The Cosmetic Ingredient Review Expert Panel (Panel) has issued an amended safety assessment of 7 Hypericum perforatum-derived ingredients as used in cosmetics. A common name for this plant is St John wort. These ingredients function in cosmetics as skin-conditioning agents-miscellaneous and antimicrobial agents. The Panel reviewed relevant animal and human data related to the H perforatum-derived ingredients. Because formulators may use more than 1 botanical ingredient in a formulation, caution was urged to avoid levels of toxicological concern for constituent chemicals and impurities. The Panel concluded that H perforatum-derived ingredients were safe as cosmetic ingredients in the practices of use and concentration as described in this safety assessment.
The safety of 6 modified terephthalate polymers as cosmetic ingredients was assessed. These ingredients mostly function as exfoliants, bulking agents, hair fixatives, and viscosity-increasing agents-nonaqueous. Polyethylene terephthalate (PET) is used in leave-on products up to 100% and in rinse-off products up to 2%. The Cosmetic Ingredient Review Expert Panel (Panel) considered that the PET used in cosmetics is chemically equivalent to that used in medical devices. The Panel determined that the Food and Drug Administration's determination of safety of PET in several medical devices, which included human and animal safety data, can be used as the basis for the determination of safety of PET and related polymers used in cosmetics. Use studies of cosmetic eye products that contain PET demonstrated no ocular irritation or dermal sensitization. The Panel concluded that modified terephthalate polymers were safe as cosmetic ingredients in the practices of use and concentration described in this safety assessment.
The Cosmetic Ingredient Review Expert Panel (Panel) reviewed the safety of 62 dimethicone crosspolymer ingredients as used in cosmetics. These ingredients function mostly as absorbents, bulking agents, film formers, hair-conditioning agents, emollient skin-conditioning agents, slip modifiers, surface modifiers, and nonaqueous viscosity-increasing agents. The Panel reviewed available animal and human data related to these polymers and addressed the issue of residual monomers. The Panel concluded that these dimethicone crosspolymer ingredients are safe in the practices of use and concentration as given in this safety assessment.
The Cosmetic Ingredient Review Expert Panel (Panel) reviewed the safety of 4 ammonium hectorite compounds used in cosmetics: disteardimonium hectorite, dihydrogenated tallow benzylmonium hectorite, stearalkonium hectorite, and quaternium-18 hectorite. These ingredients function in cosmetics mainly as nonsurfactant suspending agents. The Panel reviewed available animal and human data and concluded that these ammonium hectorite compounds were safe as cosmetic ingredients in the practices of use and concentration as given in this safety assessment.
The Cosmetic Ingredient Review Expert Panel (Panel) reviewed the safety of calcium sodium borosilicate, calcium aluminum borosilicate, calcium titanium borosilicate, silver borosilicate, and zinc borosilicate as used in cosmetics. These borosilicate glasses function mostly as bulking agents. Available animal and human data were considered along with data from a previous safety assessment of magnesium silicates. The similar structure, properties, functions, and uses of these ingredients enabled grouping them and using the available toxicological data to assess the safety of the entire group. Data submitted on calcium borosilicate, which is not a cosmetic ingredient, are also included as additional support for the safety of borosilicate glass ingredients. The Panel concluded that borosilicate glasses are safe as cosmetic ingredients in the practices of use and concentration as given in this safety assessment.
The Cosmetic Ingredient Review (CIR) Expert Panel assessed the safety of silica silylate, silica dimethyl silylate, trimethylsiloxysilicate, and trifluoropropyldimethyl/trimethylsiloxysilicate as used in cosmetics. These silylates and surface-modified siloxysilicates function in cosmetics as antifoaming agents, anticaking agents, bulking agents, binders, skin-conditioning agents--emollient, skin-conditioning agents-occlusive, slip modifiers, suspension agents--nonsurfactant, and viscosity increasing agents--nonaqueous. The Expert Panel reviewed the available animal and clinical data as well as information from a previous CIR safety assessment of amorphous silica. The CIR Expert Panel concluded that silica silylate, silica dimethyl silylate, trimethylsiloxysilicate, and trifluoropropyldimethyl/trimethylsiloxysilicate are safe as used when formulated and delivered in the final product not to be irritating or sensitizing to the respiratory tract.
Polymethyl methacrylate (PMMA) and related cosmetic ingredients methyl methacrylate crosspolymer and methyl methacrylate/glycol dimethacrylate crosspolymer are polymers that function as film formers and viscosity-increasing agents in cosmetics. The Food and Drug Administration (FDA) determination of safety of PMMA use in several medical devices, which included human and animal safety data, was used as the basis of safety of PMMA and related polymers in cosmetics by the Cosmetic Ingredient Review (CIR) Expert Panel. The PMMA used in cosmetics is substantially the same as in medical devices. The Panel concluded that these ingredients are safe as cosmetic ingredients in the practices of use and concentrations as described in this safety assessment.
Sodium dodecylbenzenesulfonate is one of a group of salts of alkylbenzene sulfonates used in cosmetics as surfactant-cleansing agents. Sodium dodecylbenzenesulfonate is soluble in water and partially soluble in alcohol, with dermal absorption dependent on pH. Dodecylbenzenesulfonate salts are not toxic in single-dose oral and dermal animal tests, and no systemic toxicities were observed in repeat-dose dermal animal studies. In dermal animal studies, no evidence of reproductive or developmental toxicity was reported. At 15% concentrations, sodium dodecylbenzenesulfonate was severely irritating to rabbit skin. The Cosmetic Ingredient Review Expert Panel concluded that the irritant properties of these ingredients are similar to those of other detergents, with severity dependent on concentration and pH. Products containing these ingredients should be formulated to ensure that the irritancy potential is minimized.
This report addresses the safety of the inorganic salts and esters of various fatty alcohols of myristic acid. Most of the esters are used as skin conditioning agents in many types of cosmetics in a range of concentrations. Myristate esters are readily hydrolyzed to the corresponding alcohols and acids, which are then further metabolized. Myristate salts readily dissociate in any likely cosmetic formulation. The Cosmetic Ingredient Review (CIR) Panel recognized that much of the data supporting the ingredients in this group were previously reviewed in safety assessments for related ingredients. Where specific data did not exist, the Panel considered structure-activity relationships in determining the safety of these ingredients as used in cosmetics. The Panel determined that myristic acid and its salts and esters are safe as cosmetic ingredients in the current practices of use and concentration.
Quaternium-15 is an antimicrobial agent used in cosmetics as a cosmetic preservative and antistatic agent. Little systemic toxicity was reported in most single-dose or repeated-dose animal studies. Quaternium-15 was an oral teratogen, but not a dermal teratogen, in rats at doses that exceeded the expected cumulative exposure from cosmetics. The frequency of sensitization increased in North America but not in Europe, where Quaternium-15 is used less often. In almost all animal and human studies, Quaternium-15 at 0.2% was not a sensitizer. The weight of evidence suggested that a 0.2% concentration is not a sensitizer and that cosmetic products containing Quaternium-15 up to that level are safe.
Allantoin is a heterocyclic organic compound. Allantoin ascorbate, allantoin biotin, allantoin galacturonic acid, allantoin glycyrrhetinic acid, allantoin panthenol, and allantoin polygalacturonic acid are complexes of allantoin. All of the ingredients in this review act as skin-conditioning agents. Allantoin was reported to be used in 1376 cosmetic products at concentrations up to 2%. There are data gaps regarding use and concentration of the remaining allantoin complexes. Ascorbic acid, biotin, glycyrrhetinic acid, and panthenol have been determined by the CIR Expert Panel to be safe. Galacturonic acid and polygalacturonic acid have not been reviewed by the CIR Expert Panel, and substantial data on these chemicals were not available. The safety test data in this safety assessment and in previous safety assessments were considered sufficient to support the safety of allantoin and the allantoin complexes in product categories and at concentrations reviewed in this safety assessment.
Sodium picramate is the sodium salt of picramic acid, a substituted phenolic compound. Sodium picramate and picramic acid function as hair colorants; they are reportedly used in 31 and 3 hair-dye products, respectively. No concentration-of-use data were available for sodium picramate, but picramic acid was reported to be used at 0.6%. The Cosmetic Ingredient Review Expert Panel recognized that adding picramic acid to a hair-dye formulation likely results in formation of a salt such as sodium picramate, which suggested that safety test data for one ingredient would be applicable to the other. Hair dyes containing these ingredients bear a caution statement and patch test instructions for determining whether the product causes skin irritation. The panel finds that the available data support the safety of these colorants in hair dyes and expects that sodium picramate would be used at concentrations comparable to those reported for picramic acid.
Hyaluronic acid, sodium hyaluronate, and potassium hyaluronate function in cosmetics as skin conditioning agents at concentrations up to 2%. Hyaluronic acid, primarily obtained from bacterial fermentation and rooster combs, does penetrate to the dermis. Hyaluronic acid was not toxic in a wide range of acute animal toxicity studies, over several species and with different exposure routes. Hyaluronic acid was not immunogenic, nor was it a sensitizer in animal studies. Hyaluronic acid was not a reproductive or developmental toxicant. Hyaluronic acid was not genotoxic. Hyaluronic acid likely does not play a causal role in cancer metastasis; rather, increased expression of hyaluronic acid genes may be a consequence of metastatic growth. Widespread clinical use of hyaluronic acid, primarily by injection, has been free of significant adverse reactions. Hyaluronic acid and its sodium and potassium salts are considered safe for use in cosmetics as described in the safety assessment.
The functions of alkyl benzoates in cosmetics include fragrance ingredients, skin-conditioning agents--emollient, skin-conditioning agents--miscellaneous, preservatives, solvents, and plasticizers. The Cosmetic Ingredient Review Expert Panel reviewed the relevant animal and human data and noted gaps in the available safety data for some of the alkyl benzoates. Similar structure activity relationships, biologic functions, and cosmetic product usage allowed the available data of many of the alkyl benzoates to be extended to the entire group. Carcinogenicity data were not available, but available data indicated that these alkyl benzoate cosmetic ingredients are not genotoxic. Also benzoic acid and tested component alcohols were not reproductive or developmental toxicants, are not genotoxic in almost all assays, and are not carcinogenic. These ingredients were determined to be safe in the present practices of use and concentration.
Quaternary ammonium salts, including alkyl chain, alkanol, and polymer derivatives (trimoniums) are used in cosmetics mainly as surfactant-cleansing agents, hair-conditioning agents, and antistatic agents. The Cosmetic Ingredient Review Expert Panel reviewed the relevant animal and human data and noted gaps in the available safety data for some of the trimomiums. The available data on many of the trimoniums are sufficient, however, and similar structural activity relationships, functions in cosmetics, and cosmetic product usage supported extending these data to the entire group. These ingredients were determined to be safe in the present practices of use and concentration when formulated to be nonirritating.
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