Final Report on the Safety Assessment of Aloe Andongensis Extract, Aloe Andongensis Leaf Juice, Aloe Arborescens Leaf Extract, Aloe Arborescens Leaf Juice, Aloe Arborescens Leaf Protoplasts, Aloe Barbadensis Flower Extract, Aloe Barbadensis Leaf, Aloe Barbadensis Leaf Extract, Aloe Barbadensis Leaf Juice, Aloe Barbadensis Leaf Polysaccharides, Aloe Barbadensis Leaf Water, Aloe Ferox Leaf Extract, Aloe Ferox Leaf Juice, and Aloe Ferox Leaf Juice Extract1

Abstract

Plant materials derived from the Aloe plant are used as cosmetic ingredients, including Aloe Andongensis Extract, Aloe Andongensis Leaf Juice, Aloe Arborescens Leaf Extract, Aloe Arborescens Leaf Juice, Aloe Arborescens Leaf Protoplasts, Aloe Barbadensis Flower Extract, Aloe Barbadensis Leaf, Aloe Barbadensis Leaf Extract, Aloe Barbadensis Leaf Juice, Aloe Barbadensis Leaf Polysaccharides, Aloe Barbadensis Leaf Water, Aloe Ferox Leaf Extract, Aloe Ferox Leaf Juice, and Aloe Ferox Leaf Juice Extract. These ingredients function primarily as skin-conditioning agents and are included in cosmetics only at low concentrations. The Aloe leaf consists of the pericyclic cells, found just below the plant's skin, and the inner central area of the leaf, i.e., the gel, which is used for cosmetic products. The pericyclic cells produce a bitter, yellow latex containing a number of anthraquinones, phototoxic compounds that are also gastrointestinal irritants responsible for cathartic effects. The gel contains polysaccharides, which can be acetylated, partially acetylated, or not acetylated. An industry established limit for anthraquinones in aloe-derived material for nonmedicinal use is 50 ppm or lower. Aloe-derived ingredients are used in a wide variety of cosmetic product types at concentrations of raw material that are 0.1% or less, although can be as high as 20%. The concentration of Aloe in the raw material also may vary from 100% to a low of 0.0005%. Oral administration of various anthraquinone components results in a rise in their blood concentrations, wide systemic distribution, accumulation in the liver and kidneys, and excretion in urine and feces; polysaccharide components are distributed systemically and metabolized into smaller molecules. aloe-derived material has fungicidal, antimicrobial, and antiviral activities, and has been effective in wound healing and infection treatment in animals. Aloe barbadensis (also known as Aloe vera)-derived ingredients were not toxic in acute oral studies using mice and rats. In parenteral studies, the LD(50) using mice was > 200 mg/kg, rats was > 50 mg/kg, and using dogs was > 50 mg/kg. In intravenous studies the LD(50) using mice was > 80 mg/kg, rats was > 15 mg/kg, and dogs was > 10 mg/kg. The 14-day no observed effect level (NOEL) for the Aloe polysaccharide, acemannan, in the diet of Sprague-Dawley rats, was 50,000 ppm or 4.1 to 4.6 g/kg day(-1). In a 3-month study using mice, Aloe vera (extracted in ethanol) given orally in drinking water at 100 mg/kg produced reproductive toxicity, inflammation, and mortality above that seen in control animals. Aloe vera extracted in methanol and given to mice at 100 mg/kg in drinking water for 3 months caused significant sperm damage compared to controls. Aloe barbadensis extracted with water and given to pregnant Charles Foster albino rats on gestational days (GDs) 0 through 9 was an abortifacient and produced skeletal abnormalities. Both negative and positive results were found in bacterial and mammalian cell genotoxicity assays using Aloe ...

Therapeutic and Medicinal Uses of <i>Aloe vera</i>: A Review

“…The parenchymatous tissue or pulp shown to contain proteins, lipids, amino acids, vitamins, enzymes, inorganic compounds and small organic compounds in addition to the different carbohydrates. There is some evidence of chemotaxonomic variation in the polysaccharide composition [15][16][17] 16-different polysaccharides and 12 major polypeptides (mol wt 15 -77 kD), and various glycoproteins (29 kD in leaf gel).…”

The phytochemical constituents and therapeutic uses of genus Aloe: A review

“…Aloin had no carcinogenic effects on mice. Case reports in humans included acute eczema, contact urticaria, and dermatitis, but no phototoxicity in topic use (Andersen, 2007).…”

Aloe vera in der Onkologie

“…Akute Ekzeme, Kontakturtikaria und Dermatitis bei topischer Anwendung sind beschrieben und können auf die Fototoxizität der Anthrachinone, die im Blattsaft (Latex) enthalten sind, zurückgeführt werden. In der Kosmetikindustrie, in der Aloe vera als Inhaltsstoff viel-fach verwendet wird, ist der Grenzwert für den Anthrachinongehalt unabhängig von der Aloe-Art auf 50 ppm festgelegt [20]. Die unsachgemäße Anwendung von Aloe-vera-Supplementen wurde zudem mit Schilddrüsenfunktionsstörungen [21], akuter Hepatitis [22] und perioperativen Blutungen [23] in Verbindung gebracht.…”

“…Bei der Verwendung von Aloe-vera-Inhaltsstoffen zur Behandlung von Asthma, ischämischen Herzkrankheiten, Diabetes, Geschwüren, Hautkrankheiten und Krebs war Durchfall die einzige nennenswerte unerwünschte Wirkung [20].…”