National Toxicology Program

[Federal Register: May 28, 1998 (Volume 63, Number 102)]
[Notices]
[Page 29236-29238]

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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 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 11chemicals 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 Eastin@NIEHS.NIH.GOV.

Dated: May 18, 1998

_______________________
Samuel H. Wilson, M.D.
Deputy Director
National Toxicology Program

[Billing Code 4140-01-P]

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Attachment

Chemicals Nominated to the NTP for Study, and
Testing Recommendations made by the ICCEC on April 23, 1998

Chemicals Recommended for Testing:

Chemical [CAS Number]	Nominated by	Recommended for	Study Rationale; Other Information
Bixin (Annatto) [6973-79-5 (1393-63-1)]	NCI	- genetic toxicity - subchronic toxicity	- widespread human exposure - natural product
Diethyl amine [109-89-7]	NIEHS	- subchronic toxicity - ocular toxicity - carcinogenicity	- high production - also present in foods - widespread human exposure
Dihydroxyacetone [96-26-4]	NCI	- skin absorption	- widely used as component of tanning compounds - natural product of metabolism
Fenchone, a-, l-, d- [1195-79-5 (a-); 7787-20-4 (l-); 4695-62-9 (d-)]	NCI	- genetic toxicity - defer prechronic studies pending completion and evaluation of NTP camphor study	- natural product - used as flavoring - widespread human exposure - production, usage, and exposure data requested
Isopropylamine [75-31-0]	NIEHS	- subchronic toxicity - ocular toxicity - carcinogenicity (through TSCA-ITC)	- high production - also present in foods - widespread human exposure
Pulegone [89-82-7] Menthofuran [494-90-6]	NIEHS	- toxicologic characterization - carcinogenicity study with pulegone	- natural product - used as flavoring - widespread human exposure - menthofuran is a metabolite of pulegone
a-Solanine [20562-02-1]	Private Individual	- carcinogenicity	- natural product - widespread human exposure - known human toxicant
a-Thujone [546-80-5]	NCI	- genetic toxicity - neurotoxicity - subchronic toxicity - multigeneration reproductive toxicity	- natural product - component of food flavoring additives - banned as direct food additive by FDA
Triethylamine [121-44-8]	UAW	- subchronic toxicity - ocular toxicity - carcinogenicity (through TSCA-ITC)	- high production - known worker exposure
Trigonelline [535-83-1]	Private Individual	- toxicologic characterization - metabolic differences between humans and rodents	- plant hormone - widespread human exposure through diet

Chemicals for Which No Testing is Recommended:

Chemical [CAS Number]	Nominated by	Nominated for	Rationale; Other Information
b-Caryophyllene [87-44-5]	NCI	- subchronic toxicity; metabolism; cell transformation; consider for carcinogenicity	- Insufficient use to warrant testing
a-Cubebene [17699-14-8]	NCI	- metabolism	- Insufficient use to warrant testing
Orthanilic acid [88-21-1]	NIEHS	- carcinogenicity	- low production; little, if any, exposure to the population
2-Phenethyl alcohol [60-12-8]	Private Individual	- carcinogenicity	- no suspicion for carcinogenicity based on structure and genetic toxicity tests

Chemicals Deferred for Additional Information:

Chemical [CAS Number]	Nominated by	Nominated for	Rationale; Other Information
a-Chaconine [20562-03-2]	Private Individual	- carcinogenicity	- defer testing pending results of a-solanine studies
St. John's Wort Hypericin [548-04-9]	NCI	- carcinogenicity (St. John's Wort); genetic toxicity and carcinogenicity (hypericin) - defer pending NTP evaluation of carcinogenicity test being performed by industry	- herbal remedy in widespread use - NCI clinical trial in progress - industry has completed subchronic toxicity studies and is completing a rodent carcinogenicity study using St. John's Wort.