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Recommendations of the ICCEC - Request for Comments

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[Federal Register: January 8, 1998 (Volume 63, Number 5)]
[Notices]
[Page 1118 - 1119]


DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

National Institute of Environmental Health Sciences (NIEHS)

Announcement of Nominated Chemicals Under Consideration for Toxicological Studies by the National Toxicology Program (NTP) -- Recommendations by the Interagency Committee for Chemical Evaluation and Coordination (ICCEC) -- Request for Comments

Background
As part of an effort to earlier inform and obtain public 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 Interagency Committee for Chemical Evaluation and Coordination (ICCEC). Summaries of the ICCEC's recommendations and public comments received are next presented to the NTP Board of Scientific Counselors for their review and comment in an open public session. ICCEC recommendations, Board recommendations, and public comments are incorporated into recommendations that are then submitted to the NTP Executive Committee. The Executive Committee reviews and approves action to move forward to test, defer, or delete each of the nominated chemicals, classes or mixtures for the various types of study, and recommends priorities.

Request for Comment
Interested parties are encouraged to comment and provide information on chemicals under consideration for study listed in the Table. The Program would welcome receiving toxicology and carcinogenesis information from completed, ongoing, or planned studies by others, 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 December 11, 1997, the ICCEC reviewed and recommended 9 chemicals or chemical classes for metabolism, toxicity, or carcinogenicity studies. It was also recommended that testing not be performed on one chemical, trans--1,4-dichloro-2-butene (CAS Number 110-57-6), because industry studies showed it to be a potent carcinogen. Chemicals with CAS numbers, nomination source, types of studies under consideration, and other information are given in the Table.

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.

Attachment

Dated: December 23, 1997

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

[ Billing Code 4140-01-P]


Attachment

Chemicals Recommended for Study by the NTP Interagency Committee for Chemical
Evaluation and Coordination (ICCEC) on December 11, 1997

Chemical
[CAS Number]
Nomination
source
Testing
Recommendations
Study Rationale/
Remarks
2-Acetylpyridine
[1122-62-9]
NCI - carcinogenicity - potential for human exposure
- suspicion of carcinogenicity
2-Chloropyridine
[109-09-1]
NCI - dermal carcinogenicity in transgenic mice - increasing production
- occupational and environmental exposure
Comfrey [72698-57-8]
Symphytine [22571-95-5]
NIEHS - carcinogenicity;
- reproductive and developmental toxicity
- extensive use as a herbal supplement and medicinal
- contains pyrrolizidine alkaloids, including symphytine
Glycoluril
[496-46-8]
NCI - in vitro and in vivo nitrosation studies - moderate production
- potential human exposure
- potential to form nitrosamides
Goldenseal
Berberine [2086-83-1]
Hydrastine [
118-08-1]
NIEHS - carcinogenicity
- reproductive and developmental toxicity
- extensive use as a herbal supplement and medicinal
- contains active alkaloids berberine and hydrastine
4-Methoxy-N-methyl-1,8- naphthalimide [3271-05-4] NCI - chemical disposition - occupational exposure
- extensive consumer exposure
Myristicin
[607-91-0]
NCI - genetic toxicity;
- metabolism;
- carcinogenicity in transgenic animals
- widespread natural product
- extensive consumer exposure
- similarity to known carcinogen safrole
7-(2H-Naphthol[1,2-d]triazol-
2-yl)-3-phenylcoumarin
[3333-62-8]
NCI - chemical disposition - moderate production
- extensive occupational and consumer exposure
Saw palmetto
b-Sitosterol [83-46-5]
NIEHS - carcinogenicity;
- multigeneration reproductive toxicity
- widely used herbal remedy
for benign prostate hyperplasia
- contains active sitosterols