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  • 1.
    The "refereed" or "peer review" status of a journal comes from the Ulrichsweb Global Serials Directory (http://ulrichsweb.serialssolutions.com/), as supplied by the publisher. The term refers to the system of critical evaluation of manuscripts/articles by professional colleagues or peers. The content of refereed publications is sanctioned, vetted, or otherwise approved by a peer-review or editorial board. The peer-review and evaluation system is utilized to protect, maintain, and raise the quality of scholarly material published in serials. Publications subject to the referee process are assumed, then, to contain higher quality content than those that are not.
    Peer
    Reviewed
    Journal
    Article
    Opinion on a request from the European Commission related to the 2nd ERF carcinogenicity study on aspartame
    Aguilar, F; Charrondiere, UR; Dusemund, B; Galtier, P; Gilbert, J; Gott, DM; Grilli, S; Guertler, R; Kass, GEN; Koenig, J; Lambré, C; Larsen, JC; Leblanc, JC; Mortensen, A; Parent-Massin, D; Pratt, I; Rietjens, IMCM; Stankovic, I; Tobback, P; Verguieva, T; Woutersen, R (2009)
    Minus Sign. Click to see only selected choices. Following a request from the European Commission, the Panel on Food Additives and Nutrient Sources added . . . Plus Sign. Click to expand choices. Following a request from the European Commission, the Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a scientific opinion on the results of a long-term carcinogenicity study with prenatal exposure to the artificial sweetener aspartame, performed by The Cesare Maltoni Cancer Research Center of the European Ramazzini Foundation (ERF) and published in June 2007 by Soffritti et al. The authors concluded that the results of their study not only confirm, but also reinforce their first experimental demonstration (published in 2005 and 2006) of aspartame’s multipotential carcinogenicity at a dose level close to the human Acceptable Daily Intake (ADI). Based on the results of this study, the authors further postulated that when lifespan exposure to aspartame begins during fetal life, its carcinogenic effects are increased. During the 1980s, aspartame has been authorised for use in foods and as a table-top sweetener by several Member States, and European legislation harmonising its use in foodstuffs was introduced in 1994 following thorough safety evaluations by the Scientific Committee on Food (SCF) in 1984 and 1988. Further reviews of aspartame data were carried out by the SCF in 1997 and 2002. In 2006, the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC) assessed a long-term carcinogenicity study on aspartame performed by the ERF and published by Soffritti et al. in 2005 and 2006. Based on all the evidence available from the ERF study and other recent studies and previous evaluations, the AFC Panel concluded that there was no reason to revise the previously established ADI for aspartame of 40 mg/kg bw (EFSA, 2006). In the second ERF study on aspartame in rats, published in 2007, dietary concentrations of 400 and 2000 mg aspartame/kg diet equivalent to doses of 20 and 100 mg aspartame/kg bw/day were used. The rats were exposed to aspartame from the 12th day of gestation until natural death. The group size was 95/sex in the control and 70/sex in the low- and high-dose groups. The authors reported a significant dose-related increase of malignant tumour-bearing males, particularly in the high-dose group (p<0.01, Cox regression model), a significant increase in incidence of lymphomas/leukaemias in males from the high-dose group (p<0.05), a significant dose-related increase in incidence of lymphomas/leukaemias in females (p<0.01), particularly in the high-dose group (p<0.01), and a significant dose-related increase in incidence of mammary carcinomas in females (p<0.05), particularly in the high-dose group (p<0.05). The Panel’s assessment of the ERF carcinogenicity study with prenatal exposure on aspartame as reported by Soffritti et al. was directed towards establishing the relevance of the reported findings to human health. In carrying out its assessment the Panel only had access to the published paper, in which the presentation of pathological findings was restricted to the incidence of malignant tumours, total number of malignant tumours per group, incidence of lymphomas/leukaemias, and incidence of mammary carcinomas. Neither further data from this study nor an explanation on the analytical method used, were provided by the authors to EFSA by the time of the adoption of this opinion. The Panel concluded that: Evaluation of aggregated malignant tumour incidences as evidence of carcinogenic potential of the test compound can only be performed based on a thorough consideration of all tumour data including onset, and data on non-neoplastic, hyperplastic and preneoplastic lesions but these data were not provided by the authors. In accordance with the previous view of the AFC Panel, the lymphomas and leukaemias might have developed in a population of rats suffering from chronic respiratory disease. The increase in incidence of mammary carcinoma is not considered indicative of a carcinogenic potential of aspartame since the incidence of mammary tumours in female rats is rather high and varies considerably between carcinogenicity studies. The Panel also noted that an increased incidence of mammary carcinomas was not reported in the previous ERF study with aspartame which used much higher doses of the compound. Overall, the Panel concluded, on the basis of all the evidence currently available from this ERF study and previous evaluations, that there is no indication of any genotoxic or carcinogenic potential of aspartame and that there is no reason to revise the previously established ADI for aspartame of 40 mg/kg bw.
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  • 2.
    The "refereed" or "peer review" status of a journal comes from the Ulrichsweb Global Serials Directory (http://ulrichsweb.serialssolutions.com/), as supplied by the publisher. The term refers to the system of critical evaluation of manuscripts/articles by professional colleagues or peers. The content of refereed publications is sanctioned, vetted, or otherwise approved by a peer-review or editorial board. The peer-review and evaluation system is utilized to protect, maintain, and raise the quality of scholarly material published in serials. Publications subject to the referee process are assumed, then, to contain higher quality content than those that are not.
    Peer
    Reviewed
    Journal
    Article
    Evaluation of ethanol-fixed, paraffin-embedded tissues for proteomic applications
    Ahram, M; Flaig, MJ; Gillespie, JW; Duray, PH; Linehan, WM; Ornstein, DK; Niu, S; Zhao, Y; Petricoin, EF; Emmert-Buck, MR (2003) Proteomics 3:413-421.
    Minus Sign. Click to see only selected choices. We previously reported that ethanol fixation and paraffin embedding of tissues produce excellent histomorphology . . . Plus Sign. Click to expand choices. We previously reported that ethanol fixation and paraffin embedding of tissues produce excellent histomorphology and good preservation of macromolecules. Here, we present a detailed evaluation of ethanol-fixed tissues for proteomic initiatives. When proteins were extracted from ethanol-fixed, paraffin-embedded prostate tissue, resolved by two-dimensional gel electrophoresis (2-DE), and stained by standard methods, several hundred protein molecules could be detected and successfully analyzed by mass spectrometry. Protein profiles obtained from ethanol-fixed tissues were highly similar to those observed from frozen tissues, in contrast to the poor protein recovery from formalin-fixed material. The protein content of specific cells that were microdissected from ethanol-fixed tissue sections using laser capture microdissection could also be successfully analyzed by 2-DE. We observed that eosin staining of tissue sections had a detrimental effect on protein separation, whereas hematoxylin staining had minimal consequence. In order to illustrate the applicability of ethanol-fixed tissues for proteomic discovery studies, we compared the protein profiles of patient-matched, normal prostatic epithelial cells and invasive adenocarcinoma cells obtained from ethanol-fixed, paraffin-embedded tissues. A number of differentially expressed proteins was discovered and identified by mass spectrometry. Immunohistochemical analyses performed on ethanol-fixed tissue sections were in agreement with the proteomic discovery findings. In light of these results, we conclude that ethanol-fixed tissues can be successfully utilized for proteomic analyses.
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  • 3.
    Book/Book Chapter
    Book/Book
    Chapter
    Evaluation of toxicity and carcinogenicity of malonaldehyde: An experimental study in Swiss mice. Acta Universitatis Ouluensis, Series D, Medica 55
    Apaja, M (1980)
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  • 4.
    The "refereed" or "peer review" status of a journal comes from the Ulrichsweb Global Serials Directory (http://ulrichsweb.serialssolutions.com/), as supplied by the publisher. The term refers to the system of critical evaluation of manuscripts/articles by professional colleagues or peers. The content of refereed publications is sanctioned, vetted, or otherwise approved by a peer-review or editorial board. The peer-review and evaluation system is utilized to protect, maintain, and raise the quality of scholarly material published in serials. Publications subject to the referee process are assumed, then, to contain higher quality content than those that are not.
    Peer
    Reviewed
    Journal
    Article
    A review of human carcinogens--part F: Chemical agents and related occupations
    Baan, R; Grosse, Y; Straif, K; Secretan, B; El Ghissassi, F; Bouvard, V; Benbrahim-Tallaa, L; Guha, N; Freeman, C; Galichet, L; Cogliano, V (2009) Lancet Oncology 10:1143-1144.
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  • 5.
    The "refereed" or "peer review" status of a journal comes from the Ulrichsweb Global Serials Directory (http://ulrichsweb.serialssolutions.com/), as supplied by the publisher. The term refers to the system of critical evaluation of manuscripts/articles by professional colleagues or peers. The content of refereed publications is sanctioned, vetted, or otherwise approved by a peer-review or editorial board. The peer-review and evaluation system is utilized to protect, maintain, and raise the quality of scholarly material published in serials. Publications subject to the referee process are assumed, then, to contain higher quality content than those that are not.
    Peer
    Reviewed
    Journal
    Article
    Hypothesis-Based Weight-of-Evidence evaluation of methanol as a human carcinogen
    Bailey, LA; Prueitt, RL; Rhomberg, LR (2012) Regulatory Toxicology and Pharmacology 62:278-291.
    Minus Sign. Click to see only selected choices. Recent scientific debate has focused on the potential for exposure to methanol to cause lymphomas in . . . Plus Sign. Click to expand choices. Recent scientific debate has focused on the potential for exposure to methanol to cause lymphomas in humans. The concern stems from a few animal studies reporting an association, although evidence suggests the studies may have been confounded by chronic respiratory infection. Although the toxicological evidence for methanol carcinogenesis is weak, two modes of action have been put forth, one involving metabolism of methanol to formaldehyde, followed by formaldehyde induction of lymphoma, and another involving oxidative stress caused by hydrogen peroxide release during catalase-induced metabolism of methanol to formaldehyde. In this article, we apply our Hypothesis-Based Weight-of-Evidence (HBWoE) approach to evaluate the evidence regarding methanol exposure and lymphoma, attending to how human, animal, and mode-of-action results inform one another, tracing the logic of inference within and across all studies, and articulating how one could account for the suite of available observations. Upon comparison of alternative proposals regarding what causal processes may have led to the array of observations as we see them, we conclude that the apparent association between methanol exposure and lymphoma in some animal studies is weak and strains biological plausibility, and is better interpreted as due to confounding or to a mechanism not relevant in humans.
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  • 6.
    Technical Report
    Technical
    Report
    Final report on a chronic inhalation toxicology study in rats and mice exposed to formaldehyde to Chemical Industry Institute of Toxicology: Volume 1
    Battelle (1981) Columbus, OH: Chemical Industry Institute of Toxicology.
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    Details   
  • 7.
    The "refereed" or "peer review" status of a journal comes from the Ulrichsweb Global Serials Directory (http://ulrichsweb.serialssolutions.com/), as supplied by the publisher. The term refers to the system of critical evaluation of manuscripts/articles by professional colleagues or peers. The content of refereed publications is sanctioned, vetted, or otherwise approved by a peer-review or editorial board. The peer-review and evaluation system is utilized to protect, maintain, and raise the quality of scholarly material published in serials. Publications subject to the referee process are assumed, then, to contain higher quality content than those that are not.
    Peer
    Reviewed
    Journal
    Article
    Results of long-term experimental studies on the carcinogenicity of methyl tert-butyl ether
    Belpoggi, F; Soffritti, M; Filippini, F; Maltoni, C (1997) Annals of the New York Academy of Sciences 837:77-95.
    Minus Sign. Click to see only selected choices. Methyl-tert-butyl ether (MTBE) was submitted to long-term carcinogenicity bioassays on Sprague-Dawley . . . Plus Sign. Click to expand choices. Methyl-tert-butyl ether (MTBE) was submitted to long-term carcinogenicity bioassays on Sprague-Dawley rats. The test compound was delivered in olive oil by stomach tube (gavage), at the doses of 1000, 250, and 0 mg/kg b.w. to groups of 60 males and 60 females, once daily, 4 times weekly, for 104 weeks. All animals were kept under control until spontaneous death. MTBE was found to cause in males an increased incidence of Leydig cell testicular tumors in the group treated with the higher dose, and in females a dose-related increase of leukemias, an increase of dysplastic proliferations of lymphoreticular tissues, and also an increase of uterine sarcomas at the lower tested dose. On the basis of the presented data, MTBE must be considered a potential carcinogen.
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  • 8.
    The "refereed" or "peer review" status of a journal comes from the Ulrichsweb Global Serials Directory (http://ulrichsweb.serialssolutions.com/), as supplied by the publisher. The term refers to the system of critical evaluation of manuscripts/articles by professional colleagues or peers. The content of refereed publications is sanctioned, vetted, or otherwise approved by a peer-review or editorial board. The peer-review and evaluation system is utilized to protect, maintain, and raise the quality of scholarly material published in serials. Publications subject to the referee process are assumed, then, to contain higher quality content than those that are not.
    Peer
    Reviewed
    Journal
    Article
    Results of long-term experimental studies on the carcinogenicity of Ethylene-bis-Dithiocarbamate (Mancozeb) in rats
    Belpoggi, F; Soffritti, M; Guarino, M; Lambertini, L; Cevolani, D; Maltoni, C (2002) Annals of the New York Academy of Sciences 982:123-136.
    Minus Sign. Click to see only selected choices. Mancozeb, an ethylene-bis-dithiocarbamate (EBDC), has been one of the most commonly used fungicides . . . Plus Sign. Click to expand choices. Mancozeb, an ethylene-bis-dithiocarbamate (EBDC), has been one of the most commonly used fungicides in commercial use for several decades. Nevertheless, up to now, no adequate published experimental studies on the carcinogenicity of Mancozeb have been published. Because of the importance of the compound and of the number of people potentially exposed (workers engaged in the production and use of the fungicide, people living in agricultural areas where the compound is sprayed, and people consuming polluted products), a long-term experimental study of Mancozeb was begun at the Cancer Research Center of the Ramazzini Foundation. Groups of 150 male and female Sprague-Dawley rats, 8 weeks old at the start of the treatment, were administered Mancozeb at the concentration of 1000, 500, 100, 10, and 0 ppm in feed supplied ad libitum for 104 weeks. At the end of the treatment, animals were kept under controlled conditions until spontaneous death. Mancozeb caused an increase in (1) total malignant tumors, (2) malignant mammary tumors, (3) Zymbal gland and ear duct carcinomas, (4) hepatocarcinomas, (5) malignant tumors of the pancreas, (6) malignant tumors of the thyroid gland, (7) osteosarcomas of the bones of the head, and (8) hemolymphoreticular neoplasias. On the basis of these data, Mancozeb must be considered a multipotent carcinogenic agent.
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  • 9.
    The "refereed" or "peer review" status of a journal comes from the Ulrichsweb Global Serials Directory (http://ulrichsweb.serialssolutions.com/), as supplied by the publisher. The term refers to the system of critical evaluation of manuscripts/articles by professional colleagues or peers. The content of refereed publications is sanctioned, vetted, or otherwise approved by a peer-review or editorial board. The peer-review and evaluation system is utilized to protect, maintain, and raise the quality of scholarly material published in serials. Publications subject to the referee process are assumed, then, to contain higher quality content than those that are not.
    Peer
    Reviewed
    Journal
    Article
    Immunoblastic lymphomas in Sprague-Dawley rats following exposure to the gasoline oxygenated additives Methyl-Tertiary-Butyl Ether (MTBE) and Ethyl-Tertiary-Butyl Ether (ETBE): early observations on their natural history
    Belpoggi, F; Soffritti, M; Maltoni, C (1999) European Journal of Oncology 4:563-572.
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  • 10.
    The "refereed" or "peer review" status of a journal comes from the Ulrichsweb Global Serials Directory (http://ulrichsweb.serialssolutions.com/), as supplied by the publisher. The term refers to the system of critical evaluation of manuscripts/articles by professional colleagues or peers. The content of refereed publications is sanctioned, vetted, or otherwise approved by a peer-review or editorial board. The peer-review and evaluation system is utilized to protect, maintain, and raise the quality of scholarly material published in serials. Publications subject to the referee process are assumed, then, to contain higher quality content than those that are not.
    Peer
    Reviewed
    Journal
    Article
    Pathological characterization of testicular tumours and lymphomas-leukaemias, and of their precursors observed in Sprague-Dawley rats exposed to methy-tertiary-butyl-ether (MTBE)
    Belpoggi, F; Soffritti, M; Maltoni C (1998) European Journal of Oncology 3:201-206.
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