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SUPPLEMENT Brown Algae Parabens Polyol Phosphates SUPPLEMENT Brown Algae Parabens Polyol Phosphates Titanium Vinylpyrrolidone Polymers Xanthine Alkaloids CIR EXPERT PANEL MEETING SEPTEMBER 24-25, 2018 Distributed for Comment Only -- Do Not Cite or Quote Commitment & Credibility since 1976 Memorandum To: CIR Expert Panel Members and Liaisons From: Priya Cherian, Scientific Writer/Analyst Date: September 14, 2018 Subject: Wave 2 – Brown Algae Since the draft report was issued at mail date, the Council has provided an ample amount of additional information regarding ingredients in the Brown Algae report. The following table provides an overview of the data received. An updated data profile has also been included (broalg092018prof_wave2). Data Point Data Data Source Alaria Esculenta Extract Method of Manufacture trade name mixture consisting of Alaria Esculenta broalg092018data7_wave2 Extract in butylene glycol and water: harvesting/identification washing grinding extraction with the solvents and butylene glycol and water filtration quality control packaging quality control trade name mixture consisting of Alaria Esculenta broalg092018data7_wave2 Extract in butylene glycol and water – dried before extraction: harvesting/identification washing drying grinding extraction with the solvents butylene glycol and water filtration quality control packaging quality control trade name mixture containing Alaria Esculenta broalg092018data7_wave2 Extract in Caprylic/Capric Triglycerides: harvesting/identification drying grinding extraction with solvent caprylic/capric triglyceride filtration quality control packaging quality control Heavy Metal Impurities trade name mixture consisting of Alaria Esculenta broalg092018data7_wave2 Extract in butylene glycol and water: < 5 ppm arsenic, < 3 ppm cadmium, < 5 ppm lead, < 2 ppm nickel, < 5 silver, < 10 ppm iodine trade name mixture consisting of Alaria Esculenta broalg092018data7_wave2 Extract in butylene glycol and water – dried before extraction: < 5 ppm arsenic, < 3 ppm cadmium, < 5 ppm lead, < 2 ppm nickel, < 5 silver, < 10 ppm iodine __________________________________________________________________________________________ 1620 L Street, NW, Suite 1200 ♢ Washington, DC 20036-4702 (Main) 202-331-0651 (Fax) 202-331-0088 (Email) [email protected] (Website) www.cir-safety.org Distributed for Comment Only -- Do Not Cite or Quote trade name mixture containing Alaria Esculenta broalg092018data7_wave2 Extract in Caprylic/Capric Triglycerides: < 2 ppm arsenic, < 3 ppm cadmium, < 5 ppm lead, < 2 ppm nickel, < 5 ppm silver, < 1 ppm mercury, < 1 ppm iodine Concentration of Use The maximum leave-on/dermal contact concentration broalg092018data3_wave2 decreased from 1% to 0.05% Dermal Irritation – In Vivo – test substance: trade name mixture consisting of broalg092018data7_wave2 Human Alaria Esculenta Extract in butylene glycol and water: 50 volunteers; 25 µL pure test substance applied 3 times a week; non-irritating test substance: trade name mixture containing Alaria broalg092018data8_wave2 Esculenta Extract in Caprylic/Capric Triglycerides: 50 volunteers; 25 µL pure test substance applied 3 times a week; non-irritating test substance: trade name mixture containing Alaria broalg092018data8_wave2 Esculenta Extract in Caprylic Capric Triglycerides: 10 volunteers; pure product applied to occlusive patch (20 µL) and then applied to skin for 24 hours; non- irritating test substance: trade name mixture containing Alaria broalg092018data9_wave2 Esculenta Extract in Caprylic Capric Triglycerides – dried before extraction: 50 volunteers; 25 µL pure test substance applied 3 times a week; non-irritating test substance: trade name mixture containing < 5% broalg092018data9_wave2 Alaria Esculenta Extract and > 95% Caprylic/Capric Triglycerides 10 volunteers; pure product (20 µL ) applied for 24 hours using an occlusive patch ; non-irritating Sensitization – In Vivo – Human test substance: trade name mixture consisting of broalg092018data7_wave2 Alaria Esculenta Extract in butylene glycol and water: 50 volunteers; pure 25 µL test substance applied 3 times a week during the induction phase and once a week during challenge phase; non-sensitizing test substance: trade name mixture containing Alaria broalg092018data8_wave2 Esculenta Extract in Caprylic Capric Triglycerides: 50 volunteers; 25 µL pure test substance applied 3 times a week during induction phase and once during challenge phase; non-sensitizing test substance: trade name mixture containing Alaria broalg092018data9_wave2 Esculenta Extract in Caprylic Capric Triglycerides – dried before extraction: 50 volunteers; 25 µL pure test substance applied 3 times a week during the induction phase and once during challenge phase; non-sensitizing Ascophyllum Nodosum Extract Method of Manufacture polyphenol trapping, aqueous extract, solid/liquid broalg092018data1_wave2 separation, filtration to remove microparticles, alginate precipitation and removal, filtration (including demineralization), depolymerization, and atomization __________________________________________________________________________________________ 1620 L Street, NW, Suite 1200 ♢ Washington, DC 20036-4702 (Main) 202-331-0651 (Fax) 202-331-0088 (Email) [email protected] (Website) www.cir-safety.org Distributed for Comment Only -- Do Not Cite or Quote Heavy Metal Specifications Heavy metal limits were specified: cadmium (≤ 0.5); broalg092018data1_wave2 lead (≤ 5 mg/kg), mercury (≤ 0.1 mg/kg), mineral arsenic (≤ 3 mg/kg); and total heavy metals (≤ 20 mg/kg) Acute Oral Toxicity Sprague-Dawley rat; OECD 401; LD50 >2000 mg/kg broalg092018data1_wave2 Genotoxicity Ames; OECD 471; Non-mutagenic broalg092018data1_wave2 Dermal Irritation – In Vivo – OECD 404; non-irritating; test organism experimental broalg092018data1_wave2 Animal details not provided Sensitization – In Vivo – Animal Magnusson and Kligman (guinea pig maximization broalg092018data1_wave2 test); OECD 406; doses: 0.1 to 0.4 mL of 25% to 75% water solutions; 20 test and 10 control animals; non- sensitizing Ocular Irritation – In Vivo – OECD 405; slightly irritating; test organism broalg092018data1_wave2 Animal experimental details not provided Cystoseira Baccata Extract Impurities arsenic: 8.8 mg/kg (far casting cross-validation broalg092018data17_wave2 (FCCV) method); 20 ppm by inductively couples plasma-optical emission spectrometry (ICP-OES method) Dermal Irritation – In Vivo – test substance: water and Cystoseira Baccata Extract; broalg092018data17_wave2 Human 24 hour patch test; occlusive dressing; 10 subjects; 100% concentration, non-irritating test substance: water and Cystoseira Baccata Extract; broalg092018data17_wave2 50 volunteers; repeated cutaneous applications; 100% concentration; hypoallergenic Cystoseira Tamaricifolia Extract Method of Manufacture Cystoseira Tamaricifolia Extract and Caprylic/Capric broalg092018data17_wave2 Triglycerides: extraction with supercritical carbon dioxide Impurities Cystoseira Tamaricifolia Extract and Caprylic/Capric broalg092018data17_wave2 Triglycerides: 1 mg/kg iodine Dermal Irritation – In Vivo – test substance: Cystoseira Tamaricifolia Extract and broalg092018data17_wave2 Human Caprylic/Capric Triglycerides; 24 hour patch test; 10 volunteers; occlusive dressing; pure test substance; non-irritating Hydrolyzed Fucus Vesiculosus Protein Heavy Metal Specifications trade name substance consisting of Hydrolyzed Fucus broalg092018data6_wave2 Vesiculosus Protein composition: < 20 ppm heavy metals; < 2 ppm arsenic Composition trade name substance consisting of Hydrolyzed Fucus broalg092018data6_wave2 Vesiculosus Protein composition: 98.9% Hydrolyzed Fucus Vesiculosus Protein, 1% of a trade name mixture consisting of phenoxyethanol, methylparaben, ethylparaben, butylparaben, propylparaben, and isobutylparaben, 0.10% tetrasodium EDTA Fucus Vesiculosus Extract Method of Manufacture trade name mixture containing water, alcohol and broalg092018data2_wave2 Fucus Vesiculosus Extract: dried raw material extract with 30% ethanolic solution filtrate concentration filtrate packaging __________________________________________________________________________________________ 1620 L Street, NW, Suite 1200 ♢ Washington, DC 20036-4702 (Main) 202-331-0651 (Fax) 202-331-0088 (Email) [email protected] (Website) www.cir-safety.org Distributed for Comment Only -- Do Not Cite or Quote trade name mixture containing sodium sulfate and broalg092018data2_wave2 Fucus Vesiculosus Extract: dried raw material extract with 30% ethanolic solution filtrate concentration add anhydrous sodium sulfate packaging Composition trade name mixture containing water, alcohol and broalg092018data2_wave2 Fucus Vesiculosus Extract: polyphenol and amino acid trade name mixture containing sodium sulfate and broalg092018data2_wave2 Fucus Vesiculosus Extract: saccharide and amino acid Heavy Metal Impurities trade name mixture containing water, alcohol and broalg092018data2_wave2 Fucus Vesiculosus Extract: not to exceed more than 30 ppm heavy metals or 10 ppm arsenic trade name mixture containing sodium sulfate and broalg092018data2_wave2 Fucus Vesiculosus Extract: not to exceed 20 ppm heavy metals or 10 ppm arsenic Concentration of Use Maximum leave-on/dermal contact concentration broalg092018data3_wave2 decreased from 6% to 5%. Himanthalia Elongata Extract Impurities Himanthalia Elongata Extract, water, and dipropylene broalg092018data17_wave2 glycol: < 9 mg/kg iodine Concentration of Use Dermal Contact/Leave-On: 0.2% broalg092018data3_wave2 Dermal Irritation
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