEPKE, N.P., Hen’s egg chorio-allantoic membrane test for irritation potentiation. Fd. Chem. 1986, 24, 6-

7, 495-496.

* Cytotoxicity on human fibroblasts.

When tested on human fibroblasts using a method patented by BIOGIR (which can be applied to both

hydrosoluble as well as liposoluble products). CAMPOLAN 2 in a 75% active aqueous phase or oily phase,

does not show any signs of toxicity towards fibroblasts in culture.

* Eyetex According to this technique, in a 75% active solution, CAMPOLAN 2 is classified non-irritant.

* Skintex

According to this technique, in a 50% active solution, CAMPOLAN 2 is non irritant. This tolerance data is

confirmed by the tests carried out in vivo on health humans.

* Test on healthy humans

When patch tests were carried out at increasing concentrations (0.5%, 1.1%, 2.2%, 4.7%, 10%,50% & 100%)

on 20 subjects, CAMPOLAN 2 did not show any significant irritant reaction at all. Its tolerance is total

satisfactory.

COMEDOGENESIS CAMPOLAN 2 was tested in a 100% active concentrate solution on human volunteers, according to the usual

protocols has proven to be free of comedogenic effect.

Because of its good level of innocuity. CAMPOLAN 2 has proved to be first class skin moisturizer and

transepidermal water loss barrier for very many skin moisturizing formulae where tolerance is imperative (

skin moisturizing cream, moisturizing lotion, etc.).

BIODEGRADABILITY

The ultimate aerobic biodegradability of CAMPOLAN 2 is measured according to STRUM TEST (OCDE 301

B, guideline EEC 84/449, Annex V. Method C5).

Under these conditions, a level of biodegradability of CAMPOLAN 2 is 100% in 28 days at 50 mg/ml.

The level of biodegradability of CAMPOLAN 2 is considered to be excellent.

Campo Research Singapore

May 9th

1997

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CAMPOLAN 3

THE ACTIVE NOVEL DRUG FOR THE COSMETIC FORMULATION

TOXICOLOGICAL & ECOTOXICOLOGICAL DATA

TOLERANCE As to ensure a good level of innocuity CAMPOLAN 3 was tested in in-vitro as follows:

*Irritation potential of the chorio-allantoic membrane of an egg.

When tested on the chorio-allantoic membrane of a chicken egg, according to the technique developed by

LUEPKE** in a 75% liposoluble solution, CAMPOLAN 3 is classified as non irritant.

**LUEPKE, N.P., Hen’s egg chorio-allantoic membrane test for irritation potentiation. Fd. Chem. 1986, 24, 6-

7, 495-496.

* Cytotoxicity on human fibroblasts.

When tested on human fibroblasts using a method patented by BIOGIR (which can be applied to both

hydrosoluble as well as liposoluble products). CAMPOLAN 3 in a 75% active aqueous phase or oily phase,

does not show any signs of toxicity towards fibroblasts in culture.

* Eyetex According to this technique, in a 50% active solution, CAMPOLAN 3 is classified non-irritant.

* Skintex

According to this technique, in a 75% active solution, CAMPOLAN 3 is non irritant. This tolerance data is

confirmed by the tests carried out in vivo on health humans.

* Test on healthy humans

When patch tests were carried out at increasing concentrations (0.5%, 1.1%, 2.2%, 4.7%, 10%,30% & 100%)

on 23 subjects, CAMPOLAN 3 did not show any significant irritant reaction at all. Its tolerance is total

satisfactory.

COMEDOGENESIS CAMPOLAN 3 was tested in a 100% active concentrate solution on human volunteers, according to the usual

protocols has proven to be free of comedogenic effect.

Because of its good level of innocuity. CAMPOLAN 3 has proved to be first class skin moisturizer and

transepidermal water loss barrier for very many skin moisturizing formulae where tolerance is imperative

(skin moisturizing cream, moisturizing lotion, etc.).

BIODEGRADABILITY

The ultimate aerobic biodegradability of CAMPOLAN 3 is measured according to STRUM TEST (OCDE 301

B, guideline EEC 84/449, Annex V. Method C5).

Under these conditions, a level of biodegradability of CAMPOLAN 3 is 100% in 28 days at 50 mg/ml.

The level of biodegradability of CAMPOLAN 3 is considered to be excellent.

Campo Research Singapore

May 9th

1997

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CAMPO HERB ACELAN LD

THE ACTIVE NOVEL DRUG FOR THE COSMETIC FORMULATION

TOXICOLOGICAL & ECOTOXICOLOGICAL DATA

TOLERANCE As to ensure a good level of innocuity Campo Herb Acelan LD was tested in in-vitro as follows:

*Irritation potential of the chorio-allantoic membrane of an egg.

When tested on the chorio-allantoic membrane of a chicken egg, according to the technique developed by

LUEPKE** in a 75% liposoluble solution, Campo Herb Acelan LD is classified as non irritant.

**LUEPKE, N.P., Hen’s egg chorio-allantoic membrane test for irritation potentiation. Fd. Chem. 1986, 24, 6-

7, 495-496.

* Cytotoxicity on human fibroblasts.

When tested on human fibroblasts using a method patented by BIOGIR (which can be applied to both

hydrosoluble as well as liposoluble products). Campo Herb Acelan LD in a 90% active aqueous phase or oily

phase, does not show any signs of toxicity towards fibroblasts in culture.

* Eyetex According to this technique, in a 100% active concentrate solution, Campo Herb Acelan LD is classified non-

irritant.

* Skintex

According to this technique, in a 100% active solution, Campo Herb Acelan LD is non irritant. This tolerance

data is confirmed by the tests carried out in vivo on health humans.

* Test on healthy humans

When patch tests were carried out at increasing concentrations (0.5%, 1.1%, 2.2%, 4.7%, 10% & 100%) on 10

subjects, Campo Herb Acelan LD did not show any significant irritant reaction at all. Its tolerance is total

satisfactory.

COMEDOGENESIS Campo Herb Acelan LD was tested in a 100% active solution on human volunteers, according to the usual

protocols has proven to be free of comedogenic effect.

Because of its good level of innocuity. Campo Herb Acelan LD has proved to be first class skin moisturizer

and transepidermal water loss barrier for very many skin moisturizing formulae where tolerance is imperative

(skin moisturizing cream, moisturizing lotion, etc.).

BIODEGRADABILITY

The ultimate aerobic biodegradability of Campo Herb Acelan LD is measured according to STRUM TEST

(OCDE 301 B, guideline EEC 84/449, Annex V. Method C5).

Under these conditions, a level of biodegradability of Campo Herb Acelan LD is 100% in 28 days at 50 mg/ml.

The level of biodegradability of Campo Herb Acelan LD is considered to be excellent.

Campo Research Singapore

May 9th

1997

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CAMPO HERB ACELAN SD

THE ACTIVE NOVEL DRUG FOR THE COSMETIC FORMULATION

TOXICOLOGICAL & ECOTOXICOLOGICAL DATA

TOLERANCE As to ensure a good level of innocuity Campo Herb Acelan SD was tested in in-vitro as follows:

*Irritation potential of the chorio-allantoic membrane of an egg.

When tested on the chorio-allantoic membrane of a chicken egg, according to the technique developed by

LUEPKE** in a 30% liposoluble solution, Campo Herb Acelan SD is classified as non irritant.

**LUEPKE, N.P., Hen’s egg chorio-allantoic membrane test for irritation potentiation. Fd. Chem. 1986, 24, 6-

7, 495-496.

* Cytotoxicity on human fibroblasts.

When tested on human fibroblasts using a method patented by BIOGIR (which can be applied to both

hydrosoluble as well as liposoluble products). Campo Herb Acelan SD in a 30% active aqueous phase or oily

phase, does not show any signs of toxicity towards fibroblasts in culture.

* Eyetex According to this technique, in a 10% active solution, Campo Herb Acelan SD is classified non-irritant.

* Skintex

According to this technique, in a 10% active solution, Campo Herb Acelan SD is non irritant. This tolerance

data is confirmed by the tests carried out in vivo on health humans.

* Test on healthy humans

When patch tests were carried out at increasing concentrations (0.5%, 1.1%, 2.2%, 4.7%, 10% & 100%) on 10

subjects, Campo Herb Acelan SD did not show any significant irritant reaction at all. Its tolerance is total

satisfactory.

COMEDOGENESIS Campo Herb Acelan SD was tested in a 10% active solution on human volunteers, according to the usual

protocols has proven to be free of comedogenic effect.

Because of its good level of innocuity. Campo Herb Acelan SD has proved to be first class skin moisturizer

and transepidermal water loss barrier for very many skin moisturizing formulae where tolerance is imperative

(skin moisturizing cream, moisturizing lotion, etc.).

BIODEGRADABILITY

The ultimate aerobic biodegradability of Campo Herb Acelan SD is measured according to STRUM TEST

(OCDE 301 B, guideline EEC 84/449, Annex V. Method C5).

Under these conditions, a level of biodegradability of Campo Herb Acelan SD is 100% in 28 days at 50 mg/ml.

The level of biodegradability of Campo Herb Acelan SD is considered to be excellent.

Campo Research Singapore

May 9th

1997

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CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 24

CAMPO VEGETAL LANOLIN, COSMETIC GRADE A

THE ACTIVE NOVEL DRUG FOR THE COSMETIC FORMULATION

TOXICOLOGICAL & ECOTOXICOLOGICAL DATA

TOLERANCE As to ensure a good level of innocuity Campo Vegetal Lanolin, Cosmetic Grade A was tested in in-vitro as

follows:

*Irritation potential of the chorio-allantoic membrane of an egg.

When tested on the chorio-allantoic membrane of a chicken egg, according to the technique developed by

LUEPKE** in a 50% liposoluble solution, Campo Vegetal Lanolin, Cosmetic Grade A is classified as non

irritant.

**LUEPKE, N.P., Hen’s egg chorio-allantoic membrane test for irritation potentiation. Fd. Chem. 1986, 24, 6-

7, 495-496.

* Cytotoxicity on human fibroblasts.

When tested on human fibroblasts using a method patented by BIOGIR (which can be applied to both

hydrosoluble as well as liposoluble products). Campo Vegetal Lanolin, Cosmetic Grade A in a 50% active

aqueous phase or oily phase, does not show any signs of toxicity towards fibroblasts in culture.

* Eyetex According to this technique, in a 100% active concentrate solution, Campo Vegetal Lanolin, Cosmetic Grade A

is classified non-irritant.

* Skintex

According to this technique, in a 100% active solution, Campo Vegetal Lanolin, Cosmetic Grade A is non

irritant. This tolerance data is confirmed by the tests carried out in vivo on health humans.

* Test on healthy humans

When patch tests were carried out at increasing concentrations (0.5%, 1.1%, 2.2%, 4.7%, 10% & 100%) on 20

subjects, Campo Vegetal Lanolin, Cosmetic Grade A did not show any significant irritant reaction at all. Its

tolerance is total satisfactory.

COMEDOGENESIS Campo Vegetal Lanolin, Cosmetic Grade A was tested in a 100% active solution on human volunteers,

according to the usual protocols has proven to be free of comedogenic effect.

Because of its good level of innocuity. Campo Vegetal Lanolin, Cosmetic Grade A has proved to be first class

skin moisturizer and transepidermal water loss barrier for very many skin moisturizing formulae where

tolerance is imperative (skin moisturizing cream, moisturizing lotion, etc.).

BIODEGRADABILITY

The ultimate aerobic biodegradability of Campo Vegetal Lanolin, Cosmetic Grade A is measured according to

STRUM TEST (OCDE 301 B, guideline EEC 84/449, Annex V. Method C5).

Under these conditions, a level of biodegradability of Campo Vegetal Lanolin, Cosmetic Grade A is 100% in

28 days at 50 mg/ml.

The level of biodegradability of Campo Vegetal Lanolin, Cosmetic Grade A is considered to be excellent.

Campo Research Singapore

May 10th

1997

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CAMPO VEGETAL LANOLIN, COSMETIC GRADE B

THE ACTIVE NOVEL DRUG FOR THE COSMETIC FORMULATION

TOXICOLOGICAL & ECOTOXICOLOGICAL DATA

TOLERANCE As to ensure a good level of innocuity Campo Vegetal Lanolin, Cosmetic Grade B was tested in in-vitro as

follows:

*Irritation potential of the chorio-allantoic membrane of an egg.

When tested on the chorio-allantoic membrane of a chicken egg, according to the technique developed by

LUEPKE** in a 30% liposoluble solution, Campo Vegetal Lanolin, Cosmetic Grade B is classified as non

irritant.

**LUEPKE, N.P., Hen’s egg chorio-allantoic membrane test for irritation potentiation. Fd. Chem. 1986, 24, 6-

7, 495-496.

* Cytotoxicity on human fibroblasts.

When tested on human fibroblasts using a method patented by BIOGIR (which can be applied to both

hydrosoluble as well as liposoluble products). Campo Vegetal Lanolin, Cosmetic Grade B in a 30% active

aqueous phase or oily phase, does not show any signs of toxicity towards fibroblasts in culture.

* Eyetex According to this technique, in a 10% active solution, Campo Vegetal Lanolin, Cosmetic Grade B is classified

non-irritant.

* Skintex

According to this technique, in a 10% active solution, Campo Vegetal Lanolin, Cosmetic Grade B is non

irritant. This tolerance data is confirmed by the tests carried out in vivo on health humans.

* Test on healthy humans

When patch tests were carried out at increasing concentrations (0.5%, 1.1%, 2.2%, 4.7%, 10% & 100%) on 10

subjects, Campo Vegetal Lanolin, Cosmetic Grade B did not show any significant irritant reaction at all. Its

tolerance is total satisfactory.

COMEDOGENESIS Campo Vegetal Lanolin, Cosmetic Grade B was tested in a 10% active solution on human volunteers,

according to the usual protocols has proven to be free of comedogenic effect.

Because of its good level of innocuity. Campo Vegetal Lanolin, Cosmetic Grade B has proved to be first class

skin moisturizer and transepidermal water loss barrier for very many skin moisturizing formulae where

tolerance is imperative ( skin moisturizing cream, moisturizing lotion, etc.).

BIODEGRADABILITY

The ultimate aerobic biodegradability of Campo Vegetal Lanolin, Cosmetic Grade B is measured according to

STRUM TEST (OCDE 301 B, guideline EEC 84/449, Annex V. Method C5).

Under these conditions, a level of biodegradability of Campo Vegetal Lanolin, Cosmetic Grade B is 100% in

28 days at 50 mg/ml.

The level of biodegradability of Campo Vegetal Lanolin, Cosmetic Grade B is considered to be excellent.

Campo Research Singapore

May 10th

1997

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CAMPO MUTHU-THULASI CHOLESTEROL 10 USP/NF eqv.

THE ACTIVE NOVEL DRUG FOR THE COSMETIC FORMULATION

TOXICOLOGICAL & ECOTOXICOLOGICAL DATA

TOLERANCE As to ensure a good level of innocuity Campo Muthu-Thulasi Cholesterol 10 USP/NF eqv.; was tested in

in-vitro as follows:

*Irritation potential of the chorio-allantoic membrane of an egg.

When tested on the chorio-allantoic membrane of a chicken egg, according to the technique developed by

LUEPKE** in a 30% liposoluble solution, Campo Muthu-Thulasi Cholesterol 10 USP/NF eqv.; is classified

as non irritant.

**LUEPKE, N.P., Hen’s egg chorio-allantoic membrane test for irritation potentiation. Fd. Chem. 1986, 24, 6-

7, 495-496.

* Cytotoxicity on human fibroblasts.

When tested on human fibroblasts using a method patented by BIOGIR (which can be applied to both

hydrosoluble as well as liposoluble products). Campo Muthu-Thulasi Cholesterol 10 USP/NF eqv.; in a 50%

active aqueous phase or oily phase, does not show any signs of toxicity towards fibroblasts in culture.

* Eyetex

According to this technique, in a 100% active concentrate solution, Campo Muthu-Thulasi Cholesterol 10

USP/NF eqv.; is classified non-irritant.

* Skintex

According to this technique, in a 100% active concentrate solution, Campo Muthu-Thulasi Cholesterol 10

USP/NF eqv., is non irritant. This tolerance data is confirmed by the tests carried out in vivo on health

humans.

* Test on healthy humans

When patch tests were carried out at increasing concentrations (0.5%, 1.1%, 2.2%, 4.7%, 10% & 100%) on 10

subjects, Campo Muthu-Thulasi Cholesterol 10 USP/NF eqv. did not show any significant irritant reaction

at all. Its tolerance is total satisfactory.

COMEDOGENESIS Campo Muthu-Thulasi Cholesterol 10 USP/NF eqv., was tested in a 10% active solution on human

volunteers, according to the usual protocols has proven to be free of comedogenic effect.

Because of its good level of innocuity. Campo Muthu-Thulasi Cholesterol 10 USP/NF eqv.; has proved to

be first class skin moisturizer and transepidermal water loss barrier for very many skin moisturizing formulae

where tolerance is imperative ( skin moisturizing cream, moisturizing lotion, etc.).

BIODEGRADABILITY

The ultimate aerobic biodegradability of Campo Muthu-Thulasi Cholesterol 10 USP/NF eqv.; is measured

according to STRUM TEST (OCDE 301 B, guideline EEC 84/449, Annex V. Method C5).

Under these conditions, a level of biodegradability of Campo Muthu-Thulasi Cholesterol 10 USP/NF.; is

100% in 28 days at 50 mg/ml.

The level of biodegradability of Campo Muthu-Thulasi Cholesterol 10 USP/NF eqv.; is considered to be

excellent.

Campo Research Singapore

May 10th

1997

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CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 27

CAMPO MUTHU-THULASI CHOLESTEROL 10 SE

THE ACTIVE NOVEL DRUG FOR THE COSMETIC FORMULATION

TOXICOLOGICAL & ECOTOXICOLOGICAL DATA

TOLERANCE As to ensure a good level of innocuity Campo Muthu-Thulasi Cholesterol 10 SE was tested in in-vitro as

follows:

*Irritation potential of the chorio-allantoic membrane of an egg.

When tested on the chorio-allantoic membrane of a chicken egg, according to the technique developed by

LUEPKE** in a 100% liposoluble concentrate solution, Campo Muthu-Thulasi Cholesterol 10 SE is

classified as non irritant.

**LUEPKE, N.P., Hen’s egg chorio-allantoic membrane test for irritation potentiation. Fd. Chem. 1986, 24, 6-

7, 495-496.

* Cytotoxicity on human fibroblasts.

When tested on human fibroblasts using a method patented by BIOGIR (which can be applied to both

hydrosoluble as well as liposoluble products). Campo Muthu-Thulasi Cholesterol 10 SE in a 75% active

aqueous phase or oily phase, does not show any signs of toxicity towards fibroblasts in culture.

* Eyetex

According to this technique, in a 100% active concentrate solution, Campo Muthu-Thulasi Cholesterol 10

SE is classified non-irritant.

* Skintex

According to this technique, in a 100% active concentrate solution, Campo Muthu-Thulasi Cholesterol 10 SE

is non irritant. This tolerance data is confirmed by the tests carried out in vivo on health humans.

* Test on healthy humans

When patch tests were carried out at increasing concentrations (0.5%, 1.1%, 2.2%, 4.7%, 10% & 100%) on 20

subjects, Campo Muthu-Thulasi Cholesterol 10 SE did not show any significant irritant reaction at all. Its

tolerance is total satisfactory.

COMEDOGENESIS

Campo Muthu-Thulasi Cholesterol 10 SE was tested in a 100% active concentrate solution on human

volunteers, according to the usual protocols has proven to be free of comedogenic effect.

Because of its good level of innocuity. Campo Muthu-Thulasi Cholesterol 10 SE has proved to be first class

skin moisturizer and transepidermal water loss barrier for very many skin moisturizing formulae where

tolerance is imperative (skin moisturizing cream, moisturizing lotion, etc.).

BIODEGRADABILITY

The ultimate aerobic biodegradability of Campo Muthu-Thulasi Cholesterol 10 SE is measured according to

STRUM TEST (OCDE 301 B, guideline EEC 84/449, Annex V. Method C5).

Under these conditions, a level of biodegradability of Campo Muthu-Thulasi Cholesterol 10 SE is 100% in

28 days at 50 mg/ml.

The level of biodegradability of Campo Muthu-Thulasi Cholesterol 10 SE is considered to be excellent.

Campo Research Singapore

May 10th

1997

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Campo Biotechnological Herbal Vegetal Cholesterol Extract

CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 28

MATERIAL SAFETY AND CONSUMER PRODUCT SAFETY TESTING LABS.

( DIVISION OF JTC KAMPOYAKI, SINGAPORE )

P.O.BOX 2105, SINGAPORE 9041

REPUBLIC OF SINGAPORE

F I N A L R E P O R T

DIVISIONAL / COMPANY / GROUP Creaderm SA Zurich, Switzerland, CH-8050

ATTENTION : Ms ELIZABETH ACKERMANN VP, Business Development

Formulation Chemist

TEST: The MATREX In Vitro Toxicity Testing System

Salmonella Typhimurium Reverse Mutation Assay

TEST ARTICLES: CAMPO MUTHU THULASI CHOLESTEROL 10

CAMPO MUTHU THULASI CHOLESTEROL 10 SE VEGETAL LANOLIN – COSMETIC GRADE A VEGETAL LANOLIN – COSMETIC GRADE B CAMPOLAN 1 CAMPOLAN 2 CAMPOLAN 3 CAMPO HERB - ACELAN LD CAMPO HERB – ACELAN SD

ACETYLATED VEGETAL LANOLIN VEGETAL CHOLESTEROL

VEGETAL LANOLIN – AN INTRODUCTION VEGETAL LANOILIN & BIOTECHNOLOGIC VEGETAL ISOPROPHYL ESTER ( Campolan 1, Campolan 2, and Campolan 3 ).

EXPERIMENTS REFERENCE NO: 1997-5-5

---------------------------------

Dr. Fergus Jes G. Velasquez

Director of Laboratories

Date: May 5th

, 1997 This report is submitted for the exclusive use of the person, partnership, or corporation to whom it is addressed, and neither the report nor the name of these

Laboratories nor of any member of it’s staff, any be used in connection with the advertising or sale of any product or process without written authorization.

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Campo Biotechnological Herbal Vegetal Cholesterol Extract

CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 29

OBJECTIVE:

To evaluate the test article for irritancy potential utilizing the MATREX in vitro toxicity testing system. INTRODUCTION:

TESTSKIN and MATREX are sophisticated in vitro systems. Developed in Organogenesis. Inc. of Cambridge, Massachusetts, they closely mimic human skin in structure and function. The Living

Dermal Matrex ( LDM) of a three-dimensional construct comprised of living cells in a collagen matrix. Nutrition is provided through the base via a permeable membrane, leaving the surface open to the atmosphere. This makes an ideal system for applying a variety of materials, including liquids, powders, oils, gels and creams.

The Living Skin Equivalent (LSE) has all the features previously described, plus the formation of an actual epidermis, complete with stratum corneum. TESTSKIN and MATREX, when used with the recommended cell metabolism assay, can quickly provide toxicological profiles. The procedure involves a solubilized, reactive tetrazolium salt (MTT), which is metabolized by, the mitochondria of living cells and converted to a purple formazan dye. The color intensity of the skin replica extract, measured photometrically, correlates directly with its viability. When measured against controls, values ranging from 0% to 1 00% (plus or minus approximately 20%) can be calculated for each dose of an applied substance.

Test Articles : CAMPO MUTHU THULASI CHOLESTEROL 10 Reference Articles: PROPYLENE GLYCOL & MORPHOLINE

METHOD:

The appropriate dilutions of test sample and control articles were applied to MATREX. After the appropriate exposure period, the articles were rinsed from the MATREX surfaces. MTT (tetrazolium salt) assay medium, vas utilized in order to quantifv cell metabolism. At the end of the staining period, excised portions of each MATREX were immersed in acidified isopropanol iviiich extracted the converted MI7 from the tissue samples. A Dynatech NM 4000 Automatic Microplate Reader was used to determine the absorbance of each extract at 57Onm. With the absorbance of a negative control defined as 100%, the percent absorbencies of the test and control articles were determined. The percentages listed below directly correlate with the cell metabolism in the MATREX samples.

RESULTS:

Test Article Percent Percent (% & Exposure ) System Viability Inhibition

CAMPO MUTHU THULASI CHOLESTEROL 10

(100% - 1 hr.) LDM 99.9% 0.1% (10% - 1 hr.) LDM 100% - % (1% - 1 hr.) LDM 100% - %

Propylene glycol

(100% - 1 hr.) LDM 73% 27% (10% - 1 hr.) LDM 99% 1% (1% - 1 hr.) LDM 96% 4%

Morpholine

(100% - 1 hr.) LDM 6% 94% (10% - 1 hr.) LDM 4% 96% (1% - 1 hr.) LDM 100% 0%

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Campo Biotechnological Herbal Vegetal Cholesterol Extract

CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 30

HISTORICAL IN VITRO RESULTS:

Propylene glycol has historically been categorized as virtually non-irritating when tested using the Draize irritation methodologies. Morpholine has been categorized as moderately irritating .when tested in the same manner. DISCUSSIONS:

The sponsor-submitted sample elicited in vitro results comparable to those recorded for propylene glycol. CONCLUSION: The results indicate that the sponsor-submitted product has virtually no irritation potential, under the conditions of this test.

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Campo Biotechnological Herbal Vegetal Cholesterol Extract

CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 31

OBJECTIVE:

To evaluate the test article for irritancy potential utilizing the MATREX in vitro toxicity testing system.

INTRODUCTION:

TESTSKIN and MATREX are sophisticated in vitro systems. Developed in Organogenesis. Inc. of Cambridge, Massachusetts, they closely mimic human skin in structure and function. The Living Dermal

Matrex (LDM) of a three-dimensional construct comprised of living cells in a collagen matrix. Nutrition is provided through the base via a permeable membrane, leaving the surface open to the atmosphere. This makes an ideal system for applying a variety of materials, including liquids, powders, oils, gels and creams.

The Living Skin Equivalent (LSE) has all the features previously described, plus the formation of an actual epidermis, complete with stratum corneum. TESTSKIN and MATREX, when used with the recommended cell metabolism assay, can quickly provide toxicological profiles. The procedure involves a solubilized, reactive tetrazolium salt (MTT), which is metabolized by, the mitochondria of living cells and converted to a purple formazan dye. The color intensity of the skin replica extract, measured photometrically, correlates directly with its viability. When measured a gainst controls, values ranging from 0% to 1 00% (plus or minus approximately 20%) can be calculated for each dose of an applied substance.

Test Articles : CAMPO MUTHU THULASI CHOLESTEROL 10 SE Reference Articles: PROPYLENE GLYCOL & MORPHOLINE METHOD:

The appropriate dilutions of test sample and control articles were applied to MATREX. After the appropriate exposure period, the articles were rinsed from the MATREX surfaces. MTT (tetrazolium salt) assay medium ,vas utilized in order to quantifv cell metabolism. At the end of the staining period, excised portions of each MATREX were immersed in acidified isopropanol iviiich extracted the converted MI7 from the tissue samples. A Dynatech NM 4000 Automatic Microplate Reader was used to determine the absorbance of each extract at 57Onm. With the absorbance of a negative control defined as 100%, the percent absorbencies of the test and control articles were determined. The percentages listed below directly correlate with the cell metabolism in the MATREX samples. RESULTS:

Test Article Percent Percent (% & Exposure ) System Viability Inhibition

CAMPO MUTHU THULASI CHOLESTEROL 10 SE

(100% - 1 hr.) LDM 99.9% 0.1% (10% - 1 hr.) LDM 100% - % (1% - 1 hr.) LDM 100% - %

Propylene glycol (100% - 1 hr.) LDM 73% 27% (10% - 1 hr.) LDM 99% 1% (1% - 1 hr.) LDM 96% 4%

Morpholine (100% - 1 hr.) LDM 6% 94% (10% - 1 hr.) LDM 4% 96% (1% - 1 hr.) LDM 100% 0%

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Campo Biotechnological Herbal Vegetal Cholesterol Extract

CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 32

HISTORICAL IN VITRO RESULTS:

Propylene glycol has historically been categorized as virtually non-irritating when tested using the Draize irritation methodologies. Morpholine has been categorized as moderately irritating .when tested in the same manner. DISCUSSIONS:

The sponsor-submitted sample elicited in vitro results comparable to those recorded for propylene glycol. CONCLUSION: The results indicate that the sponsor-submitted product has virtually no irritation potential, under the conditions of this test.

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Campo Biotechnological Herbal Vegetal Cholesterol Extract

CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 33

OBJECTIVE:

To evaluate the test article for irritancy potential utilizing the MATREX in vitro toxicity testing system.

INTRODUCTION:

TESTSKIN and MATREX are sophisticated in vitro systems. Developed in Organogenesis. Inc. of Cambridge, Massachusetts, they closely mimic human skin in structure and function. The Living Dermal

Matrex ( LDM) of a three-dimensional construct comprised of living cells in a collagen matrix. Nutrition is provided through the base via a permeable membrane, leaving the surface open to the atmosphere. This makes an ideal system for applying a variety of materials, including liquids, powders, oils, gels and creams.

The Living Skin Equivalent (LSE) has all the features previously described, plus the formation of an actual epidermis, complete with stratum corneum. TESTSKIN and MATREX, when used with the recommended cell metabolism assay, can quickly provide toxicological profiles. The procedure involves a solubilized, reactive tetrazolium salt (MTT), which is metabolized by, the mitochondria of living cells and converted to a purple formazan dye. The color intensity of the skin replica extract, measured photometrically, correlates directly with its viability. When measured against controls, values ranging from 0% to 1 00% (plus or minus approximately 20%) can be calculated for each dose of an applied substance.

Test Articles : CAMPO MUTHU THULASI VEGETAL LANOLIN – COSMETIC GRADE A Reference Articles: PROPYLENE GLYCOL & MORPHOLINE METHOD:

The appropriate dilutions of test sample and control articles were applied to MATREX. After the appropriate exposure period, the articles were rinsed from the MATREX surfaces. MTT (tetrazolium salt) assay medium ,vas utilized in order to quantifv cell metabolism. At the end of the staining period, excised portions of each MATREX were immersed in acidified isopropanol iviiich extracted the converted MI7 from the tissue samples. A Dynatech NM 4000 Automatic Microplate Reader was used to determine the absorbance of each extract at 57Onm. With the absorbance of a negative control defined as 100%, the percent absorbencies of the test and control articles were determined. The percentages listed below directly correlate with the cell metabolism in the MATREX samples. RESULTS:

Test Article Percent Percent (% & Exposure ) System Viability Inhibition

VEGETAL LANOLIN – COSMETIC GRADE A

(100% - 1 hr.) LDM 99.9% 0.1% (10% - 1 hr.) LDM 100% - % (1% - 1 hr.) LDM 100% - %

Propylene glycol

(100% - 1 hr.) LDM 73% 27% (10% - 1 hr.) LDM 99% 1% (1% - 1 hr.) LDM 96% 4%

Morpholine

(100% - 1 hr.) LDM 6% 94% (10% - 1 hr.) LDM 4% 96% (1% - 1 hr.) LDM 100% 0%

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Campo Biotechnological Herbal Vegetal Cholesterol Extract

CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 34

HISTORICAL IN VITRO RESULTS:

Propylene glycol has historically been categorized as virtually non-irritating when tested using the Draize irritation methodologies. Morpholine has been categorized as moderately irritating .when tested in the same manner. DISCUSSIONS:

The sponsor-submitted sample elicited in vitro results comparable to those recorded for propylene glycol. CONCLUSION: The results indicate that the sponsor-submitted product has virtually no irritation potential, under the conditions of this test.

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Campo Biotechnological Herbal Vegetal Cholesterol Extract

CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 35

OBJECTIVE:

To evaluate the test article for irritancy potential utilizing the MATREX in vitro toxicity testing system.

INTRODUCTION:

TESTSKIN and MATREX are sophisticated in vitro systems. Developed in Organogenesis. Inc. of Cambridge, Massachusetts, they closely mimic human skin in structure and function. The Living Dermal

Matrex ( LDM) of a three-dimensional construct comprised of living cells in a collagen matrix. Nutrition is provided through the base via a permeable membrane, leaving the surface open to the atmosphere. This makes an ideal system for applying a variety of materials, including liquids, powders, oils, gels and creams.

The Living Skin Equivalent (LSE) has all the features previously described, plus the formation of an actual pidermis, complete with stratum corneum. TESTSKIN and MATREX, when used with the recommended cell metabolism assay, can quickly provide toxicological profiles. The procedure involves a solubilized, reactive tetrazolium salt (MTT), which is metabolized by, the mitochondria of living cells and converted to a purple formazan dye. The color intensity of the skin replica extract, measured photometrically, correlates directly with its viability. When measured against controls, values ranging from 0% to 1 00% (plus or minus approximately 20%) can be calculated for each dose of an applied substance.

Test Articles : CAMPO MUTHU THULASI VEGETAL LANOLIN - COSMETIC GRADE B Reference Articles: PROPYLENE GLYCOL & MORPHOLINE METHOD:

The appropriate dilutions of test sample and control articles were applied to MATREX. After the appropriate exposure period, the articles were rinsed from the MATREX surfaces. MTT (tetrazolium salt) assay medium ,vas utilized in order to quantifv cell metabolism. At the end of the staining period, excised portions of each MATREX were immersed in acidified isopropanol iviiich extracted the converted MI7 from the tissue samples. A Dynatech NM 4000 Automatic Microplate Reader was used to determine the absorbance of each extract at 57Onm. With the absorbance of a negative control defined as 100%, the percent absorbencies of the test and control articles were determined. The percentages listed below directly correlate with the cell metabolism in the MATREX samples. RESULTS:

Test Article Percent Percent (% & Exposure ) System Viability Inhibition

VEGETAL LANOLIN – COSMETIC GRADE B

(100% - 1 hr.) LDM 99.9% 0.1% (10% - 1 hr.) LDM 100% - % (1% - 1 hr.) LDM 100% - %

Propylene glycol

(100% - 1 hr.) LDM 73% 27% (10% - 1 hr.) LDM 99% 1% (1% - 1 hr.) LDM 96% 4%

Morpholine

(100% - 1 hr.) LDM 6% 94% (10% - 1 hr.) LDM 4% 96% (1% - 1 hr.) LDM 100% 0%

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Campo Biotechnological Herbal Vegetal Cholesterol Extract

CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 36

HISTORICAL IN VITRO RESULTS:

Propylene glycol has historically been categorized as virtually non-irritating when tested using the Draize irritation methodologies. Morpholine has been categorized as moderately irritating .when tested in the same manner. DISCUSSIONS:

The sponsor-submitted sample elicited in vitro results comparable to those recorded for propylene glycol. CONCLUSION: The results indicate that the sponsor-submitted product has virtually no irritation potential, under the conditions of this test.

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Campo Biotechnological Herbal Vegetal Cholesterol Extract

CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 37

OBJECTIVE:

To evaluate the test article for irritancy potential utilizing the MATREX in vitro toxicity testing system.

INTRODUCTION:

TESTSKIN and MATREX are sophisticated in vitro systems. Developed in Organogenesis. Inc. of Cambridge, Massachusetts, they closely mimic human skin in structure and function. The Living Dermal

Matrex ( LDM) of a three-dimensional construct comprised of living cells in a collagen matrix. Nutrition is provided through the base via a permeable membrane, leaving the surface open to the atmosphere. This makes an ideal system for applying a variety of materials, including liquids, powders, oils, gels and creams.

The Living Skin Equivalent (LSE) has all the features previously described, plus the formation of an actual epidermis, complete with stratum corneum. TESTSKIN and MATREX, when used with the recommended cell metabolism assay, can quickly provide toxicological profiles. The procedure involves a solubilized, reactive tetrazolium salt (MTT), which is metabolized by, the mitochondria of living cells and converted to a purple formazan dye. The color intensity of the skin replica extract, measured photometrically, correlates directly with its viability. When measured against controls, values ranging from 0% to 1 00% (plus or minus approximately 20%) can be calculated for each dose of an applied substance.

Test Articles : CAMPO MUTHU THULASI CAMPOLAN 1 Reference Articles: PROPYLENE GLYCOL & MORPHOLINE METHOD:

The appropriate dilutions of test sample and control articles were applied to MATREX. After the appropriate exposure period, the articles were rinsed from the MATREX surfaces. MTT (tetrazolium salt) assay medium ,vas utilized in order to quantifv cell metabolism. At the end of the staining period, excised portions of each MATREX were immersed in acidified isopropanol iviiich extracted the converted MI7 from the tissue samples. A Dynatech NM 4000 Automatic Microplate Reader was used to determine the absorbance of each extract at 57Onm. With the absorbance of a negative control defined as 100%, the percent absorbencies of the test and control articles were determined. The percentages listed below directly correlate with the cell metabolism in the MATREX samples. RESULTS:

Test Article Percent Percent (% & Exposure ) System Viability Inhibition

CAMPOLAN 1

(100% - 1 hr.) LDM 99.9% 0.1% (10% - 1 hr.) LDM 100% - % (1% - 1 hr.) LDM 100% - %

Propylene glycol

(100% - 1 hr.) LDM 73% 27% (10% - 1 hr.) LDM 99% 1% (1% - 1 hr.) LDM 96% 4%

Morpholine

(100% - 1 hr.) LDM 6% 94% (10% - 1 hr.) LDM 4% 96% (1% - 1 hr.) LDM 100% 0%

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Campo Biotechnological Herbal Vegetal Cholesterol Extract

CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 38

HISTORICAL IN VITRO RESULTS:

Propylene glycol has historically been categorized as virtually non-irritating when tested using the Draize irritation methodologies. Morpholine has been categorized as moderately irritating .when tested in the same manner.

DISCUSSIONS:

The sponsor-submitted sample elicited in vitro results comparable to those recorded for propylene glycol. CONCLUSION: The results indicate that the sponsor-submitted product has virtually no irritation potential, under the conditions of this test.

Page 39: Novel functional ingredients for multi-purpose …...CAMPO® Novel Functional Active Cosmetic Ingredient & Raw Materials Novel functional ingredients for multi-purpose formulations

Campo Biotechnological Herbal Vegetal Cholesterol Extract

CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 39

OBJECTIVE:

To evaluate the test article for irritancy potential utilizing the MATREX in vitro toxicity testing system.

INTRODUCTION:

TESTSKIN and MATREX are sophisticated in vitro systems. Developed in Organogenesis. Inc. of Cambridge, Massachusetts, they closely mimic human skin in structure and function. The Living

Dermal Matrex ( LDM) of a three-dimensional construct comprised of living cells in a collagen matrix. Nutrition is provided through the base via a permeable membrane, leaving the surface open to the atmosphere. This makes an ideal system for applying a variety of materials, including liquids, powders, oils, gels and creams.

The Living Skin Equivalent (LSE) has all the features previously described, plus the formation of an actual epidermis, complete with stratum corneum. TESTSKIN and MATREX, when used with the recommended cell metabolism assay, can quickly provide toxicological profiles. The procedure involves a solubilized, reactive tetrazolium salt (MTT), which is metabolized by, the mitochondria of living cells and converted to a purple formazan dye. The color intensity of the skin replica extract, measured photometrically, correlates directly with its viability. When measured against controls, values ranging from 0% to 1 00% (plus or minus approximately 20%) can be calculated for each dose of an applied substance.

Test Articles : CAMPO MUTHU THULASI CAMPOLAN 2 Reference Articles: PROPYLENE GLYCOL & MORPHOLINE METHOD:

The appropriate dilutions of test sample and control articles were applied to MATREX. After the appropriate exposure period, the articles were rinsed from the MATREX surfaces. MTT (tetrazolium salt) assay medium ,vas utilized in order to quantifv cell metabolism. At the end of the staining period, excised portions of each MATREX were immersed in acidified isopropanol iviiich extracted the converted MI7 from the tissue samples. A Dynatech NM 4000 Automatic Microplate Reader was used to determine the absorbance of each extract at 57Onm. With the absorbance of a negative control defined as 100%, the percent absorbencies of the test and control articles were determined. The percentages listed below directly correlate with the cell metabolism in the MATREX samples. RESULTS:

Test Article Percent Percent (% & Exposure ) System Viability Inhibition

CAMPOLAN 2

(100% - 1 hr.) LDM 99.9% 0.1% (10% - 1 hr.) LDM 100% - % (1% - 1 hr.) LDM 100% - %

Propylene glycol

(100% - 1 hr.) LDM 73% 27% (10% - 1 hr.) LDM 99% 1% (1% - 1 hr.) LDM 96% 4%

Morpholine

(100% - 1 hr.) LDM 6% 94% (10% - 1 hr.) LDM 4% 96% (1% - 1 hr.) LDM 100% 0%

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Campo Biotechnological Herbal Vegetal Cholesterol Extract

CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 40

HISTORICAL IN VITRO RESULTS:

Propylene glycol has historically been categorized as virtually non-irritating when tested using the Draize irritation methodologies. Morpholine has been categorized as moderately irritating .when tested in the same manner. DISCUSSIONS:

The sponsor-submitted sample elicited in vitro results comparable to those recorded for propylene glycol. CONCLUSION: The results indicate that the sponsor-submitted product has virtually no irritation potential, under the conditions of this test.

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Campo Biotechnological Herbal Vegetal Cholesterol Extract

CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 41

OBJECTIVE:

To evaluate the test article for irritancy potential utilizing the MATREX in vitro toxicity testing system.

INTRODUCTION:

TESTSKIN and MATREX are sophisticated in vitro systems. Developed in Organogenesis. Inc. of Cambridge, Massachusetts, they closely mimic human skin in structure and function. The Living Dermal

Matrex ( LDM) of a three-dimensional construct comprised of living cells in a collagen matrix. Nutrition is provided through the base via a permeable membrane, leaving the surface open to the atmosphere. This makes an ideal system for applying a variety of materials, including liquids, powders, oils, gels and creams.

The Living Skin Equivalent (LSE) has all the features previously described, plus the formation of an actual epidermis, complete with stratum corneum. TESTSKIN and MATREX, when used with the recommended cell metabolism assay, can quickly provide toxicological profiles. The procedure involves a solubilized, reactive tetrazolium salt (MTT), which is metabolized by, the mitochondria of living cells and converted to a purple formazan dye. The color intensity of the skin replica extract, measured photometrically, correlates directly with its viability. When measured against controls, values ranging from 0% to 1 00% (plus or minus approximately 20%) can be calculated for each dose of an applied substance.

Test Articles : CAMPO MUTHU THULASI CAMPOLAN 3 Reference Articles: PROPYLENE GLYCOL & MORPHOLINE METHOD:

The appropriate dilutions of test sample and control articles were applied to MATREX. After the appropriate exposure period, the articles were rinsed from the MATREX surfaces. MTT (tetrazolium salt) assay medium ,vas utilized in order to quantifv cell metabolism. At the end of the staining period, excised portions of each MATREX were immersed in acidified isopropanol iviiich extracted the converted MI7 from the tissue samples. A Dynatech NM 4000 Automatic Microplate Reader was used to determine the absorbance of each extract at 57Onm. With the absorbance of a negative control defined as 100%, the percent absorbencies of the test and control articles were determined. The percentages listed below directly correlate with the cell metabolism in the MATREX samples. RESULTS:

Test Article Percent Percent (% & Exposure ) System Viability Inhibition

CAMPOLAN 3

(100% - 1 hr.) LDM 99.9% 0.1% (10% - 1 hr.) LDM 100% - % (1% - 1 hr.) LDM 100% - %

Propylene glycol

(100% - 1 hr.) LDM 73% 27% (10% - 1 hr.) LDM 99% 1% (1% - 1 hr.) LDM 96% 4%

Morpholine

(100% - 1 hr.) LDM 6% 94% (10% - 1 hr.) LDM 4% 96% (1% - 1 hr.) LDM 100% 0%

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Campo Biotechnological Herbal Vegetal Cholesterol Extract

CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 42

HISTORICAL IN VITRO RESULTS:

Propylene glycol has historically been categorized as virtually non-irritating when tested using the Draize irritation methodologies. Morpholine has been categorized as moderately irritating .when tested in the same manner. DISCUSSIONS:

The sponsor-submitted sample elicited in vitro results comparable to those recorded for propylene glycol. CONCLUSION: The results indicate that the sponsor-submitted product has virtually no irritation potential, under the conditions of this test.

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Campo Biotechnological Herbal Vegetal Cholesterol Extract

CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 43

OBJECTIVE:

To evaluate the test article for irritancy potential utilizing the MATREX in vitro toxicity testing system.

INTRODUCTION:

TESTSKIN and MATREX are sophisticated in vitro systems. Developed in Organogenesis. Inc. of Cambridge, Massachusetts, they closely mimic human skin in structure and function. The Living Dermal

Matrex ( LDM) of a three-dimensional construct comprised of living cells in a collagen matrix. Nutrition is provided through the base via a permeable membrane, leaving the surface open to the atmosphere. This makes an ideal system for applying a variety of materials, including liquids, powders, oils, gels and creams.

The Living Skin Equivalent (LSE) has all the features previously described, plus the formation of an actual epidermis, complete with stratum corneum. TESTSKIN and MATREX, when used with the recommended cell metabolism assay, can quickly provide toxicological profiles. The procedure involves a solubilized, reactive tetrazolium salt (MTT), which is metabolized by, the mitochondria of living cells and converted to a purple formazan dye. The color intensity of the skin replica extract, measured photometrically, correlates directly with its viability. When measured against controls, values ranging from 0% to 1 00% (plus or minus approximately 20%) can be calculated for each dose of an applied substance.

Test Articles : CAMPO MUTHU THULASI CAMPO HERB – ACELAN LD Reference Articles: PROPYLENE GLYCOL & MORPHOLINE METHOD:

The appropriate dilutions of test sample and control articles were applied to MATREX. After the appropriate exposure period, the articles were rinsed from the MATREX surfaces. MTT (tetrazolium salt) assay medium ,vas utilized in order to quantifv cell metabolism. At the end of the staining period, excised portions of each MATREX were immersed in acidified isopropanol iviiich extracted the converted MI7 from the tissue samples. A Dynatech NM 4000 Automatic Microplate Reader was used to determine the absorbance of each extract at 57Onm. With the absorbance of a negative control defined as 100%, the percent absorbencies of the test and control articles were determined. The percentages listed below directly correlate with the cell metabolism in the MATREX samples. RESULTS:

Test Article Percent Percent (% & Exposure ) System Viability Inhibition

CAMPO HERB – ACELAN LD

(100% - 1 hr.) LDM 99.9% 0.1% (10% - 1 hr.) LDM 100% - % (1% - 1 hr.) LDM 100% - %

Propylene glycol

(100% - 1 hr.) LDM 73% 27% (10% - 1 hr.) LDM 99% 1% (1% - 1 hr.) LDM 96% 4%

Morpholine

(100% - 1 hr.) LDM 6% 94% (10% - 1 hr.) LDM 4% 96% (1% - 1 hr.) LDM 100% 0%

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Campo Biotechnological Herbal Vegetal Cholesterol Extract

CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 44

HISTORICAL IN VITRO RESULTS:

Propylene glycol has historically been categorized as virtually non-irritating when tested using the Draize irritation methodologies. Morpholine has been categorized as moderately irritating .when tested in the same manner. DISCUSSIONS:

The sponsor-submitted sample elicited in vitro results comparable to those recorded for propylene glycol. CONCLUSION: The results indicate that the sponsor-submitted product has virtually no irritation potential, under the conditions of this test.

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Campo Biotechnological Herbal Vegetal Cholesterol Extract

CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 45

OBJECTIVE:

To evaluate the test article for irritancy potential utilizing the MATREX in vitro toxicity testing system.

INTRODUCTION:

TESTSKIN and MATREX are sophisticated in vitro systems. Developed in Organogenesis. Inc. of Cambridge, Massachusetts, they closely mimic human skin in structure and function. The Living Dermal

Matrex ( LDM) of a three-dimensional construct comprised of living cells in a collagen matrix. Nutrition is provided through the base via a permeable membrane, leaving the surface open to the atmosphere. This makes an ideal system for applying a variety of materials, including liquids, powders, oils, gels and creams.

The Living Skin Equivalent (LSE) has all the features previously described, plus the formation of an actual epidermis, complete with stratum corneum. TESTSKIN and MATREX, when used with the recommended cell metabolism assay, can quickly provide toxicological profiles. The procedure involves a solubilized, reactive tetrazolium salt (MTT), which is metabolized by, the mitochondria of living cells and converted to a purple formazan dye. The color intensity of the skin replica extract, measured photometrically, correlates directly with its viability. When measured against controls, values ranging from 0% to 1 00% (plus or minus approximately 20%) can be calculated for each dose of an applied substance.

Test Articles : CAMPO MUTHU THULASI CAMPO HERB – ACELAN SD Reference Articles: PROPYLENE GLYCOL & MORPHOLINE

METHOD:

The appropriate dilutions of test sample and control articles were applied to MATREX. After the appropriate exposure period, the articles were rinsed from the MATREX surfaces. MTT (tetrazolium salt) assay medium , vas utilized in order to quantifv cell metabolism. At the end of the staining period, excised portions of each MATREX were immersed in acidified isopropanol iviiich extracted the converted MI7 from the tissue samples. A Dynatech NM 4000 Automatic Microplate Reader was used to determine the absorbance of each extract at 57Onm. With the absorbance of a negative control defined as 100%, the percent absorbencies of the test and control articles were determined. The percentages listed below directly correlate with the cell metabolism in the MATREX samples. RESULTS:

Test Article Percent Percent (% & Exposure ) System Viability Inhibition

CAMPO HERB – ACELAN SD

(100% - 1 hr.) LDM 99.9% 0.1% (10% - 1 hr.) LDM 100% - % (1% - 1 hr.) LDM 100% - %

Propylene glycol

(100% - 1 hr.) LDM 73% 27% (10% - 1 hr.) LDM 99% 1% (1% - 1 hr.) LDM 96% 4%

Morpholine (100% - 1 hr.) LDM 6% 94% (10% - 1 hr.) LDM 4% 96% (1% - 1 hr.) LDM 100% 0%

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Campo Biotechnological Herbal Vegetal Cholesterol Extract

CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 46

HISTORICAL IN VITRO RESULTS:

Propylene glycol has historically been categorized as virtually non-irritating when tested using the Draize irritation methodologies. Morpholine has been categorized as moderately irritating .when tested in the same manner. DISCUSSIONS:

The sponsor-submitted sample elicited in vitro results comparable to those recorded for propylene glycol. CONCLUSION: The results indicate that the sponsor-submitted product has virtually no irritation potential, under the conditions of this test.

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Campo Biotechnological Herbal Vegetal Cholesterol Extract

CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 47

OBJECTIVE:

To evaluate the test article for irritancy potential utilizing the MATREX in vitro toxicity testing system.

INTRODUCTION:

TESTSKIN and MATREX are sophisticated in vitro systems. Developed in Organogenesis. Inc. of Cambridge, Massachusetts, they closely mimic human skin in structure and function. The Living

Dermal Matrex ( LDM) of a three-dimensional construct comprised of living cells in a collagen matrix. Nutrition is provided through the base via a permeable membrane, leaving the surface open to the atmosphere. This makes an ideal system for applying a variety of materials, including liquids, powders, oils, gels and creams.

The Living Skin Equivalent (LSE) has all the features previously described, plus the formation of an actual epidermis, complete with stratum corneum. TESTSKIN and MATREX, when used with the recommended cell metabolism assay, can quickly provide toxicological profiles. The procedure involves a solubilized, reactive tetrazolium salt (MTT), which is metabolized by, the mitochondria of living cells and converted to a purple formazan dye. The color intensity of the skin replica extract, measured photometrically, correlates directly with its viability. When measured against controls, values ranging from 0% to 1 00% (plus or minus approximately 20%) can be calculated for each dose of an applied substance.

Test Articles : CAMPO MUTHU THULASI ACETYLATED VEGETAL LANOLIN Reference Articles: PROPYLENE GLYCOL & MORPHOLINE METHOD:

The appropriate dilutions of test sample and control articles were applied to MATREX. After the appropriate exposure period, the articles were rinsed from the MATREX surfaces. MTT (tetrazolium salt) assay medium ,vas utilized in order to quantifv cell metabolism. At the end of the staining period, excised portions of each MATREX were immersed in acidified isopropanol iviiich extracted the converted MI7 from the tissue samples. A Dynatech NM 4000 Automatic Microplate Reader was used to determine the absorbance of each extract at 57Onm. With the absorbance of a negative control defined as 100%, the percent absorbencies of the test and control articles were determined. The percentages listed below directly correlate with the cell metabolism in the MATREX samples. RESULTS:

Test Article Percent Percent (% & Exposure ) System Viability Inhibition

ACETYLATED VEGETAL LANOLIN

(100% - 1 hr.) LDM 99.9% 0.1% (10% - 1 hr.) LDM 100% - % (1% - 1 hr.) LDM 100% - %

Propylene glycol

(100% - 1 hr.) LDM 73% 27% (10% - 1 hr.) LDM 99% 1% (1% - 1 hr.) LDM 96% 4%

Morpholine

(100% - 1 hr.) LDM 6% 94% (10% - 1 hr.) LDM 4% 96%

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Campo Biotechnological Herbal Vegetal Cholesterol Extract

CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 48

(1% - 1 hr.) LDM 100% 0% HISTORICAL IN VITRO RESULTS:

Propylene glycol has historically been categorized as virtually non-irritating when tested using the Draize irritation methodologies. Morpholine has been categorized as moderately irritating .when tested in the same manner. DISCUSSIONS:

The sponsor-submitted sample elicited in vitro results comparable to those recorded for propylene glycol. CONCLUSION: The results indicate that the sponsor-submitted product has virtually no irritation potential, under the conditions of this test.

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Campo Biotechnological Herbal Vegetal Cholesterol Extract

CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 49

OBJECTIVE:

To evaluate the test article for irritancy potential utilizing the MATREX in vitro toxicity testing system.

INTRODUCTION:

TESTSKIN and MATREX are sophisticated in vitro systems. Developed in Organogenesis. Inc. of Cambridge, Massachusetts, they closely mimic human skin in structure and function. The Living

Dermal Matrex ( LDM) of a three-dimensional construct comprised of living cells in a collagen matrix. Nutrition is provided through the base via a permeable membrane, leaving the surface open to the atmosphere. This makes an ideal system for applying a variety of materials, including liquids, powders, oils, gels and creams.

The Living Skin Equivalent (LSE) has all the features previously described, plus the formation of an actual epidermis, complete with stratum corneum. TESTSKIN and MATREX, when used with the recommended cell metabolism assay, can quickly provide toxicological profiles. The procedure involves a solubilized, reactive tetrazolium salt (MTT), which is metabolized by, the mitochondria of living cells and converted to a purple formazan dye. The color intensity of the skin replica extract, measured photometrically, correlates directly with its viability. When measured against controls, values ranging from 0% to 1 00% (plus or minus approximately 20%) can be calculated for each dose of an applied substance.

Test Articles : CAMPO MUTHU THULASI VEGETAL CHOLESTEROL Reference Articles: PROPYLENE GLYCOL & MORPHOLINE METHOD:

The appropriate dilutions of test sample and control articles were applied to MATREX. After the appropriate exposure period, the articles were rinsed from the MATREX surfaces. MTT (tetrazolium salt) assay medium , vas utilized in order to quantifv cell metabolism. At the end of the staining period, excised portions of each MATREX were immersed in acidified isopropanol iviiich extracted the converted MI7 from the tissue samples. A Dynatech NM 4000 Automatic Microplate Reader was used to determine the absorbance of each extract at 57Onm. With the absorbance of a negative control defined as 100%, the percent absorbencies of the test and control articles were determined. The percentages listed below directly correlate with the cell metabolism in the MATREX samples. RESULTS:

Test Article Percent Percent (% & Exposure ) System Viability Inhibition

VEGETAL CHOLESTEROL

(100% - 1 hr.) LDM 99.9% 0.1% (10% - 1 hr.) LDM 100% - % (1% - 1 hr.) LDM 100% - %

Propylene glycol

(100% - 1 hr.) LDM 73% 27% (10% - 1 hr.) LDM 99% 1% (1% - 1 hr.) LDM 96% 4%

Morpholine

(100% - 1 hr.) LDM 6% 94% (10% - 1 hr.) LDM 4% 96% (1% - 1 hr.) LDM 100% 0%

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Campo Biotechnological Herbal Vegetal Cholesterol Extract

CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 50

HISTORICAL IN VITRO RESULTS:

Propylene glycol has historically been categorized as virtually non-irritating when tested using the Draize irritation methodologies. Morpholine has been categorized as moderately irritating .when tested in the same manner. DISCUSSIONS:

The sponsor-submitted sample elicited in vitro results comparable to those recorded for propylene glycol. CONCLUSION: The results indicate that the sponsor-submitted product has virtually no irritation potential, under the conditions of this test.

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Campo Biotechnological Herbal Vegetal Cholesterol Extract

CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 51

OBJECTIVE:

To evaluate the test article for irritancy potential utilizing the MATREX in vitro toxicity testing system.

INTRODUCTION:

TESTSKIN and MATREX are sophisticated in vitro systems. Developed in Organogenesis. Inc. of Cambridge, Massachusetts, they closely mimic human skin in structure and function. The Living

Dermal Matrex ( LDM) of a three-dimensional construct comprised of living cells in a collagen matrix. Nutrition is provided through the base via a permeable membrane, leaving the surface open to the atmosphere. This makes an ideal system for applying a variety of materials, including liquids, powders, oils, gels and creams.

The Living Skin Equivalent (LSE) has all the features previously described, plus the formation of an actual epidermis, complete with stratum corneum. TESTSKIN and MATREX, when used with the recommended cell metabolism assay, can quickly provide toxicological profiles. The procedure involves a solubilized, reactive tetrazolium salt (MTT), which is metabolized by, the mitochondria of living cells and converted to a purple formazan dye. The color intensity of the skin replica extract, measured photometrically, correlates directly with its viability. When measured against controls, values ranging from 0% to 1 00% (plus or minus approximately 20%) can be calculated for each dose of an applied substance.

Test Articles : CAMPO MUTHU THULASI VEGETAL LANOLIN – AN INTRODUCTION Reference Articles: PROPYLENE GLYCOL & MORPHOLINE METHOD:

The appropriate dilutions of test sample and control articles were applied to MATREX. After the appropriate exposure period, the articles were rinsed from the MATREX surfaces. MTT (tetrazolium salt) assay medium , vas utilized in order to quantifv cell metabolism. At the end of the staining period, excised portions of each MATREX were immersed in acidified isopropanol iviiich extracted the converted MI7 from the tissue samples. A Dynatech NM 4000 Automatic Microplate Reader was used to determine the absorbance of each extract at 57Onm. With the absorbance of a negative control defined as 100%, the percent absorbencies of the test and control articles were determined. The percentages listed below directly correlate with the cell metabolism in the MATREX samples.

RESULTS:

Test Article Percent Percent (% & Exposure ) System Viability Inhibition

VEGETAL LANOLIN – AN INTRODUCTION

(100% - 1 hr.) LDM 99.9% 0.1% (10% - 1 hr.) LDM 100% - % (1% - 1 hr.) LDM 100% - %

Propylene glycol

(100% - 1 hr.) LDM 73% 27% (10% - 1 hr.) LDM 99% 1% (1% - 1 hr.) LDM 96% 4%

Morpholine

(100% - 1 hr.) LDM 6% 94% (10% - 1 hr.) LDM 4% 96%

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Campo Biotechnological Herbal Vegetal Cholesterol Extract

CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 52

(1% - 1 hr.) LDM 100% 0% HISTORICAL IN VITRO RESULTS:

Propylene glycol has historically been categorized as virtually non-irritating when tested using the Draize irritation methodologies. Morpholine has been categorized as moderately irritating .when tested in the same manner. DISCUSSIONS:

The sponsor-submitted sample elicited in vitro results comparable to those recorded for propylene glycol. CONCLUSION: The results indicate that the sponsor-submitted product has virtually no irritation potential, under the conditions of this test.

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Campo Biotechnological Herbal Vegetal Cholesterol Extract

CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 53

OBJECTIVE:

To evaluate the test article for irritancy potential utilizing the MATREX in vitro toxicity testing system.

INTRODUCTION:

TESTSKIN and MATREX are sophisticated in vitro systems. Developed in Organogenesis. Inc. of Cambridge, Massachusetts, they closely mimic human skin in structure and function. The Living Dermal

Matrex ( LDM) of a three-dimensional construct comprised of living cells in a collagen matrix. Nutrition is provided through the base via a permeable membrane, leaving the surface open to the atmosphere. This makes an ideal system for applying a variety of materials, including liquids, powders, oils, gels and creams.

The Living Skin Equivalent (LSE) has all the features previously described, plus the formation of an actual epidermis, complete with stratum corneum. TESTSKIN and MATREX, when used with the recommended cell metabolism assay, can quickly provide toxicological profiles. The procedure involves a solubilized, reactive tetrazolium salt (MTT), which is metabolized by, the mitochondria of living cells and converted to a purple formazan dye. The color intensity of the skin replica extract, measured photometrically, correlates directly with its viability. When measured against controls, values ranging from 0% to 1 00% (plus or minus approximately 20%) can be calculated for each dose of an applied substance.

Test Articles : CAMPO MUTHU THULASI VEGETAL LANOILIN & BIOTECHNOLOGIC VEGETAL ISOPROPHYL ESTER ( Campolan 1, Campolan 2, and Campolan 3 ).

Reference Articles: PROPYLENE GLYCOL & MORPHOLINE METHOD:

The appropriate dilutions of test sample and control articles were applied to MATREX. After the appropriate exposure period, the articles were rinsed from the MATREX surfaces. MTT (tetrazolium salt) assay medium ,vas utilized in order to quantifv cell metabolism. At the end of the staining period, excised portions of each MATREX were immersed in acidified isopropanol iviiich extracted the converted MI7 from the tissue samples. A Dynatech NM 4000 Automatic Microplate Reader was used to determine the absorbance of each extract at 57Onm. With the absorbance of a negative control defined as 100%, the percent absorbencies of the test and control articles were determined. The percentages listed below directly correlate with the cell metabolism in the MATREX samples.

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Campo Biotechnological Herbal Vegetal Cholesterol Extract

CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 54

RESULTS:

Test Article Percent Percent (% & Exposure ) System Viability Inhibition

VEGETAL LAOILIN & BIOTECHNOLOGIC VEGETAL

ISOPROPYL ESTER

( Campolan 1, Campolan 2, and Campolan 3 )

(100% - 1 hr.) LDM 99.9% 0.1% (10% - 1 hr.) LDM 100% - % (1% - 1 hr.) LDM 100% - %

Propylene glycol

(100% - 1 hr.) LDM 73% 27% (10% - 1 hr.) LDM 99% 1% (1% - 1 hr.) LDM 96% 4%

Morpholine

(100% - 1 hr.) LDM 6% 94% (10% - 1 hr.) LDM 4% 96% (1% - 1 hr.) LDM 100% 0% HISTORICAL IN VITRO RESULTS:

Propylene glycol has historically been categorized as virtually non-irritating when tested using the Draize irritation methodologies. Morpholine has been categorized as moderately irritating .when tested in the same manner. DISCUSSIONS:

The sponsor-submitted sample elicited in vitro results comparable to those recorded for propylene glycol. CONCLUSION: The results indicate that the sponsor-submitted product has virtually no irritation potential, under the conditions of this test.

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Campo Biotechnological Herbal Vegetal Cholesterol Extract

CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 55

CCR – Cytotest Cell Research

CCR PROJECT 97/05

SALMONELLA TYPHIMURIUM

REVERSE MUTATION ASSAY

REPORT

Study Completion Date :

May 5th

, 1997

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Campo Biotechnological Herbal Vegetal Cholesterol Extract

CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 56

Test Report CCR Project 97/05

CONCLUSIONS

The test article Cholesterol SE 10 was assessed for its potential to induce gene mutations

asccording to the plate incorporations test ( experiment I ) and the pre-incubation test (

experiment II ) using Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100

and TA 102.

The assay was performed in two independent experiments both with and without liver

microsomal activation. Each concentration, including the controls, was tested in trilicate. The

test article was tested at the following concentrations :

33.3; 100.0; 333.3; 1000.0; 2500.0; and 5000.0 ug/plate

No toxic effects occurred in the test groups with and without metabolic activation in

experiment I and II in all strains used.

The plates incubated with the test article showed normal background growth up to

5000.0ug/plate with and without S9 mix in all strains used.

No substantial increase in revertant colony numbers of any of the five tester strains were

observed following treatment with Cholesterol SE 10.at any dose level, either in the presence

or absence of metabolic activation ( S9 mix ). There was also no tendency of higher mutation

rates with increasing concentrations in the range below the generally acknowledged border of

significance.

A slightly decrease ( 0.0001% ) in revertant colony numbers was observed in strain TA

102 at 333.3 and 1000.0 ug/plate in experiment I in the presence of metabolic activation.

However, this effect is considered not to be relevant since it could not be reproduced in

the normally more sensitive pre-incubation assays.

Appropriate, it can be stated that during the described mutagenicity test and under the

experimental conditions reported, the test article did not induce point mutations by base pair

changes or frameshifts in the genome of the strains used.

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Campo Biotechnological Herbal Vegetal Cholesterol Extract

CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 57

CCR – Cytotest Cell Research

CCR PROJECT 97/05

SALMONELLA TYPHIMURIUM

REVERSE MUTATION ASSAY

REPORT

Study Completion Date :

May 5th

, 1997

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Campo Biotechnological Herbal Vegetal Cholesterol Extract

CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 58

Vegetal Lanolin Cosmetic Grade A

Test Report CCR Project 97/05

CONCLUSIONS

The test article Vegetal Lanolin Cosmetic Grade A was assessed for its potential to induce

gene mutations asccording to the plate incorporations test ( experiment I ) and the pre-

incubation test ( experiment II ) using Salmonella typhimurium strains TA 1535, TA 1537,

TA 98, TA 100 and TA 102.

The assay was performed in two independent experiments both with and without liver

microsomal activation. Each concentration, including the controls, was tested in trilicate. The

test article was tested at the following concentrations :

33.3; 100.0; 333.3; 1000.0; 2500.0; and 5000.0 ug/plate

No toxic effects occurred in the test groups with and without metabolic activation in

experiment I and II in all strains used.

The plates incubated with the test article showed normal background growth up to

5000.0ug/plate with and without S9 mix in all strains used.

No substantial increase in revertant colony numbers of any of the five tester strains were

observed following treatment with Vegetal Lanolin Cosmetic Grade A at any dose level,

either in the presence or absence of metabolic activation ( S9 mix ). There was also no

tendency of higher mutation rates with increasing concentrations in the range below the

generally acknowledged border of significance.

A slightly decrease ( 0.0001% ) in revertant colony numbers was observed in strain TA

102 at 333.3 and 1000.0 ug/plate in experiment I in the presence of metabolic activation.

However, this effect is considered not to be relevant since it could not be reproduced in

the normally more sensitive pre-incubation assays.

Appropriate, it can be stated that during the described mutagenicity test and under the

experimental conditions reported, the test article did not induce point mutations by base pair

changes or frameshifts in the genome of the strains used.

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Campo Biotechnological Herbal Vegetal Cholesterol Extract

CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 59

Vegetal Lanolin Cosmetic Grade B

CCR – Cytotest Cell Research

CCR PROJECT 97/05

SALMONELLA TYPHIMURIUM

REVERSE MUTATION ASSAY

REPORT

Study Completion Date :

May 5th

, 1997

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Campo Biotechnological Herbal Vegetal Cholesterol Extract

CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 60

Vegetal Lanolin Cosmetic Grade B

Test Report CCR Project 97/05

CONCLUSIONS

The test article Vegetal Lanolin Cosmetic Grade B was assessed for its potential to induce

gene mutations asccording to the plate incorporations test ( experiment I ) and the pre-

incubation test ( experiment II ) using Salmonella typhimurium strains TA 1535, TA 1537,

TA 98, TA 100 and TA 102.

The assay was performed in two independent experiments both with and without liver

microsomal activation. Each concentration, including the controls, was tested in trilicate. The

test article was tested at the following concentrations :

33.3; 100.0; 333.3; 1000.0; 2500.0; and 5000.0 ug/plate

No toxic effects occurred in the test groups with and without metabolic activation in

experiment I and II in all strains used.

The plates incubated with the test article showed normal background growth up to

5000.0ug/plate with and without S9 mix in all strains used.

No substantial increase in revertant colony numbers of any of the five tester strains were

observed following treatment with Vegetal Lanolin Cosmetic Grade B at any dose level,

either in the presence or absence of metabolic activation ( S9 mix ). There was also no

tendency of higher mutation rates with increasing concentrations in the range below the

generally acknowledged border of significance.

A slightly decrease ( 0.0001% ) in revertant colony numbers was observed in strain TA

102 at 333.3 and 1000.0 ug/plate in experiment I in the presence of metabolic activation.

However, this effect is considered not to be relevant since it could not be reproduced in

the normally more sensitive pre-incubation assays.

Appropriate, it can be stated that during the described mutagenicity test and under the

experimental conditions reported, the test article did not induce point mutations by base

pair changes or frameshifts in the genome of the strains used

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Campo Biotechnological Herbal Vegetal Cholesterol Extract

CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 61

USP/NF. eqv

CCR – Cytotest Cell Research

CCR PROJECT 97/05

SALMONELLA TYPHIMURIUM

REVERSE MUTATION ASSAY

REPORT

Study Completion Date :

May 5th

, 1997

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Campo Biotechnological Herbal Vegetal Cholesterol Extract

CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 62

Test Report CCR Project 97/05

CONCLUSIONS

The test article Cholesterol. USP/NF.eqv was assessed for its potential to induce gene

mutations asccording to the plate incorporations test ( experiment I ) and the pre-incubation

test ( experiment II ) using Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA

100 and TA 102.

The assay was performed in two independent experiments both with and without liver

microsomal activation. Each concentration, including the controls, was tested in trilicate. The

test article was tested at the following concentrations :

33.3; 100.0; 333.3; 1000.0; 2500.0; and 5000.0 ug/plate

No toxic effects occurred in the test groups with and without metabolic activation in

experiment I and II in all strains used.

The plates incubated with the test article showed normal background growth up to

5000.0ug/plate with and without S9 mix in all strains used.

No substantial increase in revertant colony numbers of any of the five tester strains were

observed following treatment with Cholesterol USP/NF.eqv at any dose level, either in the

presence or absence of metabolic activation ( S9 mix ). There was also no tendency of higher

mutation rates with increasing concentrations in the range below the generally acknowledged

border of significance.

A slightly decrease ( 0.0001% ) in revertant colony numbers was observed in strain TA

102 at 333.3 and 1000.0 ug/plate in experiment I in the presence of metabolic activation.

However, this effect is considered not to be relevant since it could not be reproduced in

the normally more sensitive pre-incubation assays.

Appropriate, it can be stated that during the described mutagenicity test and under the

experimental conditions reported, the test article did not induce point mutations by base pair

changes or frameshifts in the genome of the strains used.

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Campo Biotechnological Herbal Vegetal Cholesterol Extract

CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 63

Herb Acelan LD

CCR – Cytotest Cell Research

CCR PROJECT 97/05

SALMONELLA TYPHIMURIUM

REVERSE MUTATION ASSAY

REPORT

Study Completion Date :

May 5th

, 1997

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Campo Biotechnological Herbal Vegetal Cholesterol Extract

CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 64

Herb Acelan LD

Test Report CCR Project 97/05

CONCLUSIONS

The test article Herb Acelan LD was assessed for its potential to induce gene mutations

asccording to the plate incorporations test ( experiment I ) and the pre-incubation test (

experiment II ) using Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100

and TA 102.

The assay was performed in two independent experiments both with and without liver

microsomal activation. Each concentration, including the controls, was tested in trilicate. The

test article was tested at the following concentrations :

33.3; 100.0; 333.3; 1000.0; 2500.0; and 5000.0 ug/plate

No toxic effects occurred in the test groups with and without metabolic activation in

experiment I and II in all strains used.

The plates incubated with the test article showed normal background growth up to

5000.0ug/plate with and without S9 mix in all strains used.

No substantial increase in revertant colony numbers of any of the five tester strains were

observed following treatment with Herb Acelan LD at any dose level, either in the presence or

absence of metabolic activation ( S9 mix ). There was also no tendency of higher mutation

rates with increasing concentrations in the range below the generally acknowledged border of

significance.

A slightly decrease ( 0.0001% ) in revertant colony numbers was observed in strain TA

102 at 333.3 and 1000.0 ug/plate in experiment I in the presence of metabolic activation.

However, this effect is considered not to be relevant since it could not be reproduced in

the normally more sensitive pre-incubation assays.

Appropriate, it can be stated that during the described mutagenicity test and under the

experimental conditions reported, the test article did not induce point mutations by base pair

changes or frameshifts in the genome of the strains used.

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Herb Acelan SD

CCR – Cytotest Cell Research

CCR PROJECT 97/05

SALMONELLA TYPHIMURIUM

REVERSE MUTATION ASSAY

REPORT

Study Completion Date :

May 5th

, 1997

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Herb Acelan SD

Test Report CCR Project 97/05

CONCLUSIONS

The test article Herb Acelan SD was assessed for its potential to induce gene mutations

asccording to the plate incorporations test ( experiment I ) and the pre-incubation test (

experiment II ) using Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100

and TA 102.

The assay was performed in two independent experiments both with and without liver

microsomal activation. Each concentration, including the controls, was tested in trilicate. The

test article was tested at the following concentrations :

33.3; 100.0; 333.3; 1000.0; 2500.0; and 5000.0 ug/plate

No toxic effects occurred in the test groups with and without metabolic activation in

experiment I and II in all strains used.

The plates incubated with the test article showed normal background growth up to

5000.0ug/plate with and without S9 mix in all strains used.

No substantial increase in revertant colony numbers of any of the five tester strains were

observed following treatment with Herb Acelan SD at any dose level, either in the presence or

absence of metabolic activation ( S9 mix ). There was also no tendency of higher mutation

rates with increasing concentrations in the range below the generally acknowledged border of

significance.

A slightly decrease ( 0.0001% ) in revertant colony numbers was observed in strain TA

102 at 333.3 and 1000.0 ug/plate in experiment I in the presence of metabolic activation.

However, this effect is considered not to be relevant since it could not be reproduced in

the normally more sensitive pre-incubation assays.

Appropriate, it can be stated that during the described mutagenicity test and under the

experimental conditions reported, the test article did not induce point mutations by base pair

changes or frameshifts in the genome of the strains used.

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CAMPOLAN 1

THE ACTIVE NOVEL DRUG FOR THE COSMETIC FORMULATION

TOXICOLOGICAL & ECOTOXICOLOGICAL DATA

TOLERANCE As to ensure a good level of innocuity CAMPOLAN 1 was tested in in-vitro as follows:

*Irritation potential of the chorio-allantoic membrane of an egg.

When tested on the chorio-allantoic membrane of a chicken egg, according to the technique developed by

LUEPKE** in a 90% liposoluble solution, CAMPOLAN 1 is classified as non irritant.

**LUEPKE, N.P., Hen’s egg chorio-allantoic membrane test for irritation potentiation. Fd. Chem. 1986, 24, 6-

7, 495-496.

* Cytotoxicity on human fibroblasts.

When tested on human fibroblasts using a method patented by BIOGIR (which can be applied to both

hydrosoluble as well as liposoluble products). CAMPOLAN 1 in a 50% active aqueous phase or oily phase,

does not show any signs of toxicity towards fibroblasts in culture.

* Eyetex According to this technique, in a 75% active solution, CAMPOLAN 1 is classified non-irritant.

* Skintex

According to this technique, in a 50% active solution, CAMPOLAN 1 is non irritant. This tolerance data is

confirmed by the tests carried out in vivo on health humans.

* Test on healthy humans

When patch tests were carried out at increasing concentrations (0.5%, 1.1%, 2.2%, 4.7%, 10% & 100%) on 10

subjects, CAMPOLAN 1 did not show any significant irritant reaction at all. Its tolerance is total satisfactory.

COMEDOGENESIS CAMPOLAN 1 was tested in a 100% active concentrate solution on human volunteers, according to the usual

protocols has proven to be free of comedogenic effect.

Because of its good level of innocuity. CAMPOLAN 1 has proved to be first class skin moisturizer and

transepidermal water loss barrier for very many skin moisturizing formulae where tolerance is imperative (

skin moisturizing cream, moisturizing lotion, etc.).

BIODEGRADABILITY

The ultimate aerobic biodegradability of CAMPOLAN 1 is measured according to STRUM TEST (OCDE 301

B, guideline EEC 84/449, Annex V. Method C5).

Under these conditions, a level of biodegradability of CAMPOLAN 1 is 100% in 28 days at 50 mg/ml.

The level of biodegradability of CAMPOLAN 1 is considered to be excellent.

Campo Research Singapore

May 10th

1997

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CAMPOLAN 2

THE ACTIVE NOVEL DRUG FOR THE COSMETIC FORMULATION

TOXICOLOGICAL & ECOTOXICOLOGICAL DATA

TOLERANCE As to ensure a good level of innocuity CAMPOLAN 2 was tested in in-vitro as follows:

*Irritation potential of the chorio-allantoic membrane of an egg.

When tested on the chorio-allantoic membrane of a chicken egg, according to the technique developed by

LUEPKE** in a 50% liposoluble solution, CAMPOLAN 2 is classified as non irritant.

**LUEPKE, N.P., Hen’s egg chorio-allantoic membrane test for irritation potentiation. Fd. Chem. 1986, 24, 6-

7, 495-496.

* Cytotoxicity on human fibroblasts.

When tested on human fibroblasts using a method patented by BIOGIR (which can be applied to both

hydrosoluble as well as liposoluble products). CAMPOLAN 2 in a 75% active aqueous phase or oily phase,

does not show any signs of toxicity towards fibroblasts in culture.

* Eyetex According to this technique, in a 75% active solution, CAMPOLAN 2 is classified non-irritant.

* Skintex

According to this technique, in a 50% active solution, CAMPOLAN 2 is non irritant. This tolerance data is

confirmed by the tests carried out in vivo on health humans.

* Test on healthy humans

When patch tests were carried out at increasing concentrations (0.5%, 1.1%, 2.2%, 4.7%, 10%,50% & 100%)

on 20 subjects, CAMPOLAN 2 did not show any significant irritant reaction at all. Its tolerance is total

satisfactory.

COMEDOGENESIS CAMPOLAN 2 was tested in a 100% active concentrate solution on human volunteers, according to the usual

protocols has proven to be free of comedogenic effect.

Because of its good level of innocuity. CAMPOLAN 2 has proved to be first class skin moisturizer and

transepidermal water loss barrier for very many skin moisturizing formulae where tolerance is imperative (

skin moisturizing cream, moisturizing lotion, etc.).

BIODEGRADABILITY

The ultimate aerobic biodegradability of CAMPOLAN 2 is measured according to STRUM TEST (OCDE 301

B, guideline EEC 84/449, Annex V. Method C5).

Under these conditions, a level of biodegradability of CAMPOLAN 2 is 100% in 28 days at 50 mg/ml.

The level of biodegradability of CAMPOLAN 2 is considered to be excellent.

Campo Research Singapore

May 9th

1997

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CAMPOLAN 3

THE ACTIVE NOVEL DRUG FOR THE COSMETIC FORMULATION

TOXICOLOGICAL & ECOTOXICOLOGICAL DATA

TOLERANCE As to ensure a good level of innocuity CAMPOLAN 3 was tested in in-vitro as follows:

*Irritation potential of the chorio-allantoic membrane of an egg.

When tested on the chorio-allantoic membrane of a chicken egg, according to the technique developed by

LUEPKE** in a 75% liposoluble solution, CAMPOLAN 3 is classified as non irritant.

**LUEPKE, N.P., Hen’s egg chorio-allantoic membrane test for irritation potentiation. Fd. Chem. 1986, 24, 6-

7, 495-496.

* Cytotoxicity on human fibroblasts.

When tested on human fibroblasts using a method patented by BIOGIR (which can be applied to both

hydrosoluble as well as liposoluble products). CAMPOLAN 3 in a 75% active aqueous phase or oily phase,

does not show any signs of toxicity towards fibroblasts in culture.

* Eyetex According to this technique, in a 50% active solution, CAMPOLAN 3 is classified non-irritant.

* Skintex

According to this technique, in a 75% active solution, CAMPOLAN 3 is non irritant. This tolerance data is

confirmed by the tests carried out in vivo on health humans.

* Test on healthy humans

When patch tests were carried out at increasing concentrations (0.5%, 1.1%, 2.2%, 4.7%, 10%,30% & 100%)

on 23 subjects, CAMPOLAN 3 did not show any significant irritant reaction at all. Its tolerance is total

satisfactory.

COMEDOGENESIS CAMPOLAN 3 was tested in a 100% active concentrate solution on human volunteers, according to the usual

protocols has proven to be free of comedogenic effect.

Because of its good level of innocuity. CAMPOLAN 3 has proved to be first class skin moisturizer and

transepidermal water loss barrier for very many skin moisturizing formulae where tolerance is imperative

(skin moisturizing cream, moisturizing lotion, etc.).

BIODEGRADABILITY

The ultimate aerobic biodegradability of CAMPOLAN 3 is measured according to STRUM TEST (OCDE 301

B, guideline EEC 84/449, Annex V. Method C5).

Under these conditions, a level of biodegradability of CAMPOLAN 3 is 100% in 28 days at 50 mg/ml.

The level of biodegradability of CAMPOLAN 3 is considered to be excellent.

Campo Research Singapore

May 9th

1997

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CAMPO HERB ACELAN LD

THE ACTIVE NOVEL DRUG FOR THE COSMETIC FORMULATION

TOXICOLOGICAL & ECOTOXICOLOGICAL DATA

TOLERANCE As to ensure a good level of innocuity Campo Herb Acelan LD was tested in in-vitro as follows:

*Irritation potential of the chorio-allantoic membrane of an egg.

When tested on the chorio-allantoic membrane of a chicken egg, according to the technique developed by

LUEPKE** in a 75% liposoluble solution, Campo Herb Acelan LD is classified as non irritant.

**LUEPKE, N.P., Hen’s egg chorio-allantoic membrane test for irritation potentiation. Fd. Chem. 1986, 24, 6-

7, 495-496.

* Cytotoxicity on human fibroblasts.

When tested on human fibroblasts using a method patented by BIOGIR (which can be applied to both

hydrosoluble as well as liposoluble products). Campo Herb Acelan LD in a 90% active aqueous phase or oily

phase, does not show any signs of toxicity towards fibroblasts in culture.

* Eyetex According to this technique, in a 100% active concentrate solution, Campo Herb Acelan LD is classified non-

irritant.

* Skintex

According to this technique, in a 100% active solution, Campo Herb Acelan LD is non irritant. This tolerance

data is confirmed by the tests carried out in vivo on health humans.

* Test on healthy humans

When patch tests were carried out at increasing concentrations (0.5%, 1.1%, 2.2%, 4.7%, 10% & 100%) on 10

subjects, Campo Herb Acelan LD did not show any significant irritant reaction at all. Its tolerance is total

satisfactory.

COMEDOGENESIS Campo Herb Acelan LD was tested in a 100% active solution on human volunteers, according to the usual

protocols has proven to be free of comedogenic effect.

Because of its good level of innocuity. Campo Herb Acelan LD has proved to be first class skin moisturizer

and transepidermal water loss barrier for very many skin moisturizing formulae where tolerance is imperative

(skin moisturizing cream, moisturizing lotion, etc.).

BIODEGRADABILITY

The ultimate aerobic biodegradability of Campo Herb Acelan LD is measured according to STRUM TEST

(OCDE 301 B, guideline EEC 84/449, Annex V. Method C5).

Under these conditions, a level of biodegradability of Campo Herb Acelan LD is 100% in 28 days at 50 mg/ml.

The level of biodegradability of Campo Herb Acelan LD is considered to be excellent.

Campo Research Singapore

May 9th

1997

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CAMPO HERB ACELAN SD

THE ACTIVE NOVEL DRUG FOR THE COSMETIC FORMULATION

TOXICOLOGICAL & ECOTOXICOLOGICAL DATA

TOLERANCE As to ensure a good level of innocuity Campo Herb Acelan SD was tested in in-vitro as follows:

*Irritation potential of the chorio-allantoic membrane of an egg.

When tested on the chorio-allantoic membrane of a chicken egg, according to the technique developed by

LUEPKE** in a 30% liposoluble solution, Campo Herb Acelan SD is classified as non irritant.

**LUEPKE, N.P., Hen’s egg chorio-allantoic membrane test for irritation potentiation. Fd. Chem. 1986, 24, 6-

7, 495-496.

* Cytotoxicity on human fibroblasts.

When tested on human fibroblasts using a method patented by BIOGIR (which can be applied to both

hydrosoluble as well as liposoluble products). Campo Herb Acelan SD in a 30% active aqueous phase or oily

phase, does not show any signs of toxicity towards fibroblasts in culture.

* Eyetex According to this technique, in a 10% active solution, Campo Herb Acelan SD is classified non-irritant.

* Skintex

According to this technique, in a 10% active solution, Campo Herb Acelan SD is non irritant. This tolerance

data is confirmed by the tests carried out in vivo on health humans.

* Test on healthy humans

When patch tests were carried out at increasing concentrations (0.5%, 1.1%, 2.2%, 4.7%, 10% & 100%) on 10

subjects, Campo Herb Acelan SD did not show any significant irritant reaction at all. Its tolerance is total

satisfactory.

COMEDOGENESIS Campo Herb Acelan SD was tested in a 10% active solution on human volunteers, according to the usual

protocols has proven to be free of comedogenic effect.

Because of its good level of innocuity. Campo Herb Acelan SD has proved to be first class skin moisturizer

and transepidermal water loss barrier for very many skin moisturizing formulae where tolerance is imperative

(skin moisturizing cream, moisturizing lotion, etc.).

BIODEGRADABILITY

The ultimate aerobic biodegradability of Campo Herb Acelan SD is measured according to STRUM TEST

(OCDE 301 B, guideline EEC 84/449, Annex V. Method C5).

Under these conditions, a level of biodegradability of Campo Herb Acelan SD is 100% in 28 days at 50 mg/ml.

The level of biodegradability of Campo Herb Acelan SD is considered to be excellent.

Campo Research Singapore

May 9th

1997

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CAMPO VEGETAL LANOLIN, COSMETIC GRADE A

THE ACTIVE NOVEL DRUG FOR THE COSMETIC FORMULATION

TOXICOLOGICAL & ECOTOXICOLOGICAL DATA

TOLERANCE As to ensure a good level of innocuity Campo Vegetal Lanolin, Cosmetic Grade A was tested in in-vitro as

follows:

*Irritation potential of the chorio-allantoic membrane of an egg.

When tested on the chorio-allantoic membrane of a chicken egg, according to the technique developed by

LUEPKE** in a 50% liposoluble solution, Campo Vegetal Lanolin, Cosmetic Grade A is classified as non

irritant.

**LUEPKE, N.P., Hen’s egg chorio-allantoic membrane test for irritation potentiation. Fd. Chem. 1986, 24, 6-

7, 495-496.

* Cytotoxicity on human fibroblasts.

When tested on human fibroblasts using a method patented by BIOGIR (which can be applied to both

hydrosoluble as well as liposoluble products). Campo Vegetal Lanolin, Cosmetic Grade A in a 50% active

aqueous phase or oily phase, does not show any signs of toxicity towards fibroblasts in culture.

* Eyetex According to this technique, in a 100% active concentrate solution, Campo Vegetal Lanolin, Cosmetic Grade A

is classified non-irritant.

* Skintex

According to this technique, in a 100% active solution, Campo Vegetal Lanolin, Cosmetic Grade A is non

irritant. This tolerance data is confirmed by the tests carried out in vivo on health humans.

* Test on healthy humans

When patch tests were carried out at increasing concentrations (0.5%, 1.1%, 2.2%, 4.7%, 10% & 100%) on 20

subjects, Campo Vegetal Lanolin, Cosmetic Grade A did not show any significant irritant reaction at all. Its

tolerance is total satisfactory.

COMEDOGENESIS Campo Vegetal Lanolin, Cosmetic Grade A was tested in a 100% active solution on human volunteers,

according to the usual protocols has proven to be free of comedogenic effect.

Because of its good level of innocuity. Campo Vegetal Lanolin, Cosmetic Grade A has proved to be first class

skin moisturizer and transepidermal water loss barrier for very many skin moisturizing formulae where

tolerance is imperative (skin moisturizing cream, moisturizing lotion, etc.).

BIODEGRADABILITY

The ultimate aerobic biodegradability of Campo Vegetal Lanolin, Cosmetic Grade A is measured according to

STRUM TEST (OCDE 301 B, guideline EEC 84/449, Annex V. Method C5).

Under these conditions, a level of biodegradability of Campo Vegetal Lanolin, Cosmetic Grade A is 100% in

28 days at 50 mg/ml.

The level of biodegradability of Campo Vegetal Lanolin, Cosmetic Grade A is considered to be excellent.

Campo Research Singapore

May 10th

1997

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CAMPO VEGETAL LANOLIN, COSMETIC GRADE B

THE ACTIVE NOVEL DRUG FOR THE COSMETIC FORMULATION

TOXICOLOGICAL & ECOTOXICOLOGICAL DATA

TOLERANCE As to ensure a good level of innocuity Campo Vegetal Lanolin, Cosmetic Grade B was tested in in-vitro as

follows:

*Irritation potential of the chorio-allantoic membrane of an egg.

When tested on the chorio-allantoic membrane of a chicken egg, according to the technique developed by

LUEPKE** in a 30% liposoluble solution, Campo Vegetal Lanolin, Cosmetic Grade B is classified as non

irritant.

**LUEPKE, N.P., Hen’s egg chorio-allantoic membrane test for irritation potentiation. Fd. Chem. 1986, 24, 6-

7, 495-496.

* Cytotoxicity on human fibroblasts.

When tested on human fibroblasts using a method patented by BIOGIR (which can be applied to both

hydrosoluble as well as liposoluble products). Campo Vegetal Lanolin, Cosmetic Grade B in a 30% active

aqueous phase or oily phase, does not show any signs of toxicity towards fibroblasts in culture.

* Eyetex According to this technique, in a 10% active solution, Campo Vegetal Lanolin, Cosmetic Grade B is classified

non-irritant.

* Skintex

According to this technique, in a 10% active solution, Campo Vegetal Lanolin, Cosmetic Grade B is non

irritant. This tolerance data is confirmed by the tests carried out in vivo on health humans.

* Test on healthy humans

When patch tests were carried out at increasing concentrations (0.5%, 1.1%, 2.2%, 4.7%, 10% & 100%) on 10

subjects, Campo Vegetal Lanolin, Cosmetic Grade B did not show any significant irritant reaction at all. Its

tolerance is total satisfactory.

COMEDOGENESIS Campo Vegetal Lanolin, Cosmetic Grade B was tested in a 10% active solution on human volunteers,

according to the usual protocols has proven to be free of comedogenic effect.

Because of its good level of innocuity. Campo Vegetal Lanolin, Cosmetic Grade B has proved to be first class

skin moisturizer and transepidermal water loss barrier for very many skin moisturizing formulae where

tolerance is imperative ( skin moisturizing cream, moisturizing lotion, etc.).

BIODEGRADABILITY

The ultimate aerobic biodegradability of Campo Vegetal Lanolin, Cosmetic Grade B is measured according to

STRUM TEST (OCDE 301 B, guideline EEC 84/449, Annex V. Method C5).

Under these conditions, a level of biodegradability of Campo Vegetal Lanolin, Cosmetic Grade B is 100% in

28 days at 50 mg/ml.

The level of biodegradability of Campo Vegetal Lanolin, Cosmetic Grade B is considered to be excellent.

Campo Research Singapore

May 10th

1997

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CAMPO MUTHU-THULASI CHOLESTEROL 10 USP/NF eqv.

THE ACTIVE NOVEL DRUG FOR THE COSMETIC FORMULATION

TOXICOLOGICAL & ECOTOXICOLOGICAL DATA

TOLERANCE As to ensure a good level of innocuity Campo Muthu-Thulasi Cholesterol 10 USP/NF eqv.; was tested in

in-vitro as follows:

*Irritation potential of the chorio-allantoic membrane of an egg.

When tested on the chorio-allantoic membrane of a chicken egg, according to the technique developed by

LUEPKE** in a 30% liposoluble solution, Campo Muthu-Thulasi Cholesterol 10 USP/NF eqv.; is classified

as non irritant.

**LUEPKE, N.P., Hen’s egg chorio-allantoic membrane test for irritation potentiation. Fd. Chem. 1986, 24, 6-

7, 495-496.

* Cytotoxicity on human fibroblasts.

When tested on human fibroblasts using a method patented by BIOGIR (which can be applied to both

hydrosoluble as well as liposoluble products). Campo Muthu-Thulasi Cholesterol 10 USP/NF eqv.; in a 50%

active aqueous phase or oily phase, does not show any signs of toxicity towards fibroblasts in culture.

* Eyetex

According to this technique, in a 100% active concentrate solution, Campo Muthu-Thulasi Cholesterol 10

USP/NF eqv.; is classified non-irritant.

* Skintex

According to this technique, in a 100% active concentrate solution, Campo Muthu-Thulasi Cholesterol 10

USP/NF eqv., is non irritant. This tolerance data is confirmed by the tests carried out in vivo on health

humans.

* Test on healthy humans

When patch tests were carried out at increasing concentrations (0.5%, 1.1%, 2.2%, 4.7%, 10% & 100%) on 10

subjects, Campo Muthu-Thulasi Cholesterol 10 USP/NF eqv. did not show any significant irritant reaction

at all. Its tolerance is total satisfactory.

COMEDOGENESIS Campo Muthu-Thulasi Cholesterol 10 USP/NF eqv., was tested in a 10% active solution on human

volunteers, according to the usual protocols has proven to be free of comedogenic effect.

Because of its good level of innocuity. Campo Muthu-Thulasi Cholesterol 10 USP/NF eqv.; has proved to

be first class skin moisturizer and transepidermal water loss barrier for very many skin moisturizing formulae

where tolerance is imperative ( skin moisturizing cream, moisturizing lotion, etc.).

BIODEGRADABILITY

The ultimate aerobic biodegradability of Campo Muthu-Thulasi Cholesterol 10 USP/NF eqv.; is measured

according to STRUM TEST (OCDE 301 B, guideline EEC 84/449, Annex V. Method C5).

Under these conditions, a level of biodegradability of Campo Muthu-Thulasi Cholesterol 10 USP/NF.; is

100% in 28 days at 50 mg/ml.

The level of biodegradability of Campo Muthu-Thulasi Cholesterol 10 USP/NF eqv.; is considered to be

excellent.

Campo Research Singapore

May 10th

1997

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CAMPO MUTHU-THULASI CHOLESTEROL 10 SE

THE ACTIVE NOVEL DRUG FOR THE COSMETIC FORMULATION

TOXICOLOGICAL & ECOTOXICOLOGICAL DATA

TOLERANCE As to ensure a good level of innocuity Campo Muthu-Thulasi Cholesterol 10 SE was tested in in-vitro as

follows:

*Irritation potential of the chorio-allantoic membrane of an egg.

When tested on the chorio-allantoic membrane of a chicken egg, according to the technique developed by

LUEPKE** in a 100% liposoluble concentrate solution, Campo Muthu-Thulasi Cholesterol 10 SE is

classified as non irritant.

**LUEPKE, N.P., Hen’s egg chorio-allantoic membrane test for irritation potentiation. Fd. Chem. 1986, 24, 6-

7, 495-496.

* Cytotoxicity on human fibroblasts.

When tested on human fibroblasts using a method patented by BIOGIR (which can be applied to both

hydrosoluble as well as liposoluble products). Campo Muthu-Thulasi Cholesterol 10 SE in a 75% active

aqueous phase or oily phase, does not show any signs of toxicity towards fibroblasts in culture.

* Eyetex

According to this technique, in a 100% active concentrate solution, Campo Muthu-Thulasi Cholesterol 10

SE is classified non-irritant.

* Skintex

According to this technique, in a 100% active concentrate solution, Campo Muthu-Thulasi Cholesterol 10 SE

is non irritant. This tolerance data is confirmed by the tests carried out in vivo on health humans.

* Test on healthy humans

When patch tests were carried out at increasing concentrations (0.5%, 1.1%, 2.2%, 4.7%, 10% & 100%) on 20

subjects, Campo Muthu-Thulasi Cholesterol 10 SE did not show any significant irritant reaction at all. Its

tolerance is total satisfactory.

COMEDOGENESIS

Campo Muthu-Thulasi Cholesterol 10 SE was tested in a 100% active concentrate solution on human

volunteers, according to the usual protocols has proven to be free of comedogenic effect.

Because of its good level of innocuity. Campo Muthu-Thulasi Cholesterol 10 SE has proved to be first class

skin moisturizer and transepidermal water loss barrier for very many skin moisturizing formulae where

tolerance is imperative (skin moisturizing cream, moisturizing lotion, etc.).

BIODEGRADABILITY

The ultimate aerobic biodegradability of Campo Muthu-Thulasi Cholesterol 10 SE is measured according to

STRUM TEST (OCDE 301 B, guideline EEC 84/449, Annex V. Method C5).

Under these conditions, a level of biodegradability of Campo Muthu-Thulasi Cholesterol 10 SE is 100% in

28 days at 50 mg/ml.

The level of biodegradability of Campo Muthu-Thulasi Cholesterol 10 SE is considered to be excellent.

Campo Research Singapore

May 10th

1997

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Campo Biotechnological Herbal Vegetal Cholesterol Extract

CAMPO CD VERSION 3.7.2 dated 23 November 2013 © 2013 Library of Congress Wash.DC 76

DISCLAIMER : The information contained herein is accurate to the best knowledge and belief of Campo Research Pte Ltd, and specification quoted may change without prior notice. Information contained in this technical literature is believed to be accurate and is offered in good faith for the benefit of the customer. The company, Campo Research Pte Ltd, however, cannot assume any liabilities or risks involved in the use of its natural products or their derivatives or raw materials or ingredients, since the conditions of use are beyond Campo Research Pte Ltd’ s control. Statements concerning the possible use are not intended as recommendations to use our materials in the infringement of any patents or infringements of mandatory regulatory requirements or without any safety evaluations conducted when used in combination with materials of other suppliers.. We make no warranty of any kind, expressed or implied, other than that the material conforms to the applicable standard specifications. Campo Research Pte Ltd accepts no liabilities of whatsoever either expressed or as otherwise arising out of the information supplied, the application, adaptation or processing of the products described herein, or the use of other materials in lieu of the Campo materials or the use of Campo raw materials or ingredients in conjunction with any other products and raw materials. The use of Campo Research Pte Ltd's raw materials or ingredients in any formulations are to be compulsory tested and to be assayed for safety and toxicology profiles evaluations and according the mandatory regulations as required by the laws and regulations of the countries where the evaluation and use of Campo Research Pte Ltd's raw materials or ingredients has been formulated as single components in any carrier systems or as in multi-components formularies. The end-users, marketers; manufacturers, formulation laboratories or importers of Campo Research Pte Ltd' raw materials and ingredients which are incorporated into any formularies as formulated or re-sold or re-exported or assayed in accordance with any mandatory regulatory requirements of any country or infringement of any patents assume all liabilities as that may arise out of the use of Campo Research Pte Ltd's raw materials and ingredients in any formularies in combination with raw materials and ingredients of other suppliers or as single components in any carriers. The definition of users as mentioned in these instances are manufacturers, marketers, formulation laboratories, consultants, and importers assumed all liabilities arising as either personal injuries suits, infringements of patents suits, infringements of or failures to meet regulatory requirements suits of a formulary either as single components in any carrier systems or in as multi-components formularies in which are may consist of a Campo Research Pte Ltd's raw material or ingredients.

IMPORTANT NOTICE Specifications may change without prior notice. Information contained in this technical literature is believed to be accurate and is offered in good faith for the benefit of the customer. The company, however, cannot assume any liability or risk involved in the use of its natural products or their derivatives, since the conditions of use are beyond our control. Statements concerning the possible use are not intended as recommendations to use our products in the infringement of any patent. We make no warranty of any kind; expressed or implied, other than that the material conforms to the applicable standard specifications.