Federal Register, Volume 63 Issue 102 (Thursday, May 28, 1998)

[Federal Register Volume 63, Number 102 (Thursday, May 28, 1998)]
[Notices]
[Pages 29236-29238]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-14138]

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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 Toxicology 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 April 23, 1998, the ICCEC reviewed 18 agents
nominated to the NTP for consideration to study and recommended 11
chemicals for absorption, toxicity, or carcinogenicity studies,
recommended that no studies be performed on 4 chemicals, and deferred 3
substances pending receipt of test data from other organizations or
from related studies in progress by the NTP, and information on
production, exposure, and use patterns. Chemicals with CAS numbers,
nomination source types of studies under consideration, 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].

Dated: May 18, 1998.
Samuel H. Wilson,
Deputy Director, National Toxicology Program.

Attachment

[[Page 29237]]

Chemicals Nominated to the NTP for Study, and Testing Recommendations Made by the ICCEC on April 23, 1998
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Nominated Study rationale; other
Chemical [CAS No.] by Recommended for information
----------------------------------------------------------------------------------------------------------------
Chemicals Recommended for Testing
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Bixin (Annatto) [6973-79-5 NCI --Genetic toxicity --Widespread human exposure.
(1393-63-1)]. --Subchronic toxicity --Natural product.
Diethyl amine [109-89-7]..... NIEHS --Subchronic toxicity --High production.
--Ocular toxicity --Also present in foods.
--Carcinogenicity --Widespread human exposure.
Dihydroxyacetone [96-26-4]... NCI --Skin absorption --Widely used as component of
tanning compounds.
--Natural product of metabolism.
Fenchone, -, l-, d-, NCI --Genetic toxicity --Natural product.
[1195-79-5 (-); --Defer prechronic studies --Used as flavoring.
7787-20-4 (l-); 4695-62-9 (d- pending completion and --Widespread human exposure.
)]. evaluation of NTP camphor study --Production, usage, and exposure
data requested.
Isopropylamine [75-31-0]..... NIEHS --Subchronic toxicity --High production.
--Ocular toxicity --Also present in foods.
--Carcinogenicity (through TSCA- --Widespread human exposure.
ITC)
Pulegone [89-82-7] NIEHS --Toxicologic characterization --Natural product.
Menthofuran (494-90-6]. --Carcinogenicity study with --Used as flavoring.
pulegone --Widespread human exposure.
--Menthofuran is a metabolite of
pulegone.
-Solanine [20562-02- ^{(1) --Carcinogenicity --Natural product.
1. --Widespread human exposure.
--Known human toxicant.
-Thujone (546-80-5]. NCI --Genetic toxicity --Natural product.
--Neurotoxicity --Component of food flavoring
--Subchronic toxicity additives.
--Multigeneration reproductive --Banned as direct food additive
toxicity by FDA.
Triethylamine [121-44-8]..... UAW --Subchronic toxicity --High production.
--Ocular toxicity --Known worker exposure.
--Carcinogenicity (through TSCA-
ITC)
Trigonelline [535-83-1]...... ^{(1) --Toxicologic characterization --Plant hormone.
--Metabolic differences between --Widespread human exposure
humans and rodents through diet.
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\1\ Private Individual.

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Rationale; other
Chemical [CAS No.] Nominated by Recommended for information
----------------------------------------------------------------------------------------------------------------
Chemicals For Which No Testing Is Recommended
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-Caryophyllene [87-44- NCI............................... --Subchronic --Insufficient use to
5]. toxicity; warrant testing.
metabolism; cell
transformation;
consider for
carcinogenicity.
-Cubebene [17699-14- NCI............................... --metabolism......... --Insufficient use to
8]. warrant testing.
Orthanilic acid [88-21-1]..... NIEHS............................. --Carcinogenicity.... --Low production;
little, if any,
exposure to the
population.
2-Phenethyl alcohol (60-12-8]. ^{(1)............................... --Carcinogenicity.... --No suspicion for
carcinogenicity
based on structure
and genetic toxicity
tests.
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Chemicals Deferred for Additional Information
----------------------------------------------------------------------------------------------------------------
-Chaconine [20562-03- ^{(1)............................... --Carcinogenicity.... --Defer testing
2]. pending results of
-solanine
studies.
St John's Wort Hypericin [548- NCI............................... --Carnogenicity (St. --Herbal remedy in
04-9]. John's Wort); widespread use.
genetic toxicity and --NCI clinical trial
carcinogenicity in progress.
(hypericin). --Industry has
--Defer pending NTP completed subchronic
evaluation of toxicity studies and
carcinogenicity is completing a
testing being rodent
performed by carcinogenicity
industry. study using St.
John's Wort.
----------------------------------------------------------------------------------------------------------------
\1\ Private Individual.

[[Page 29238]]

[FR Doc. 98-14138 Filed 5-27-98; 8:45 am]
BILLING CODE 4140-01-M}}}}