[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 
[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
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[FR Doc. 98-33761 Filed 12-21-98; 8:45 am]
BILLING CODE 4140-01-M