Article
Pharmacology & Pharmacy
Ji Yeon Park, Dong Ho Oh, Sang-Wook Park, Bo Ram Chae, Chul Woo Kim, Sang Heon Han, Hyeon Jong Shin, Soo Bin Yeom, Da Yeong Lee, Min Kyu Park, Sang-Eun Park, Jun-Bom Park, Kyung-Tae Lee
Summary: PEL-T exhibits improved solubility, permeability, GI safety, and absorption compared to PEL, with experimental results confirming its structural integrity. It is recommended as a candidate with enhanced gastrointestinal safety and absorption.
Review
Pharmacology & Pharmacy
Chiara Ferraris, Clara Rimicci, Sara Garelli, Elena Ugazio, Luigi Battaglia
Summary: Nanosystems have various cosmetic functions and properties being widely used in the global market. However, safety concerns and regulatory landscape still need to be considered. The European context shows the most restrictive regulations and main safety concerns regarding nanomaterials.
Article
Oncology
Ke Cheng, Xiao-Yu Li, Yu-Wen Zhou, Zheng-Yin Liao, Meng Qiu, Feng Bi, Li Zheng
Summary: MET overexpression is uncommon, with positive MET immunohistochemistry being an independent positive prognostic factor. Metatinib was well tolerated, safe, and effective in patients with advanced solid tumors.
Review
Food Science & Technology
A. M. Api, D. Belsito, S. Biserta, D. Botelho, M. Bruze, G. A. Burton, J. Buschmann, M. A. Cancellieri, M. L. Dagli, M. Date, W. Dekant, C. Deodhar, A. D. Fryer, S. Gadhia, L. Jones, K. Joshi, M. Kumar, A. Lapczynski, M. Lavelle, I Lee, D. C. Liebler, H. Moustakas, M. Na, T. M. Penning, G. Ritacco, J. Romine, N. Sadekar, T. W. Schultz, D. Selechnik, F. Siddiqi, I. G. Sipes, G. Sullivan, Y. Thakkar, Y. Tokura
Summary: The assessment of cyclohexanol for toxicity and environmental impact shows that there are no safety concerns, supporting its safe use.
FOOD AND CHEMICAL TOXICOLOGY
(2021)
Review
Food Science & Technology
A. M. Api, D. Belsito, D. Botelho, M. Bruze, G. A. Burton, J. Buschmann, M. A. Cancellieri, M. L. Dagli, M. Date, W. Dekant, C. Deodhar, A. D. Fryer, L. Jones, K. Joshi, M. Kumar, A. Lapczynski, M. Lavelle, I Lee, D. C. Liebler, H. Moustakas, M. Na, T. M. Penning, G. Ritacco, J. Romine, N. Sadekar, T. W. Schultz, D. Selechnik, F. Siddiqi, I. G. Sipes, G. Sullivan, Y. Thakkar, Y. Tokura
Summary: The assessment on citronellyl acetate indicates low risk in terms of genotoxicity, repeated dose toxicity, and reproductive toxicity, while also meeting environmental safety standards.
FOOD AND CHEMICAL TOXICOLOGY
(2022)
Article
Food Science & Technology
A. M. Api, D. Belsito, D. Botelho, M. Bruze, G. A. Burton, M. A. Cancellieri, H. Chon, M. L. Dagli, M. Date, W. Dekant, C. Deodhar, A. D. Fryer, L. Jones, K. Joshi, M. Kumar, A. Lapczynski, M. Lavelle, I Lee, D. C. Liebler, H. Moustakas, M. Na, T. M. Penning, G. Ritacco, J. Romine, N. Sadekar, T. W. Schultz, D. Selechnik, F. Siddiqi, I. G. Sipes, G. Sullivan, Y. Thakkar, Y. Tokura
Summary: Based on the safety assessment, the available information supports the use of 1-Menthyl methylether in terms of genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, photoirritation/photoallergenicity, skin sensitization, and environmental safety.
FOOD AND CHEMICAL TOXICOLOGY
(2022)
Review
Food Science & Technology
A. M. Api, D. Belsito, D. Botelho, M. Bruze, G. A. Burton, J. Buschmann, M. A. Cancellieri, M. L. Dagli, M. Date, W. Dekant, C. Deodhar, A. D. Fryer, L. Jones, K. Joshi, M. Kumar, A. Lapczynski, M. Lavelle, I Lee, D. C. Liebler, H. Moustakas, M. Na, T. M. Penning, G. Ritacco, J. Romine, N. Sadekar, T. W. Schultz, D. Selechnik, F. Siddiqi, I. G. Sipes, G. Sullivan, Y. Thakkar, Y. Tokura
Summary: The existing data supports the use of alpha-cyclohexylidene benzeneacetonitrile in safety assessment for various aspects. The material is not genotoxic and shows a Margin of Exposure (MOE) > 100 for repeated dose toxicity and reproductive toxicity. Additionally, it is found to have a No Expected Sensitization Induction Level (NESIL) for skin sensitization and is not expected to be phototoxic/ photoallergenic.
FOOD AND CHEMICAL TOXICOLOGY
(2022)
Article
Food Science & Technology
A. M. Api, D. Belsito, D. Botelho, M. Bruze, G. A. Jr Jr Burton, M. A. Cancellieri, H. Chon, M. L. Dagli, M. Date, W. Dekant, C. Deodhar, A. D. Fryer, L. Jones, K. Joshi, M. Kumar, A. Lapczynski, M. Lavelle, I Lee, D. C. Liebler, H. Moustakas, M. Na, T. M. Penning, G. Ritacco, J. Romine, N. Sadekar, T. W. Schultz, D. Selechnik, F. Siddiqi, I. G. Sipes, G. Sullivan, Y. Thakkar, Y. Tokura
Summary: Based on the safety assessment, the available data supports the use of phenylacetaldehyde dimethyl acetal without any safety concerns regarding genotoxicity, repeated dose toxicity, reproductive toxicity, skin sensitization, and environmental safety.
FOOD AND CHEMICAL TOXICOLOGY
(2022)
Article
Food Science & Technology
A. M. Api, D. Belsito, D. Botelho, M. Bruze, G. A. Burton, M. A. Cancellieri, H. Chon, M. L. Dagli, M. Date, W. Dekant, C. Deodhar, A. D. Fryer, L. Jones, K. Joshi, M. Kumar, A. Lapczynski, M. Lavelle, I Lee, D. C. Liebler, H. Moustakas, M. Na, T. M. Penning, G. Ritacco, J. Romine, N. Sadekar, T. W. Schultz, D. Selechnik, F. Siddiqi, I. G. Sipes, G. Sullivan, Y. Thakkar, Y. Tokura
Summary: The safety assessment of acetoin supports its use in various aspects, including genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. The data show that acetoin does not pose genotoxic risks and has sufficient margin of exposure for repeated dose toxicity and local respiratory toxicity. It also does not exceed the threshold of toxicological concern for reproductive toxicity. There are no safety concerns for skin sensitization at current declared levels of use. Acetoin is not expected to be phototoxic/photoallergenic and meets the environmental standards for persistence, bioaccumulation, and toxicity.
FOOD AND CHEMICAL TOXICOLOGY
(2022)
Review
Food Science & Technology
A. M. Api, D. Belsito, D. Botelho, M. Bruze, G. A. Burton, J. Buschmann, M. A. Cancellieri, M. L. Dagli, M. Date, W. Dekant, C. Deodhar, A. D. Fryer, L. Jones, K. Joshi, M. Kumar, A. Lapczynski, M. Lavelle, I. Lee, D. C. Liebler, H. Moustakas, M. Na, T. M. Penning, G. Ritacco, J. Romine, N. Sadekar, T. W. Schultz, D. Selechnik, F. Siddiqi, I. G. Sipes, G. Sullivan, Y. Thakkar, Y. Tokura
Summary: Based on the evaluation of various endpoints, data show that 2,6-nonadienenitrile does not pose any safety concerns for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety.
FOOD AND CHEMICAL TOXICOLOGY
(2022)
Review
Food Science & Technology
A. M. Api, D. Belsito, D. Botelho, M. Bruze, G. A. Burton, J. Buschmann, M. A. Cancellieri, M. L. Dagli, M. Date, W. Dekant, C. Deodhar, A. D. Fryer, L. Jones, K. Joshi, M. Kumar, A. Lapczynski, M. Lavelle, I Lee, D. C. Liebler, H. Moustakas, M. Na, T. M. Penning, G. Ritacco, J. Romine, N. Sadekar, T. W. Schultz, D. Selechnik, F. Siddiqi, I. G. Sipes, G. Sullivan, Y. Thakkar, Y. Tokura
Summary: The compound 2-cyclohexylidene-2-o-tolylacetonitrile has shown non-genotoxic properties and a calculated Margin of Exposure (MOE) > 100 for repeated dose toxicity and reproductive toxicity. It is considered a skin sensitizer with a No Expected Sensitization Induction Level (NESIL) of 1200 μg/cm². Phototoxicity/photoallergenicity is not expected, and its environmental impact is deemed to be low based on the risk quotients.
FOOD AND CHEMICAL TOXICOLOGY
(2022)
Article
Food Science & Technology
A. M. Api, D. Belsito, D. Botelho, M. Bruze, G. A. Jr Jr Burton, M. A. Cancellieri, H. Chon, M. L. Dagli, M. Date, W. Dekant, C. Deodhar, A. D. Fryer, L. Jones, K. Joshi, M. Kumar, A. Lapczynski, M. Lavelle, I Lee, D. C. Liebler, H. Moustakas, M. Na, T. M. Penning, G. Ritacco, J. Romine, N. Sadekar, T. W. Schultz, D. Selechnik, F. Siddiqi, I. G. Sipes, G. Sullivan, Y. Thakkar, Y. Tokura
Summary: Based on various toxicity tests and environmental safety assessments, isodecyl acetate is determined to be safe for use at the declared levels, as it does not present genotoxicity, repeated dose toxicity, reproductive toxicity, phototoxicity/photoallergenicity, or skin sensitization concerns. The substance is also found to have low environmental risk quotients.
FOOD AND CHEMICAL TOXICOLOGY
(2022)
Review
Food Science & Technology
A. M. Api, D. Belsito, D. Botelho, M. Bruze, G. A. Burton, J. Buschmann, M. A. Cancellieri, M. L. Dagli, M. Date, W. Dekant, C. Deodhar, A. D. Fryer, L. Jones, K. Joshi, M. Kumar, A. Lapczynski, M. Lavelle, I Lee, D. C. Liebler, H. Moustakas, M. Na, T. M. Penning, G. Ritacco, J. Romine, N. Sadekar, T. W. Schultz, D. Selechnik, F. Siddiqi, I. G. Sipes, G. Sullivan, Y. Thakkar, Y. Tokura
Summary: The safety assessment of carvyl acetate indicates that it is not toxic in various aspects, such as genotoxicity. The skin sensitization data show a No Expected Sensitization Induction Level of 550 mu g/cm(2) for carvyl acetate. The environmental evaluation reveals that carvyl acetate is not Persistent, Bioaccumulative, and Toxic.
FOOD AND CHEMICAL TOXICOLOGY
(2022)
Article
Food Science & Technology
A. M. Api, D. Belsito, D. Botelho, M. Bruze, G. A. Burton, M. A. Cancellieri, H. Chon, M. L. Dagli, M. Date, W. Dekant, C. Deodhar, A. D. Fryer, L. Jones, K. Joshi, M. Kumar, A. Lapczynski, M. Lavelle, I Lee, D. C. Liebler, H. Moustakas, M. Na, T. M. Penning, G. Ritacco, J. Romine, N. Sadekar, T. W. Schultz, D. Selechnik, F. Siddiqi, I. G. Sipes, G. Sullivan, Y. Thakkar, Y. Tokura
Summary: This safety assessment confirms that methyl propionate has no safety concerns in terms of genotoxicity, repeated dose toxicity, reproductive toxicity, skin sensitization, and environmental safety. Data from analogs also support the lack of adverse effects on health and the environment.
FOOD AND CHEMICAL TOXICOLOGY
(2022)
Review
Food Science & Technology
A. M. Api, D. Belsito, D. Botelho, M. Bruze, G. A. Burton, J. Buschmann, M. A. Cancellieri, M. L. Dagli, M. Date, W. Dekant, C. Deodhar, A. D. Fryer, L. Jones, K. Joshi, M. Kumar, A. Lapczynski, M. Lavelle, I Lee, D. C. Liebler, H. Moustakas, M. Na, T. M. Penning, G. Ritacco, J. Romine, N. Sadekar, T. W. Schultz, D. Selechnik, F. Siddiqi, I. G. Sipes, G. Sullivan, Y. Thakkar, Y. Tokura
Summary: The safety assessment supports the use of citronellyl butyrate in various aspects such as genotoxicity, repeated dose toxicity, reproductive toxicity, and skin sensitization. It also meets environmental standards and is not persistent, bioaccumulative, or toxic.
FOOD AND CHEMICAL TOXICOLOGY
(2022)
Article
Pharmacology & Pharmacy
Christina L. Burnett, Wilma F. Bergfeld, Donald V. Belsito, Ronald A. Hill, Curtis D. Klaassen, Daniel C. Liebler, James G. Marks, Ronald C. Shank, Thomas J. Slaga, Paul W. Snyder, Lillian J. Gill, Bart Heldreth
Summary: The Expert Panel for Cosmetic Ingredient Safety assessed the safety of 80 Citrus fruit-derived ingredients and concluded that they are safe for use in cosmetics when formulated to be non-sensitizing and non-irritating.
INTERNATIONAL JOURNAL OF TOXICOLOGY
(2021)
Article
Pharmacology & Pharmacy
Christina L. Burnett, Wilma F. Bergfeld, Donald Belsito, David Cohen, Curtis D. Klaassen, Daniel C. Liebler, James G. Marks, Lisa A. Peterson, Ronald C. Shank, Thomas J. Slaga, Paul W. Snyder, Bart Heldreth
Summary: Methylisothiazolinone is deemed safe for use as a preservative in cosmetics at concentrations up to 100 ppm in rinse-off products, and safe in leave-on products if formulated to be nonsensitizing, which can be determined by quantitative risk assessment or similar methodology.
INTERNATIONAL JOURNAL OF TOXICOLOGY
(2021)
Article
Pharmacology & Pharmacy
Monice M. Fiume, Wilma F. Bergfeld, Donald Belsito, Ronald A. Hill, Curtis D. Klaassen, Daniel C. Liebler, James G. Jr Jr Marks, Ronald C. Shank, Thomas J. Slaga, Paul W. Snyder, Lillian J. Gill, Bart Heldreth
Summary: Acid Violet 43, an unapproved colorant ingredient, has been deemed safe for use in hair dye formulations at present levels of use and concentration, despite potential impurities not allowed in approved colors.
INTERNATIONAL JOURNAL OF TOXICOLOGY
(2021)
Article
Pharmacology & Pharmacy
Wilbur Johnson, Ivan Boyer, Wilma F. Bergfeld, Donald Belsito, Ronald A. Hill, Curtis D. Klaassen, Daniel C. Liebler, James G. Marks, Ronald C. Shank, Thomas J. Slaga, Paul W. Snyder, Lillian J. Gill, Bart Heldreth
Summary: After reviewing the safety data on Phosphoric Acid and its salts, the Expert Panel concluded that they are safe to use in cosmetics when formulated to be nonirritating.
INTERNATIONAL JOURNAL OF TOXICOLOGY
(2021)
Article
Pharmacology & Pharmacy
Christina L. Burnett, Wilma F. Bergfeld, Donald Belsito, Curtis D. Klaassen, Daniel C. Liebler, James G. Marks, Lisa A. Peterson, Ronald C. Shank, Thomas J. Slaga, Paul W. Snyder, Bart Heldreth
Summary: The Expert Panel on Cosmetic Ingredient Safety reassessed the safety of the MCI/MI mixture as a preservative in cosmetics, determining that it is safe when formulated to be non-sensitizing. Concentrations should not exceed 7.5 ppm in leave-on products or 15 ppm in rinse-off products.
INTERNATIONAL JOURNAL OF TOXICOLOGY
(2021)
Article
Pharmacology & Pharmacy
Christina L. Burnett, Wilma F. Bergfeld, Donald Belsito, Ronald A. Hill, Curtis D. Klaassen, Daniel C. Liebler, James G. Marks, Ronald C. Shank, Thomas J. Slaga, Paul W. Snyder, Lillian J. Gill, Bart Heldreth
Summary: The Expert Panel for Cosmetic Ingredient Safety assessed the safety of 47 Citrus peel-derived ingredients, finding them safe in cosmetics when formulated to be non-sensitizing and non-irritating. It is advised for formulators to be aware of harmful constituents in botanical ingredients and to avoid hazardous levels. Good manufacturing practices should be used by the industry to limit impurities in botanical ingredients.
INTERNATIONAL JOURNAL OF TOXICOLOGY
(2021)
Article
Pharmacology & Pharmacy
Monice M. Fiume, Wilma F. Bergfeld, Donald Belsito, Ronald A. Hill, Curtis D. Klaassen, Daniel C. Liebler, James G. Marks, Ronald C. Shank, Thomas J. Slaga, Paul W. Snyder, Lillian J. Gill, Bart Heldreth
Summary: The safety of a group of 46 butyl polyoxyalkylene ethers used in cosmetics was assessed, and it was concluded that these ingredients are safe when formulated to be non-irritating under current usage and concentration practices.
INTERNATIONAL JOURNAL OF TOXICOLOGY
(2022)
Article
Pharmacology & Pharmacy
Christina L. Burnett, Wilma F. Bergfeld, Donald Belsito, Ronald A. Hill, Curtis D. Klaassen, Daniel C. Liebler, James G. Marks, Ronald C. Shank, Thomas J. Slaga, Paul W. Snyder, Lillian J. Gill, Bart Heldreth
Summary: The Expert Panel for Cosmetic Ingredient Safety has reviewed and concluded that 1-Hydroxyethyl 4,5-Diamino Pyrazole Sulfate, an oxidative hair dye ingredient, is safe to use in present formulations and concentrations.
INTERNATIONAL JOURNAL OF TOXICOLOGY
(2022)
Article
Pharmacology & Pharmacy
Wilbur Johnson, Wilma F. Bergfeld, Donald Belsito, Ronald A. Hill, Curtis D. Klaassen, Daniel C. Liebler, James G. Marks, Ronald C. Shank, Thomas J. Slaga, Paul W. Snyder, Lillian J. Gill, Bart Heldreth
Summary: The Expert Panel for Cosmetic Ingredient Safety assessed the safety of 6 carbonate salts in cosmetic products and concluded that they are safe when used in non-irritating formulations.
INTERNATIONAL JOURNAL OF TOXICOLOGY
(2022)
Article
Pharmacology & Pharmacy
Christina L. Burnett, Ivan J. Boyer, Wilma F. Bergfeld, Donald V. Belsito, Ronald A. Hill, Curtis D. Klaassen, Daniel C. Liebler, James G. Marks, Ronald C. Shank, Thomas J. Slaga, Paul W. Snyder, Bart Heldreth
Summary: The safety of 19 plant-derived proteins and peptides used in personal care products was assessed by an expert panel. Most of them were deemed safe, except for one where data was insufficient to determine its safety.
INTERNATIONAL JOURNAL OF TOXICOLOGY
(2022)
Article
Pharmacology & Pharmacy
Christina L. Burnett, Wilma F. Bergfeld, Donald Belsito, Ronald A. Hill, Curtis D. Klaassen, Daniel C. Liebler, James G. Marks, Ronald C. Shank, Thomas J. Slaga, Paul W. Snyder, Lillian J. Gill, Bart Heldreth
Summary: This article presents the safety assessment results of cosmetic ingredient Hydrofluorocarbon 152a, and the Expert Panel concluded that it is safe under the current practices of use and concentration.
INTERNATIONAL JOURNAL OF TOXICOLOGY
(2022)
Article
Pharmacology & Pharmacy
Wilbur Johnson, Wilma F. Bergfeld, Donald Belsito, Ronald A. Hill, Curtis D. Klaassen, Daniel C. Liebler, James G. Marks, Ronald C. Shank, Thomas J. Slaga, Paul W. Snyder, Lillian J. Gill, Bart Heldreth
Summary: This article presents the safety assessment results of 12 Rosa canina-derived ingredients in cosmetic products. These ingredients are considered safe for consumers when used at appropriate levels and formulations.
INTERNATIONAL JOURNAL OF TOXICOLOGY
(2022)
Article
Pharmacology & Pharmacy
Wilbur Johnson, Ivan J. Boyer, Wilma F. Bergfeld, Donald Belsito, Ronald A. Hill, Curtis D. Klaassen, Daniel C. Liebler, James G. Marks, Ronald C. Shank, Thomas J. Slaga, Paul W. Snyder, Bart Heldreth
Summary: The Expert Panel for Cosmetic Ingredient Safety reviewed the safety of 7 ethers and esters of ascorbic acid in cosmetic products, and concluded that they are safe in the current practices of use and concentration.
INTERNATIONAL JOURNAL OF TOXICOLOGY
(2022)
Article
Pharmacology & Pharmacy
Laura N. Scott, Wilma F. Bergfeld, Donald Belsito, Ronald A. Hill, Curtis D. Klaassen, Daniel C. Liebler, James G. Marks, Ronald C. Shank, Thomas J. Slaga, Paul W. Snyder, Bart Heldreth
Summary: The ingredient Hydroxyethyl-3,4-Methylenedioxyaniline HCl is deemed safe for use as a hair dye ingredient, but should not be used in cosmetic products where N-nitroso compounds can be formed.
INTERNATIONAL JOURNAL OF TOXICOLOGY
(2022)
Article
Pharmacology & Pharmacy
Christina L. Burnett, Wilma F. Bergfeld, Donald Belsito, Ronald A. Hill, Curtis D. Klaassen, Daniel C. Liebler, James G. Marks, Ronald C. Shank, Thomas J. Slaga, Paul W. Snyder, Bart Heldreth
Summary: This article presents the safety assessment conducted by the Expert Panel for Cosmetic Ingredient Safety on 19 skin and connective tissue-derived proteins and peptides, concluding that these ingredients are safe in the present practices of use and concentration.
INTERNATIONAL JOURNAL OF TOXICOLOGY
(2022)
