G MYSTIC OIL Version: 25-03/APR/2018

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1 G MYSTIC OIL Version: 25-03/APR/ PRODUCT IDENTIFICATION Trade Name: MYSTIC OIL Manufacturer: PROVITAL Responsible for the Safety Assessment: Lourdes Mayordomo Tf./Fax: / Kind of Raw Material: Active Ingredient Function of the Ingredient (PCPC Inventory): Skin-Conditioning Agent-Emollient, Skin-Conditioning Agents-Miscellaneous, Skin-Conditioning Agents - Occlusive, Fragrance Ingredients; Hair Conditioning Agents, Nail Conditioning Agents Function of the Ingredient (UE Inventory): Emollient, Masking, Skin conditioning, Perfuming, Hair conditioning, Nail Conditioning 2. PRODUCT COMPOSITION Components Breakdown (INCI). Including actives, solvents, preservatives, antioxidants and other additives: [EU] CAS EINECS Helianthus Annuus Seed Oil % Macadamia Ternifolia Seed Oil 2-3 % Olea Europaea Fruit Oil 2-3 % Elaeis Guineensis Oil 2-3 % Argania Spinosa Kernel Oil 2-3 % Cocos Nucifera Oil 2-3 % Commiphora Myrrha Resin Extract 0,3-0,5 % Gardenia Taitensis Flower Extract 0,025-0,125 % Antioxidants Rosmarinus Officinalis Leaf Extract 0,1-0,15 % Tocopherol 0,001-0,006 % PCPC [CTFA] CAS EINECS Helianthus Annuus (Sunflower) Seed Oil % Macadamia Ternifolia Seed Oil 2-3 % Olea Europaea (Olive) Fruit Oil 2-3 % Elaeis Guineensis (Palm) Oil 2-3 % Argania Spinosa Kernel Oil 2-3 % Cocos Nucifera (Coconut) Oil 2-3 %

2 Commiphora Myrrha Resin Extract 0,3-0,5 % Gardenia Taitensis Flower Extract 0,025-0,125 % Antioxidants Rosmarinus Officinalis (Rosemary) Leaf Extract 0,1-0,15 % Tocopherol 0,001-0,006 % TOXICOLOGICAL INFORMATION Data obtained in our own toxicological tests and/or bibliographical research Animal testing: This product has not been the subject of animal testing or retesting for cosmetic purposes by or on behalf of this company. General information: The CIR Expert Panel concluded that Helianthus annuus (Sunflower) Seed Oil is safe in the practices of use and concentration described in the safety assessment: Plant-Derived Fatty Acid Oils as Used in Cosmetics, March 4, alfa-tocopherol: Clinical experience indicates that the safety margin is substantial even with the prolonged daily administration (Fed. Reg. 1979; Briggs 1978). The CIR Expert Panel reviewed reports on edible vegetable oils and nut oils and determined that the Macadamia oil is safe in the present practice of use and concentration in cosmetic products. (CIR Expert Panel meeting, December 13-14, 2010) The CIR Expert Panel reviewed reports on edible vegetable oils and nut oils and determined that the Olive Oil is safe in the present practice of use and concentration in cosmetic products (CIR Expert Panel meeting, December 13-14, 2010) The CIR Expert Panel reviewed reports on edible vegetable oils and nut oils and determined that Argan oil is safe in the present practice of use and concentration in cosmetic products. (CIR Expert Panel meeting, December 13-14, 2010) It exists a CIR Final Report on Safety Assessment of Coconut Oil, Coconut Acid, Hydrogenated Coconut Acid and Hydrogenated Coconut Oil including all the toxicological data: JACT, 5 (3) 1986 The Tocopherol has the GRAS status ('Generally Recognized As Safe'): (21CFR ), (21 CFR ), (21CFR ). The following substances have the GRAS status ('Generally Recognized As Safe'): Linoleic Acid (21CFR ), Rosmarinus officinalis (21CFR182.20) Myrrh is an herbal product that has been used since ancient ages for traditional medication as well as in perfume and incense industries. The following substances are used as Food Additives permitted for human consume by FDA: Myrrh (21CFR ) The following herbs have been approved by the German Commission E Monographs: Myrrha (Published October 15, 1987) The CIR panel concluded that the Tocopherol is safe in the present practices of use and concentration in cosmetics when formulated to be nonirritating (CIR Final Amended Report March, 2014) The CIR Expert Panel concluded that Helianthus annuus (Sunflower) Seed Oil is safe in the practices of use and concentration described in the safety assessment: Plant-Derived Fatty Acid Oils as Used in Cosmetics, March 4, There is a CIR Final Report on the Safety Assessment of Palm (fruit) oil (IJT-19 (Suppl.2) 2000). This report was included in a later evaluation of plant-derived fatty acid oils, which concluded that Palm Oil is safe in the present practices of use and concentration described in this safety assessment (CIR Final Report, March 4, 2011). The following herbs have been approved by the German Commission E Monographs:, Rosemary Leaf (published November 30, 1985; revised November 28, 1986, and March 13, 1990). Based on the margins of safety identified the Panel concluded that the use of the rosemary extracts described in the opinion "The EFSA Journal (2008) 721, 1-29" at the proposed uses and use levels would not be of safety 2

3 concern. It exists a Final Report from CIR called " Safety Assessment of Rosmarinus Officinalis (Rosemary)-Derived Ingredients as Used in Cosmetics" that concluded that 10 different Rosemary-derived-ingredients are safe as used in cosmetics when formulated to be non-sensitizing. (CIR, June 9, 2014) Classification according to Council of Europe (*): Helianthus:---, Macadamia:---, Olea:---, Elaeis:----, Argania:---, Commiphora:3 *(1)- Non-recommended ingredients (2)-Ingredients which could not be assessed (3) Recommended ingredients Cytotoxicity: Main phenols present in the extra virgin olive oil (Hydroxytyrosol, tyrosol and oleuropein) showed inhibition both the novo of fatty acid and cholesterol synthesis without an effect on cell viability.(j Nutr Biochem Jul;25(7):683-91) In Olea European oil it has been found that phenolic compounds improve cellular integrity and viability of CaCo2 intestinal cells. (Int. J. Mol. Sci. 2010, 11, ) Olea europaea, phenolic fraction from olive oil, (RTECS No. SL ) : ICLo Human cell HeLa = 1g/L/4H Skin Irritation: Test performed with other products of Provital: Macadamia Oil (Cod ): No irritant on Patch Test (10 vol., occlusive patch during 48 h) Linoleic Acid (RTECS no. RF ): Standard Draize Test, skin, human = 75 mg/3d-i, moderate irritation. Linoleic Acid (HSDB no. 5200): Test on guinea pig, occlusive patch for 24 h, slight skin irritation. Palmitic Acid (RTECS no. RT ): Standard Draize Test, skin, human = 75 mg/3d-i, mild irritation. Oleic Acid (RTECS no. RG ): Standard Draize Test, skin, human = 15 g/3d-i, moderate irritation; Open Irritation Test = 500 mg, mild irritation. Olive oil (RTECS no. RK ): Standard Draize Test on the skin of rabbit and guinea pig, 100 mg/48h = moderate. Olive oil (RTECS no. RK ): Standard Draize Test on the skin of human = 300 mg/3d and 50 mg/48h: Mild. Olive oil: Study on human, olive oil is very weakly irritant. Its irritant capacity increases under occlusive conditions (Contact Dermatitis 1997 Jan; 36(1):5-10). Palm oil (from fruit): when administered undiluted was practically nonirritating to the skin of rabbits (IJT-19, Suppl.2, 2000) A randomized double-blind clinical trial with Cocos nucifera Oil showed negative patch-test results in 34 volunteers (Dermatitis; 2004 Sep; 15(3):109-16). Undiluted coconut oil was applied to the skin of 9 rabbits by means of a 24-hour occlusive patch-test; no irritation was observed (Journal of the American College of Toxicology; 1986; vol.5, nr.3). A skin irritation test was made with a 1% aqueous solution of a bar soap containing 13% Coconut Oil. Very minimal skin reactions were recorded in 106 volunteers. The product was considered safe. (Journal of the American College of Toxicology; 1986; vol.5, nr.3). Monoi oil: Cutaneous irritation test in a reconstituted epidermis. The oil didn't cause any signs of skin irritation. (Supplier data) Clinical study of skin tolerance. In the experimental conditions Monoi oil doesn't cause any histological alteration. According to the protocol realized in 10 volunteers Monoi oil is not irritating. (Supplier data) 1% myrrh oil in methanol,undiluted myrrh oil and Myrrh absolute was not irritating to skin of hairless mice and swine. (Plants in cosmetics, Vol. II, Council of Europe Publishing, 2001) No irritation was reported from 8% myrrh oil and myrrh absolute in petrolatum in 48-hour patch-test on human volunteers (Plants in cosmetics, Vol. II, Council of Europe Publishing, 2001) In two studies of primary cutaneous irritation with 108 volunteers; a skin cream and a face serum containing 6 and 20% of Helianthus annuus (Sunflower) Seed Oil, respectively, resulted not primary irritants. (Final report: Plant-Derived Fatty Acid Oils as Used in Cosmetics, March 4, 2011) Myrrh: non-irritant (ESCOP,4, 1999) Skin Sensitization: A clinical trial was carried out to evaluate the effect of a pharmaceutical formulation containing macadamia oil on 26 patients with vitiligo. The treatment regimen consisted of trice-daily topical application for 9 months to the skin lesions. No allergic or toxic effect was observed on the patients' skin. The pharmaceutical formula containing macadamia oil showed absence of toxicity and was considered safe (Lat. Am. J. Pharm 30(7): ) Contact allergy to olive oil is considered rare. There are described only rare occupational allergic contact 3

4 dermatitis (J. Am. Acad. dermatol Aug; 41(2Pt2):312-5). Palm oil (from fruit): wat 5% was nonallergenic in guinea pig maximization test (IJT-19, Suppl.2, 2000) Palm oil (from fruit): Administrated at 15% the product did not induce sensitization in any of the 110 subjects in a RIPT test (IJT-19, Suppl.2, 2000) An assay evaluates the allergenic potential of coconut oil at concentrations of 50 and 100% in guinea pigs; the oil showed to be non-irritating and failed to produce an allergic response (Journal of the American College of Toxicology; 1986; vol.5, nr.3). A skin sensitization assay with coconut oil at 2.5% (nine 24h-induction-patches applied over a 3-week period) did not show erythematous reactions (Journal of the American College of Toxicology; 1986; vol.5, nr.3). Monoi oil: Cutaneous sensitization test according to the Marzulli and Maibach method in 25 healthy volunteers. There were no symptoms of cutaneous Sensitization in the 25 volunteers. The study concluded that in normal conditions of use the oil is well tolerated. (Supplier data) Evaluation of skin tolerance and allergic potential: According to the results in 107 volunteers who said they have sensitive skin, in the certain experimental conditions, Monoi oil didn't show any skin irritant or allergic potential. (Supplier data) Sensitisation: no reaction reported in volunteers treated with 8% myrrh oil in petrolatum (Plants in cosmetics, Vol. II, Council of Europe Publishing, 2001) In various sensitization tests (HRIPT) with up to 108 volunteers, different cosmetic products containing from to 39.8% of Helianthus Annuus Seed Oil, resulted not a dermal irritants or sensitizers. (Final report: Plant- Derived Fatty Acid Oils as Used in Cosmetics, March 4, 2011) Myrrh: non-sensitizant (ESCOP,4, 1999) Eye Irritation: Test performed with other products of Provital: Macadamia Oil (Cod ):In-vitro Irritation Index: HET-CAM (con.100%) :0.0; Macadamia Oil (Cod ): MTT Test on fibroblasts: Slightly Irritant Linoleic Acid (HSDB no. 5200): Irritation Test on rabbit eye, mild conjunctive erythema. Oleic Acid (RTECS no. RG ): Standard Draize Test, eye, rabbit = 100 mg, mild irritation. Palm oil (from fruit): when administered undiluted induced minimal ocular irritation in rabbits (IJT-19, Suppl.2, 2000) Undiluted coconut oil was assayed for eye irritation in rabbits; the results were indicative of minimal eye irritation (Journal of the American College of Toxicology; 1986; vol.5, nr.3). Monoi oil: Ocular irritation In vitro Test in fibroblasts. The oil was classified as a very mild irritant. (Supplier data) The ocular irritation potencial of high purity olive oil was evaluated using in vivo Draize test in rabbits. Undiluted olive oil was not an ocular irritant in this test. Using human conjunctival epithelial cells in an in vitro study, olive oil did not induce cellular necrosis or apoptosis. (CIR Expert Panel Meeting, August 2010, p.14) Mutagenicity: Sunflower Seed Oil (RTECS no. WT ): Specific locus test, oral D. melanogaster = 12 pph/48h. Olive oil (RTECS no. RK ): EPA GENETOX PROGRAM 1988, Inconclusive: E coli pola without and with S9. Olive oil (CCRIS no. 8702): Negative in in vivo cromosomal aberrations test on rat at 5 ml/kg. Oleic Acid (HSDB no. 1240): Ames Test on Salmonella with and without S9, Results: negative, the substance did not show mutagenic activity. Oleic Acid (RTECS no. RG ): Cytogenetic analysis Saccharomyces cerevisae = 100 mg/l; Unscheduled DNA synthesis rectal mouse = 35 mg/kg; Cytogenetic analysis hamster fibroblast = 2500 µg/l. The genotoxicity and the antigenotoxicity of argan oil and its unsaponifiable fraction (UF) against Drosophila melanogaster was evaluated using wing spots enumeration. Results showed that the argan oil (at 20% dosage) and the UF (at g/l) were not genotoxic. Results on the effects of argan oil and UF on the mutagenic properties of methyl methanesulfonate (MMS) and ethyl carbamate (urethane) showed an inhibition rate between 43 and 75 %. The result of the present study suggests that argan oil prevent mutations induced by urethane and MMS in D. melanogaster, as a consequence consumption of argan oil can prevent human DNA lesion induced by some environmental mutagens. (African Journal of Food Science 4(7), pp , 2010) Vanillin (RTECS nº YW ): Cytogenetic analysis on human lymphocytes = 4mmol/L; Sister chromatid exchange = 750 umol/l; DNA damage on human cells = 2,5 mmol/l/4h. Myrrh administered orally to mice for 7 days at mg/kg/day showed no mutagenicity in the micronucleous test (ESCOP MONOGRAPHS, Second Edition 2003) Olive oil (RTECS no. RK ): Specific locus test p.o. Drosophilla melanogaster = 12 pph/48h-c. 4

5 Palm oil (from fruit): no mutagenic in Ames Test and no mutagenic in chromosomal aberrations test (IJT-19, Suppl.2, 2000) Coconut oil, saponified: Salmonella typhimurium, Dose: 62,5 ng/plate/2d. (RTECS nº GG ) A myrrh extract, administrated in rats, of 500 mg/kg during 6 weeks was safe and didn't cause hepatotoxic, genotoxic or carcinogenic effects (J Egypt Soc Parasitol. 2005, Apr; 35(1):313-29). Acute toxicity: Sunflower Seed Oil (RTECS no. WT ): TDLo i.m. rat = 1 ml/kg. Linoleic Acid (RTECS no. RF ): LD50 i.p. rat > 50 g/kg; LD50 p.o. mouse > 50 g/kg; LD50 i.p. mouse = 280 mg/kg. Palmitic Acid (RTECS no. RT ): LD50 p.o. rat > 10 g/kg; LD50 i.v.mouse = 57 mg/kg. Oleic Acid (RTECS no. RG ): LD50 i.v. rat = 2400 µg/kg; LD50 i.p. mouse = 282 mg/kg; LD50 i.v. mouse = 230 mg/kg; LD i.v. monkey > 40 µl/kg; LD i.v. mouse > 55 mg/kg; TDLo i.v. monkey = 0.08 mg/kg; LD50 p.o. rat = mg/kg; LD50 p.o. mouse = mg/kg; TDLo rabbit skin = 100 pph; TDLo i.d. guinea pig = 400 µg/kg; TCLo inhalation rat = 30 mg/m3/4h; TDLo i.v. rat = 0.15 ml/kg; TDLo i.v. rat = 100 mg/kg; TDLo i.v. guinea pig = 15 µl/kg; TDLo skin rabbit = 100 pph/2h. Oleic Acid (HSDB no. 1240): LD50 p.o. rat = 74 g/kg; LD50 i.v. rat = 2.4 mg/kg; LD50 i.v. mouse = 230 mg/kg; LD50 guinea pig > 3000 mg/kg. Olive oil (RTECS no. RK ): LD50 i.p. mouse > 50 g/kg; LD 50 i.v. mouse = 1320 mg/kg. Olive oil (RTECS no. RK ): TDLo intramuscular rat = 1 ml/kg; p.o. = 10 ml/kg; intraperitoneal = 10 ml/kg; intraduodenal = 10 ml/kg. Paml oil (From Fruit): LD50 p.o. rat > 5 g/kg (IJT-19, Suppl.2, 2000) Oral administration of an Elais guineensis methanol extract in brine shrimp at the highest dose of mg/kg resulted in no mortalities or evidence of adverse effects, implying that E. guineensis is nontoxic. The LC(50) had values of more than 1,0 mg/ml (9,00 y 3,87 mg/ml, at 6 and 24h, respectively). Maximum mortalities ocurred at 100 mg/ml concentration while the least mortalities happened to be at mg/ml concentration. The results of both test confirm that E. guineensis is nontoxic and hence safe for commercial utilization. (Molecules Nov 10;15(11): ) In a study aimed to identify the in vivo effects of oil palm phenolics (OPP) mice were supplemented with OPP as drinking fluid. The antioxidant content of the OPP given was 1500 ppm gallic acid equivalent and fluid intake was monitored every day during six weeks. Results showed non-toxicity. This study implies the potential application of OPP as a valuable source of wellness nutraceuticals. (BMC Genomics, 2011 Aug 25;12:432) Coconut Oil: LD50> 5 g/kg rat p.o. (Journal of the American College of Toxicology; 1986; vol.5, nr.3). Myrrh ( C. molmol): LD50 p.o. mice > 3 g/kg (ESCOP MONOGRAPHS, Second Edition 2003) Essential oil of myrrh: LD50 p.o. rat = 1650 mg/kg (Plants in cosmetics, Vol. II, Council of Europe Publishing, 2001) Myrrh: LD50 i.p. rat = 175 mg/kg (THBRAA 64, 413, 91) Myrrh Extract: LD50 i.p. mouse = 750 mg/kg (IJEBA 6 11, 43, 73) Polysaccharides from Commiphora myrrha: LD50 rat i.p. =175 mg/kg (THBRAA 64,413,91) Commiphora molmol ethanolic extract (resin) (RTECS nº GK ): TDLo p.o. mouse = 200 mg/kg; i.p. = 400 mg/kg. Subchronic and chronic toxicity: Coconut Oil (RTECS GG ): TDLo p.o. rat = 1688 g/kg/90d-c Palm Oil (from fruit): No toxic in rats when administered in diet for 28 days (IJT-19, Suppl.2, 2000) Oleic Acid (RTECS no. RG ): TDLo i.p. mouse = 2712 mg/kg/6w-i; TDLo mouse skin = 1500 mg/kg/3d-i. Linoleic Acid (RTECS no. RF ): TDLo, skin, mouse = 1500 mg/kg/3d-i. Argania spinosa, seed oil (RTECS no. CF ): TDLo p.o. rat= 490 ml/kg/7w Coconut oil at 25% in the diet showed no toxic effects in a study in rats for 90 days. (Journal of the American College of Toxicology; 1986; vol.5, nr.3). Commiphora myrrha (resin) (RTECS nº GK ): TDLo p.o. rat = 14 g/kg/14d-c; i.p. = 3500 mg/kg/14d-i; intramuscular = 7 g/kg/14d-i. Commiphora molmol ethanolic extract (resin) (RTECS nº GK ): TDLo p.o. rat = 2400 mg/kg/6d-i. Myrrh ( C. molmol): TDLo p.o. mice > 100 mg/kg/day for 90 days (ESCOP MONOGRAPHS, Second Edition 2003) Palma oil (RTECS RJ ): TDLo oral rat= 112,5 ml/kg/30d-i Myrrh: well tolerated at 10 mg/kg/day for 3-9 days and no signs of toxicity at 12 mg/kg/day for 6 days (ESCOP 5

6 MONOGRAPHS, Second Edition 2003) An ethanolic extract of Commiphora myrrha gum resin, was administrated at doses of 500 mg/kg/day p.o. and 250 mg/kg/day i.m. in rats during 2 weeks and was no lethal (Vet Hum Toxicol Aug;41(4):193-6). A myrrh extract, administrated in rats, of 500 mg/kg during 6 weeks was safe and didn't cause hepatotoxic, genotoxic or carcinogenic effects (J Egypt Soc Parasitol. 2005, Apr; 35(1):313-29). Reproductive effects: Sunflower Seed Oil (RTECS no. WT ): TDLo i.m. rat = 1 ml/kg, female 1 day pre-mating. Palm oil (from Fruit) (RTECS nº RJ ): TDLo p.o. rat= 55 and 165 g/kg, female 5-15 days after conception, TDLo p.o. rat g/kg Olive oil (RTECS no. RK ): TDLo intramuscular rat = 1 ml/kg, female 1 day pre-mating. Other data: A controlled feeding study (5-wk diet periods) compared a Macadamia nut-rich diet (42.5g/2100 kcal) versus an average American diet was performed in 25 moderately hypercholesterolemic subjects. The results demonstrate that the inclusion of macadamia nuts in a diet significantly reduces total cholesterol and LDL cholesterol concentrations. Thus, macadamia nuts can be included in a heart-healthy dietary pattern that reduces cardiovascular disease risk factors. (J. Nutr. 138: , 2008) Oleic Acid (HSDB no. 1240): Practically not toxic. Lethal dose in humans > 15 g/kg. Palm oil (from fruit) (HSDB nº2188): Non-toxic ingestion Argan oil is likely to enhance the cancer prevention effects of the Moroccan diet. ( Eur J Cancer Prev 2003 Feb; 12 (1): 67-75) The potential health benefits of dietary oils in ralation to cardiovascular disease and cancer are receiving considerable attention. It was performed an study to investigate the effect of argan oil in hyperlipidemic rats. The animals were treated with argan oil (1 ml/100 g weight) daily by oral route during 7 weeks. The results indicate the beneficial effect of argan oil in the treatment of the hyperlipidemia and hypercholesterolemia (J Ethnopharmacol Nov; 89 (1): 15-8) A phototoxicity test was made with a 3% aqueous solution of a bar soap containing 13% Coconut Oil. The occlusive patches and UVA exposure were applied to 10 volunteers over a 6-week period; no evidence of phototoxicity was observed (Journal of the American College of Toxicology; 1986; vol.5, nr.3). A photosensitization test was made with a 3% aqueous solution of a bar soap containing 13% Coconut Oil. The product was tested in 52 volunteers; it was applied during 3 weeks before exposition to sunlight. No evidence of photosensitization was noted (Journal of the American College of Toxicology; 1986; vol.5, nr.3). Olea European oil: Phenolic compounds have a beneficial effect on cellular function. In a study using MCF-7 and SKBR3 breast tumor cells, they have showed that these compounds inhibited cell growth in these cell lines in a dose-dependent manner and reduced expression of the HER2 oncogene which palys a integral role in malignant transformation, tumorigenesis and metastasis. The hydroxytyrosol phenolic compound has unveiled an antiproliferative effects against human colon adenocarcinoma cells. (Int. J. Mol. Sci. 2010, 11, ) A study aimed to determine whether diets supplemented with olive oil are able to regulate MMP-2 and MMP-9 activities in the placenta and serum from diabetic rats. Serum and placentas from diabetic rats showed increased MMP-2 and MMP-9 activities and protein concentrations, and both were decreased when diabetic rats received the olive dietary treatment.this study demonstrates that olive oil-supplemented diets were able to prevent MMPs overactivities in the placenta from diabetic rats, and that these beneficial effects are reflected in rat sera. (Placenta. 2012;33(1):8-16). Olive oil (CCRIS no. 8702): Study on SD rat, dose 15% in diet, Significant antitumorigen effects. Olive oil (HSDB no. 5151): Non-Toxic ingestion. Phototoxicity: 1% myrrh oil and myrrh absolute in methanol was not phototoxic to hairless mice (Plants in cosmetics, Vol. II, Council of Europe Publishing, 2001) 6

7 4. ECOLOGICAL DATA Biodegradability: Vanillin: The study of biodegradability under anaerobic conditions shows that vanillin degrades rapidly (OECD Screening Information Data Sets, SIDS, Vanilin) Aquatic Toxicity: Palmitic Acid : LD goldfish=11 mg/l; LC50 Oryzias latipes =150mg/l 96-h (HSDB nº 5001 Last Revison Date ) Oleic Acid: LC50 Pimephales promelas: ug/l for 1h, ug/l for 24h, ug/l for 48h, ug/l for 72h, ug/l for 96h (Hazardous Substances Databank nº 1240; Last revision ). Vanillin: Acute toxicity (fish): CL50/pimephales promelas: mg/l/96h Acute toxicity (daphnia) : CL50 (24h) : 180 mg/l (OECD Screening Information Data Sets, SIDS, Vanilin) Other data: Vanillin: There is no trend to bioaccumulation. (OECD Screening Information Data Sets, SIDS, Vanilin) 5. CONCLUSION The European cosmetics legislation (Regulation (EC) No 1223/2009) establishes the need to assess the safety of cosmetic products, taking into account the toxicological profile of the ingredients. To do this, in the case of possible systemic effects, it is necessary to obtain the NOAEL (no observed adverse effects level) for the calculation of MoS (margin of safety). The absence of these considerations shall be duly justified. The NOAEL value, or else other data used for the same purpose (LOAEL, LD50, etc.), can only be calculated experimentally from toxicological studies that require the use of animals. Since Provital does not perform any animal testing, it has established a system to ensure the safety of its products without the need of NOAEL and the subsequent calculation of MoS. This systematic, in the case of natural complex substances (NCS) has been endorsed by international organisms and renowned toxicologists. The safety of this ingredient is then established based on the following information: known uses of the active in different fields (medicine, food, cosmetics, etc.), profile of the chemical compounds of the ingredient and bibliographic toxicological information available for the active and its components. The integration and study of all these data allows for a conclusion on the safety of the ingredient. The components of this product have registered adverse effects neither in its described uses nor in the historical marketing of this company. These data and the available toxicological information lead to the conclusion that the use of this product, under the normal conditions of cosmetic use, involves no risk for consumers. This information is based on Provital's current knowledge and experience and Provital has no legal obligation or liability in relation to any damage, loss or offense, including in regard to patent rights. Risks and liabilities arising from the use of this information, the product or its applications are accepted by the user according to current local laws. Provital does not guarantee efficacy experimental results under conditions other than those specified. Provital also reserves the right to make changes to this document due to technical progress or further developments. 7