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3. GA4GH: International policies and standards for data sharing across genomic research and healthcare

Author

Rehm, HL, Page, AJH, Smith, L, Adams, JB, Alterovitz, G, Babb, LJ, Barkley, MP, Baudis, M, Beauvais, MJS, Beck, T, Beckmann, JS, Beltran, S, Bernick, D, Bernier, A, Bonfield, JK, Boughtwood, TF, Bourque, G, Bowers, SR, Brookes, AJ, Brudno, M, Brush, MH, Bujold, D, Burdett, T, Buske, OJ, Cabili, MN, Cameron, DL, Carroll, RJ, Casas-Silva, E, Chakravarty, D, Chaudhari, BP, Chen, SH, Cherry, JM, Chung, J, Cline, M, Clissold, HL, Cook-Deegan, RM, Courtot, M, Cunningham, F, Cupak, M, Davies, RM, Denisko, D, Doerr, MJ, Dolman, LI, Dove, ES, Dursi, LJ, Dyke, SOM, Eddy, JA, Eilbeck, K, Ellrott, KP, Fairley, S, Fakhro, KA, Firth, HV, Fitzsimons, MS, Fiume, M, Flicek, P, Fore, IM, Freeberg, MA, Freimuth, RR, Fromont, LA, Fuerth, J, Gaff, CL, Gan, W, Ghanaim, EM, Glazer, D, Green, RC, Griffith, M, Griffith, OL, Grossman, RL, Groza, T, Auvil, JMG, Guigo, R, Gupta, D, Haendel, MA, Hamosh, A, Hansen, DP, Hart, RK, Hartley, DM, Haussler, D, Hendricks-Sturrup, RM, Ho, CWL, Hobb, AE, Hoffman, MM, Hofmann, OM, Holub, P, Hsu, JS, Hubaux, J-P, Hunt, SE, Husami, A, Jacobsen, JO, Jamuar, SS, Janes, EL, Jeanson, F, Jene, A, Johns, AL, Joly, Y, Jones, SJM, Kanitz, A, Kato, K, Keane, TM, Kekesi-Lafrance, K, Kelleher, J, Kerry, G, Khor, S-S, Knoppers, BM, Konopko, MA, Kosaki, K, Kuba, M, Lawson, J, Leinonen, R, Li, S, Lin, MF, Linden, M, Liu, X, Liyanage, IU, Lopez, J, Lucassen, AM, Lukowski, M, Mann, AL, Marshall, J, Mattioni, M, Metke-Jimenez, A, Middleton, A, Milne, RJ, Molnar-Gabor, F, Mulder, N, Munoz-Torres, MC, Nag, R, Nakagawa, H, Nasir, J, Navarro, A, Nelson, TH, Niewielska, A, Nisselle, A, Niu, J, Nyronen, TH, O'Connor, BD, Oesterle, S, Ogishima, S, Wang, VO, Paglione, LAD, Palumbo, E, Parkinson, HE, Philippakis, AA, Pizarro, AD, Prlic, A, Rambla, J, Rendon, A, Rider, RA, Robinson, PN, Rodarmer, KW, Rodriguez, LL, Rubin, AF, Rueda, M, Rushton, GA, Ryan, RS, Saunders, GI, Schuilenburg, H, Schwede, T, Scollen, S, Senf, A, Sheffield, NC, Skantharajah, N, Smith, AV, Sofia, HJ, Spalding, D, Spurdle, AB, Stark, Z, Stein, LD, Suematsu, M, Tan, P, Tedds, JA, Thomson, AA, Thorogood, A, Tickle, TL, Tokunaga, K, Tomroos, J, Torrents, D, Upchurch, S, Valencia, A, Guimera, RV, Vamathevan, J, Varma, S, Vears, DF, Viner, C, Voisin, C, Wagner, AH, Wallace, SE, Walsh, BP, Williams, MS, Winkler, EC, Wold, BJ, Wood, GM, Woolley, JP, Yamasaki, C, Yates, AD, Yung, CK, Zass, LJ, Zaytseva, K, Zhang, J, Goodhand, P, North, K, Birney, E, Rehm, HL, Page, AJH, Smith, L, Adams, JB, Alterovitz, G, Babb, LJ, Barkley, MP, Baudis, M, Beauvais, MJS, Beck, T, Beckmann, JS, Beltran, S, Bernick, D, Bernier, A, Bonfield, JK, Boughtwood, TF, Bourque, G, Bowers, SR, Brookes, AJ, Brudno, M, Brush, MH, Bujold, D, Burdett, T, Buske, OJ, Cabili, MN, Cameron, DL, Carroll, RJ, Casas-Silva, E, Chakravarty, D, Chaudhari, BP, Chen, SH, Cherry, JM, Chung, J, Cline, M, Clissold, HL, Cook-Deegan, RM, Courtot, M, Cunningham, F, Cupak, M, Davies, RM, Denisko, D, Doerr, MJ, Dolman, LI, Dove, ES, Dursi, LJ, Dyke, SOM, Eddy, JA, Eilbeck, K, Ellrott, KP, Fairley, S, Fakhro, KA, Firth, HV, Fitzsimons, MS, Fiume, M, Flicek, P, Fore, IM, Freeberg, MA, Freimuth, RR, Fromont, LA, Fuerth, J, Gaff, CL, Gan, W, Ghanaim, EM, Glazer, D, Green, RC, Griffith, M, Griffith, OL, Grossman, RL, Groza, T, Auvil, JMG, Guigo, R, Gupta, D, Haendel, MA, Hamosh, A, Hansen, DP, Hart, RK, Hartley, DM, Haussler, D, Hendricks-Sturrup, RM, Ho, CWL, Hobb, AE, Hoffman, MM, Hofmann, OM, Holub, P, Hsu, JS, Hubaux, J-P, Hunt, SE, Husami, A, Jacobsen, JO, Jamuar, SS, Janes, EL, Jeanson, F, Jene, A, Johns, AL, Joly, Y, Jones, SJM, Kanitz, A, Kato, K, Keane, TM, Kekesi-Lafrance, K, Kelleher, J, Kerry, G, Khor, S-S, Knoppers, BM, Konopko, MA, Kosaki, K, Kuba, M, Lawson, J, Leinonen, R, Li, S, Lin, MF, Linden, M, Liu, X, Liyanage, IU, Lopez, J, Lucassen, AM, Lukowski, M, Mann, AL, Marshall, J, Mattioni, M, Metke-Jimenez, A, Middleton, A, Milne, RJ, Molnar-Gabor, F, Mulder, N, Munoz-Torres, MC, Nag, R, Nakagawa, H, Nasir, J, Navarro, A, Nelson, TH, Niewielska, A, Nisselle, A, Niu, J, Nyronen, TH, O'Connor, BD, Oesterle, S, Ogishima, S, Wang, VO, Paglione, LAD, Palumbo, E, Parkinson, HE, Philippakis, AA, Pizarro, AD, Prlic, A, Rambla, J, Rendon, A, Rider, RA, Robinson, PN, Rodarmer, KW, Rodriguez, LL, Rubin, AF, Rueda, M, Rushton, GA, Ryan, RS, Saunders, GI, Schuilenburg, H, Schwede, T, Scollen, S, Senf, A, Sheffield, NC, Skantharajah, N, Smith, AV, Sofia, HJ, Spalding, D, Spurdle, AB, Stark, Z, Stein, LD, Suematsu, M, Tan, P, Tedds, JA, Thomson, AA, Thorogood, A, Tickle, TL, Tokunaga, K, Tomroos, J, Torrents, D, Upchurch, S, Valencia, A, Guimera, RV, Vamathevan, J, Varma, S, Vears, DF, Viner, C, Voisin, C, Wagner, AH, Wallace, SE, Walsh, BP, Williams, MS, Winkler, EC, Wold, BJ, Wood, GM, Woolley, JP, Yamasaki, C, Yates, AD, Yung, CK, Zass, LJ, Zaytseva, K, Zhang, J, Goodhand, P, North, K, and Birney, E

Abstract

The Global Alliance for Genomics and Health (GA4GH) aims to accelerate biomedical advances by enabling the responsible sharing of clinical and genomic data through both harmonized data aggregation and federated approaches. The decreasing cost of genomic sequencing (along with other genome-wide molecular assays) and increasing evidence of its clinical utility will soon drive the generation of sequence data from tens of millions of humans, with increasing levels of diversity. In this perspective, we present the GA4GH strategies for addressing the major challenges of this data revolution. We describe the GA4GH organization, which is fueled by the development efforts of eight Work Streams and informed by the needs of 24 Driver Projects and other key stakeholders. We present the GA4GH suite of secure, interoperable technical standards and policy frameworks and review the current status of standards, their relevance to key domains of research and clinical care, and future plans of GA4GH. Broad international participation in building, adopting, and deploying GA4GH standards and frameworks will catalyze an unprecedented effort in data sharing that will be critical to advancing genomic medicine and ensuring that all populations can access its benefits.

Published
2021

4. BRCA Challenge: BRCA Exchange as a global resource for variants in BRCA1 and BRCA2

Author

Cline, M.S., Liao, R.G., Parsons, M.T., Paten, B., Alquaddoomi, F., Antoniou, A., Baxter, S., Brody, L., Cook-Deegan, R., Coffin, A., Couch, F.J., Craft, B., Currie, R., Dlott, C.C., Dolman, L., Dunnen, J.T. den, Dyke, S.O.M., Domchek, S.M., Easton, D., Fischmann, Z., Foulkes, W.D., Garber, J., Goldgar, D., Goldman, M.J., Goodhand, P., Harrison, S., Haussler, D., Kato, K., Knoppers, B., Markello, C., Nussbaum, R., Offit, K., Plon, S.E., Rashbass, J., Rehm, H.L., Robson, M., Rubinstein, W.S., Stoppa-Lyonnet, D., Tavtigian, S., Thorogood, A., Zhang, C., Zimmermann, M., Burn, J., Chanock, S., Ratsch, G., Spurdle, A.B., Andreoletti, G., Baker, D., Brenner, S., Brush, M., Caputo, S., Castera, L., Cunningham, F., Hoya, M. de la, Diekhans, M., Dolinsky, J., Dwight, S., Eccles, D., Feng, B., Fiume, M., Flicek, P., Gaudet, P., Garcia, E.G., Haendel, M., Haeussler, M., Hahnen, E., Houdayer, C., Hunt, S., James, P., Lebo, M., Lee, J., Lerner-Ellis, J., Lin, M., Lincoln, S., Malheiro, A., Mesenkamp, A., Monteiro, A., Natzijl-Visser, E., Ngeow, J., North, K., Parkinson, H., Paschall, J., Patrinos, G., Phimister, B., Radice, P., Rainville, I., Rasmussen, M., Riley, G., Rouleau, E., Schmutzler, R., Shefchek, K., Sofia, H., Southey, M., Stuart, J., Thomas, J., Toland, A., Truty, R., Turn-Bull, C., Vaur, D., Vreeswijk, M.P.G., Walker, L., Walsh, M., Wappenschmidt, B., Weitzel, J., Wright, M., Zalunin, V., Zaranek, A., Zerbino, D., Zhou, A., Zhou, J., Zook, J., BRCA Challenge Authors, Eng, Charis, Liao, Rachel G [0000-0002-7830-1976], Parsons, Michael T [0000-0003-3242-8477], Alquaddoomi, Faisal [0000-0003-4297-8747], Baxter, Samantha [0000-0003-4616-9234], Coffin, Amy [0000-0003-2723-8222], Currie, Robert [0000-0003-1828-1827], Dlott, Chloe C [0000-0002-7268-7230], Dolman, Lena [0000-0002-3938-588X], Fischmann, Zachary [0000-0002-7687-0972], Foulkes, William D [0000-0001-7427-4651], Goldman, Mary J [0000-0002-9808-6388], Goodhand, Peter [0000-0002-2624-2820], Harrison, Steven [0000-0002-9614-9111], Haussler, David [0000-0003-1533-4575], Markello, Charles [0000-0002-3653-7155], Plon, Sharon E [0000-0002-9626-0936], Rehm, Heidi L [0000-0002-6025-0015], Rubinstein, Wendy S [0000-0002-8790-9959], Tavtigian, Sean [0000-0002-7543-8221], Thorogood, Adrian [0000-0001-5078-8164], Chanock, Stephen [0000-0002-2324-3393], Rätsch, Gunnar [0000-0001-5486-8532], Spurdle, Amanda B [0000-0003-1337-7897], and Apollo - University of Cambridge Repository

Subjects
0301 basic medicine, Male, Cancer Research, Research Facilities, endocrine system diseases, Epidemiology, Genes, BRCA2, Genes, BRCA1, Social Sciences, Penetrance, QH426-470, Patient advocacy, Database and Informatics Methods, 0302 clinical medicine, Resource (project management), Sociology, Gene Frequency, Consortia, Risk Factors, Databases, Genetic, Medicine and Health Sciences, Aetiology, skin and connective tissue diseases, Genetics (clinical), Cancer, Ovarian Neoplasms, education.field_of_study, Cancer Risk Factors, Genomics, Genomic Databases, 3. Good health, Viewpoints, Phenotype, Oncology, 030220 oncology & carcinogenesis, Female, Research Laboratories, Population, Genetic Causes of Cancer, MEDLINE, Information Dissemination, Breast Neoplasms, Patient Advocacy, Biology, Research and Analysis Methods, Human Genomics, 03 medical and health sciences, Databases, Genetic, Breast Cancer, Genetics, Humans, Genetic Predisposition to Disease, education, Molecular Biology, Ecology, Evolution, Behavior and Systematics, Alleles, Human Genome, Biology and Life Sciences, Computational Biology, Genetic Variation, Genome Analysis, Genomic Libraries, BRCA1, Data science, BRCA2, Data sharing, Health Care, 030104 developmental biology, Biological Databases, Good Health and Well Being, Genes, Genetic Loci, Medical Risk Factors, BRCA Challenge Authors, Mutation, Leiden Open Variation Database, 2.6 Resources and infrastructure (aetiology), Government Laboratories, Developmental Biology
Abstract

The BRCA Challenge is a long-term data-sharing project initiated within the Global Alliance for Genomics and Health (GA4GH) to aggregate BRCA1 and BRCA2 data to support highly collaborative research activities. Its goal is to generate an informed and current understanding of the impact of genetic variation on cancer risk across the iconic cancer predisposition genes, BRCA1 and BRCA2. Initially, reported variants in BRCA1 and BRCA2 available from public databases were integrated into a single, newly created site, www.brcaexchange.org. The purpose of the BRCA Exchange is to provide the community with a reliable and easily accessible record of variants interpreted for a high-penetrance phenotype. More than 20,000 variants have been aggregated, three times the number found in the next-largest public database at the project’s outset, of which approximately 7,250 have expert classifications. The data set is based on shared information from existing clinical databases—Breast Cancer Information Core (BIC), ClinVar, and the Leiden Open Variation Database (LOVD)—as well as population databases, all linked to a single point of access. The BRCA Challenge has brought together the existing international Evidence-based Network for the Interpretation of Germline Mutant Alleles (ENIGMA) consortium expert panel, along with expert clinicians, diagnosticians, researchers, and database providers, all with a common goal of advancing our understanding of BRCA1 and BRCA2 variation. Ongoing work includes direct contact with national centers with access to BRCA1 and BRCA2 diagnostic data to encourage data sharing, development of methods suitable for extraction of genetic variation at the level of individual laboratory reports, and engagement with participant communities to enable a more comprehensive understanding of the clinical significance of genetic variation in BRCA1 and BRCA2., Author summary The goal of this study and paper has been to develop an international resource to generate an informed and current understanding of the impact of genetic variation on cancer risk across the cancer predisposition genes, BRCA1 and BRCA2. Reported variants in BRCA1 and BRCA2 available from public databases were integrated into a single, newly created site, www.brcaexchange.org, to provide a reliable and easily accessible record of variants interpreted for a high-penetrance phenotype.

Published
2018

5. Final Report on the Safety Assessment of Acrylates Copolymer and 33 Related Cosmetic Ingredients

Author

Zondlo Fiume M

Subjects
Inhalation Exposure, Acrylate copolymer, Dose-Response Relationship, Drug, Polymers, Chemistry, Guinea Pigs, Cosmetics, 030206 dentistry, Administration, Cutaneous, Toxicology, Risk Assessment, 030226 pharmacology & pharmacy, Mice, 03 medical and health sciences, 0302 clinical medicine, Acrylates, Consumer Product Safety, Toxicity Tests, Animals, Humans, Methacrylates, Organic chemistry, Rabbits
Abstract

Ingredients in the Acrylates Copolymer group all contain the monomers acrylic acid or methacrylic acid or one of their salts or esters. These ingredients are considered similar in that they are uniformly produced in chemical reactions that leave very little residual monomer. Although residual acrylic acid may be as high as 1500 ppm, typical levels are 10 to 1000 ppm. There is sufficient odor if residual monomers are present to cause producers to keep levels as low as possible. These ingredients function in cosmetics as binders, film formers, hair fixatives, suspending agents, viscosity-increasing agents, and emulsion stabilizers. Concentrations may be as high as 25% if used as a binder, film former, or fixative; or as low as 0.5% if used as a viscosity-increasing agent, suspending agent, or emulsion stabilizer. These very large polymers exhibit little toxicity. In rabbits and guinea pigs, Acrylates Copolymer did produce irritation, but no evidence of sensitization was found. The principle concern regarding the use of these polymer ingredients is the presence of toxic residual monomers. In particular, although 2-ethylhexyl acrylate was not genotoxic, it was carcinogenic when applied at a concentration of 21% to the skin of C3H mice. Lower concentrations (2.5%) and stop-dose studies at high concentrations (43%) were not carcinogenic. 2-Ethylhexyl acrylate was not carcinogenic in studies using NMRI mice. Whether an increase in carcinogenesis was seen or not, there was evidence of severe dermal irritation in these 2-ethylhexyl acrylate studies. Another concern regarding residual monomers was inhalation toxicity. Although the acrylic acid monomer is a nasal irritant, exposure to the monomer from use of these polymers in cosmetic formulations would always be less than the established occupational exposure limits for nasal irritation. Although there appears to be a huge variation in the mix of monomers used in the synthesis of these polymers, they are similar in that the polymers, except for dermal irritation, are not significantly toxic, and residual monomer levels are kept as low as possible. Although the monomers may be toxic, the levels that would be found in cosmetic formulations are not considered to present a safety risk. Accordingly, these Acrylate Copolymers are considered safe for use in cosmetic formulations when formulated to avoid irritation.

Published
2002
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6. iReckon: Simultaneous isoform discovery and abundance estimation from RNA-seq data

Author

Smith, E. J. M., Savich, G. L., Brudno, M., Fiume, M., Goldenberg, A., Chiang, D. Y., Buske, O., Aparicio, S., Shah, S., and Mezlini, A. M.

Abstract

High-throughput RNA sequencing (RNA-seq) promises to revolutionize our understanding of genes and their role in human disease by characterizing the RNA content of tissues and cells. The realization of this promise, however, is conditional on the development of effective computational methods for the identification and quantification of transcripts from incomplete and noisy data. In this article, we introduce iReckon, a method for simultaneous determination of the isoforms and estimation of their abundances. Our probabilistic approach incorporates multiple biological and technical phenomena, including novel isoforms, intron retention, unspliced pre-mRNA, PCR amplification biases, and multimapped reads. iReckon utilizes regularized expectation-maximization to accurately estimate the abundances of known and novel isoforms. Our results on simulated and real data demonstrate a superior ability to discover novel isoforms with a significantly reduced number of false-positive predictions, and our abundance accuracy prediction outmatches that of other state-of-the-art tools. Furthermore, we have applied iReckon to two cancer transcriptome data sets, a triple-negative breast cancer patient sample and the MCF7 breast cancer cell line, and show that iReckon is able to reconstruct the complex splicing changes that were not previously identified. QT-PCR validations of the isoforms detected in the MCF7 cell line confirmed all of iReckon's predictions and also showed strong agreement (r2 = 0.94) with the predicted abundances.

Published
2013
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7. Indagini geofisiche nella conca del Laceno (AV)

Author

CELLA F, FEDI, MAURIZIO, FIUME M. G, FLORIO, GIOVANNI, GRIMALDI M, RAPOLLA A, ROBERTI N., CARRARA, EUGENIO, Cella, F, Carrara, Eugenio, Fedi, Maurizio, FIUME M., G, Florio, Giovanni, Grimaldi, M, Rapolla, A, and Roberti, N.

Published
1993

14. ENHANCING READING ACHIEVEMENT: A COLLABORATIVE, COMMUNITY-BASED INTERVENTION MODEL.

Author

GARMAN, F., HAMMANN, S., HOODAK, G., FIUME, M., MANINO-CORSE, F., and WISE, S.

Subjects
*URBAN education, *INFORMATION technology education, *EDUCATION of poor people, *READING equipment
Abstract

This overview presents a model of a successful community- based, collaborative partnership that utilized information technology resources to enhance, increase and maximize learning opportunities in a highly transient, socio-economically disadvantaged, urban student population. Use of coordinated information technology resources and programming, in diverse organizations and locations, appeared to have in a favorable impact on academic achievement by contributing to a reduction of students reading "below level" of 15.1% and had its greatest impact on reading performance by precipitating a 36.7% reduction in students reading "3 years below level." [ABSTRACT FROM AUTHOR]

Published
2000

15. Scritture femminili e storia delle donne nell’Italia in formazione: tra pubblico e privato

Author

FAZIO, Ida, Fiume M, and Fazio, Ida

Subjects
Storia delle donne e di genere, Storia d'Italia - XIX secolo, Storia moderna, Storia sociale, Settore M-STO/04 - Storia Contemporanea, Settore M-STO/02 - Storia Moderna
Abstract

Il saggio prende in esame le più significative tipologie di scritture femminili nel XIX secolo in Italia, a partire dalle più recenti acquisizioni storiografiche della storia delle donne e di genere

Published
2016

17. Eleonora d’Angiò

Author

RUSSO, Maria Antonietta, Fiume, M, and RUSSO MA

Subjects
Eleonora d'Angiò, regina, Federico III, Settore M-STO/01 - Storia Medievale
Abstract

Voce biografica su Eleonora d'Angiò, figlia di Carlo II d'Angiò e Maria d'Ungheria e sposa di Federico III

Published
2006

18. Lucrezia Giuffré Piazza

Author

POLIZZI, Francesco Gabriele, Fiume, M, and Polizzi Francesco Gabriele

Subjects
Donne, Sicilia, Dizionario, Biografia
Abstract

Voce biografica dell'artista Lucrezia Giuffré Piazza

Published
2006

19. Isabella d’Aragona

Author

RUSSO, Maria Antonietta, Fiume, M, and RUSSO MA

Subjects
Settore M-STO/01 - Storia Medievale, Isabella d'Aragona, Raimondo Peralta, contea di Caltabellotta
Abstract

Voce biografica su Isabella d'Aragona, figlia naturale di Federico III e moglie di Raimondo Peralta primo conte di Caltabellotta

Published
2006

20. Margherita Peralta

Author

RUSSO, Maria Antonietta, Fiume, M, and RUSSO MA

Subjects
Margherita Peralta, contea di Caltabellotta, Settore M-STO/01 - Storia Medievale
Abstract

Voce biografica su Margherita Peralta, figlia di Nicola quarto conte di Caltabellotta ed erede del titolo comitale

Published
2006

21. Safety Assessment of Mannitol, Sorbitol, and Xylitol as Used in Cosmetics.

Author

Cherian P, Bergfeld WF, Belsito DV, Klaassen CD, Liebler DC, Marks JG Jr, Peterson LA, Shank RC, Slaga TJ, Snyder PW, Fiume M, and Heldreth B

Abstract

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of Mannitol, Sorbitol, and Xylitol as used in cosmetics. These ingredients are reported to function as humectants, skin-conditioning agents, or flavoring agents. The Panel considered the available data and concluded that these sugar alcohol ingredients are safe in cosmetics in the present practices of use and concentration described in the safety assessment., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Published
2024
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22. Safety Assessment of Wheat-Derived Ingredients as Used in Cosmetics.

Author

Burnett CL, Bergfeld WF, Belsito DV, Cohen DE, Klaassen CD, Liebler DC, Marks JG Jr, Peterson LA, Shank RC, Slaga TJ, Snyder PW, Fiume M, and Heldreth B

Abstract

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 27 wheat-derived ingredients. Most of these ingredients are reported to function as skin conditioning agents in cosmetic products. The Panel reviewed the available data to determine the safety of these ingredients. Industry should continue to use good manufacturing practices to limit impurities that could be present in botanical ingredients. The Panel concluded that 21 wheat-derived ingredients are safe in cosmetics in the practices of use and concentration described in this safety assessment. However, the Panel also concluded that the available data are insufficient to make a determination of safety that the remaining six wheat-derived ingredients are safe under the intended conditions of use in cosmetic formulations., Competing Interests: Declaration of Conflicting InterestThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Published
2024
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23. Safety Assessment of Ascorbyl Glucoside and Sodium Ascorbyl Glucoside as Used in Cosmetics.

Author

Johnson W Jr, Bergfeld WF, Belsito DV, Klaassen CD, Liebler DC, Marks JG Jr, Peterson LA, Shank RC, Slaga TJ, Snyder PW, Fiume M, and Heldreth B

Abstract

The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of Ascorbyl Glucoside and Sodium Ascorbyl Glucoside in cosmetic products. These ingredients are reported to have the following functions in cosmetics: antioxidant, and skin-conditioning agent-miscellaneous. The Panel reviewed data relevant to the safety of these ingredients in cosmetic formulations, and concluded that Ascorbyl Glucoside and Sodium Ascorbyl Glucoside are safe in cosmetics in the present practices of use and concentration described in this safety assessment., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Published
2024
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24. Safety Assessment of Alkyl Amide MIPA Ingredients as Used in Cosmetics.

Author

Akinsulie A, Bergfeld WF, Belsito DV, Klaassen CD, Liebler DC, Marks JG Jr, Peterson LA, Shank RC, Slaga TJ, Snyder PW, Fiume M, and Heldreth B

Abstract

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 14 alkyl amide MIPA ingredients as used in cosmetics. All of these ingredients are reported to function in cosmetics as a surfactant - foam booster and/or viscosity increasing agent. The Panel considered the available data, as well as data on read-across sources, and concluded 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., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Published
2024
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25. The Canadian VirusSeq Data Portal and Duotang: open resources for SARS-CoV-2 viral sequences and genomic epidemiology.

Author

Gill EE, Jia B, Murall CL, Poujol R, Anwar MZ, John NS, Richardsson J, Hobb A, Olabode AS, Lepsa A, Duggan AT, Tyler AD, N'Guessan A, Kachru A, Chan B, Yoshida C, Yung CK, Bujold D, Andric D, Su E, Griffiths EJ, Van Domselaar G, Jolly GW, Ward HKE, Feher H, Baker J, Simpson JT, Uddin J, Ragoussis J, Eubank J, Fritz JH, Gálvez JH, Fang K, Cullion K, Rivera L, Xiang L, Croxen MA, Shiell M, Prystajecky N, Quirion PO, Bajari R, Rich S, Mubareka S, Moreira S, Cain S, Sutcliffe SG, Kraemer SA, Alturmessov Y, Joly Y, Cphln Consortium, CanCOGeN Consortium, VirusSeq Data Portal Academic And Health Network, Fiume M, Snutch TP, Bell C, Lopez-Correa C, Hussin JG, Joy JB, Colijn C, Gordon PMK, Hsiao WWL, Poon AFY, Knox NC, Courtot M, Stein L, Otto SP, Bourque G, Shapiro BJ, and Brinkman FSL

Subjects
Canada epidemiology, Humans, Genomics methods, Pandemics, Databases, Genetic, SARS-CoV-2 genetics, COVID-19 epidemiology, COVID-19 virology, Genome, Viral
Abstract

The COVID-19 pandemic led to a large global effort to sequence SARS-CoV-2 genomes from patient samples to track viral evolution and inform the public health response. Millions of SARS-CoV-2 genome sequences have been deposited in global public repositories. The Canadian COVID-19 Genomics Network (CanCOGeN - VirusSeq), a consortium tasked with coordinating expanded sequencing of SARS-CoV-2 genomes across Canada early in the pandemic, created the Canadian VirusSeq Data Portal, with associated data pipelines and procedures, to support these efforts. The goal of VirusSeq was to allow open access to Canadian SARS-CoV-2 genomic sequences and enhanced, standardized contextual data that were unavailable in other repositories and that meet FAIR standards (Findable, Accessible, Interoperable and Reusable). In addition, the portal data submission pipeline contains data quality checking procedures and appropriate acknowledgement of data generators that encourages collaboration. From inception to execution, the portal was developed with a conscientious focus on strong data governance principles and practices. Extensive efforts ensured a commitment to Canadian privacy laws, data security standards, and organizational processes. This portal has been coupled with other resources, such as Viral AI, and was further leveraged by the Coronavirus Variants Rapid Response Network (CoVaRR-Net) to produce a suite of continually updated analytical tools and notebooks. Here we highlight this portal (https://virusseq-dataportal.ca/), including its contextual data not available elsewhere, and the Duotang (https://covarr-net.github.io/duotang/duotang.html), a web platform that presents key genomic epidemiology and modelling analyses on circulating and emerging SARS-CoV-2 variants in Canada. Duotang presents dynamic changes in variant composition of SARS-CoV-2 in Canada and by province, estimates variant growth, and displays complementary interactive visualizations, with a text overview of the current situation. The VirusSeq Data Portal and Duotang resources, alongside additional analyses and resources computed from the portal (COVID-MVP, CoVizu), are all open source and freely available. Together, they provide an updated picture of SARS-CoV-2 evolution to spur scientific discussions, inform public discourse, and support communication with and within public health authorities. They also serve as a framework for other jurisdictions interested in open, collaborative sequence data sharing and analyses.

Published
2024
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26. Safety Assessment of Methylxanthines as Used in Cosmetics.

Author

Cherian PA, Bergfeld WF, Belsito DV, Hill RA, Klaassen CD, Liebler DC, Marks JG Jr, Shank RC, Slaga TJ, Snyder PW, Fiume M, and Heldreth B

Subjects
Humans, Animals, Caffeine toxicity, Caffeine pharmacokinetics, Theobromine toxicity, Theophylline toxicity, Theophylline pharmacokinetics, Risk Assessment, Toxicity Tests, Xanthines toxicity, Cosmetics toxicity, Cosmetics chemistry, Consumer Product Safety
Abstract

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of three methylxanthines, Caffeine, Theobromine, and Theophylline, as used in cosmetics. All of these ingredients are reported to function as skin-conditioning agents in cosmetic products. The Panel reviewed the data relevant to the safety of these ingredients and concluded that Caffeine, Theobromine, and Theophylline are safe in cosmetics in the present practices of use and concentration described in this safety assessment., Competing Interests: Declaration of Conflicting InterestThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Published
2024
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27. Safety Assessment of Polyol Phosphates as Used in Cosmetics.

Author

Johnson W Jr, Bergfeld WF, Belsito DV, Hill RA, Klaassen CD, Liebler DC, Marks JG Jr, Shank RC, Slaga TJ, Snyder PW, Fiume M, and Heldreth B

Subjects
Humans, Animals, Phosphates toxicity, Phosphates chemistry, Polymers toxicity, Polymers chemistry, Toxicity Tests, Risk Assessment, Cosmetics toxicity, Cosmetics chemistry, Consumer Product Safety
Abstract

The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of 10 polyol phosphates. Some of the possible functions in cosmetics that are reported for this ingredient group are chelating agents, oral care agents, and skin conditioning agents. The Panel reviewed relevant data relating to the safety of these ingredients under the intended conditions of use in cosmetic formulations, and concluded that Sodium Phytate, Phytic Acid, Phytin, and Trisodium Inositol Triphosphate are safe in cosmetics in the present practices of use and concentration described in the safety assessment. The Panel also concluded that the data are insufficient to determine the safety of the following 6 ingredients as used in cosmetics: Disodium Glucose Phosphate, Manganese Fructose Diphosphate, Sodium Mannose Phosphate, Trisodium Fructose Diphosphate, Xylityl Phosphate, and Zinc Fructose Diphosphate., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Published
2024
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28. Sodium Dehydroacetate and Dehydroacetic Acid.

Author

Cherian P, Bergfeld WF, Belsito DV, Cohen DE, Klaassen CD, Rettie AE, Ross D, Slaga TJ, Snyder PW, Tilton S, Fiume M, and Heldreth B

Subjects
Humans, Animals, Consumer Product Safety, Risk Assessment, Toxicity Tests, Pyrones, Cosmetics toxicity, Cosmetics chemistry, Cosmetics pharmacokinetics
Abstract

The Expert Panel for Cosmetic Ingredient Safety (Panel) first published a safety assessment of Sodium Dehydroacetate and Dehydroacetic Acid in 1985. The Panel previously concluded that Sodium Dehydroacetate and Dehydroacetic Acid are safe as used in the present practices of use and concentration, as stated in that report. Upon re-review in 2003, the Panel reaffirmed the original conclusion, as published in 2006. The Panel reviewed updated frequency and concentration of use data again in 2023, in addition to any newly available, relevant safety data. Considering this information, as well as the information provided in the original safety assessment and the prior re-review document, the Panel reaffirmed the 1985 conclusion., Competing Interests: Declaration of Conflicting InterestThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Published
2024
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29. Safety Assessment of Alkanoyl Lactyl Lactate Salts as Used in Cosmetics.

Author

Johnson W Jr, Bergfeld WF, Belsito DV, Hill RA, Klaassen CD, Liebler DC, Marks JG Jr, Shank RC, Slaga TJ, Snyder PW, Fiume M, and Heldreth B

Subjects
Humans, Animals, Risk Assessment, Lactates toxicity, Lactates chemistry, Toxicity Tests, Surface-Active Agents toxicity, Surface-Active Agents chemistry, Surface-Active Agents pharmacokinetics, Cosmetics toxicity, Cosmetics chemistry, Consumer Product Safety
Abstract

The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of 10 alkanoyl lactyl lactate salts. These ingredients have the surfactant function in cosmetics in common. The Panel reviewed data relevant to the safety of these ingredients, and concluded that these 10 ingredients are safe in cosmetics in the present practices of use and concentration described in the safety assessment when formulated to be nonirritating and nonsensitizing, which may be based on a quantitative risk assessment (QRA) or other accepted methodologies., Competing Interests: Declaration of Conflicting InterestThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Published
2024
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30. Safety Assessment of Vinylpyrrolidone Polymers as Used in Cosmetics.

Author

Johnson W Jr, Bergfeld WF, Belsito DV, Hill RA, Klaassen CD, Liebler DC, Marks JG Jr, Shank RC, Slaga TJ, Snyder PW, Fiume M, and Heldreth B

Subjects
Humans, Animals, Toxicity Tests, Risk Assessment, Cosmetics toxicity, Cosmetics chemistry, Consumer Product Safety, Polymers toxicity, Polymers chemistry, Pyrrolidinones toxicity, Pyrrolidinones chemistry, Pyrrolidinones pharmacokinetics
Abstract

The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of 30 vinylpyrrolidone polymers as used in cosmetic products; most of these ingredients have the reported cosmetic function of film former in common. The Panel reviewed data relevant to the safety of these ingredients, and determined that 27 vinylpyrrolidone polymers are safe in cosmetics in the present practices of use and concentration described in the safety assessment. The Panel also concluded that the available data are insufficient to make a determination that 3 vinylpyrrolidone polymers (all urethanes) are safe under the intended conditions of use in cosmetic formulations., Competing Interests: Declaration of Conflicting InterestThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Published
2024
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31. Safety Assessment of Hydrogen Peroxide as Used in Cosmetics.

Author

Becker LC, Cherian PA, Bergfeld WF, Belsito DV, Hill RA, Klaassen CD, Liebler DC, Marks JG Jr, Shank RC, Slaga TJ, Snyder PW, Fiume M, and Heldreth B

Subjects
Humans, Animals, Risk Assessment, Toxicity Tests, Oxidants toxicity, Hydrogen Peroxide toxicity, Cosmetics toxicity, Cosmetics chemistry, Consumer Product Safety
Abstract

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., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Published
2024
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32. Safety Assessment of Polysilicone-11 as Used in Cosmetics.

Author

Cherian P, Bergfeld WF, Belsito DV, Cohen DE, Klaassen CD, Liebler DC, Marks JG, Peterson LA, Shank RC, Slaga TJ, Snyder PW, Fiume M, and Heldreth B

Subjects
Humans, Animals, Risk Assessment, Toxicity Tests, Silicones toxicity, Silicones chemistry, Cosmetics toxicity, Cosmetics chemistry, Consumer Product Safety
Abstract

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., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Published
2024
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33. Safety Assessment of Palm-Derived Ingredients as Used in Cosmetics.

Author

Johnson W Jr, Bergfeld WF, Belsito DV, Klaassen CD, Liebler DC, Marks JG Jr, Peterson LA, Shank RC, Slaga TJ, Snyder PW, Fiume M, and Heldreth B

Subjects
Humans, Animals, Euterpe chemistry, Euterpe toxicity, Toxicity Tests, Risk Assessment, Cosmetics toxicity, Cosmetics chemistry, Consumer Product Safety
Abstract

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., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Published
2024
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34. Safety Assessment of Basic Red 76 as Used in Cosmetics.

Author

Cherian P, Bergfeld WF, Belsito DV, Hill RA, Klaassen CD, Liebler DC, Marks JG Jr, Shank RC, Slaga TJ, Snyder PW, Fiume M, and Heldreth B

Subjects
Animals, Humans, Rats, Risk Assessment, Toxicity Tests, Consumer Product Safety, Cosmetics toxicity, Cosmetics chemistry, Hair Dyes toxicity, Hair Dyes chemistry, Hair Dyes pharmacokinetics
Abstract

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., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Published
2024
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35. Safety Assessment of Hydroxyethyl Urea as Used in Cosmetics.

Author

Akinsulie A, Bergfeld WF, Belsito DV, Hill RA, Klaassen CD, Liebler DC, Marks JG Jr, Shank RC, Slaga TJ, Snyder PW, Fiume M, and Heldreth B

Subjects
Animals, Humans, Risk Assessment, Toxicity Tests, Consumer Product Safety, Cosmetics toxicity, Cosmetics chemistry, Cosmetics pharmacokinetics, Urea analogs & derivatives, Urea toxicity
Abstract

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., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Published
2024
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36. Zinc Phenolsulfonate.

Author

Tucker R, Bergfeld WF, Belsito DV, Cohen DE, Klaassen CD, Rettie A, Ross D, Slaga TJ, Snyder PW, Tilton S, Fiume M, and Heldreth B

Subjects
Animals, Humans, Consumer Product Safety, Organometallic Compounds toxicity, Risk Assessment, Toxicity Tests, Cosmetics toxicity, Cosmetics chemistry, Zinc chemistry, Zinc toxicity, Sulfates chemistry, Sulfates toxicity, Phenols chemistry, Phenols toxicity
Abstract

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., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Published
2024
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37. Safety Assessment of Capryloyl Salicylic Acid as Used in Cosmetics.

Author

Johnson W Jr, Bergfeld WF, Belsito DV, Klaassen CD, Liebler DC, Marks JG Jr, Peterson LA, Shank RC, Slaga TJ, Snyder PW, Fiume M, and Heldreth B

Subjects
Animals, Humans, Risk Assessment, Salicylic Acid toxicity, Salicylic Acid pharmacokinetics, Salicylic Acid chemistry, Toxicity Tests, Consumer Product Safety, Cosmetics toxicity, Cosmetics chemistry, Salicylates toxicity, Salicylates pharmacokinetics
Abstract

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., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Published
2024
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38. Laneth Acetates.

Author

Cherian P, Bergfeld WF, Belsito DV, Cohen DE, Klaassen CD, Rettie A, Ross D, Slaga TJ, Snyder PW, Tilton S, Fiume M, and Heldreth B

Subjects
Animals, Humans, Consumer Product Safety, Acetates toxicity, Acetates pharmacokinetics, Cosmetics toxicity
Abstract

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., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Published
2024
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39. Safety Assessment of Triphenyl Phosphate as Used in Cosmetics.

Author

Burnett CL, Bergfeld WF, Belsito DV, Hill RA, Klaassen CD, Liebler DC, Marks JG Jr, Shank RC, Slaga TJ, Snyder PW, Fiume M, and Heldreth B

Abstract

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of Triphenyl Phosphate, which is reported to function as a plasticizer in manicuring products. The Panel reviewed the available data to determine the safety of this ingredient. The Panel concluded that Triphenyl Phosphate is safe in cosmetics in the present practices of use and concentration described in this safety assessment., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Published
2024
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40. Isobutane, Isopentane, Butane, and Propane.

Author

Tucker R, Bergfeld WF, Belsito DV, Cohen DE, Klaassen CD, Rettie AE, Ross D, Slaga TJ, Snyder PW, Tilton S, Fiume M, and Heldreth B

Abstract

The Expert Panel for Cosmetic Ingredient Safety (Panel) first published the Final Report of the safety of Isobutane, Isopentane, Butane, and Propane in 1982. The Panel previously concluded that these ingredients are considered safe as cosmetic ingredients under the present conditions of concentration and use, as described in that safety assessment. Upon re-review in 2002, the Panel reaffirmed the original conclusion, as published in 2005. The Panel reviewed update frequency and concentration of use data again in 2023, in addition to newly available, relevant safety data. Considering this information, as well as the information provided in the original safety assessment and the prior re-review document, the Panel reaffirmed the 1982 conclusion for Isobutane, Isopentane, Butane, and Propane., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Published
2024
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41. The Canadian VirusSeq Data Portal & Duotang: open resources for SARS-CoV-2 viral sequences and genomic epidemiology.

Author

Gill EE, Jia B, Murall CL, Poujol R, Anwar MZ, John NS, Richardsson J, Hobb A, Olabode AS, Lepsa A, Duggan AT, Tyler AD, N'Guessan A, Kachru A, Chan B, Yoshida C, Yung CK, Bujold D, Andric D, Su E, Griffiths EJ, Van Domselaar G, Jolly GW, Ward HKE, Feher H, Baker J, Simpson JT, Uddin J, Ragoussis J, Eubank J, Fritz JH, Gálvez JH, Fang K, Cullion K, Rivera L, Xiang L, Croxen MA, Shiell M, Prystajecky N, Quirion PO, Bajari R, Rich S, Mubareka S, Moreira S, Cain S, Sutcliffe SG, Kraemer SA, Joly Y, Alturmessov Y, Consortium C, Consortium C, Fiume M, Snutch TP, Bell C, Lopez-Correa C, Hussin JG, Joy JB, Colijn C, Gordon PMK, Hsiao WWL, Poon AFY, Knox NC, Courtot M, Stein L, Otto SP, Bourque G, Shapiro BJ, and Brinkman FSL

Abstract

The COVID-19 pandemic led to a large global effort to sequence SARS-CoV-2 genomes from patient samples to track viral evolution and inform public health response. Millions of SARS-CoV-2 genome sequences have been deposited in global public repositories. The Canadian COVID-19 Genomics Network (CanCOGeN - VirusSeq), a consortium tasked with coordinating expanded sequencing of SARS-CoV-2 genomes across Canada early in the pandemic, created the Canadian VirusSeq Data Portal, with associated data pipelines and procedures, to support these efforts. The goal of VirusSeq was to allow open access to Canadian SARS-CoV-2 genomic sequences and enhanced, standardized contextual data that were unavailable in other repositories and that meet FAIR standards (Findable, Accessible, Interoperable and Reusable). In addition, the Portal data submission pipeline contains data quality checking procedures and appropriate acknowledgement of data generators that encourages collaboration. From inception to execution, the portal was developed with a conscientious focus on strong data governance principles and practices. Extensive efforts ensured a commitment to Canadian privacy laws, data security standards, and organizational processes. This Portal has been coupled with other resources like Viral AI and was further leveraged by the Coronavirus Variants Rapid Response Network (CoVaRR-Net) to produce a suite of continually updated analytical tools and notebooks. Here we highlight this Portal, including its contextual data not available elsewhere, and the 'Duotang', a web platform that presents key genomic epidemiology and modeling analyses on circulating and emerging SARS-CoV-2 variants in Canada. Duotang presents dynamic changes in variant composition of SARS-CoV-2 in Canada and by province, estimates variant growth, and displays complementary interactive visualizations, with a text overview of the current situation. The VirusSeq Data Portal and Duotang resources, alongside additional analyses and resources computed from the Portal (COVID-MVP, CoVizu), are all open-source and freely available. Together, they provide an updated picture of SARS-CoV-2 evolution to spur scientific discussions, inform public discourse, and support communication with and within public health authorities. They also serve as a framework for other jurisdictions interested in open, collaborative sequence data sharing and analyses., Competing Interests: J.T.S. receives research funding from Oxford Nanopore Technologies (ONT) and has received travel support to attend and speak at meetings organized by ONT, and is on the Scientific Advisory Board of Day Zero Diagnostics.

Published
2024

42. Safety Assessment of Alkane Diols as Used in Cosmetics.

Author

Scott LN, Fiume M, Bergfeld WF, Belsito DV, Hill RA, Klaassen CD, Liebler DC, Marks JG Jr, Shank RC, Slaga TJ, Snyder PW, and Heldreth B

Subjects
Alcohols, Solvents, Risk Assessment, Consumer Product Safety, Cosmetics toxicity
Abstract

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., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: The articles in this supplement were sponsored by the Cosmetic Ingredient Review.

Published
2024
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43. Safety Assessment of Zinc Salts as Used in Cosmetics.

Author

Scott LN, Fiume M, Zhu J, Bergfeld WF, Belsito DV, Hill RA, Klaassen CD, Liebler DC, Marks JG Jr, Shank RC, Slaga TJ, Snyder PW, and Heldreth B

Subjects
Salts, Consumer Product Safety, Chelating Agents toxicity, Risk Assessment, Cosmetics toxicity, Dermatologic Agents
Abstract

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., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: The articles in this supplement were sponsored by the Cosmetic Ingredient Review.

Published
2024
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44. Long-term results and quality of life after stapled hemorrhoidopexy vs Doppler-guided HAL-RAR: a propensity score matching analysis.

Author

Lauricella S, Palmisano D, Brucchi F, Agoglitta D, Fiume M, Bottero L, and Faillace G

Subjects
Humans, Cohort Studies, Propensity Score, Pain, Postoperative etiology, Quality of Life, Hemorrhoids diagnostic imaging, Hemorrhoids surgery
Abstract

Aim: The study aimed to evaluate and compare the short and long-term outcomes of doppler-guided (DG) hemorrhoidal artery ligation and rectoanal repair (HAL-RAR) using a wireless-doppler-guided probe and stapled hemorrhoidopexy (SH) for treatment of II-III hemorrhoids., Methods: This cohort study included patients who underwent HAL-RAR (n = 89) or SH (n = 174) for grade II-III hemorrhoids between January 2020 and December 2021. After propensity score matching at a 1:1 ratio, 76 patients for each group were analyzed. Short and long-term outcomes were collected. Pain was measured using a Visual Analogue Scale (VAS) at POD1, POD 10, 1 month, and 6 months after surgery. The enrolled patients completed the Hemorrhoidal Disease Symptom Score and Short Health ScaleHD quality of life (HDSS/SHS QoL) questionnaire preoperatively and during a regular follow-up visit at 24 months after surgery., Results: Groups exhibited comparable overall postoperative complication rates (23% HAL-RAR/ 21% SH; p = 0.295). Postoperative pain via VAS showed median scores of 4, 3, 1, 1 for HAL-RAR and 6, 4, 2, 1 for SH at POD1, POD10, 1 month, and 6 months, respectively (p =  < 0.001, 0.004, 0.025, 0.019). At a median follow-up of 12 months, the recurrence rate was 10.5% in the HAL-RAR group and 9.2% in the SH group (p = 0.785), respectively. At 24 months, 15.7% of HAL-RAR patients and 19.7% of SH patients remained symptomatic (p = 0.223). Median post-op QoL index was 1 (HAL-RAR) and 0.92 (SH), p = 0.036., Conclusions: HAL-RAR is a safe and feasible technique in treating grade II-III hemorrhoids showing better outcomes in terms of postoperative pain and QoL., Significance: This paper adds a new perspective in comparing the HAL-RAR and SH, focusing the attention on the patients and not surgical techniques. A long and difficult follow-up was completed to fully understand the long-term results and the impact on the QoL of the patients who underwent these procedures., (© 2024. The Author(s).)

Published
2024
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45. Safety Assessment of Soy-Derived Ingredients as Used in Cosmetics.

Author

Cherian P, Bergfeld WF, Belsito DV, Klaassen CD, Liebler DC, Marks JG Jr, Peterson LA, Shank RC, Slaga TJ, Snyder PW, Fiume M, and Heldreth B

Abstract

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., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: The articles in this supplement were sponsored by the Cosmetic Ingredient Review.

Published
2024
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46. Safety Assessment of Alkyl Sultaines as Used in Cosmetics.

Author

Burnett CL, Bergfeld WF, Belsito DV, Hill RA, Klaassen CD, Liebler DC, Marks JG Jr, Shank RC, Slaga TJ, Snyder PW, Fiume M, and Heldreth B

Subjects
Skin, Surface-Active Agents, Risk Assessment, Consumer Product Safety, Cosmetics toxicity
Abstract

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., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: The articles in this supplement were sponsored by the Cosmetic Ingredient Review.

Published
2024
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47. Safety Assessment of Butyrospermum parkii (Shea)-Derived Ingredients as Used in Cosmetics.

Author

Burnett CL, Bergfeld WF, Belsito DV, Hill RA, Klaassen CD, Liebler DC, Marks JG Jr, Shank RC, Slaga TJ, Snyder PW, Fiume M, and Heldreth B

Subjects
Consumer Product Safety, Cosmetics toxicity
Abstract

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., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: The articles in this supplement were sponsored by the Cosmetic Ingredient Review.

Published
2024
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48. Safety Assessment of Hops as Used in Cosmetics.

Author

Becker L, Boyer I, Bergfeld WF, Belsito DV, Hill RA, Klaassen CD, Liebler DC, Marks JG Jr, Shank RC, Slaga TJ, Snyder PW, Fiume M, and Heldreth B

Subjects
Consumer Product Safety, Plant Extracts toxicity, Humulus, Biological Products, Cosmetics toxicity
Abstract

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, β-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., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: The articles in this supplement were sponsored by the Cosmetic Ingredient Review.

Published
2024
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49. Safety Assessment of Ginkgo biloba -Derived Ingredients as Used in Cosmetics.

Author

Burnett CL, Bergfeld WF, Belsito DV, Hill RA, Klaassen CD, Liebler DC, Marks JG, Shank RC, Slaga TJ, Snyder PW, Fiume M, and Heldreth B

Subjects
Consumer Product Safety, Plant Extracts toxicity, Antioxidants, Ginkgo biloba toxicity, Cosmetics toxicity
Abstract

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., Competing Interests: Declaration of conflicting interestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Cosmetic Ingredient Review.

Published
2024
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50. Safety Assessment of Adenosine as Used in Cosmetics.

Author

Cherian P, Bergfeld WF, Belsito DV, Hill RA, Klaassen CD, Liebler DC, Marks JG Jr, Shank RC, Slaga TJ, Snyder PW, Fiume M, and Heldreth B

Subjects
Consumer Product Safety, Adenosine Triphosphate, Risk Assessment, Adenosine toxicity, Cosmetics toxicity
Abstract

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., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: The articles in this supplement were sponsored by the Cosmetic Ingredient Review.

Published
2024
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