Document Detail


The FEMA GRAS assessment of aromatic substituted secondary alcohols, ketones, and related esters used as flavor ingredients.
MedLine Citation:
PMID:  17046133     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
This publication is the 11th in a series of safety evaluations performed by the Expert Panel of the Flavor and Extract Manufacturers Association (FEMA). In 1993, the Panel initiated a comprehensive program to re-evaluate the safety of more than 1700 GRAS flavoring substances under conditions of intended use. The list of GRAS substances has now grown to more than 2100 substances. Elements that are fundamental to the safety evaluation of flavor ingredients include exposure, structural analogy, metabolism, pharmacokinetics and toxicology. Flavor ingredients are evaluated individually and in the context of the available scientific information on the group of structurally related substances. In this monograph, a detailed interpretation is presented on the renal carcinogenic potential of the aromatic secondary alcohol alpha-methylbenzyl alcohol, aromatic ketone benzophenone, and corresponding alcohol benzhydrol. The relevance of these effects to the flavor use of these substances is also discussed. The group of aromatic substituted secondary alcohols, ketones, and related esters was reaffirmed as GRAS (GRASr) based, in part, on their rapid absorption, metabolic detoxication, and excretion in humans and other animals; their low level of flavor use; the wide margins of safety between the conservative estimates of intake and the no-observed-adverse effect levels determined from subchronic and chronic studies and the lack of significant genotoxic and mutagenic potential.
Authors:
T B Adams; M M McGowen; M C Williams; S M Cohen; V J Feron; J I Goodman; L J Marnett; I C Munro; P S Portoghese; R L Smith; W J Waddell
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Publication Detail:
Type:  Journal Article; Review     Date:  2006-08-30
Journal Detail:
Title:  Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association     Volume:  45     ISSN:  0278-6915     ISO Abbreviation:  Food Chem. Toxicol.     Publication Date:  2007 Feb 
Date Detail:
Created Date:  2006-12-12     Completed Date:  2007-03-05     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8207483     Medline TA:  Food Chem Toxicol     Country:  England    
Other Details:
Languages:  eng     Pagination:  171-201     Citation Subset:  IM    
Affiliation:
Flavor and Extract Manufacturers Association, 1620 I Street, NW, Suite 925, Washington, DC 20006, USA. tadams@therobertsgroup.net
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MeSH Terms
Descriptor/Qualifier:
Alcohols / pharmacokinetics,  standards,  toxicity*
Animals
Benzophenones / pharmacokinetics,  standards,  toxicity
Consumer Product Safety*
Esters
Flavoring Agents / pharmacokinetics,  standards,  toxicity*
Food Industry / standards*
Humans
Ketones / pharmacokinetics,  standards,  toxicity*
No-Observed-Adverse-Effect Level
Phenylethyl Alcohol / analogs & derivatives,  pharmacokinetics,  standards,  toxicity
Toxicity Tests
United States
United States Food and Drug Administration
Chemical
Reg. No./Substance:
0/1-phenyl-2-propanol; 0/Alcohols; 0/Benzophenones; 0/Esters; 0/Flavoring Agents; 0/Ketones; 60-12-8/Phenylethyl Alcohol

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