Nominations in Review 2001

http://ntp.niehs.nih.gov/go/198

Substances Recommended for Study:

Apigenin
Bladderwrack
n-Butyl bromide
Cylindrospermopsin
Dibenzofuran
Diphenolic acid
Epigallocatechin-3-gallate
2-Ethylhexyl-p- dimethylaminobenzoic acid
Grape seed and pine bark extracts
Metalworking fluids
Methyl soyate
Methyl tetrahydrofuran
Polybrominated diphenyl ethers

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 toxicological 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 ]

Apigenin
Substance [CAS No.]	Nominated by	Nominated for	Rationale for Nomination	ICCEC Recommendations
Apigenin [520-36-5]	National Cancer Institute	genotoxicity testing developmental toxicity testing	Naturally occurring flavonoid with potential oxidant and estrogenic activity; lack of toxicity information	No toxicological studies due to low potential for toxicity and human exposure

Bladderwrack
Substance [CAS No.]	Nominated by	Nominated for	Rationale for Nomination	ICCEC Recommendations
Bladderwrack [68917-51-1],[84696-13-9]	National Cancer Institute	chemical characterization (iodine content) short-term (subacute) toxicity	significant human exposure through use as a dietary supplement safety concern due to potential thyroid stimulation limited available toxicity information	Toxicological studies: Chemical characterization (iodine content) Subchronic toxicity testing with evaluation of reproductive parameters

n -Butyl Bromide
Substance [CAS No.]	Nominated by	Nominated for	Rationale for Nomination	ICCEC Recommendations
n -Butyl bromide [109-65-9]	National Cancer Institute	Subchronic toxicity testing Reproductive toxicity testing	industrial chemical with significant production volume and human exposure potential mutagenic potential for carcinogenicity lack of toxicity information	Consideration deferred pending receipt of manufacturers' voluntary testing plans

Cylindrospermopsin
Substance [CAS No.]	Nominated by	Nominated for	Rationale for Nomination	ICCEC Recommendations
Cylindrospermopsin [14345-90-8]	National Institute of Environmental Health Sciences	Complete toxicological characterization	Cyanobacterial toxin with potential for widespread human exposure through drinking water high acute toxicity limited available toxicity information	Toxicological studies: Complete toxicological characterization including chronic toxicity and carcinogenicity testing

Dibenzofuran
Substance [CAS No.]	Nominated by	Nominated for	Rationale for Nomination	ICCEC Recommendations
Dibenzofuran [132-64-9]	National Cancer Institute	genotoxicity testing Subchronic toxicity testing	widespread human exposure as an environmental contaminant potential for carcinogenicity lack of toxicity information	No toxicological studies due to low commercial production volume and low potential for human exposure

Diphenolic acid
Substance [CAS No.]	Nominated by	Nominated for	Rationale for Nomination	ICCEC Recommendations
Diphenolic acid [126-00-1]	National Cancer Institute	genotoxicity testing Subchronic toxicity testing	industrial chemical with potential for increasing use structurally related to bisphenol A lack of toxicity information	No toxicological studies due to low commercial production volume and low potential for human exposure

Epigallocatechin-3-gallate
Substance [CAS No.]	Nominated by	Nominated for	Rationale for Nomination	ICCEC Recommendations
Epigallocatechin-3-gallate [989-51-5]	National Cancer Institute	Genotoxicity battery Subchronic toxicity	Major polyphenol in green tea and green tea extract dietary supplements; potential chemopreventive agent; limited available toxicity information	Toxicological studies: Genotoxicity testing Subchronic toxicity testing Consider testing green tea extract

2-Ethylhexyl- p- Dimethylaminobenzoic Acid
Substance [CAS No.]	Nominated by	Nominated for	Rationale for Nomination	ICCEC Recommendations
2-Ethylhexyl- p- dimethylaminobenzoic acid [21245-02-3]	Private Individual	Dermal absorption and pharmacokinetics Reproductive toxicity Developmental toxicity (pre- and post-natal) Subchronic dermal toxicity	high production volume chemical with industrial and consumer (sunscreen) uses evidence for phototoxicity and testicular toxicity limited available toxicity information	Toxicological studies: Subchronic toxicity and developmental and reproductive toxicity testing by the dermal route of exposure Phototoxicity and photocarcinogenicity testing

Grape Seed and Pine Bark Extracts
Substance [CAS No.]	Nominated by	Nominated for	Rationale for Nomination	ICCEC Recommendations
Grape seed and pine bark extracts	National Cancer Institute	Genotoxicity (bacterial mutagenicity and mammalian micronucleus assays) Subchronic toxicity Reproductive toxicity Teratogenicity	Significant human exposure through use as a dietary supplement; limited available toxicity information	Toxicological studies: Genotoxicity testing Subchronic toxicity testing Developmental and reproductive toxicity testing Select a standardized commercial pine bark extract for study

Metalworking Fluids
Substance [CAS No.]	Nominated by	Nominated for	Rationale for Nomination	ICCEC Recommendations
Metalworking fluids	National Institute for Occupational Safety and Health	In vitro, short-term in vivo and subchronic toxicity studies aimed at evaluating carcinogenic potential of multiple formulations Carcinogenicity (inhalation) study of at least one formulation	high production volume large number of occupationally-exposed workers lack of carcinogenicity and chronic toxicity data	Toxicological studies: In vitro, short-term in vivo and subchronic toxicity studies aimed at evaluating toxicity and carcinogenicity potential of multiple commercial formulations Recommendations regarding further testing will be made after reviewing the results of NTP preliminary studies

Methyl Soyate
Substance [CAS No.]	Nominated by	Nominated for	Rationale for Nomination	ICCEC Recommendations
Methyl soyate [67784-80-9]	National Cancer Institute	Genotoxicity testing Subchronic toxicity testing by the dermal route of exposure	increasing production volume as an alternative fuel (biodiesel) lack of toxicity information	Consideration deferred pending receipt of toxicity data development plans through existing or future regulatory programs

Methyl Tetrahydrofuran
Substance [CAS No.]	Nominated by	Nominated for	Rationale for Nomination	ICCEC Recommendations
Methyl tetrahydrofuran [96-47-9]	National Cancer Institute	Genotoxicity (bacterial mutagenicity and mammalian micronucleus assays) Subchronic toxicity Mechanistic studies (related to a 2-globulin) Carcinogenicity in Tg.AC mice	Increasing use in alternative fuels; suspicion of toxicity and carcinogenicity based on structure; limited available toxicity information	Toxicological studies Genotoxicity testing Short-term toxicity testing Consider dermal and inhalation routes of exposure

Polybrominated Diphenyl Ethers
Substance [CAS No.]	Nominated by	Nominated for	Rationale for Nomination	ICCEC Recommendations
Polybrominated diphenyl ethers Pentabromodiphenyl ether (technical) [32534-81-9] Octabromodiphenyl ether (technical) [32536-52-0] 2,2?,4,4?- Tetrabromodiphenyl ether [5436-43-1] 2,2?,4,4?,5- Pentabromodiphenyl ether [60348-60-9] 2,2?,4,4?,5,5?- Hexabromodiphenyl ether [68631-49-2]	Private Individuals California Environmental Protection Agency	Toxicological characterization including genotoxicity and neurotoxicity	high production volume flame retardants widespread human exposure occupationally and as environmental contaminants persistent and bioaccumulative evidence for toxicity but significant knowledge gaps remain	Toxicological studies: subchronic toxicity, developmental neurotoxicity and chronic toxicity testing of selected individual congeners no testing of technical mixture

Web page last updated on September 12, 2008