International Journal of Toxicology最新文献

This is a safety assessment of VA/Crotonates Copolymer as used in cosmetics. This ingredient is reported to function as a film forming agent. The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed relevant animal and human data related to this ingredient. The Panel concluded that VA/Crotonates Copolymer is safe as cosmetic ingredient in the practices of use and concentrations as described in the safety assessment.

This is a safety assessment of Sodium Sesquicarbonate, Sodium Bicarbonate, and Sodium Carbonate as used in cosmetics. These ingredients are used in bath, skin, and hair preparations. The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed relevant animal and human data related to these ingredients. The Panel concluded that Sodium Sesquicarbonate, Sodium Bicarbonate, and Sodium Carbonate are safe as cosmetic ingredients in the practices of use and concentrations as described in the safety assessment.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of Levulinic Acid and Sodium Levulinate as used in cosmetic formulations. These ingredients are both reported to function in cosmetics as skin conditioning agents, while Levulinic Acid is also reported to function as a fragrance ingredient. The Panel reviewed relevant data relating to the safety of these ingredients in cosmetic formulations, and concluded that these ingredients are safe in cosmetics in the present practices of use and concentration described in this safety assessment when formulated to be non-irritating.

The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of Polyquaternium-6 as used in cosmetic formulations. This ingredient is reported to function as an antimicrobial agent, antistatic agent, film former, and hair fixative in cosmetics. The Panel cautions that products containing Polyquaternium-6 should be formulated to avoid the formation of nitrosamines. The Panel reviewed data relevant to the safety of this ingredient in cosmetic formulations, and concluded that Polyquaternium-6 is safe in cosmetics in the present practices of use and concentration described in this safety assessment.

The Expert Panel for Cosmetic Ingredient Safety (Panel) considered whether the safety of PEG Stearate ingredients as used in cosmetics should be reassessed. These ingredients are reported to function primarily as surfactants and emollients. The Panel reviewed newly available animal and human data related to these ingredients. The Panel concluded that the PEG Stearates are safe as cosmetic ingredients in the practices of use and concentrations described in the safety assessment.

This is a safety assessment of Ricinus Communis (Castor) Seed Oil and various ricinoleate ingredients as used in cosmetics. These ingredients are reported to function primarily as skin-conditioning agents, emulsion stabilizers, and surfactants in cosmetics, although other functions are described. The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed relevant animal and human data related to these ingredients. The Panel concluded that Ethyl Ricinoleate, Glycol Ricinoleate, Hydrogenated Castor Oil, Methyl Ricinoleate, Potassium Ricinoleate, Ricinoleic Acid, Ricinus Communis (Castor) Seed Oil, and Sodium Ricinoleate are safe as cosmetic ingredients in the practices of use and concentrations as described in the safety assessment.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 5 Carica papaya (papaya)-derived ingredients as used in cosmetic formulations. These ingredients are mostly reported to function in cosmetics as skin-conditioning agents. Industry should continue to use good manufacturing practices to limit impurities that could be present in these botanical ingredients. The Panel considered all the information, and concluded that Carica Papaya (Papaya) Fruit, Carica Papaya (Papaya) Fruit Extract, Carica Papaya (Papaya) Fruit Juice, and Carica Papaya (Papaya) Fruit Water are safe in cosmetics in the present practices of use and concentration described in this safety assessment, and that the available data are insufficient to make a determination of safety for Carica Papaya (Papaya) Leaf Extract under the intended conditions of use in cosmetic formulations.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of Diacetone Alcohol as used in cosmetic formulations. This ingredient is reported to function as a fragrance ingredient and solvent. The Panel considered the available data and concluded that Diacetone Alcohol is safe in cosmetics in the present practices of use and concentration described in this safety assessment.

Traditional tobacco products are harmful to the body, especially the respiratory system. In recent years, different kinds of novel and emerging nicotine and tobacco products have emerged on the market and are becoming increasingly popular with young people. Some regulatory policies have been implemented, but the public still lacks a systematic understanding of the health risks of these novel products. To provide a summary of these topics to date, we performed a literature review, in which we summarized studies on novel and emerging nicotine and tobacco products in terms of cell models, three-dimensional models, animal models, and population and their potential advantages and disadvantages, which will provide support for the market supervision and policy control and the comprehensive health risks of novel and emerging nicotine and tobacco products to the public.

2-Deoxy-D-Glucose (2-DG) has anticonvulsant and antiseizure effects in rodent models and is in the development phase for novel antiseizure treatment. To evaluate potential toxicity, Beagle dogs (five/sex/group) were orally gavaged with either vehicle (deionized water) or 2-DG (5, 30, and 90 mg/kg BID) for 28 days followed by a 14-day recovery period. The safety endpoints evaluated were mortality, clinical observations, body temperature, respiratory assessment, body weights, food consumption, ophthalmic examinations, electrocardiograph (ECG), blood pressure, cardiac biomarker (NT-proBNP), and pathology. Toxicokinetic analysis was conducted after the first dose on days 1 and 28. The dose formulation analysis confirmed that 2-DG concentrations were within 93%-107% of the target concentrations. There were no 2-DG associated effects observed in mortality, clinical signs, body temperature, respiratory parameters, body weights, food consumption, ophthalmic examination, ECG, blood pressure, and NT-proBNP. There was an increase (∼1.7X) in aspartate transaminase on day 29, while histopathological evaluation revealed hepatic cytoplasmic alterations in 2 of 6 dogs on day 29 and only in 1 of 4 dogs on day 43 at 90 mg/kg BID. These changes were considered non-adverse because of minimal severity, reversibility trend after recovery period and no correlative increase in alanine transaminase. Toxicokinetic evaluation revealed dose dependent increases in C_max of ∼7.8, 39.5, and 114 μg/mL, and AUCs of 12.2, 70.8, and 202 h*μg/mL at 5, 30, and 90 mg/kg, respectively with T_max of ∼0.5-0.9 h and T_1/2 of ∼3.8-5.4 h. In conclusion, 90 mg/kg BID of 2-DG was considered as the No Observed Adverse Effect Level following 28-day administration in dogs.