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Juveneye CLR™ Table of Contents Print Pages JuvenEye CLR™ Table of Contents Print Pages Raw Material Documentation (6 pages) 2 - 7 Product Specification (3 pages) 8 - 10 Safety Data Sheet (7 pages) 11 – 17 JuvenEye CLR Raw Material Documentation 1. Trade name: JuvenEye CLR Use: Active for cosmetics Manufacturer: Supplier: CLR – Chemisches Laboratorium Dr. Kurt Richter GmbH Sperenberger Straße 3 D-12277 Berlin / Germany Tel.: +49 30 851026 – 0 Contact for information: Sales Department 2. Raw Material Composition Chemical Name (IUPAC), Formula Not applicable, as mixture. Characterization JuvenEye CLR is derived from Hieracium pilosella (aerial parts) and flowers of Bellis perennis. It contains triterpene glycosides (saponins), polyphenols, umbelliferon glycosides, flavonoid glycosides as well as anthocyanins in an aqueous buffer. Origin plant-derived 3. INCI Name (composition in percentages [ranges] according to FDA recommendations) INCI Name EU Name Range (FDA) Hieracium Pilosella Hieracium Pilosella > 25 % (Hawkweed) Extract Extract Bellis Perennis (Daisy) Flower Bellis Perennis Extract > 50 % Extract 4. Registration EC Designation: EC No.: CAS No.: Hieracium Pilosella, ext. 281-668-2 84012-22-6 Bellis perennis, ext. 283-935-9 84776-11-4 Page 1 Date of completion/revision: 04-07-2017 According to (EC) 1223/2009 JuvenEye CLR Raw Material Documentation 5. Pharmacopoeial Registration ./. 6. Manufacturing Procedure Hawkweed and daisy flower blossoms are gently extracted using an aqueous buffer system and following an internal procedure. Then, the extract is fractionated by means of ultrafiltration and finally filtered. 7. Raw Material Properties Appearance, odor Translucent, cognac colored liquid. Characteristic odor. Product may form a slight deposit over time which does not affect its bioactivity. Solubility Clearly soluble in water at any proportion. Recommended Use JuvenEye CLR is recommended for being used in face care products, particularly eye care applications. It counteracts dark circles and puffy eyes. 8. Analytical Data Quality Control 20 Refractive index nD 1.335 – 1.345 Density 20 °C 1.015 – 1.025 g/ml pH value 4.0 – 5.5 Dry residue (2 h, 102 °C) 3.8 – 4.8 % Color value (Gardner) 6 – 12.5 Sodium Benzoate 0.40 - 0.55 % Sodium Dehydroacetate 0.10 - 0.20 % Colony forming units Total aerobic microbial count (TAMC) < 100/ml Total combined yeasts/moulds count (TYMC) < 10/ml in absence of non-conforming organisms Page 2 Date of completion/revision: 04-07-2017 According to (EC) 1223/2009 JuvenEye CLR Raw Material Documentation 9. Methods of Identification Total of quality control data. 10. Contaminants/Reaction Intermediates occurring in the Raw Material or its Production Process: Contaminants not to be expected Concentrations Methods Formaldehyde x Nitrosamines x 1,4-Dioxane x Ethylene oxide x Monochloroacetic acid x Dichloroacetic acid x Monomers x Halogenous organic compounds x Polycyclic aromatic hydrocarbons ** Pesticides Screening < detection GC/MS*** limits Heavy metals As < 0.1 mg/kg DIN EN ISO 15763 (2010) *** Cd 0.01 mg/kg “ Pb < 0.05 mg/kg “ Hg < 0.005 mg/kg § 64 LFGB L00.00-19/4 Sb < 0.05 mg/kg DIN EN ISO 17294-2-E29 Allergenic substances (acc. to 2003/15/EC) 24 allergens < 1 mg/kg GC/MS*** Oakmoss and Treemoss negative “ Others ./. ** no data available *** spot-checked Page 3 Date of completion/revision: 04-07-2017 According to (EC) 1223/2009 JuvenEye CLR Raw Material Documentation 11. Stabilizing Additives Preserving agents: approx. 0.45 % Sodium Benzoate CAS No. 532-32-1 EC No. 208-534-8 approx. 0.15 % Sodium Dehydroacetate CAS No. 4418-26-2 EC No. 224-580-1 Other additives: approx. 0.6 % Citric acid CAS No. 77-92-9 EC No. 201-069-1 approx. 1.6% Sodium Citrate CAS No.68-04-2 EC No. 200-675-3 12. Microbiology Colony forming units Total aerobic microbial count (TAMC) < 100/ml Total combined yeasts/moulds count (TYMC): < 10/ml Check for absence of characteristic pathogenic germs (Aspergillus brasiliensis, Candida albicans, Staphylococcus aureus, E. coli, Pseudomonas aeruginosa) is done using a sample of 10 ml. 13. Physiological Safety Acute oral toxicity Both, Hieracium pilosella (aerial parts) and Bellis perennis flowers have a long tradition in plant medicine and are used, for example, as herbal tea. Hence there is no need for testing the acute oral toxicity. Eye irritation potential JuvenEye CLR (undiluted) was tested on the chorioallantoic membrane of the hen's egg. The calculated mean irritation score was 0. JuvenEye CLR therefore was classified as "non- irritant" to mucous membranes. Skin compatibility A 48 hour Patch test with a 50% solution of JuvenEye CLR has been performed on a panel of 50 volunteers (18-70 years; 28 normal healthy, 5 eczema, 4 allergy and 13 subjects with sensitive skin). All participants completed the study. Under the test conditions, SDS (1% in water) caused positive reactions in 19 subjects. The negative control water showed no reactions. None of the subjects showed any reaction to the test product. On the basis of these test results and under the test conditions, the product "JuvenEye CLR" is to be classified as 'harmless' with regard to the possibility of skin irritation. Page 4 Date of completion/revision: 04-07-2017 According to (EC) 1223/2009 JuvenEye CLR Raw Material Documentation 14. Information on Percutaneous Permeation no data available 15. Genotoxicity Bacterial Testing no data available Non-Bacterial Testing no data available 16. Human Experience (as far as available) cf. 13. Skin compatibility/sensitization 17. Other Information Chronic Toxicity no data available Subchronic Toxicity no data available Teratogenicity no data available Toxicokinetics no data available Additional Genotoxicological Tests (as far as required) no data available Mutagenicity JuvenEye CLR was investigated for its potential to induce gene mutations according the bacterial reverse mutation assay using 4 different strains of Salmonella typhimurium and E. coli WP2 uvrA bacteria, with and without metabolic activation. No mutagenic effects could be observed in any of the five tester strains up to the highest dosage. Page 5 Date of completion/revision: 04-07-2017 According to (EC) 1223/2009 JuvenEye CLR Raw Material Documentation BSE Hazard JuvenEye CLR does not imply any risk of BSE since it contains neither animal nor animal- derived raw materials. 18. Potential Risks presented by UV Exposure and on Inhalation Phototoxicity JuvenEye CLR has been tested in vitro using the 3T3 Neutral Red Uptake Phototoxicity Assay. No phototoxic effects have been observed up to the highest dosage in this assay. Photosensitization no data available Toxicity on Inhalation no data available 19. Ecology Biodegradability JuvenEye CLR is non-toxic and its ingredients are easily biodegradable. Acute Aquatic Toxicity - Bacteria - Algae - Daphnia no data available - Fish Water Pollution Hazard Class: Presents no water pollution hazard (self-classification). authorized by: W. Reinhold (Director Quality Assurance) – valid without signature – Page 6 Date of completion/revision: 04-07-2017 According to (EC) 1223/2009 JuvenEye CLR Product Specification Characteristics JuvenEye CLR is derived from Hieracium pilosella (aerial parts) and flowers of Bellis perennis. It contains triterpene glycosides (saponins), polyphenols, umbelliferon glycosides, flavonoid glycosides as well as anthocyanins in an aqueous buffer. INCI Name CAS No. EC No. Hieracium Pilosella (Hawkweed) Extract 84012-22-6 281-668-2 (EU Name: Hieracium Pilosella Extract) Bellis Perennis (Daisy) Flower Extract 84776-11-4 283-935-9 (EU Name: Bellis Perennis Extract) Analytical Data 20 Refractive index nD 1.335 – 1.345 Density 20 °C 1.015 – 1.025 g/ml pH value 4.0 – 5.5 Dry residue (2 h, 102 °C) 3.8 – 4.8 % Color value (Gardner) 6 – 12.5 Sodium Benzoate 0.40 - 0.55 % Sodium Dehydroacetate 0.10 - 0.20 % Colony forming units Total aerobic microbial count (TAMC) < 100/ml Total combined yeasts/moulds count < 10/ml (TYMC) in absence of non-conforming organisms Physiological Safety Acute oral toxicity Both, Hieracium pilosella (aerial parts) and Bellis perennis flowers have a long tradition in plant medicine and are used, for example, as herbal tea. Hence there is no need for testing the acute oral toxicity. Eye irritation potential JuvenEye CLR (undiluted) was tested on the chorioallantoic membrane of the hen's egg. The calculated mean irritation score was 0. JuvenEye CLR therefore was classified as "non-irritant" to mucous membranes. Page 1 07/17 JuvenEye CLR Product Specification Skin compatibility A 48 hour Patch test with a 50% solution of JuvenEye CLR has been performed on a panel of 50 volunteers (18-70 years; 28 normal healthy, 5 eczema, 4 allergy and 13 subjects with sensitive skin). All participants completed the study. Under the test conditions, SDS (1% in water) caused positive reactions in 19 subjects. The negative control water showed no reactions. None of the subjects showed any reaction to the test product. On the basis of these test results and under the test conditions, the product "JuvenEye CLR" is to be classified as 'harmless' with regard to the possibility of skin irritation. Mutagenicity JuvenEye CLR was investigated for its potential to induce gene mutations according the bacterial reverse mutation assay using 4 different strains of Salmonella typhimurium and E. coli WP2 uvrA bacteria, with and without metabolic activation. No mutagenic effects could be observed in any of the five tester strains up to the highest dosage. Phototoxicity JuvenEye CLR has been tested in vitro using the 3T3 Neutral Red Uptake Phototoxicity Assay. No phototoxic effects have been observed up to the highest dosage in this assay. Mode of action Based on a synergistic combination of extracts of Hieracium pilosella and Bellis perennis flowers, JuvenEye CLR addresses the most important aspects in the formation and maintenance of dark circles and puffy eyes. JuvenEye CLR induces the production of heme oxygenase and VEGF-C, activates autophagy and increases cellular functionality and energy. It also acts on melanin deposition. The appearance of dark circles, their color and surface area are reduced.
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