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[Federal Register: September 11, 1997 (volume 62, Number 176)]
[Notices]
[Page 47821-47822]


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 Further Supporting Information

Background

As part of an effort to earlier inform and obtain public 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 Interagency Committee for Chemical Evaluation and Coordination (ICCEC). Summaries of the ICCEC's recommendations and public comments received on the nominated chemicals are next presented to the NTP Board of Scientific Counselors for their review and comment in an open, public session. ICCEC recommendations, Board recommendations, and public comments are incorporated into recommendations that are then submitted to the NTP Executive Committee. The Executive Committee reviews and approves action to move forward to test, defer, or delete each of the nominated chemicals for the various types of study, and recommends priorities.

Request for Comment

Interested parties are encouraged to comment 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 its meeting on August 15, 1997, the ICCEC reviewed and recommended 4 chemicals or substances for toxicity and/or carcinogenicity studies, recommended that no studies be performed on 5 chemicals, and deferred 4 chemicals pending receipt of test data from other agencies, and additional information on production, exposure, and use patterns. Chemicals with CAS numbers, nomination source, types of studies recommended, and other supporting information, are given in the following tables.

Comments may be forwarded 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) 541-4714; or by email at Eastin@NIEHS.NIH.GOV.

Dated: August 29, 1997

______________________________
Kenneth Olden, Ph.D.
Director, National Toxicology Program


Chemicals Nominated to the NTP for Study and Testing
Recommendations Made by the ICCEC on August 15, 1997

Chemicals Recommended for Testing

Chemical CASRNNomin. by recommended for Rationale; other info.
Asphalt fumes 8052-42-4 NIOSH;
Calif.
- 28-day toxicological assessment
- pulmonary function and irritation
- biomarkers of exposure
- high exposure

- lack of adequate short term toxicity information

- need to identify biomarkers of exposure

Luminol
(o-Aminophthalic hydrazide)
521-31-3 private indiv.; NIOSH - toxicity
- carcinogenicity
- in vivo genetic toxicity
- widespread use and potential for exposure
Orthanilic acid 88-21-1NIEHS - short-term toxicity studies - high production

- very little toxicology data available

Phenothiazine 92-84-2NIEHS - carcinogenicity - high production and exposure
- no carcinogenicity data available

Chemicals for Which No Testing is Recommended

Chemical CASRNNomin. by Recommendeded for Rationale; other info.
Dicyclopentadiene 77-73-6NCI - reproductive toxicity
- carcinogenicity
- no adverse effects seen in teratology tests
- not mutagenic in Salmonella
- low potential for human exposure
C.I. Direct Black 80 8003-69-8NCI - carcinogenicity by dermal route - dermal absorption too low (1.3%) to support a study
Ethyl cyanoacrylate 7085-85-0NCI - reproductive and developmental toxicity
- neurotoxicity
- carcinogenicity
- stable aerosol cannot be generated
- rapidly polymerizes in presence of atmospheric moisture
Isoamyl acetate 123-92-2NIEHS - toxicity
- neurotoxicity
- carcinogenicity
- rapidly hydrolyzed in blood to isoamyl alcohol, which has been studied, and acetic acid
2,4,6-Tribromophenol 118-79-6NIEHS - carcinogenicity - low production and exposure
- little chance for bioaccumulation

Chemicals Deferred for Additional Information

Chemical CASRNNomin. by Recommended for Rationale; other info.
3-Amino-5-
mercapto-1,2,4-
triazole
16691-43-3NIEHS toxicity; carcinogenicity - high production
- suspect chemical structure
Diethylamine 109-89-7NIEHS toxicity; carcinogenicity - high production and exposure
- very little toxicology data available
- not mutagenic in Salmonella
Isopropylamine 75-31-0NIEHS toxicity; carcinogenicity - high production and exposure
- very little toxicology data available
- not mutagenic in Salmonella
Triethylamine 121-44-8UAW; NIEHS carcinogenicity - high production and exposure
- not mutagenic in Salmonella

[FR Doc. 97-24048 Filed 9-10-97; 8:45 am]
[Billing Code 4140-01-P]