National Institute of Environmental Health Sciences National Toxicology Program

[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]

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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
Eastin@NIEHS.NIH.GOV. The URL for the NTP homepage is https://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
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Study rationale; other
Chemical [CAS No.] Nominated by ICCEC recommendations information
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Chemicals Recommended for Testing
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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).
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Rationale; other
Chemical [CAS Number] Nominated by Nominated for information
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Chemical for Which No Testing is Recommended
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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.
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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.
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Chemicals to be Removed from Consideration
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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
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Chemical for Which Previous Testing Recommendation Has Been Modified
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Propargyl alcohol [107-19-7]...... NCI.................. --carcinogenicity......... --high production
--widespread human
exposure
--subchronic study
available
--suspicion of
carcinogenicty based on
structure
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[FR Doc. 98-33761 Filed 12-21-98; 8:45 am]
BILLING CODE 4140-01-M

National Institute of Environmental Health Sciences National Toxicology Program

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