Press Center
Request for Comments - Chemical Recommendations
[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 |
Nominated by |
ICCEC |
Study Rationale; |
Androstenedione |
NCI |
-subchronic (cardiovascular and reproductive) toxicity |
-widely used steroid dietary supplement |
Bentonite |
NIOSH |
-chronic inhalation toxicity |
-naturally-occurring silicate |
Bis(2-chloroethoxy)methane |
NIEHS |
-carcinogenicity |
-high production |
Chromium picolinate |
NCI; Private Individual |
-subchronic toxicity |
-widely used dietary supplement |
Cumene hydroperoxide |
NIEHS |
-carcinogenicity |
-high production |
Echinacea |
NCI |
-subchronic toxicity |
-natural product |
Fluasterone |
NCI |
-toxicological characterization |
-fluorine-substituted DHEA analogue |
Ginkgo biloba extract Ginkgolide B |
NCI NCI |
-toxicological characterization |
-natural product (standardized plant extract) |
Pyrogallol |
Private individual |
-subchronic toxicity |
-natural and industrial product |
Triallyl isocyanurate |
NIEHS |
-subchronic toxicity |
-moderate production |
Chemicals for Which No Testing is Recommended
Chemical |
Nominated |
|
Rationale; |
Caffeic acid [331-39-5] Chlorogenic acid [327-97-9]
|
Private Individual |
-carcinogenicity |
-naturally occurring in a wide variety of nutritionally important foods |
Chemical Deferred for Additional Information
Chemical |
Nominated |
|
Rationale; |
Dehydroepiandosterone (DHEA) |
NCI; Private Individual |
-toxicological characterization |
-widely used steroid dietary supplement |
Chemicals to be Removed from Consideration
Chemical |
Nominated |
|
Rationale; |
2-Acetylpyridine |
NCI |
-carcinogenicity |
-insufficient production and use to warrant testing |
Cyanogen chloride |
EPA |
-metabolism |
-rapid conversion to cyanide in blood |
Diethylamine Isopropylamine Triethylamine |
NIEHS NIEHS UAW |
-subchronic inhalation toxicity |
-adequate NIOSH studies of DEA and TEA |
Ethidium bromide |
Private Individual |
-toxicological characterization |
-already labeled as possible carcinogen |
Ethyl bromoacetate |
NCI |
-metabolism |
-rapid hydrolysis hydrolysis in blood |
4-Methoxy-N-methyl-1,8-napthalimide |
NCI |
-chemical disposition |
-unable to obtain material |
b -Myrcene |
NIEHS |
-metabolism |
-unable to obtain radiolabeled material |
Phenothiazine |
NIEHS NIOSH |
-toxicological characterization |
-low production |
Saw palmetto |
Private Individual |
-toxicological characterization |
-low potential for reproductive toxicity |
Trigonelline |
Private Individual |
-subchronic toxicity |
-naturally occurring in a wide variety of nutritionally important foods |
Chemical for Which Previous Testing Recommendation Has Been Modified
Chemical |
Nominated |
|
Rationale; |
Propargyl alcohol |
NCI |
-carcinogenicity |
-high production |
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