Nominations in Review 2006

http://ntp.niehs.nih.gov/go/21158

Substances Recommended for Study:

Arbutin
tert-Butylacrylamide
Ceric Oxide
Diazonaphthoquinone derivatives:
- Sodium 1,2-naphthoquinone- 2-diazide-5-sulfonate
- 2,3,4-Trihydroxybenxophenone tris(1,2-naphthoquinonediazide- 5-sulfonate
- 2,3,4-Trihydroxybenzophenone 1,2-naphthoquinonediazide-5- sulfonate
3-Dimethylaminopropyl methacrylamide
Flame Retardants:
- Antimony trioxide
- Decabromodiphenyl oxide
- Tris(chloropropyl)phosphate, mixture of four isomers)
- Phosphonic acid, (3-((hydroxymethyl)amino)-3- oxopropyl)-,dimethyl ester
- Tris(hydroxymethyl)phosphine oxide
- Aromatic Phosphates:
  - tert-Butylphenyl diphenyl phosphate
  - 2-Ethylhexyl diphenyl phosphate
  - Isodecyl diphenyl phosphate
  - Phenol, isopropylated, phosphate (3:1)
  - Tricresyl phosphate
  - Triphenyl phosphate
Gypsum, natural and synthetic forms
N-methyl-3-oxobutanamide

Substances for Which No Study is Recommended at this Time:

Phenoxethyl acrylate
Trifluoromethylbenzene

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.

* Note: A recommendation for "toxicological characterization" in this table includes studies for genotoxicity, subchronic toxicity, and chronic toxicity/carcinogenicity, as determined to be appropriate during the conceptualization and design of a research program to address toxicological data needs. Though other types of studies (e.g. metabolism and disposition, immunotoxicity, reproductive/developmental toxicity) may be conducted as part of a complete toxicological characterization, these types of studies are not listed unless they were specifically recommended. Preliminary study recommendations are developed and refined by the nominator, NTP staff, and the ICCEC.

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 ]

Arbutin
Substance [CAS No.]	Nominated by	Nomination Rationale (Principles*)	Preliminary Study Recommendations
Arbutin [497-76-7]	National Institute of Environmental Health Sciences	Consumer exposure through food, cosmetics and dietary supplements; lack of adequate toxicological data; suspicion of toxicity based on chemical structure (1, 6)	In vitro and in vivometabolism and disposition studies In vitro and in vivogenotoxicity studies Emphasis on understanding gastrointestinal metabolism and disposition, identifying experimental animal model representative of humans, and development of appropriate biomarkers

tert-Butylacrylamide
Substance [CAS No.]	Nominated by	Nomination Rationale (Principles*)	Preliminary Study Recommendations
tert-Butylacrylamide [107-48-4]	National Cancer Institute	High production volume; potential worker and consumer exposures; lack of adequate toxicological data; suspicion of toxicity based on chemical structure (1, 6, 7)	Metabolism and disposition studies Subchronic toxicity studies Mammalian genotoxicity studies Coordinate with voluntary data development activities of the Extended HPV (EHPV) Program

Ceric oxide
Substance [CAS No.]	Nominated by	Nomination Rationale (Principles*)	Preliminary Study Recommendations
Ceric oxide [1306-38-3]	National Institute of Environmental Health Sciences	Widespread industrial use and potential for increasing exposure; demonstrated pulmonary toxicity; lack of toxicity data for nanoscale form (1, 6, 7)	Toxicological characterization including chemical disposition and toxicokinetics Comparative inhalation toxicity studies of microscale and nanoscale forms Dermal penetration studies

Diazonaphthoquinone derivatives
Substance [CAS No.]	Nominated by	Nomination Rationale (Principles*)	Preliminary Study Recommendations
Diazonaphthoquinone derivatives: Sodium 1,2-naphthoquinone-2- diazide-5-sulfonate [2657-00-3] 2,3,4-Trihydroxybenzophenone tris(1,2-naphthoquinonediazide -5-sulfonate) [5610-94-6] 2,3,4-Trihydroxybenzophenone 1,2-naphthoquinonediazide-5- sulfonate [68510-93-0]	National Institute of Environmental Health Sciences	Moderate production volume; potential worker exposures from use in photolithography processes; lack of adequate toxicological data (1, 6, 7)	In vitro toxicity studies evaluating genotoxicity, immunotoxicity and phototoxicity Dermal penetration studies

3-Dimethylaminopropyl methacrylamide
Substance [CAS No.]	Nominated by	Nomination Rationale (Principles*)	Preliminary Study Recommendations
3-Dimethylaminopropyl methacrylamide [5205-93-6]	National Cancer Institute	High production volume; potential worker and consumer exposures; lack of adequate toxicological data; demonstrated toxicity in short-term studies (1, 6, 7)	Metabolism and disposition studies Genotoxicity studies Subchronic toxicity studies Coordinate with voluntary data development activities through the Extended HPV (EHPV) Program

Flame retardants
Substance [CAS No.]	Nominated by	Nomination Rationale (Principles*)	Preliminary Study Recommendations
Flame retardants:	Consumer Project Safety Commission	Anticipated increased use in upholstered furniture and bedding and potential consumer exposures from these uses; insufficient toxicity data to assess potential health risks (1, 6, 7)	See individual recommendations
Antimony trioxide [1309-64-4]			Chronic toxicity studies (oral route) Consider studies of nanoscale form if used in or released during flame retardant applications
Decabromodiphenyl oxide [1163-19-5]			Developmental neurotoxicity studies Studies only to be performed if adequate private sector study not identified or planned
Tris(chloropropyl) phosphate, mixture of four isomers [13674-84-5; 76025-08-6; 76649-15-5; 6145-73-9]			Subchronic and chronic toxicity studies (oral route) Studies to focus on commercial mixture or major isomers present in commercially used mixtures
Phosphonic acid, (3-((hydroxymethyl) amino)-3- oxopropyl)-, dimethyl ester [20120-33-6]			Subchronic and chronic toxicity studies (oral route) Dermal absorption studies
Tris(hydroxymethyl) phosphine oxide [1067-12-5]			Subchronic and chronic toxicity studies (oral route) Dermal absorption studies
Aromatic phosphates: tert-Butylphenyl diphenyl phosphate [56803-37-3] 2-Ethylhexyl diphenyl phosphate [1241-94-7] Isodecyl diphenyl phosphate [29761-21-5] Phenol, isopropylated, phosphate (3:1) [68937-41-7] Tricresyl phosphate [1330-78-5] Triphenyl phosphate [115-86-6]			For one or more representative aromatic phosphates: Subchronic and chronic toxicity studies (oral route) Neurotoxicity and/or developmental neurotoxicity studies Coordinate with U.S. EPA to pursue additional testing by manufacturers

Gypsum, natural and synthetic forms
Substance [CAS No.]	Nominated by	Nomination Rationale (Principles*)	Preliminary Study Recommendations
Gypsum, natural and synthetic forms [13397-24-5]	Mount Sinai-Irving J. Selikoff Center for Occupational and Environmental Medicine Operative Plasterers' and Cement Masons' International Association of the United States and Canada	Widespread worker exposures in numerous occupations and to the general population after destruction of the World Trade Centers in 2001; limited toxicity data to assess potential health risks (1, 2, 3, 6)	Short-term pulmonary toxicity studies Comparative studies of intratracheal vs. inhalation routes of administration Studies are of relatively low priority given low suspicion of toxicity

N-methyl-3-oxobutanamide
Substance [CAS No.]	Nominated by	Nomination Rationale (Principles*)	Preliminary Study Recommendations
N-methyl-3-oxobutanamide [20306-75-6]	National Cancer Institute	High production volume; potential worker and environmental exposures; lack of adequate toxicological data (1, 6, 7)	In vitro and in vivo genotoxicity studies Include structurally-related diketene compounds and N-phenyl derivatives

Phenoxyethyl acrylate
Substance [CAS No.]	Nominated by	Nomination Rationale (Principles*)	Preliminary Study Recommendations
Phenoxyethyl acrylate [48145-04-6]	National Cancer Institute	High production volume; potential worker and consumer exposures; lack of adequate toxicological data (1, 6, 7)	Defer pending voluntary data submission through the Extended HPV (EHPV) Program

Trifluoromethylbenzene
Substance [CAS No.]	Nominated by	Nomination Rationale (Principles*)	Preliminary Study Recommendations
Trifluoromethylbenzene [98-08-8]	National Cancer Institute	High production volume and potential for increased use; potential worker exposures; lack of adequate toxicological data; demonstrated toxicity in short-term studies (1, 6, 7)	Defer pending review of: production data through the 2006 Toxic Substances Control Act (TSCA) Inventory Update Rule, and Organization for Economic Cooperation and Development (OECD) Screening Information Data Sets (SIDS) program output

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