Laneth Acetates.

The Expert Panel for Cosmetic Ingredient Safety reviewed newly available studies since their original assessment in 1982 and a previous re-review in 2002, along with updated information regarding product types and concentrations of use. Considering this information, the Panel confirmed that Laneth-9 Acetate and Laneth-10 Acetate are safe for topical application to humans in the present practices of use and concentration as described in this report.

Zinc Phenolsulfonate.

The Expert Panel for Cosmetic Ingredient Safety reviewed newly available studies since their original assessment in 1986 and a previous re-review in 2004, along with updated information regarding product types and concentrations of use. Considering this information, the Panel confirmed that Zinc Phenolsulfonate is safe as a cosmetic ingredient in the present practices of use and concentration as described in this report.

Safety Assessment of Palm-Derived Ingredients as Used in Cosmetics.

The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of 8 palm tree (Euterpe edulis (juçara) and Euterpe oleracea (açaí))-derived ingredients as used in cosmetic products; these ingredients are reported to function mostly as skin conditioning agents. The Panel reviewed relevant data relating to the safety of these ingredients in cosmetic formulations. Industry should continue to use good manufacturing practices to limit impurities. The Panel concluded that palm tree (açaí and juçara)-derived ingredients are safe in cosmetics in the present practices of use and concentration described in this safety assessment.

Validez actual de la litotricia extracorpórea como tratamiento de primera línea de la litiasis / Is extracorporeal lithotripsy a first-line treatment for urinary stones today?

Objetivo Evaluar la eficacia y complicaciones de la litotricia extracorpórea por ondas de choque (LEOCh) como tratamiento de primera línea de la litiasis renal y ureteral. Métodos Estudio observacional retrospectivo de todos los pacientes tratados con litotricia en un centro de tercer nivel entre enero de 2014 y enero de 2021. Se recogieron las características de los pacientes, de la litiasis, y las complicaciones y resultados de la LEOCh. Se realizó una regresión logística multivariante de los factores asociados a la reducción del tamaño litiásico. También se llevó a cabo un análisis estadístico de los factores asociados a la necesidad de tratamiento adicional tras la LEOCh y de los factores asociados a las complicaciones. Resultados Se incluyeron 1.727 pacientes. El tamaño litiásico medio fue de 9,5 mm. En 1.540 (89,4%) pacientes se observó la reducción del tamaño litiásico. En el análisis multivariante, el tamaño (OR=1,13; p=0,00), la localización de la litiasis en el uréter (OR=1,15; p=0,052) y el número de ondas (p=0,002; OR=1,00) utilizadas en la LEOCh son los factores asociados a la reducción del tamaño litiásico. Un total de 665 pacientes (38,5%) precisaron tratamiento adicional tras la litotricia. Los factores asociados a la necesidad de retratamiento fueron el tamaño litiásico (OR=1.131; p=0,000), el número de ondas (OR=1.000; p=0,000) y la energía administrada (OR=1.005; p=0,000). En 153 pacientes (8,8%) se produjeron complicaciones tras la LEOCh. Se encontró una asociación estadísticamente significativa entre el tamaño de la litiasis (p=0,024; OR=1.054) y la derivación urinaria previa (p=0,004; OR=0,571). Conclusión La litotricia sigue siendo eficaz como tratamiento de primera línea para la litiasis reno-ureteral, con un bajo porcentaje de complicaciones. (AU)

Objective To evaluate the efficacy and complications of extracorporeal lithotripsy (SWL) as a first-line treatment for renal and ureteral stones. Methods Retrospective and observational study of all the patients treated with lithotripsy in a third level center between January 2014 and January 2021; characteristics of the patients, the stones, complications and results of SWL is recollected. Multivariate logistic regression of the factors associated with stone size reduction was performed. A statistical analysis of the factors associated with additional treatment after SWL and factors associated with complications is also executed. Results 1727 patients are included. Stone mean size was 9,5 mm. 1540 (89.4%) patients presented reduction in stone size. In multivariate analysis, stone size (OR=1.13; P=0.00), ureteral location of the lithiasis (OR=1.15; P=0.052) and number of waves (P=0.002; OR=1.00) used in SWL are the factors associated with reduction of stone size. Additional treatment after lithotripsy was needed in 665 patients (38.5%). The factors associated with the need for retreatment were stone size (OR=1.131; P=0.000), number of waves (OR=1.000; P=0.000), energy (OR=1.005; P=0.000). 153 patients (8.8%) suffered complications after SWL. A statistically significant association was found between the size of the lithiasis (P=0.024, OR=1.054) and the previous urinary diversion (P=0.004, OR=0.571). Conclusion Lithotripsy remains an effective treatment as the first line of therapy for reno-ureteral lithiasis with a low percentage of complications. (AU)

Safety Assessment of Polysilicone-11 as Used in Cosmetics.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of Polysilicone-11 as used in cosmetic formulations. This ingredient is reported to function as a film former. The Panel considered the available data and concluded that Polysilicone-11 is safe in cosmetics in the present practices of use and concentration described in this safety assessment.

Safety Assessment of Basic Red 76 as Used in Cosmetics.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of Basic Red 76, which is reported to function in cosmetics as a hair colorant and hair-conditioning agent. The Panel reviewed the available data to determine the safety of this ingredient. The Panel concluded that Basic Red 76 is safe for use as a hair dye ingredient in the present practices of use and concentration described in the safety assessment.

Safety Assessment of Hydrogen Peroxide as Used in Cosmetics.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of Hydrogen Peroxide for use in cosmetics. This ingredient is reported to function in cosmetics as an antimicrobial agent, cosmetic biocide, oral health care agent, and oxidizing agent. The Panel reviewed the data relevant to the safety of this ingredient and concluded that Hydrogen Peroxide is safe in cosmetics in the present practices of use and concentration described in this safety assessment.

Safety Assessment of Hydroxyethyl Urea as Used in Cosmetics.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of Hydroxyethyl Urea, which is reported to function as a humectant and a hair and skin conditioning agent. The Panel reviewed the available data to determine the safety of this ingredient. The Panel concluded that Hydroxyethyl Urea is safe in cosmetics in the present practices of use and concentration described in the safety assessment when formulated to be non-irritating.

Safety Assessment of Capryloyl Salicylic Acid as Used in Cosmetics.

The Expert Panel for Cosmetic Ingredient Safety (Panel) reassessed the safety of Capryloyl Salicylic Acid in cosmetic products; this ingredient is reported to function as a skin conditioning agent. The Panel reviewed relevant data relating to the safety of this ingredient in cosmetic formulations, and concluded that the available data are insufficient to make a determination that Capryloyl Salicylic Acid is safe under the intended conditions of use in cosmetic formulations.

Safety Assessment of Soy-Derived Ingredients as Used in Cosmetics.

The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of 28 soy-derived ingredients as used in cosmetic products. These ingredients are reported to primarily function as antioxidants, skin protectants, skin-conditioning agents, and hair-conditioning agents. The Panel considered the available data relating to the safety of these ingredients in cosmetic formulations, and concluded that 24 of the 28 soy-derived ingredients are safe in cosmetics in the present practices of use and concentration described in this safety assessment. The Panel also concluded that the available data are insufficient to make a determination that Glycine Max (Soybean) Callus Culture, Glycine Max (Soybean) Callus Culture Extract, Glycine Max (Soybean) Callus Extract, and Glycine Max (Soybean) Phytoplacenta Conditioned Media are safe under the intended conditions of use in cosmetic formulations.

Impact of infectious diseases consultation for hospitalized patients with Clostridioides difficile infection.

Clostridioides difficile infection (CDI) is associated with substantial morbidity and mortality. This study described outcomes associated with mandatory infectious diseases (ID) consultation in hospitalized patients with CDI. ID consultation was associated with increased appropriate concomitant antibiotic use, however longer courses of concomitant antibiotics were administered.

Safety Assessment of Butyrospermum parkii (Shea)-Derived Ingredients as Used in Cosmetics.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 13 Butyrospermum parkii (shea)-derived ingredients, which are most frequently reported to function in cosmetics as skin and hair conditioning agents. The Panel reviewed the available data to determine the safety of these ingredients. Because final product formulations may contain multiple botanicals, each containing similar constituents of concern, formulators are advised to be aware of these constituents and to avoid reaching levels that may be hazardous to consumers. Industry should use good manufacturing practices to limit impurities that could be present in botanical ingredients. The Panel concluded that these ingredients are safe in the present practices of use and concentration when formulated to be non-sensitizing.

Distinct bile acid alterations in response to a single administration of PFOA and PFDA in mice.

Per- and polyfluoroalkyl substances (PFASs), a group of synthetic chemicals that were once widely used for industrial purposes and in consumer products, are widely found in the environment and in human blood due to their extraordinary resistance to degradation. Once inside the body, PFASs can activate nuclear receptors such as PPARα and CAR. The present study aimed to investigate the impact of perfluorooctanoic acid (PFOA) and perfluorodecanoic acid (PFDA) on liver structure and functions, as well as bile acid homeostasis in mice. A single administration of 0.1 mmole/kg of PFDA, not PFOA, elevated serum ALT and bilirubin levels and caused cholestasis in WT mice. PFDA increased total and various bile acid species in serum but decreased them in the liver. Furthermore, in mouse livers, PFDA, not PFOA, down-regulated mRNA expression of uptake transporters (Ntcp, Oatp1a1, 1a4, 1b2, and 2b1) but induced efflux transporters (Bcrp, Mdr2, and Mrp2-4). In addition, PFDA, not PFOA, decreased Cyp7a1, 7b1, 8b1, and 27a1 mRNA expression in mouse livers with concomitant hepatic accumulation of cholesterol. In contrast, in PPARα-null mice, PFDA did not increase serum ALT, bilirubin, or total bile acids, but produced prominent hepatosteatosis; and the observed PFDA-induced expression changes of transporters and Cyps in WT mice were largely attenuated or abolished. In CAR-null mice, the observed PFDA-induced bile acid alterations in WT mice were mostly sustained. These results indicate that, at the dose employed, PFDA has more negative effects than PFOA on liver function. PPARα appears to play a major role in mediating most of PFDA-induced effects, which were absent or attenuated in PPARα-null mice. Lack of PPARα, however, exacerbated hepatic steatosis. Our findings indicate separated roles of PPARα in mediating the adaptive responses to PFDA: protective against hepatosteatosis but exacerbating cholestasis.

Safety Assessment of Alkane Diols as Used in Cosmetics.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 10 alkane diol ingredients as used in cosmetics. The alkane diols are structurally related to each other as small diols, and most are reported to function in cosmetics as solvents. The Panel reviewed the relevant data for these ingredients, and concluded that seven alkane diols are safe in cosmetics in the present practices of use and concentration described in this safety assessment, but that the available data are insufficient to make a determination of safety for three ingredients, namely 1,4-Butanediol, 2,3-Butanediol, and Octanediol.

Safety Assessment of Zinc Salts as Used in Cosmetics.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 27 inorganic and organometallic zinc salts as used in cosmetic formulations; these salts are specifically of the 2+ (II) oxidation state cation of zinc. These ingredients included in this report have various reported functions in cosmetics, including hair conditioning agents, skin conditioning agents, cosmetic astringents, cosmetic biocides, preservatives, oral care agents, buffering agents, bulking agents, chelating agents, and viscosity increasing agents. The Panel reviewed the relevant data for these ingredients, and concluded that these 27 ingredients are safe in cosmetics in the present practices of use and concentration described in this safety assessment when formulated to be non-irritating.

Is extracorporeal lithotripsy a first-line treatment for urinary stones today?

OBJECTIVE: To evaluate the efficacy and complications of extracorporeal lithotripsy (SWL) as a first-line treatment for renal and ureteral stones METHODS: Retrospective and observational study of all the patients treated with lithotripsy in a third level center between January 2014 and January 2021; characteristics of the patients, the stones, complications and results of SWL is recollected. Multivariate logistic regression of the factors associated with stone size reduction was performed. A statistical analysis of the factors associated with additional treatment after SWL and factors associated with complications is also executed. RESULTS: 1727 patients are included. Stone mean size was 9,5mm. 1540 (89.4%) patients presented reduction in stone size. In multivariate analysis, stone size (OR=1.13; p=0.00), ureteral location of the lithiasis (OR=1.15; p=0.052) and number of waves (p=0.002; OR=1.00) used in SWL are the factors associated with reduction of stone size. Additional treatment after lithotripsy was needed in 665 patients (38.5%). The factors associated with the need for retreatment were stone size (OR=1.131; p=0.000), number of waves (OR=1.000; p=0.000), energy (OR=1.005; p=0.000). 153 patients (8.8%) suffered complications after SWL. A statistically significant association was found between the size of the lithiasis (p=0.024, OR=1.054) and the previous urinary diversion (P=0.004, OR=0.571). CONCLUSION: Lithotripsy remains an effective treatment as the first line of therapy for reno-ureteral lithiasis with a low percentage of complications.

Safety Assessment of Ginkgo biloba-Derived Ingredients as Used in Cosmetics.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 10 Ginkgo biloba-derived ingredients, which are most frequently reported to function in cosmetics as skin conditioning agents or antioxidants. The Panel reviewed the available data to determine the safety of 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 be hazardous to consumers. The Panel was concerned about the presence of ginkgolic acid in cosmetics. Industry should use good manufacturing practices to limit impurities. The Panel concluded that 5 Ginkgo biloba leaf-derived ingredients are safe in the present practices of use and concentration described in this safety assessment when formulated to be non-sensitizing; data are insufficient to determine the safety of the remaining 5 ingredients under the intended conditions of use in cosmetic formulations.

Safety Assessment of Hops as Used in Cosmetics.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of Humulus Lupulus (Hops) Extract (reported functions include antimicrobial agent and hair conditioning agent) and Humulus Lupulus (Hops) Oil (reported function is fragrance). The Panel reviewed the relevant 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 be hazardous to consumers. For these ingredients, the Panel was concerned about the presence of 8-prenylnaringenin, ß-myrcene, and quercetin in cosmetics, which could result in estrogenic effects, dermal irritation, and genotoxicity, respectively. Industry should use current good manufacturing practices to limit impurities and constituents of concern. The Panel concluded that Humulus Lupulus (Hops) Extract and Humulus Lupulus (Hops) Oil are safe in cosmetics in the present practices of use and concentration when formulated to be non-sensitizing.

Safety Assessment of Alkyl Sultaines as Used in Cosmetics.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 13 alkyl sultaines, which are most frequently reported to function in cosmetics as antistatic agents, surfactants, and skin and hair conditioning agents. The Panel reviewed the available data to determine the safety of these ingredients. The Panel noted gaps in the available safety data for some of the alkyl sultaines in this safety assessment; the available data on some of the ingredients are sufficient, however, and can be read across to support the safety of other members of the group. The Panel concluded that these alkyl sultaines are safe in cosmetics in the present practices of use and concentration described in this safety assessment.

Safety Assessment of Adenosine as Used in Cosmetics.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of Adenosine, Adenosine Phosphate, Adenosine Triphosphate, Disodium Adenosine Phosphate, and Disodium Adenosine Triphosphate. These ingredients are reported to function in cosmetics as skin-conditioning agents - miscellaneous. The Panel considered the available data and concluded that the five adenosine ingredients reviewed in this report are safe in cosmetics in the present practices of use and concentration described in this safety assessment.