scholarly journals The Safety Assessment of Food Additives by Reproductive and Developmental Toxicity Studies

Food Additive ◽  
10.5772/30787 ◽  
2012 ◽  
Author(s):  
Cansn Gngrm ◽  
Aysun Kl
Keyword(s):  
Safety Assessment ◽  
Developmental Toxicity ◽  
Food Additives ◽  
Toxicity Studies

Use of Pharmacokinetic Data Under the FDA's Redbook II Guidelines for Direct Food Additives

1998 ◽  
Vol 17 (3) ◽  
pp. 355-381 ◽  
Author(s):  
William L. Roth ◽  
John F. Young
Keyword(s):  
Developmental Toxicity ◽  
Food Additives ◽  
Kinetic Studies ◽  
Food Additive ◽  
Whole Body ◽  
Pharmacokinetic Data ◽  
Tissue Slices ◽  
Toxicity Studies ◽  
Guide Lines

Experience with food additive petitions submited after publication of the Food and Drug Administration's Redbook I (U. S. FDA, 1982) guide lines indicated a number of areas in which improvements were needed, and advances in toxicol-ogy testing during the last decade required additional rev is ions. In March 1993, the FDA's Center for Food Safety and Applied Nutrition (CFSAN) distributed copies of a draft of Redbook II for public comment. Since that time, revisions have been made based on comments received on the initial draft. This article describes the rationale for Redbook II guidance on the design of pharm acoki-netic studies and discusses some common problems the FDA has encountered in reviewing pharmacokine tic data submitted as part of food additive petitions. Points emphasized are that (1) pharmaco kinetic information is needed for the interpretation of toxicity studies and is most use ful when conducted before major toxicity studies, (2) the use of whole-body autoradiography is encouraged as a means to select tissues of interest, and as a substitute for dissection and tis-sue sampling, (3) kinetic and mechanistic studies conducted with blood compo-nents, tissue slices, hepatocytes, and othercell types in vitro ofien provide more useful information on the fate of chemicals in specific tissues than information extracted from whole-animal studies. The intention of th e new guide lines for pharmaco kinetic studies is to increase the information content of data gathered and to encourage the use of pharmaco kinetic models and results in the selection of doses for subchronic, chronic, and developmental toxicity studies.

scholarly journals REPRODUCTIVE AND DEVELOPMENTAL TOXICITY STUDIES OF PRULIFLOXACIN (NM441) (4) : A Perinatal and Postnatal Study in Rats by Oral Administration

1996 ◽  
Vol 21 (SupplementI) ◽  
pp. 219-230 ◽  
Author(s):  
Tagahiko MORINAGA ◽  
Shigenobu FUJII ◽  
Shigenori FURUKAWA ◽  
Mikito KIKUMORI ◽  
Kimio YASUHIRA ◽  
...  
Keyword(s):  
Oral Administration ◽  
Developmental Toxicity ◽  
Toxicity Studies

Historical control data on developmental toxicity studies in rodents

2014 ◽  
Vol 54 (3) ◽  
pp. 150-161 ◽  
Author(s):  
Makoto Ema ◽  
Katsumi Endoh ◽  
Ryou Fukushima ◽  
Sakiko Fujii ◽  
Hiroaki Hara ◽  
...  
Keyword(s):  
Developmental Toxicity ◽  
Historical Control ◽  
Control Data ◽  
Toxicity Studies ◽  
Historical Control Data

scholarly journals Developmental Toxicity Studies with Atrazine and its Major Metabolites in Rats and Rabbits

2014 ◽  
Vol 101 (3) ◽  
pp. 199-214 ◽  
Author(s):  
Anthony R. Scialli ◽  
John M. DeSesso ◽  
Charles B. Breckenridge
Keyword(s):  
Developmental Toxicity ◽  
Toxicity Studies

scholarly journals Dietary Route of Exposure for Rabbit Developmental Toxicity Studies

2016 ◽  
Vol 154 (1) ◽  
pp. 90-100
Author(s):  
Bethany R. Hannas ◽  
Robert G. Ellis-Hutchings ◽  
Valerie A. Marshall ◽  
Claire Terry ◽  
Alene A. McCoy ◽  
...  
Keyword(s):  
Developmental Toxicity ◽  
Toxicity Studies ◽  
Route Of Exposure

A science driven framework for the safety assessment of technologically justified food additives during early life

2016 ◽  
Vol 259 ◽  
pp. S230
Author(s):  
B. Mahadevan ◽  
J.A. Garthoff ◽  
L. Meunier ◽  
C.L. Bradley ◽  
J.D. Richards ◽  
...  
Keyword(s):  
Early Life ◽  
Safety Assessment ◽  
Food Additives

Safety assessment of widely used fermented virgin coconut oil (Cocos nucifera) in Malaysia: Chronic toxicity studies and SAR analysis of the active components

2016 ◽  
Vol 81 ◽  
pp. 457-467 ◽  
Author(s):  
Ahmad H. Ibrahim ◽  
Md Shamsuddin Sultan Khan ◽  
Sawsan S. Al-Rawi ◽  
Mohamed B. Khadeer Ahamed ◽  
Aman Shah Bin Abdul Majid ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Chronic Toxicity ◽  
Cocos Nucifera ◽  
Coconut Oil ◽  
Virgin Coconut Oil ◽  
Active Components ◽  
Toxicity Studies ◽  
Sar Analysis
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