Cosmetic Ingredient Dossier

Cosmetic Ingredient DossierFor personal use only.

RonaCare® ASC III®Item No.: 110154

Nicht überwachte KopieUncontrolled Copy

For further information please contact:

Mrs. Ina Höfgen-MüllerRegulatory Affairs CosmeticsPhone +49 (0) 6151/72-7869Fax +49 (0) 6151/72-917869

Cosmetic Ingredient DossierTradename: RonaCare® ASC III® Item No.: 110154

Table of ContentsIf you're viewing this document online, you can click any of the topics below to link directly to that section.

Foreword. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3

Regulatory Data

Chemical Description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4

Molecular Formula. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4

Synonyms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4

CAS-No.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4

EC / EG (EINECS)-No.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4

CI-No.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4

INCI-Name. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4

Registration Status. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10

Chemical Data

Composition. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11

Shelf life / storage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11

Technical Data Sheet. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12

Specification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14

Additives / By-products / Impurities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15

Safety Evaluation

Safety Data Sheet (according to 91/155/EEC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17

Toxicological Review. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21

Ecotoxicological Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25

Microbiology. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26

Origin. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26

BSE declaration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26

GMO declaration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26

Allergen declaration (according to 2003/15/EC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27

CMR declaration (according to 2003/15/EC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29

©2005 Merck KGaA Darmstadt, Germany 2007-01-29 Page 2 of 36


Foreword

The following data are in the main specific and refer only to the namedproduct of Merck KGaA.

These data cannot be transferred to other products even if the productsare chemically identical.

We advise our customer on information matters to the best of ourknowledge in the given circumstances. The information andrecommendations provided are non-binding. We do not claim the CosmeticIngredient Dossier to be complete and existing laws and regulations mustbe observed in all cases. This applies also with respect to any rights ofthird parties. Our suggestions do not relieve our customer of theresponsibility for checking the suitability of our products for the envisagedpurpose. Quotations from our literature are allowed only with our writtenpermission and quoting us as the information source.



Regulatory Data

Chemical Description : 1. Water2. Lecithin3. Dipalmitoyl hydroxyproline4. Tall oil sterol5. Linoleic acid6. Tocopherol7. Sodium ascorbate8. Mannitol9. Phenoxyethanol10. Methylparaben11. Butylparaben12. Ethylparaben13. Propylparaben14. Isobutylparaben

1. Chemical Substance:

Molecular Formula: H2OCAS-No.: 7732-18-5EC / EG (EINECS)-No.: 231-791-2CI-No.: -Synonyms: Deionized Water; Distilled Water; Purified

WaterINCI-Name: Water (for EU: Aqua)




Molecular Formula: naturally occuring mixture of diglycerides ofstearic, palmitic and oleic acid, linked to thecholine ester of phosphoric acid

CAS-No.: 8002-43-5EC / EG (EINECS)-No.: 232-307-2CI-No.: -Synonyms: E 322INCI-Name: Lecithin


Molecular Formula: C37H69NO5CAS-No.: 41672-81-5EC / EG (EINECS)-No.: 255-490-0CI-No.: -Synonyms: L-Proline, 1-(1-Oxohexadecyl)-4-[(1-

Oxohexadecyl) Oxy]- Trans-;INCI-Name: Dipalmitoyl Hydroxyproline


Molecular Formula: C29H50OCAS-No.: 83-46-5EC / EG (EINECS)-No.: 201-480-6CI-No.: -Synonyms: ß-SitosterolINCI-Name: Tall Oil Sterol




Molecular Formula: C18H32O2CAS-No.: 60-33-3EC / EG (EINECS)-No.: 200-470-9CI-No.: -Synonyms: 9,12-Octadecadienoic AcidINCI-Name: Linoleic Acid


Molecular Formula: C29H50O2CAS-No.: 59-02-9EC / EG (EINECS)-No.: 200-02-9CI-No.: -Synonyms: D-Alpha Tocopherol; Vitamin E; 3,4-

Dihydro-2,5,7,8-Tetramethyl-2-(4,8,12-Trimethyltridecyl)-2H-1-Benzopyran-6-ol

INCI-Name: Tocopherol


Molecular Formula: C6H8O6• NaCAS-No.: 134-03-2EC / EG (EINECS)-No.: 205-126-1CI-No.: -Synonyms: L-Ascorbic Acid, Monosodium SaltINCI-Name: Sodium Ascorbate




Molecular Formula: C6H14O6CAS-No.: 69-65-8EC / EG (EINECS)-No.: 200-711-8CI-No.: -Synonyms: -INCI-Name: Mannitol


Molecular Formula: C8H10O2CAS-No.: 122-99-6EC / EG (EINECS)-No.: 204-589-7CI-No.: -Synonyms: Phenoxytol; 2-Phenoxyethanol Ethanol, 2-

Phenoxy; Ethylene glycol monophenyl etherINCI-Name: Phenoxyethanol


Molecular Formula: C8H8O3CAS-No.: 99-76-3EC / EG (EINECS)-No.: 202-785-7CI-No.: -Synonyms: Methyl Parahydroxybenzoate; Methyl 4-

Hydroxybenzoate; Benzoic Acid, 4-Hydroxy-, Methyl Ester

INCI-Name: Methylparaben




Molecular Formula: C11H14O3CAS-No.: 94-26-8EC / EG (EINECS)-No.: 202-318-7CI-No.: -Synonyms: Butyl Parahydroxybenzoate ; Butyl 4-

Hydroxybenzoate; Benzoic Acid, 4-Hydroxy-, Butyl Ester

INCI-Name: Butylparaben


Molecular Formula: C9H10O3CAS-No.: 120-47-8EC / EG (EINECS)-No.: 204-399-4CI-No.: -Synonyms: Ethyl Parahydroxybenzoate Ethyl p-

Hydroxybenzoate Benzoic Acid, 4-Hydroxy-, Ethyl Ester

INCI-Name: Ethylparaben


Molecular Formula: C10H12O3CAS-No.: 94-13-3EC / EG (EINECS)-No.: 202-307-7CI-No.: -Synonyms: Propyl Parahydroxybenzoate; Propyl 4-

Hydroxybenzoate; Benzoic Acid, 4-Hydroxy-, Propyl Ester

INCI-Name: Propylparaben




Molecular Formula: C11H14O3CAS-No.: 4247-02-3EC / EG (EINECS)-No.: 224-208-8CI-No.: -Synonyms: Parahydroxybenzoic Acid, Isobutyl Ester;

Isobutyl p-Hydroxybenzoate; Isobutyl 4-Hydroxybenzoate

INCI-Name: Isobutylparaben



Registration Status

EU: No direct regulations, except for the preservatives.

RonaCare® ASCIII® is permitted for cosmetic use according tothe Cosmetics Directive 76/768/EEC.

USA: No direct regulations.

Permited for cosmetic use (responsibility for safety by themanufacturer).

Japan : The ingredients of RonaCare® ASCIII® are not specificallyregulated, except the preservatives, according to the NewCosmetic Standards, enforced on April 1st, 2001 by the Ministryof Health and Welfare (MHW).

RonaCare® ASCIII® can be used for cosmetic formulationsunder the responsibility of the cosmetic manufacturer.



Chemical Data

Composition : Water > 90 %Lecithin < 8 %Dipalmitoyl hydroxyproline 1.4 - 1.9 %Tall oil sterol < 1 %Linoleic acid < 0.5 %Tocopherol < 0.5 %Sodium ascorbate < 0.5 %Mannitol < 0.5 %Phenoxyethanol 0.30-0.40 %Parabens 0.1 - 0.2 %

Shelf life : at least 1.5 years

Storage Conditions : Store at a temperature between 5° to 30° C. Useimmediately after opening.



Technical Data Sheet





Specification



Additives / By-products / Impurities

Additives :Antioxidant: Tocopherol

Sodium ascorbate Stabilizer: Mannitol Preservative: Phenoxyethanol

Methyl parabeneButyl parabeneEthyl parabenePropyl parabene

Isobutyl parabeneSolvent: WaterColourant: not presentBleaching agents: not present

By-products :Specific by-products fromthe production process:

not present

Solvents (Alcohols): not present



Impurities : Heavy metals: Cd ≤ 0.0002 % Pb ≤ 0.001 %

Ethylene oxide:

Based on themanufacturingprocess - not to beexpected.

sec. Dialkanolamins:Pesticides:Nitrosamines:1,4-Dioxan:Dioxine:Benzene:Phenol:Polycyclic aromatichydrocarbons:- PCP- PCPMonomer



Safety Data Sheet









Toxicological Review









Ecotoxicological Data

No specific data available.

An ecotoxicological influence on the environment is not expected, becausemore than 97 % of the product consists of natural substances (e. g. water,lecithin, tall oil sterol, tocopherol).



Microbiology

Microbial Purity: ≤ 100 CFU/gPathogens: Escherichia coli absent in 1 g

Pseudomonas aeruginosa absent in 1 gStaphylococcus aureus absent in 1 gSalmonella absent in 10 g

Origin

The ingredients of RonaCare® ASC III® are of chemical or vegetableorigin.

BSE declaration

not applicable

GMO declaration

This is to certify that neither genetically modified organisms (GMOs) norGMO-derived raw material are used in the manufacturing of the referencedproduct.

In addition we would like to inform that because of the specific origin of theused raw materials (chemical or vegetable) and manufacturing proceduresthe final product is not associated with the GMO problematic.



Allergen declaration

With the 7th Amendment of the Cosmetics Directive (2003/15/EC)published on March 11th 2003 twenty-six potential allergens have beenlisted in Annex III of the Directive. These allergens have been identified asmain cause of allergic reactions in persons who have shown an allergy toperfumes.

None of these twenty-six allergens (see Attachment 1) have beenintentionally added to RonaCare® ASC III®.

An analytical check on the presence of these allergens in traces is notperformed in cosmetic raw materials, which are chemically produced.





CMR declaration

With the 7th Amendment of the Cosmetics Directive (2003/15/EC)published on March 11th 2003 the use substances classified ascarcinogenic, mutagenic or toxic for reproduction (CMR) of category 1, 2and 3, under Annex I of the Directive 67/548/EEC, in cosmeticproducts shall be prohibited.

With Commission Directive 2004/93/EC, September 21st , 2004, thesubstances of Annex I of the Directive 67/548/EEC (CMR substancesclass 1, 2 and 3) are listed under Annex II (negative list) of the CosmeticsDirective 76/768/EEC.

The ingredients of RonaCare® ASC III® are not classified as CMRsubstances under Annex I of Directive 67/548/EEC (not classified ashazardous to human health; see Safety Data Sheet, Chapter 15) and arenot listed under Annex II of Cosmetics Directive 76/768/EEC.

RonaCare® ASC III® can be used as ingredient for cosmetic formulationswithout problems.
















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Cosmetic Ingredient Dossier