[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 
<a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="9edbffedeaf7f0ded0d7dbd6cdb0d9d1c8">[email protected]</a>.

    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   
----------------------------------------------------------------------------------------------------------------
                                Nominated                                            Study rationale; other     
      Chemical [CAS No.]            by               Recommended for                      information           
----------------------------------------------------------------------------------------------------------------
                                        Chemicals Recommended for Testing                                       
----------------------------------------------------------------------------------------------------------------
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, <greek-a>-, l-, d-,  NCI          --Genetic toxicity                 --Natural product.               
 [1195-79-5 (<greek-a>-);                   --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.                       
<greek-a>-Solanine [20562-02-  <SUP>(1)          --Carcinogenicity                  --Natural product.               
 1.                                                                            --Widespread human exposure.     
                                                                               --Known human toxicant.          
<greek-a>-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]......  <SUP>(1)          --Toxicologic characterization     --Plant hormone.                 
                                            --Metabolic differences between    --Widespread human exposure      
                                             humans and rodents                 through diet.                   
----------------------------------------------------------------------------------------------------------------
\1\ Private Individual.                                                                                         


                                                                                                                
----------------------------------------------------------------------------------------------------------------
                                                                                              Rationale; other  
      Chemical [CAS No.]                   Nominated by                Recommended for          information     
----------------------------------------------------------------------------------------------------------------
                                  Chemicals For Which No Testing Is Recommended                                 
----------------------------------------------------------------------------------------------------------------
<greek-b>-Caryophyllene [87-44- NCI...............................  --Subchronic           --Insufficient use to
 5].                                                                 toxicity;              warrant testing.    
                                                                     metabolism; cell                           
                                                                     transformation;                            
                                                                     consider for                               
                                                                     carcinogenicity.                           
<greek-a>-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].  <SUP>(1)...............................  --Carcinogenicity....  --No suspicion for   
                                                                                            carcinogenicity     
                                                                                            based on structure  
                                                                                            and genetic toxicity
                                                                                            tests.              
----------------------------------------------------------------------------------------------------------------
                                  Chemicals Deferred for Additional Information                                 
----------------------------------------------------------------------------------------------------------------
<greek-a>-Chaconine [20562-03-  <SUP>(1)...............................  --Carcinogenicity....  --Defer testing      
 2].                                                                                        pending results of  
                                                                                            <greek-a>-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


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