Nominations in Review 2003

http://ntp.niehs.nih.gov/go/197

Substances Recommended for Study:

Acrylamide and Glycidamide
Antimony trisulfide
Cadmium telluride
Cedarwood oil, Virginia
Chondroitin sulfate
Dimethylethanolamine
Drugs positive for QT Interval Prolongation/Induction of Torsade Proarrhythmia
Glucosamine
Nanoscale materials
trans-Resveratrol
Tetrabromobisphenol A
Tetrabromobisphenol A bis(2,3-dibromopropyl ether)
Tungsten

Substances for Which No Study is Recommended at this Time:

4-Phenylcyclohexene

Chemicals studied by the NTP are selected mainly on the basis of human exposure, production levels, chemical structure, and available toxicological data. Selection of an agent for a study does not imply that the agent is hazardous or a potential carcinogen in laboratory animals; likewise, an agent not selected for toxicologic study by the Program should not be taken to mean that the agent is not potentially hazardous or potentially carcinogenic in laboratory rodents. Substances are identified by a common or generic name and CAS Registry No. where appropriate.

For information, questions or comments, contact:
Dr. Scott A. Masten
Office of Chemical Nomination and Selection
Environmental Toxicology Program
National Institute of Environmental Health Sciences

P.O. Box 12233, MD A3-07
111 T.W. Alexander Drive
Research Triangle Park, NC
(919) 541-5710 (voice)
(919) 541-3647 (fax)

[ Send Email ]

Acrylamide and Glycidamide
Substance [CAS No.]	Nominated by	Nominated for	Rationale for Nomination	ICCEC Recommendations
Acrylamide and Glycidamide (additional information) [79-06-1],[5694-00-8]	U.S Food and Drug Administration	Toxicological characterization including toxicokinetic, mechanistic, and carcinogenicity studies	Inadequate information available to accurately assess human health risks from exposure to acrylamide in foodstuffs; a properly designed well-conducted, GLP-compliant bioassay with appropriate ancillary studies is needed to provide dose response information and account for the food matrix through which humans are exposed	Toxicological studies: Toxicological characterization Toxicokinetics Mechanistic (hemoglobin adducts) Carcinogenicity Bioavailability from food and drinking water

Antimony Trisulfide
Substance [CAS No.]	Nominated by	Nominated for	Rationale for Nomination	ICCEC Recommendations
Antimony trisulfide [1345-04-6]	National Cancer Institute	Chronic toxicity/ carcinogenicity	Significant human exposure in occupational settings and suspicion of carcinogenicity	Toxicological studies: Chronic toxicity/ carcinogenicity

Cadmium Telluride
Substance [CAS No.]	Nominated by	Nominated for	Rationale for Nomination	ICCEC Recommendations
Cadmium telluride (additional information) [1306-25-8]	U.S. Department of Energy Brookhaven National Laboratory National Renewable Energy Laboratory First Solar, Inc.	Long-term oral and inhalation toxicity studies Chemical disposition, metabolism, and pharmacokinetic studies	potential for widespread applications in photovoltaic energy generation anticipated increase in human exposures further data needed to address health and safety issues related to manufacture and use	Toxicological studies: Toxicological characterization Chemical disposition (oral and inhalation)

Cedarwood oil, Virginia
Substance [CAS No.]	Nominated by	Nominated for	Rationale for Nomination	ICCEC Recommendations
Cedarwood oil, Virginia [8000-27-9]	National Cancer Institute	Subchronic toxicity	widespread occupational and consumer exposure lack of basic toxicology data	Toxicological studies: Toxicological characterization Developmental toxicity

Chondroitin Sulfate
Substance [CAS No.]	Nominated by	Nominated for	Rationale for Nomination	ICCEC Recommendations
Chondroitin sulfate [9007-28-7] [9082-07-9] (sodium salt)	National Cancer Institute	Chronic toxicity/ carcinogenicity alone and in combination with glucosamine	Widespread long-term use as a dietary supplement and inadequate data to assess safety	Toxicological studies: Chronic toxicity/ carcinogenicity Carcinogenicity of chondroitin sulfate and glucosamine combined

Dimethylethanolamine
Substance [CAS No.]	Nominated by	Nominated for	Rationale for Nomination	ICCEC Recommendations
Dimethylethanolamine [108-01-0]	National Institute of Environmental Health Sciences	Toxicological characterization including toxicokinetic, reproductive and developmental toxicity, mechanistic, and carcinogenicity studies	potential for widespread human exposure to DMAE through its use in industrial and consumer products inadequate toxicological database some ethanolamines can interfere with choline uptake and utilization and may also generate nitrosamines	Toxicological studies: Metabolism

Drugs positive for QT Interval Prolongation/Induction of Torsade Proarrhythmia
Substance [CAS No.]	Nominated by	Nominated for	Rationale for Nomination	ICCEC Recommendations
Drugs positive for QT Interval Prolongation/Induction of Torsade Proarrhythmia [No CAS No.]	U.S Food and Drug Administration	Non-clinical safety pharmacology studies of both problematic and non-problematic drugs in the conscious canine telemetry model to better establish the sensitivity and specificity of this in vivo model system for evaluating the property of a test agent to prolong QT interval at relevant exposures in humans	QT interval prolongation and torsade de pointes is a high priority cause for concern in drug development and regulatory safety evaluation; a clear definition of the strengths, limitations, and future performance characteristics of the canine telemetry model for pre-clinical safety assessment is needed	Initiate a study program to develop in vitro and in vivo test systems for assessing QT interval prolongation

Glucosamine
Substance [CAS No.]	Nominated by	Nominated for	Rationale for Nomination	ICCEC Recommendations
Glucosamine [3416-24-8]	National Cancer Institute	Chronic toxicity/ carcinogenicity alone and in combination with chondroitin sulfate	Widespread long-term use as a dietary supplement and inadequate data to assess safety	Toxicological studies: Chronic toxicity/ carcinogenicity Carcinogenicity of chondroitin sulfate and glucosamine combined

Nanoscale Materials
Substance [CAS No.]	Nominated by	Nominated for	Rationale for Nomination	ICCEC Recommendations
Nanoscale materials [No CAS No.]	Rice University Center for Biological and Environmental Nanotechnology	Toxicological characterization of several representative classes of nanomaterials	Intense current and anticipated future research and development focus; further studies and development of appropriate toxicological methods are needed to adequately assess health effects	Toxicological studies: Size- and composition-dependent biological disposition of nanocrystalline fluorescent semiconductor materials Toxicological characterization of high aspect ratio carbon nanomaterials Role of particle core and surface composition in the immunotoxicity of the above listed materials Phototoxicity of representative metal oxide nanoparticles

trans-Resveratrol
Substance [CAS No.]	Nominated by	Nominated for	Rationale for Nomination	ICCEC Recommendations
trans-Resveratrol [501-36-0]	National Institute of Environmental Health Sciences	Toxicological characterization	widespread human exposure from natural dietary sources and use of dietary supplements suspicion of toxicity based on estrogenic and genotoxic activity insufficient data available to characterize safety	Toxicological studies: Toxicological characterization Carcinogenicity Reproductive toxicity

Tetrabromobisphenol A
Substance [CAS No.]	Nominated by	Nominated for	Rationale for Nomination	ICCEC Recommendations
Tetrabromobisphenol A [79-94-7]	National Institute of Environmental Health Sciences	Toxicological characterization including neurodevelopmental toxicity and carcinogencity studies	High production volume, widespread human exposure and suspicion of thyroid toxicity/tumorigenicity	Toxicological studies: Toxicological characterization Neurodevelopmental toxicity Carcinogencity

Tetrabromobisphenol A bis(2,3-dibromopropyl ether)
Substance [CAS No.]	Nominated by	Nominated for	Rationale for Nomination	ICCEC Recommendations
Tetrabromobisphenol A bis(2,3-dibromopropyl ether) [21850-44-2]	National Institute of Environmental Health Sciences	Toxicological characterization In vivo genotoxicity	High production volume little toxicity data available suspicion of carcinogenic potential due to 2,3-dibromo-1-propanol substructure	Toxicological studies: Toxicological characterization In vivo genotoxicity Metabolism Carcinogencity

Tungsten
Substance [CAS No.]	Nominated by	Nominated for	Rationale for Nomination	ICCEC Recommendations
Tungsten [7440-33-7]	National Center for Environmental Health	Toxicological characterization including carcinogenicity	Important industrial materials; insufficient data to assess human health implications of elevated urinary tungsten levels	Toxicological studies: Toxicological characterization Carcinogenicity Studies should focus on a representative soluble tungsten compound

4-Phenylcyclohexene
Substance [CAS No.]	Nominated by	Nominated for	Rationale for Nomination	ICCEC Recommendations
4-Phenylcyclohexene [4994-16-5]	Private Individuals	Toxicological characterization including genotoxicity and neurotoxicity	Present in indoor environments primarily from carpet emissions; concern that it has not been adequately tested for potential health effects	No toxicological studies at this time due to low suspicion of hazard based on available human exposure and toxicity information

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