[Federal Register Volume 59, Number 214 (Monday, November 7, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-27468]
[[Page Unknown]]
[Federal Register: November 7, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
National Toxicology Program; Chemicals (6) Nominated for
Toxicological Studies; Request for Comments
SUMMARY: The National Toxicology Program (NTP) is soliciting public
comments on six chemicals nominated for toxicological studies. These
comments will assist the NTP in making informed decisions about whether
to perform toxicological testing on these chemicals.
FOR FURTHER INFORMATION CONTACT:
Dr. Errol Zeiger, AO-01; National Toxicology Program, NIEHS, P.O.
Box 12233, Research Triangle Park, NC l27709; (919) 541-4482.
SUPPLEMENTARY INFORMATION: The NTP was established in 1978 as a
cooperative effort within the Public Health Service of the Department
of Health and Human Services to coordinate toxicology research and
testing activities within the Department to provide information about
potentially toxic chemicals to regulatory and research agencies and the
public, and to strengthen the science base in toxicology. The chemical
nomination and selection process remains integral to the effective
operation and success of the NTP with respect to the testing of
chemicals using current methodologies, the validation of new testing
methodologies, and the evaluation of mechanisms of toxicity.
As part of the nomination and selection process, the NTP
Interagency Committee for Chemical Evaluation and Coordination (ICCEC)
(formerly the Chemical Evaluation Committee [CEC]), composed of
representatives from Federal agencies participating in the NTP,
evaluates chemicals nominated to the Program and makes recommendations
for study. Nominated chemicals which have been reviewed by the ICCEC
are published in the Federal Register with request for comment. The
purpose is to encourage active participation in the NTP chemical
evaluation process, thereby helping the NTP to make more informed
decisions as to whether to select, defer or reject chemicals for
toxicology study. Comments and data submitted in response to this
announcement will be reviewed by NTP technical staff for use in the
further evaluation of the nominated chemicals. The NTP chemical
nomination and selection process is summarized in the NTP FY 1993
Annual Report, pages 17-19.
On September 22, 1994, the ICCEC met to evaluate six chemicals
nominated to the NTP for toxicological studies. The following table
lists the chemicals, their Chemical Abstract Service (CAS) registry
numbers, and the types of toxicological studies recommended by the
ICCEC.
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CAS registry
Chemical No. Committee recommendations
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1. Dimethyl adipate......... 627-93-0 -Carcinogenicity
-Genotoxicity
-Sensory irritation
-Dermal subchronic
-Reproductive and
developmental effects
(other than rat)
-Neutrotox-
icity
-Metabolism and toxicity
(using human upper
respiratory tissues)
2. 2,3-Butanedione.......... 431-03-8 -Carcinogenicity
-Metabolism
-In vivo genotoxicity
3. 2,2'-Dipyridyl........... 366-18-7 -No testing
4. Methyl styryl............ 122-57-6 -Metabolism
-Pharma-
cokinetics
-In vivo genotoxicity
-Mechanistic studies
5. N-Bromosuc- cinimide..... 128-08-5 -No testing
6. 5-Nitroindazole.......... 5401-94-5 -No testing
------------------------------------------------------------------------
The ICCEC also recommended that two chemicals, ecdysterone and 2,3-
dichloropropylene, be removed from consideration for testing at this
time based on lack of evidence of human exposure with the understanding
that these chemicals may be reconsidered at a later date if actual
human exposure is demonstrated.
Interested parties are requested to submit pertinent information on
all of the nominated chemicals. The following types of data are of
particular relevance:
(1) Modes of production, present production levels, and
occupational exposure potential;
(2) Uses and resulting exposure levels, where known;
(3) Completed, ongoing and/or planned toxicological testing in the
public or private sector including detailed experimental protocols and
results; and
(4) Results of toxicological studies of structurally related
compounds.
Please submit all information in writing (by 30 days after date of
publication) to Dr. Zeigler by mail or by FAX, (919) 541-4704. Any
submissions received after the above date will be accepted and utilized
if possible.
Dated: October 31, 1994.
Richard A. Griesemer,
Deputy Director, NIEHS.
[FR Doc. 94-27468 Filed 11-4-94; 8:45 am]
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