[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.

------------------------------------------------------------------------
                              CAS registry                              
          Chemical                No.        Committee recommendations  
------------------------------------------------------------------------
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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