[Federal Register Volume 63, Number 245 (Tuesday, December 22, 1998)] [Notices] [Pages 70790-70792] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 98-33761] ----------------------------------------------------------------------- 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 recommendations, Board recommendation, 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 [email protected]. The URL for the NTP homepage is http://ntp- server.niehs.nih.gov. Dated: December 11, 1998. Kenenth Olden, Director, National Toxicology Program. Attachment Chemicals Nominated to the NTP for Study, and Testing Recommendations made by the ICCEC on November 23, 1998 ---------------------------------------------------------------------------------------------------------------- Study rationale; other Chemical [CAS No.] Nominated by ICCEC recommendations information ---------------------------------------------------------------------------------------------------------------- Chemicals Recommended for Testing ---------------------------------------------------------------------------------------------------------------- Androstenedione [63-05-8]......... NCI.................. --subchronic --widely used steroid (cardiovascular and dietary supplement. reproductive) toxicity. --estrogen and --metabolism.............. testosterone precursor. --carcinogenicity......... Bentonite [1302-78-9]............. NIOSH................ --chronic inhalation --naturally occurring toxicity. silicate. --known worker exposure. Bis(2-chloroethoxy)methane [111-91- NIEHS................ --carcinogenicity......... --high production. 1]. --metabolism and --environmentally disposition. persistent. --potential high worker exposure. Chromium picolinate [14639-25-9].. NCI; Private --subchronic toxicity..... --widely used dietary individual. --metabolism and supplement. pharmacokinetics. --picolinate ligand --reproductive toxicity... enhances chromium --carcinogenicity......... absorption. [[Page 70791]] Cumene hydroperoxide [80-15-9].... NIEHS................ --carcinogenicity......... --high production. --known worker exposure. Echinacea......................... NCI.................. --subchronic toxicity..... --natural product. --immunotoxicity.......... --widely used dietary --chronic toxicity........ supplement. --wide variety of preparations available. Fluasterone [112859-71-9]......... NCI.................. --toxicological --fluorine-substituted characterization. DHEA analogue. --carcinogenicity......... --NCI considering for clinical trial. Ginkgo biloba extract............. NCI.................. --toxicological --natural product characterization. (standardized plant --neurotoxicity........... extract). --carcinogenicity......... --widely used dietary supplement. Ginkgolide B [15291-75-5]......... NCI.................. --micronucleus test --Ginkgolide B is a (Ginkgolide B). constituent of Ginkgo biloba extract. Pyrogallol [87-66-1].............. Private individual... --subchronic toxicity..... --natural and industrial --carcinogenicity......... product. --FDA approved coloring additive. --widespread human exposure. Triallyl isocyanurate [1025-15-6]. NIEHS................ --subchronic toxicity..... --moderate production. --metabolism and --indirect food additive. pharmacokinetics (pending confirmation of significant production). ---------------------------------------------------------------------------------------------------------------- ---------------------------------------------------------------------------------------------------------------- Rationale; other Chemical [CAS Number] Nominated by Nominated for information ---------------------------------------------------------------------------------------------------------------- Chemical for Which No Testing is Recommended ---------------------------------------------------------------------------------------------------------------- Caffeic acid [331-39-5], Private individual... --carcinogenicty.......... --naturally occurring in Chlorogenic acid [327-97-9]. a wide variety of nutritionally important foods. --generally weak evidence of toxicity in existing studies. ---------------------------------------------------------------------------------------------------------------- Chemical Deferred for Additional Information ---------------------------------------------------------------------------------------------------------------- Dehydroepiandosterone (DHEA) [53- NCI; Private --Toxicological --widely used steroid 43-0]. individual. characterization. dietary supplement. --carcinogenicity......... --has FDA IND status. --reproductive toxicity... --metabolized to adrostenedione. --defer until results of androstendione studies available. ---------------------------------------------------------------------------------------------------------------- Chemicals to be Removed from Consideration ---------------------------------------------------------------------------------------------------------------- 2-Acetylpyridine [1122-62-9]...... NCI.................. --carcinogenicity......... --insufficient production and use to warrant testing. Cyanogen chloride [506-77-4]...... EPA.................. --metabolism.............. --rapid conversion to --carcinogenicity......... cyanide in blood. Diethylamine [109-89-7], NIEHS, NIEHS, UAW.... --subchronic inhalation --adequate NIOSH studies Isopropylamine [75-31-0], toxicity. of DEA and TEA. Triethylamine [121-44-8]. --ocular toxicity......... --too corrosive for humane study. --ocular irritation in workers already well documented. Ethidium bromide [1239-45-8]...... Private individual... --toxicological --already labeled as characterization. possible carcinogen. --carcinogenicity......... --few people exposed. Ethyl bromoacetate [105-36-2]..... NCI.................. --metabolism.............. --rapid hydrolysis in blood --animals would be distressed --other haloacetic acids being studies 4-Methoxy-N-methyl-1,8- NCI.................. --chemical disposition.... --unable to obtain napthalimide [3271-05-4]. material --Myrcene [123-35-3].............. NIEHS................ --metabolism.............. --unable to obtain --alkylating ability...... radiolabeled material Phenothiazine [92-84-2]........... NIEHS, NIOSH......... --toxicological --low production characterization. --no longer in --carcinogenicity......... agricultural or veterinary use Saw palmetto, Sitosterol [83-46-5] Private individual... --toxicological --low potential for characterization. reproductive toxicity --carcinogenicity......... --two-generation and 13- week studies available --subject of FDA-approved clinical trial [[Page 70792]] Trigonelline [535-83-1]........... Private individual... --subchronic toxicity..... --naturally occurring in --comparative metabolism.. 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 ---------------------------------------------------------------------------------------------------------------- Propargyl alcohol [107-19-7]...... NCI.................. --carcinogenicity......... --high production --widespread human exposure --subchronic study available --suspicion of carcinogenicty based on structure ---------------------------------------------------------------------------------------------------------------- [FR Doc. 98-33761 Filed 12-21-98; 8:45 am] BILLING CODE 4140-01-M