کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
5857656 | 1132019 | 2013 | 14 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Calcium lignosulphonate: Re-evaluation of relevant endpoints to re-confirm validity and NOAEL of a 90-day feeding study in rats
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کلمات کلیدی
NTPEFSApathology working groupSRBCPWGNOAELTDARNasal associated lymphoid tissueBALTH&E - H & ENALT - NaltëSTP - PTSEuropean Food Safety Authority - اداره ایمنی اروپاNational Toxicology Program - برنامه سم شناسی ملیLignosulphonate - لیگنوسولفوناتHematoxylin & Eosin - هماتوکسیلین و ائوزینHistiocytosis - هیوستسیتوزNo observed adverse effect level - هیچ عوارض جانبی مشاهده نشدهSheep Red Blood Cell - گوسفند سلول های قرمز خون
موضوعات مرتبط
علوم زیستی و بیوفناوری
علوم محیط زیست
بهداشت، سم شناسی و جهش زایی
پیش نمایش صفحه اول مقاله
چکیده انگلیسی
A 90-day feeding study in Han/Wistar rats with calcium lignosulphonate was evaluated by the EFSA. The study was considered to be inadequate due to potentially impaired health status of the animals based upon a high incidence of minimal lymphoid hyperplasia in mesenteric/mandibular lymph nodes and Peyer's patches, and minimal lymphoid cell infiltration in the liver in all animals. The EFSA Panel further disagreed with the conclusion that the treatment-related observation of foamy histiocytosis in mesenteric lymph nodes was non-adverse and asked whether this observation would progress to something more adverse over time. A PWG was convened to assess the sections of lymph nodes, Peyer's patches and liver. In addition, all lymphoid tissues were re-examined. The clinical pathology and animal colony health screening data were re-evaluated. The question whether the foamy histiocytosis could progress to an adverse finding with increasing exposure duration was addressed by read-across. In conclusion, the animals on the 90-day feeding study were in good health, the study was adequate for safety evaluation, and the foamy histiocytes in the mesenteric lymph nodes were not considered adverse, but rather an adaptive response that was considered unlikely to progress to an adverse condition with time. The NOAEL was re-affirmed to be 2000 mg/kg bw/d.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Regulatory Toxicology and Pharmacology - Volume 66, Issue 3, August 2013, Pages 286-299
Journal: Regulatory Toxicology and Pharmacology - Volume 66, Issue 3, August 2013, Pages 286-299
نویسندگان
Anette Thiel, William Braun, Maurice G. Cary, Jeffery A. Engelhardt, Dawn G. Goodman, William C. Hall, Annette Romeike, Jerrold M. Ward,