scholarly journals Safety Assessment of Avena sativa (Oat)-Derived Ingredients As Used in Cosmetics

2019 ◽  
Vol 38 (3_suppl) ◽  
pp. 23S-47S
Author(s):  
Lillian C. Becker ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
Curtis D. Klaassen ◽  
...  
Keyword(s):  
Avena Sativa ◽  
Safety Assessment ◽  
Cell Extract ◽  
Toxic Effects ◽  
Bulking Agents ◽  
Meristem Cell ◽  
Human Data ◽  
Cosmetic Ingredients ◽  
Good Manufacturing Practices ◽  
To Come

This is a safety assessment of Avena sativa (oat)–derived ingredients. The reported functions of these ingredients in cosmetics include abrasives, antioxidant, skin conditioning agents, absorbents, and bulking agents. The Panel reviewed relevant animal and human data related to these ingredients. Because final product formulations may contain multiple botanicals, each containing the same constituents of concern, formulators are advised to be aware of these constituents and to avoid reaching levels that may lead to sensitization or other toxic effects. The Panel stated that industry should continue to use good manufacturing practices to limit impurities and concluded that all but one of the Avena sativa (oat)–derived ingredients are safe as cosmetic ingredients in the practices of use and concentration described in this safety assessment when formulated to be nonsensitizing; data are insufficient to come to a conclusion of safety for Avena Sativa (Oat) Meristem Cell Extract.

scholarly journals Safety Assessment of Camellia sinensis–Derived Ingredients As Used in Cosmetics

2019 ◽  
Vol 38 (3_suppl) ◽  
pp. 48S-70S ◽  
Author(s):  
Lillian C. Becker ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
Curtis D. Klaassen ◽  
...  
Keyword(s):  
Camellia Sinensis ◽  
Safety Assessment ◽  
Expert Panel ◽  
Tea Plant ◽  
Systemic Toxicity ◽  
Toxic Effects ◽  
Plant Parts ◽  
Human Data ◽  
Toxicity Potential ◽  
Cosmetic Ingredients

Cosmetic ingredients derived from Camellia sinensis (tea) plant parts function as antioxidants and skin conditioning agents—humectant and miscellaneous. The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) reviewed relevant animal and human data related to these ingredients. The use of the leaf ingredients in beverages results in much larger systemic exposures than those possible from cosmetic use. Accordingly, concern over the systemic toxicity potential of leaf-derived ingredients is mitigated. Because product formulations may contain multiple botanical ingredients, each containing the same constituents of concern, formulators are advised to be aware of these constituents and to avoid reaching levels that may lead to sensitization or other toxic effects. The Panel concluded that the C sinensis leaf-derived ingredients are safe in the present practices of use and concentration described in this safety assessment when formulated to be nonsensitizing. However, the available data are insufficient to determine whether the non-leaf-derived ingredients are safe for use in cosmetics.

scholarly journals Safety Assessment of Achillea millefolium as Used in Cosmetics

2016 ◽  
Vol 35 (3_suppl) ◽  
pp. 5S-15S ◽  
Author(s):  
Lillian C. Becker ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
Curtis D. Klaassen ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Expert Panel ◽  
Achillea Millefolium ◽  
Flower Extract ◽  
Human Data ◽  
Cosmetic Ingredients ◽  
Good Manufacturing Practices ◽  
Stem Extract

Cosmetic ingredients derived from Achillea millefolium function in cosmetics as skin-conditioning agents—miscellaneous, skin-conditioning agents—humectants, and fragrance ingredients. The Cosmetic Ingredient Review Expert Panel (Panel) reviewed relevant animal and human data to determine their safety in cosmetics and raised concerns about cosmetics containing linalool, thujone, quercetin, hydroquinone, or α-peroxyachifolid. Because final product formulations may contain multiple botanicals, each containing similar constituents of concern, formulators are advised to be aware of these components and to avoid reaching levels that may be hazardous to consumers. Additionally, industry was advised to use good manufacturing practices to limit impurities. The Panel concluded that achillea millefolium extract, achillea millefolium flower extract, and achillea millefolium flower/leaf/stem extract are safe in the present practices of use and concentration in cosmetics when formulated to be nonsensitizing.

Amended Safety Assessment of Hypericum Perforatum-Derived Ingredients as Used in Cosmetics

2014 ◽  
Vol 33 (3_suppl) ◽  
pp. 5S-23S ◽  
Author(s):  
Lillian C. Becker ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
Curtis D. Klaassen ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Hypericum Perforatum ◽  
Antimicrobial Agents ◽  
Expert Panel ◽  
Human Data ◽  
Cosmetic Ingredients

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.

Safety Assessment of Modified Terephthalate Polymers as Used in Cosmetics

2014 ◽  
Vol 33 (3_suppl) ◽  
pp. 36S-47S ◽  
Author(s):  
Lillian C. Becker ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
Curtis D. Klaassen ◽  
...  
Keyword(s):  
Medical Devices ◽  
Safety Assessment ◽  
Expert Panel ◽  
Safety Data ◽  
Bulking Agents ◽  
Ocular Irritation ◽  
Cosmetic Ingredients ◽  
Animal Safety ◽  
Use Studies

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.

scholarly journals Safety Assessment of Borosilicate Glasses as Used in Cosmetics

2013 ◽  
Vol 32 (5_suppl) ◽  
pp. 65S-72S ◽  
Author(s):  
Lillian C. Becker ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
Curtis D. Klaassen ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Entire Group ◽  
Bulking Agents ◽  
Borosilicate Glasses ◽  
Group Data ◽  
Cosmetic Ingredients ◽  
Toxicological Data ◽  
Calcium Borosilicate ◽  
Additional Support ◽  
Zinc Borosilicate

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.

Safety Assessment of Ammonium Hectorites as Used in Cosmetics

2013 ◽  
Vol 32 (6_suppl) ◽  
pp. 33S-40S
Author(s):  
Lillian C. Becker ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
Curtis D. Klaassen ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Expert Panel ◽  
Human Data ◽  
Cosmetic Ingredients ◽  
Suspending Agents

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.

Safety Assessment of Lauriminodipropionic Acid, Sodium Lauriminodipropionate, and Disodium Lauriminodipropionate as Used in Cosmetics

2013 ◽  
Vol 32 (5_suppl) ◽  
pp. 49S-55S
Author(s):  
Christina L. Burnett ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
Curtis D. Klaassen ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Expert Panel ◽  
Human Data ◽  
Cosmetic Ingredients

The Cosmetic Ingredient Review Expert Panel assessed the safety of lauriminodipropionic acid, sodium lauriminodipropionate, and disodium lauriminodipropionate as used in cosmetics. These ingredients function in cosmetics as hair-conditioning agents and surfactant-cleansing agents. The Panel reviewed relevant animal and human data related to the safety of these ingredients in cosmetics. The Panel concluded that lauriminodipropionic acid, sodium lauriminodipropionate, and disodium lauriminodipropionate are safe as cosmetic ingredients in the present practices of use and concentration.

Safety Assessment of PEGylated Oils as Used in Cosmetics

2014 ◽  
Vol 33 (4_suppl) ◽  
pp. 13S-39S ◽  
Author(s):  
Christina L. Burnett ◽  
Bart Heldreth ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
...  
Keyword(s):  
Fatty Acids ◽  
Ethylene Oxide ◽  
Safety Assessment ◽  
Expert Panel ◽  
Cosmetic Products ◽  
Human Data ◽  
Cosmetic Ingredients

PEGylated oil is a terminology used to describe cosmetic ingredients that are the etherification and esterification products of glycerides and fatty acids with ethylene oxide. The Cosmetic Ingredient Review Expert Panel (Panel) considered the safety of PEGylated oils, which function primarily as surfactants in cosmetic products. The Panel reviewed relevant animal and human data provided in this safety assessment and concluded that the 130 chemically related PEGylated oils were safe as cosmetic ingredients in the present practices of use and concentration when formulated to be nonirritating.

Safety Assessment of Dimethicone Crosspolymers as Used in Cosmetics

2014 ◽  
Vol 33 (2_suppl) ◽  
pp. 65S-115S
Author(s):  
Lillian C. Becker ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
Curtis D. Klaassen ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Expert Panel ◽  
Bulking Agents ◽  
Surface Modifiers ◽  
Human Data

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.

scholarly journals Safety Assessment of Fatty Acid Amidopropyl Dimethylamines as Used in Cosmetics

2019 ◽  
Vol 38 (1_suppl) ◽  
pp. 39S-69S ◽  
Author(s):  
Christina L. Burnett ◽  
Ivan Boyer ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Fatty Acid ◽  
Safety Assessment ◽  
Expert Panel ◽  
Quantitative Risk Assessment ◽  
Cosmetic Products ◽  
Human Data ◽  
Cosmetic Ingredients

The Cosmetic Ingredient Review Expert Panel (Panel) reviewed the safety of fatty acid amidopropyl dimethylamines, which function primarily as antistatic agents in cosmetic products. The relevant animal and human data reviewed for these ingredients indicate that they are potential dermal sensitizers that may be due in part by the sensitizing impurity, 3,3-dimethylaminopropylamine. The Panel concluded that fatty acid amidopropyl dimethylamines were safe as cosmetic ingredients when they are formulated to be nonsensitizing, which may be based on a quantitative risk assessment.

Sign in / Sign up

Export Citation Format

Share Document