Request for Comments - Chemical Recommendations

http://ntp.niehs.nih.gov/go/6579

[Federal Register: December 22, 1998 (Volume 63, Number 245)]
[Notices]
[Pages 70790 - 70792]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

National Institute of Environmental Health Sciences -- National Toxicology Program

Request for Comments on Chemicals Nominated to the National Toxicology Program (NTP) for Toxicological Studies - Recommendations by the Interagency Committee for Chemical Evaluation and Coordination (ICCEC) for Study, No Studies, or Deferral to Obtain Additional Information

Background

As part of an effort to earlier inform the public and obtain input into the selection of chemicals for evaluation, the National Toxicology Program (NTP) routinely seeks public input on (1) chemicals nominated to the Program for toxicological studies, and (2) the testing recommendations made by the ICCEC, the Federal interagency committee that serves as the first level of review for nominations. Summaries of the ICCEC¿s recommendations and public comments received on the nominated chemicals are next presented to the NTP Board of Scientific Counselors (the Program¿s external scientific advisory committee) for their review and comment in an open, public session. The ICCEC recommendation, Board recommendations, and public comments are incorporated into the recommendations that are then submitted to the NTP Executive Committee, the Federal interagency policy oversight body. The Executive Committee reviews and approves action to move forward to test, defer, or delete on each of the nominated chemicals for the various types of study, and recommends priorities.

Request for Comment

Interested parties are encouraged to comment on the recommendations and provide information on the chemicals listed below. The Program would welcome receiving toxicology and carcinogenesis information from completed or ongoing studies, and information on planned studies, as well as current production data, human exposure information, use patterns, and environmental occurrence for any of the chemicals listed in this announcement. To provide comments or information, please contact Dr. William Eastin at the address given below within 60 days of the appearance of this announcement.

At their meeting on November 23, 1998, the ICCEC reviewed 13 agents nominated to the NTP for consideration to study and recommended 10 agents for metabolism, toxicity, or carcinogenicity studies, recommended that no studies be performed on 2 chemicals, and deferred 1 substance pending receipt of test data from other organizations or from related studies anticipated or in progress by the NTP, and information on production, exposure, and use patterns. Additionally, the ICCEC reviewed 13 agents recommended for study in previous ICCEC meetings. Following review of additional data received from the public and elsewhere, 12 are no longer considered priority candidates for study, and 1 chemical previously recommended for toxicity study was recommended for carcinogenicity study. Chemicals with CAS numbers, nomination source, types of studies under consideration, and rationale and other information are given in the following tables.

Contact may be made by mail to: Dr. William Eastin, NIEHS/NTP, P. O. Box 12233, Research Triangle Park, North Carolina 27709; by telephone at (919) 541-7941; by FAX at (919) 541-3687; or by email at Eastin@NIEHS.NIH.GOV. The URL for the NTP homepage is http://ntp.niehs.nih.gov/ntp.

Dated: December 14, 1998

__________________________
Kenneth Olden, Ph. D.
Director
National Toxicology Program

[Billing Code 4140-01-P]

Attachment

Chemicals Nominated to the NTP for Study, and Testing Recommendations made by the ICCEC on November 23, 1998

Chemicals Recommended for Testing

Chemical [CAS Number]	Nominated by	ICCEC Recommendations	Study Rationale; Other Information
Androstenedione [63-05-8]	NCI	-subchronic (cardiovascular and reproductive) toxicity -metabolism -carcinogenicity	-widely used steroid dietary supplement -estrogen and testosterone precursor
Bentonite [1302-78-9]	NIOSH	-chronic inhalation toxicity	-naturally-occurring silicate -known worker exposure
Bis(2-chloroethoxy)methane [111-91-1]	NIEHS	-carcinogenicity -metabolism and disposition	-high production -environmentally persistent -potential high worker exposure
Chromium picolinate [14639-25-9]	NCI; Private Individual	-subchronic toxicity -metabolism and pharmacokinetics -reproductive toxicity -carcinogenicity	-widely used dietary supplement -picolinate ligand enhances chromium absorption
Cumene hydroperoxide [80-15-9]	NIEHS	-carcinogenicity	-high production -known worker exposure
Echinacea	NCI	-subchronic toxicity -immunotoxicity -chronic toxicity	-natural product -widely used dietary supplement -wide variety of preparations available
Fluasterone [112859-71-9]	NCI	-toxicological characterization -carcinogenicity	-fluorine-substituted DHEA analogue -NCI considering for clinical trial
Ginkgo biloba extract Ginkgolide B [15291-75-5]	NCI NCI	-toxicological characterization -neurotoxicity -carcinogenicity -micronucleus test (Ginkgolide B)	-natural product (standardized plant extract) -widely used dietary supplement Ginkgolide B is a constituent of GinkoGinkgo biloba extract
Pyrogallol [87-66-1]	Private individual	-subchronic toxicity -carcinogenicity	-natural and industrial product -FDA approved coloring additive -widespread human exposure
Triallyl isocyanurate [1025-15-6]	NIEHS	-subchronic toxicity -metabolism and pharmacokinetics (pending confirmation of significant production)	-moderate production -indirect food additive

Chemicals for Which No Testing is Recommended

Chemical
[CAS Number]

Nominated
by

Nominated for

Rationale;
Other Information

Caffeic acid [331-39-5]

Chlorogenic acid [327-97-9]

Private Individual

-carcinogenicity

-naturally occurring in a wide variety of nutritionally important foods
-generally weak evidence of toxicity in existing studies

Chemical Deferred for Additional Information

Chemical [CAS Number]	Nominated by	Nominated for	Rationale; Other Information
Dehydroepiandosterone (DHEA) [53-43-0]	NCI; Private Individual	-toxicological characterization -carcinogenicity -reproductive toxicity	-widely used steroid dietary supplement -has FDA IND status -metabolized to adrostenedione -defer until results of androstendione studies complete or additional information available

Chemicals to be Removed from Consideration

Chemical [CAS Number]	Nominated by	Nominated for	Rationale; Other Information
2-Acetylpyridine [1122-62-9]	NCI	-carcinogenicity	-insufficient production and use to warrant testing
Cyanogen chloride [506-77-4]	EPA	-metabolism -carcinogenicity	-rapid conversion to cyanide in blood
Diethylamine [109-89-7] Isopropylamine [75-31-0] Triethylamine [121-44-8]	NIEHS NIEHS UAW	-subchronic inhalation toxicity -ocular toxicity	-adequate NIOSH studies of DEA and TEA -too corrosive for humane study -ocular irritation in workers already well documented
Ethidium bromide [1239-45-8]	Private Individual	-toxicological characterization -carcinogenicity	-already labeled as possible carcinogen -few people exposed
Ethyl bromoacetate [105-36-2]	NCI	-metabolism	-rapid hydrolysis hydrolysis in blood -animals would be distressed -other haloacetic acids being studied
4-Methoxy-N-methyl-1,8-napthalimide [3271-05-4]	NCI	-chemical disposition	-unable to obtain material
b -Myrcene [1253-35-3]	NIEHS	-metabolism -alkylating ability	-unable to obtain radiolabeled material
Phenothiazine [92-84-2]	NIEHS NIOSH	-toxicological characterization -carcinogenicity	-low production -no longer in agricultural or veterinary use
Saw palmetto Sitosterol [83-46-5]	Private Individual	-toxicological characterization -carcinogenicity	-low potential for reproductive toxicity -two-generation and 13-week studies available -subject of FDA-approved clinical trial
Trigonelline [535-83-1]	Private Individual	-subchronic toxicity -comparative metabolism	-naturally occurring in a wide variety of nutritionally important foods -metabolite of niacin in humans -metabolized differently in rats and humans -very low acute toxicity

Chemical for Which Previous Testing Recommendation Has Been Modified

Chemical [CAS Number]	Nominated by	Nominated for	Rationale; Other Information
Propargyl alcohol [107-19-7]	NCI	-carcinogenicity	-high production -widespread human exposure -subchronic study available -suspicion of carcinogenicity based on structure

Web page last updated on April 19, 2006