[Federal Register Volume 60, Number 159 (Thursday, August 17, 1995)]
[Notices]
[Pages 42982-42988]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-20422]




[[Page 42981]]

_______________________________________________________________________

Part V





Environmental Protection Agency





_______________________________________________________________________



Thirty-Sixth Report of the TSCA Interagency Testing Committee to the 
Administrator; Receipt of Report, Request for Comments, Solicitation of 
Use and Exposure Data; Notice

  Federal Register / Vol. 60, No. 159 / Thursday, August 17, 1995 / 
Notices  
=======================================================================
-----------------------------------------------------------------------

[[Page 42982]]


ENVIRONMENTAL PROTECTION AGENCY

[OPPTS-41043; FRL-4965-6]


Thirty-Sixth Report of the TSCA Interagency Testing Committee to 
the Administrator; Receipt of Report, Request for Comments, 
Solicitation of Use and Exposure Data

AGENCY: Environmental Protection Agency (EPA).
ACTION:  Notice.

-----------------------------------------------------------------------

SUMMARY: The TSCA Interagency Testing Committee (ITC), established 
under section 4(e) of the Toxic Substances Control Act (TSCA), 
transmitted its Thirty-Sixth Report to the Administrator of EPA on May 
23, 1995. This Report, included with this notice, adds no chemicals to 
the Priority Testing List for consideration by the EPA Administrator 
for promulgation of test rules under section 4(a) of the Act. In this 
Report the ITC recommended 12 High Production Volume Chemicals (HPVCs) 
for an information solicitation. The ITC removed cyclohexanone, a 
previously-designated chemical, and 34 previously-recommended chemicals 
from the List: butyraldehyde, 9 chloroalkyl phosphates, sulfonyl bis(4-
chlorobenzene), m-dinitrobenzene, 4 cyanoacrylates, 2 methyl ethylene 
glycol ethers and esters, 11 propylene glycol ethers and esters, and 5 
HPVCs. The ITC's reasons for removing these chemicals from the List are 
listed in the Thirty-Sixth Report. EPA invites interested persons to 
submit written comments on the Report.
DATES: Written comments on the Thirty-Sixth ITC Report should be 
submitted by September 18, 1995.
ADDRESS: Send six copies of written submissions to: TSCA Public Docket 
Office (7407), Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, Rm. G-99 ET, 401 M St., SW., Washington, DC 20460. 
Submissions should bear the document control number OPPTS-41043.
    The public record supporting this action, including comments, is 
available for public inspection in Rm. B-607 NEM at the address noted 
above from 12 noon to 4 p.m., Monday through Friday, except legal 
holidays.
    Comments and data may also be submitted electronically by sending 
electronic mail (e-mail) to: [email protected]. Electronic comments 
must be submitted as an ASCII file avoiding the use of special 
characters and any form of encryption. Comments and data will also be 
accepted on disks in WordPerfect in 5.1 file format or ASCII file 
format. All comments and data in electronic form must be identified by 
the docket number OPPT-41043. No CBI should be submitted through e-
mail. Electronic comments on this notice may be filed online at many 
Federal Depository Libraries. Additional information on electronic 
submissions can be found in Unit III of this document.
FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director, 
Environmental Assistance Division (7408), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 401 M Street, 
SW., Rm. E-543B, Washington, DC 20460, (202) 554-1404, TDD (202) 554-
0551, Internet: TSCA-H[email protected].
SUPPLEMENTARY INFORMATION:  EPA has received the TSCA Interagency 
Testing Committee's Thirty-Sixth Report to the Administrator.

I. Background

    TSCA (Pub. L. 94-469, 90 Stat. 2003 et seq; 15 U.S.C. 260l et seq.) 
authorizes the Administrator of EPA to promulgate regulations under 
section 4(a) requiring testing of chemicals and chemical groups in 
order to develop data relevant to determining the risks that such 
chemicals and chemical groups may present to health or the environment. 
Section 4(e) of TSCA established the Interagency Testing Committee to 
recommend chemicals and chemical groups to the Administrator of EPA for 
priority testing consideration. Section 4(e) directs the ITC to revise 
the TSCA section 4(e) Priority Testing List at least every 6 months. 
The most recent revisions to this List are included in the ITC's 
Thirty-Sixth Report. The Report was received by the Administrator on 
May 23, 1995, and is included in this Notice. The Report solicits use 
and exposure data for 12 HPVCs, and removes cyclohexanone, a 
previously-designated chemical, and 34 previously-recommended chemicals 
from the List.

II. Status of List

    The ITC's Thirty-Sixth Report requests certain use and exposure 
data for 12 HPVCs, and removes one previously-designated chemical, and 
34 previously-recommended chemicals from the List. The current TSCA 
section 4(e) Priority Testing List contains 5 chemicals and 8 chemical 
groups, with 3 chemical groups and 3 chemicals designated for testing.

III. Electronic and Written Comments

    EPA invites interested persons to submit detailed comments on the 
ITC's Report. A record has been established for this notice under 
docket number ``OPPTS-41043'' (including comments and data submitted 
electronically as described below). A public version of this record, 
including printed, paper versions of electronic comments, which does 
not include any information claimed as confidential business 
information (CBI), is available for inspection from 12 noon to 4 p.m., 
Monday through Friday, excluding legal holidays. The public record is 
located in the TSCA Nonconfidential Information Center, Rm. NE-B607, 
401 M St., SW., Washington, DC 20460.
    Electronic comments can be sent directly to EPA at:
    [email protected]


    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption.
    The official record for the Thirty-Sixth Report, as well as the 
public version as described above, will be kept in paper form. 
Accordingly, EPA will transfer all comments received electronically 
into printed, paper form as they are received and will place the paper 
copies in the official record which will also include all comments 
submitted directly in writing. The official record is the paper record 
maintained at the address in ``ADDRESSES'' at the beginning of this 
document.
    Authority: 15 U.S.C. 2603.

    Dated: August 11, 1995.

Paul J. Campanella,

Acting Director, Chemical Control Division, Office of Pollution 
Prevention and Toxics.

Thirty-Sixth Report of the TSCA Interagency Testing Committee to 
the Administrator

Summary

    This is the 36th Report of the TSCA Interagency Testing Committee 
(ITC) to the Administrator of the U.S. Environmental Protection Agency 
(EPA). In this Report, the ITC is revising its TSCA section 4(e) 
Priority Testing List by soliciting use and exposure data for 12 High 
Production Volume Chemicals (HPVCs), removing a previously-designated 
chemical, cyclohexanone, and removing 34 previously-recommended 
chemicals: butyraldehyde, 9 chloroalkyl phosphates, sulfonyl bis(4-
chlorobenzene), m-dinitrobenzene, 4 cyanoacrylates, 2 methyl ethylene 
glycol ethers and esters, 11 propylene glycol ethers and esters, and 5 
HPVCs.
    The revised TSCA section 4(e) Priority Testing List follows as 
Table 1.

                                                                        

[[Page 42983]]
    Table 1.--The TSCA Section 4(e) Priority Testing List (May 1995)    
------------------------------------------------------------------------
   Report           Date            Chemical/Group           Action     
------------------------------------------------------------------------
                                                                        
26.........  May 1990           15 Isocyanates          Recommended with
                                                                        
27.........  November 1990      62 Aldehydes            Recommended with
                                                         intent-to-     
                                                         designate      
                                                                        
28.........  May 1991           Acetone                 Designated      
                                                                        
28.........  May 1991           Thiophenol              Designated      
                                                                        
29.........  November 1991      10 Alkyl-, bromo-,      Recommended     
                                 chloro-,                               
                                 hydroxymethyl diaryl                   
                                 ethers                                 
                                                                        
30.........  May 1992           56 Siloxanes            Recommended     
                                                                        
31.........  January 1993       24 Chemicals with no    Designated      
                                 dermal toxicity data                   
                                                                        
32.........  May 1993           32 Chemicals with       Designated      
                                 insufficient dermal                    
                                 absorption data                        
                                                                        
34.........  May 1994           White phosphorus        Designated      
                                                                        
34.........  May 1994           Ethyl tert-butyl ether  Recommended     
                                                                        
34.........  May 1994           Tert-amyl methyl ether  Recommended     
                                                                        
35.........  November 1994      24 Chemicals with       Designated      
                                 insufficient dermal                    
                                 absorption data                        
                                                                        
36.........  May 1995           12 High Production      Recommended     
                                 Volume Chemicals:                      
                                 Solicitation for Use                   
                                 and Exposure Data                      
------------------------------------------------------------------------



I. Background

    The TSCA Interagency Testing Committee (ITC) was established by 
section 4(e) of the Toxic Substances Control Act (TSCA) ``to make 
recommendations to the Administrator respecting the chemical substances 
and mixtures to which the Administrator should give priority 
consideration for the promulgation of a rule for testing under section 
4(a).... At least every 6 months..., the Committee shall make such 
revisions in the List as it determines to be necessary and to transmit 
them to the Administrator together with the Committee's reasons for the 
revisions'' (Public Law 94-469, 90 Stat. 2003 et seq., 15 U.S.C. 2601 
et seq.). Since its creation in 1976, the ITC has submitted 35 semi-
annual Reports to the EPA Administrator transmitting the Priority 
Testing List and its revisions. These Reports have been published in 
the Federal Register and are available from the ITC. The ITC meets 
monthly and produces its revisions of the List with the help of staff 
and technical contract support provided by EPA. ITC membership and 
support personnel are listed at the end of this Report.
    Following receipt of the ITC's Report and the addition of chemicals 
to the Priority Testing List, EPA's Office of Pollution Prevention and 
Toxics generally adds new chemicals from the List to TSCA section 8(a) 
and 8(d) rules that require manufacturers and importers of these 
chemicals to submit TSCA section 8(a) production and exposure data and 
manufacturers, importers and processors of the listed chemicals to 
submit TSCA section 8(d) health and safety studies within 60 days of 
the rule's effective date. The submissions are indexed and maintained 
by EPA. The ITC reviews the TSCA section 8(a) and 8(d) information and 
other available data on chemicals and chemical groups (e.g., TSCA 
section 8(e) ``substantial risk'' studies, ``For Your Information'' 
(FYI) submissions to EPA, and published papers) to determine if 
revisions to the List are necessary. Revisions can include changing a 
recommendation to a designation for testing action by the EPA 
Administrator within 12 months, modifying the recommended testing, or 
removing the chemical or chemical group from the List.

II. Revisions to the TSCA Section 4(e) Priority Testing List

    Revisions to the TSCA section 4(e) Priority Testing List are 
summarized in the following Table 2:

   Table 2.--Revisions to the TSCA section 4(e) Priority Testing List   
                      (November 1994 to April 1995)                     
------------------------------------------------------------------------
      CAS No.         Chemical/Group        Action             Date     
------------------------------------------------------------------------
                                                                        
  .................   High Production  Solicit use and   5/95           
                                                                        
80-51-3............    p,p'-                                            
                      Oxybis(benzenes                                   
                      ulfonyl                                           
                      hydrazide)                                        
                                                                        
81-84-5............    Naphthalene                                      
                      dicarboxylic                                      
                      anhydride                                         
                                                                        
99-54-7............    3,4-                                             
                      Dichloronitrobe                                   
                      nzene                                             
                                                                        
100-29-8...........    4-                                               
                      Ethoxynitrobenz                                   
                      ene                                               
                                                                        
111-96-6...........    Diethylene                                       
                      glycol dimethyl                                   
                      ether                                             
                                                                        
112-15-2...........    Diethylene                                       
                      glycol                                            
                      monoethyl ether                                   
                      acetate                                           
                                                                        
119-33-5...........    4-Methyl-2-                                      
                      nitrophenol                                       
                                                                        
121-60-8...........    4-                                               
                      (Acetylamino)be                                   
                      nzenesulfonyl                                     
                      chloride                                          
                                                                        
594-42-3...........    Trichlorometha                                   
                      ne sulfenyl                                       
                      chloride                                          
                                                                        

[[Page 42984]]
                                                                        
626-17-5...........    1,3-                                             
                      Dicyanobenzene                                    
                                                                        
929-06-6...........    2-(2-                                            
                      Aminoethoxy)eth                                   
                      anol                                              
                                                                        
3089-11-0..........    Hexa(methoxyme                                   
                      thyl) melamine                                    
                                                                        
  .................   High Production  Remove            5/95           
                           Volume       previously                      
                         Chemicals      recommended                     
                                        chemicals                       
                                                                        
90-15-3............     1-Naphthol                                      
                                                                        
94-28-0............    Triethylene                                      
                      glycol bis(2-                                     
                      ethylhexanoate)                                   
                                                                        
97-88-1............    n-Butyl                                          
                      methacrylate                                      
                                                                        
106-63-8...........    Isobutyl                                         
                      acrylate                                          
                                                                        
142-16-5...........    Bis(2-                                           
                      ethylhexyl)-2-                                    
                      butenedioate                                      
                                                                        
  .................     Chloroalkyl    Remove            5/95           
                         phosphates     previously                      
                                        recommended                     
                                        chemicals                       
                                                                        
115-96-8...........    Tris(2-                                          
                      chloroethyl)                                      
                      phosphate                                         
                                                                        
6145 -73-9.........    Tris(2-chloro-                                   
                      1-propyl)                                         
                      phosphate                                         
                                                                        
13674-84-5.........    Tris(2-                                          
                      chloroisopropyl                                   
                      ) phosphate                                       
                                                                        
13674-87-8.........    Tris(1,3-                                        
                      dichloro-2-                                       
                      propyl)                                           
                      phosphate                                         
                                                                        
33125-86-9.........    Tetrakis(2-                                      
                      chloroethyl)                                      
                      ethylene                                          
                      diphosphate                                       
                                                                        
34621-99-3.........    1,2-Ethanediyl                                   
                      tetrakis(2-                                       
                      chloro-1-                                         
                      methylethyl)                                      
                      phosphate                                         
                                                                        
38051-10-4.........    2,2-                                             
                      Bis(chloromethy                                   
                      l) 1,3-                                           
                      propanediyl                                       
                      tetrakis(2-                                       
                      chloroethyl)                                      
                      phosphate                                         
                                                                        
53461-82-8.........    Oxydi-2,1-                                       
                      ethanediyl                                        
                      tetrakis(2-                                       
                      chloroethyl)                                      
                      phosphate                                         
                                                                        
76649-15-5.........     2-Chloro-1-                                     
                      methylethyl bis-                                  
                      (2-                                               
                      chloropropyl)                                     
                      phosphate                                         
                                                                        
  .................   Cyanoacrylates   Remove            5/95           
                                        previously                      
                                        recommended                     
                                        chemicals                       
                                                                        
137-05-3               2-Propenoic                                      
                      acid, 2-cyano-,                                   
                      methyl ester                                      
                                                                        
6197-30-4..........     2-propenoic                                     
                      acid, 2-cyano-                                    
                      3,3-diphenyl-,2-                                  
                      ethylhexyl                                        
                      ester                                             
                                                                        
7085-85-0..........     2-propenoic                                     
                      acid, 2-cyano-,                                   
                      ethyl ester                                       
                                                                        
64992-16-1.........    Ethanaminium,                                    
                      2-[[2-cyano-3-                                    
                      [4-                                               
                      (diethylamino)p                                   
                      henyl]-1-oxo-2-                                   
                      propenyl]oxy]-                                    
                      N,N,N-trimethyl-                                  
                      , chloride                                        
                                                                        
  .................  Propylene glycol  Remove            5/95           
                         ethers and     previously                      
                           esters       recommended                     
                                        chemicals                       
                                                                        
  108-65-6.........    Propylene                                        
                      glycol                                            
                      monomethyl                                        
                      ether acetate                                     
                                                                        
110-98-5...........     Dipropylene                                     
                      glycol                                            
                                                                        
770-35-4...........     1-Phenoxy-2-                                    
                      propanol                                          
                                                                        
20324-32-7.........     Dipropylene                                     
                      glycol methyl                                     
                      ether                                             
                                                                        
20324-33-8.........     Tripropylene                                    
                      glycol methyl                                     
                      ether                                             
                                                                        
28677-93-2.........     Methoxy-1-                                      
                      propanol                                          
                                                                        
29387-86-8.........     Propylene                                       
                      glycol                                            
                      monobutyl ether                                   
                                                                        
29911-28-2.........     Dipropylene                                     
                      glycol butyl                                      
                      ether                                             
                                                                        
42978-66-5.........     Tripropylene                                    
                      glycol                                            
                      diacrylate                                        
                                                                        
57018-52-7.........     Propylene                                       
                      glycol mono-                                      
                      tert-butyl                                        
                      ether                                             
                                                                        
88917-22-0.........     Dipropylene                                     
                      glycol                                            
                      monomethyl                                        
                      ether acetate                                     
                                                                        
  .................   Methyl ethylene  Remove            5/95           
                       glycol ethers    previously                      
                         and esters     recommended                     
                                        chemicals                       
                                                                        
  3121-67-7........    Ethylene                                         
                      glycol methyl                                     
                      ether acrylate                                    
                                                                        
23783-42-8.........    Tetraethylene                                    
                      glycol methyl                                     
                      ether                                             
                      Other Chemicals                                   
                                                                        
80-07-9                Sulfonyl bis(4- Remove            5/95           
                      chlorobenzene)    previously                      
                                        recommended                     
                                        chemical                        
                                                                        
99-65-0                m-              Remove            5/95           
                      Dinitrobenzene    previously                      
                                        recommended                     
                                        chemical                        
                                                                        
108-94-1               Cyclohexanone   Remove            5/95           
                                        previously                      
                                        recommended                     
                                        chemical                        
                                                                        
123-72-8               Butyraldehyde   Remove            5/95           
                                        previously                      
                                        recommended                     
                                        chemical                        
------------------------------------------------------------------------

                                                          

[[Page 42985]]


III. Rationale for the revisions

A. ITC's Activities During this Reporting Period

    During the 6 months covered by this Report, November 1994 through 
April 1995, the ITC reviewed TSCA section 8(a) and 8(d) data, use data 
that were solicited from manufacturers, and toxicology data obtained 
from published papers, for 17 HPVCs that were previously recommended as 
chemicals in need of subchronic (90-day) toxicity data in the ITC's 
27th Report (56 FR 9534, March 6, 1991). The ITC also reviewed 
available data for butyraldehyde and 5 chloroalkyl phosphates that were 
recommended in the 23rd Report (53 FR 46262, November 16, 1988); for 
sulfonyl bis(4-chlorobenzene) that was recommended, as a member of the 
sulfone group, in the 27th Report; for m-dinitrobenzene and 4 
cyanoacrylates that were recommended in the 28th Report (56 FR 41212, 
August 19, 1991); for 4 chloroalkyl phosphates that were recommended in 
the 30th Report (57 FR 30608, July 9, 1992); for 2 methyl ethylene 
glycol ethers and esters and 11 propylene glycol ethers and esters that 
were recommended in the 31st Report (58 FR 26898, May 5, 1993); and for 
cyclohexanone that was designated in the 35th Report (59 FR 67596, 
December 29, 1994).

B. Specific Rationales

    1. Recommended chemicals--a. HPVCs. A group of 35 HPVCs that did 
not have 90-day subchronic toxicity test data were recommended by the 
ITC in its 27th Report (56 FR 9534, March 6, 1991). For these HPVCs, 
i.e., chemicals with domestic production or importation volumes greater 
than 1 million pounds, the ITC reviewed an extensive amount of 
production, importation, use, exposure and health and safety data, as 
noted in the 35th Report. After reviewing these data and considering 
the data needs of U.S. Government organizations represented on the ITC, 
the ITC removed 18 of these chemicals from the Priority Testing List in 
its 35th Report. To facilitate development of the ITC's testing 
decisions regarding designations for the 12 HPVCs listed in Table 2 of 
this Report, the ITC needs to know specific uses of the chemical, 
including use as an intermediate in industrial processes (with 
descriptions of those processes) and use as an end product (including 
use as an industrial or consumer end product). For each use, the ITC 
needs to know the estimated number of workers or consumers that may be 
exposed to the chemical and the estimated worker, consumer, and 
environmental exposure levels. The ITC also needs an estimate of the 
quantities of diethylene glycol dimethyl ether (CAS No. 111-96-6) used 
as a solvent in semiconductor clean rooms.
    The use and exposure data needed by the ITC should be submitted to 
the ITC Executive Director at the address provided at the end of this 
Report. The ITC will review all data that are received within 60 days 
of the date this 36th ITC Report is published in the Federal Register, 
and will use these data to determine if any of these HPVC should be 
designated for testing or removed from the Priority Testing List.
    2. Removal of chemicals from the Priority Testing List-- a. HPVCs. 
The ITC is removing 5 HPVCs from the Priority Testing List (Table 2).
    1-Naphthol (CAS No. 90-15-3) is being removed because there are 
sufficient data to reasonably determine or predict effects and no 
additional U.S. Government data needs were identified.
    Two acrylate derivatives, n-butyl methacrylate (CAS No. 97-88-1) 
and isobutyl acrylate (CAS No. 106-63-8) are being removed because some 
ecological effects, chemical fate and health effects screening data 
have been developed, other testing is ongoing or scheduled and there 
are no current U.S. government data needs.
    Two ethylhexyl derivatives, triethylene glycol bis(2-
ethylhexanoate) (CAS No. 94-28-0) and bis(2-ethylhexyl)2-butenedioate 
(CAS No. 142-16-5) are being removed because testing to elucidate the 
relationship between peroxisomal proliferation caused by chemicals 
containing ethylhexyl substructures and cancer is ongoing and because 
there are no current U.S. Government data needs.
    b. Butyraldehyde. Butyraldehyde (CAS No. 123-72-8) was recommended 
for testing in the 23rd Report (53 FR 46262, November 16, 1988). The 
ITC recommended that environmental monitoring be conducted in the 
vicinity of major manufacturing and use sites, and that in-depth health 
and ecological effects studies be conducted, if warranted by monitoring 
data.
    The ITC was particularly concerned about potential reproductive and 
developmental effects, and, in its 23rd Report, included a discussion 
of studies conducted by Moutschen-Dahmen et al. (1975, 1976). The 1975 
study demonstrated that a single intraperitoneal injection of 1 mg 
butyraldehyde per animal produced chromosomal damage and meiotic 
anomalies, including degenerative nuclei, multispindle cells and 
polyploid cells at all stages of spermatogenesis in male mice 1 month 
following the treatment. The 1976 study examined one group of male mice 
that received a single intraperitoneal dose of 30 mg butyraldehyde per 
kg, and a second group that received 0.2 mg/L in their drinking water 
for 50 days. Administration of butyraldehyde by either route damaged 
the spermatogenic cells of the seminiferous tubules. In addition to 
gross degeneration, polyploidy was observed at all stages of 
spermatogenesis and abnormal pairing of sex chromosomes occurred at 
metaphase I; there was also an increased incidence, in the vas 
deferens, of spermatozoa without acrosomes.
    Three events, related to butyraldehyde, occurred after the 23rd 
Report was published. First, the ITC received comments from the 
Butyraldehyde Task Group of the Chemical Manufacturers Association 
(CMA). Second, butyraldehyde was selected for review as part of the 
Organisation for Economic Cooperation and Development (OECD) Screening 
Information Data Set (SIDS) program and an OECD SIDS dossier was 
developed by the CMA's Oxo Process Panel. Third, the ITC learned that 
the National Toxicology Program (NTP) had sponsored a reproductive 
screening test of butyraldehyde.
    The ITC received comments from the CMA's Butyraldehyde Task Group 
in 1989, 1993 and 1995 (CMA, 1989, 1993, 1995a,b). In 1989, the CMA 
commented that butyraldehyde environmental releases were below the 
levels reported by the ITC that were based on the 1987 Toxic Release 
Inventory (TRI) and that numbers of exposed workers were less than 
estimates based on the National Occupational Exposure Survey (NOES) 
data (CMA, 1989). The Task Group stated that the NOES projection of 
5,392 workers overestimated the number of workers potentially exposed 
to butyraldehyde. The Task Group estimated that no more than 500 to 600 
workers are potentially exposed to butyraldehyde at manufacturing and 
processing facilities. In addition, the CMA reported that 
concentrations of butyraldehyde to which workers and the general 
population were exposed were less than 1 part per million and 1 part 
per billion, respectively (CMA, 1989). In 1993, the CMA reported that, 
based on 1988 and 1991 TRI reporting, environmental releases of 
butyraldehyde were decreasing (CMA, 1993). In 1995, the CMA reported 
that, based on 1992 TRI reporting, environmental releases of 
butyraldehyde were about 25% of 1987 TRI releases, and that 
butyraldehyde's offensive odor and low odor threshold should mitigate 
the potential for 

[[Page 42986]]
significant worker exposures (CMA, 1995a).
    The February 1993 OECD SIDS butyraldehyde dossier noted in the 
section on reproductive and developmental toxicity that no data were 
submitted. However, in the section on genetic toxicity, the dossier 
referenced the 1975 and 1976 Moutschen-Dahmen et al. studies that were 
discussed in the 23rd Report. The dossier was discussed at a September 
1993 OECD SIDS meeting and the participants agreed that no additional 
testing should be required for butyraldehyde and that dossiers should 
be prepared for propionaldehyde and isobutyraldehyde. At that meeting, 
it was noted that reproductive and developmental toxicity data were not 
available for butyraldehyde, but that data from analogs could be used 
to predict toxicity. Dossiers for propionaldehyde and isobutyraldehyde 
were discussed at the February 1995 OECD SIDS Initial Assessment 
Meeting (SIAM). At this SIAM, propionaldehyde was assigned a low 
priority for further testing and isobutyraldehyde was selected for 
developmental toxicity testing. The butyraldehyde dossier will be 
discussed at an OECD SIAM in late 1995 or early 1996. In the interim, 
the CMA's Oxo Process Panel is sponsoring two studies on butyl acetate 
that may provide some indirect data on butyraldehyde, because it is a 
butyl acetate metabolic intermediate. The Panel will begin a butyl 
acetate in vivo (rats) hydrolysis study in mid-1995 and complete a 90-
day subchronic neurotoxicity study (including an evaluation of the 
effects of butyl acetate on testicular toxicity and numbers of 
elongated spermatids) in late 1995 (CMA, 1995b).
    The NTP sponsored a 90-day butyraldehyde subchronic toxicity study 
in mice and rats (EHRT, 1986). This study included sperm morphology and 
motility and vaginal cytology evaluations. Butyraldehyde administered 
by gavage to mice at a dose range of 150 - 600 mg/kg, and to rats at a 
dose range of 75-300 mg/kg, had no significant effects on sperm 
morphology or motility, caudal, epididymal or testicular weights, or on 
the estrous cycle.
    The ITC discussed studies related to reproductive and developmental 
toxicity of butyraldehyde, the CMA's exposure data, the OECD SIDS 
dossier, the results of the OECD SIAM and the CMA's plans to conduct 
future studies. The ITC is removing butyraldehyde from the Priority 
Testing List because of the ongoing international activities (Table 2).
    c. Chloroalkyl phosphates. Five chloroalkyl phosphates were 
recommended in the 23rd Report (53 FR 46262, November 15, 1988). 
Another 4 were recommended in the 30th Report (57 FR 30608, July 9, 
1992). The published and unpublished data received for these nine 
chloroalkyl phosphates listed in Table 2 were reviewed by the ITC. 
About 95% of the data received were for the five chloroalkyl phosphates 
recommended in the 23rd Report; most of these data were for tris(2-
chloroethyl) phosphate and tris(1,3-dichloro-2-propyl) phosphate. Both 
of these chloroalkyl phosphates caused cancer in rodents. Chemical fate 
and monitoring data for these two chloroalkyl phosphates suggest that 
they would persist in the environment. Aquatic toxicity data suggest 
that both these chloroalkyl phosphates would cause acute effects at 
milligram per liter concentrations.
    The ITC is removing the chloroalkyl phosphates from the List 
because the data or structure activity relationships considered by the 
ITC do not indicate a need to designate the chloroalkyl phosphates for 
further testing at this time. The structure activity relationships 
considered by the ITC for the chloroalkyl phosphates were based on an 
analysis of beta-chloroalkyl phosphate substructures identified by the 
Substructure-based Computerized Chemical Selection Expert System 
(SuCCSES) developed by Walker (1991, 1995). The rationales for removing 
the individual chloroalkyl phosphates follow:
    Tris(2-chloroethyl) phosphate (CAS No. 115-96-8) and Tris(1,3-
dichloro-2-propyl) phosphate (CAS No. 13674-87-8). The ITC is removing 
these chemicals from the List because they are well-tested and cause 
cancer in rodents.
    Tris(2-chloroisopropyl) phosphate (CAS No. 13674-84-5). The ITC is 
removing tris(2-chloroisopropyl) phosphate from the List, because 
sufficient screening test data are likely to be developed under the 
OECD SIDS program and because it contains beta-chloroalkyl phosphate 
substructures similar to those contained in tris(2-chloroethyl) 
phosphate and tris(1,3-dichloro-2-propyl) phosphate and this 
substructural relationship to these known rodent carcinogens may be 
sufficient to predict its ability to cause cancer in rodents.
    Tris(2-chloro-1-propyl) phosphate (CAS No. 6145-73-9), tetrakis(2-
chloroethyl) ethylene diphosphate (CAS No. 33125-86-9) and 2,2-
bis(chloromethyl) 1,3-propanediyl tetrakis(2-chloroethyl) phosphate 
(CAS No. 38051-10-4). The ITC is removing these chemicals from the List 
because there are no current U.S. Government data needs and because 
they all contain beta-chloroalkyl phosphate substructures similar to 
those contained in tris(2-chloroethyl) phosphate and tris(1,3-dichloro-
2-propyl) phosphate and this substructural relationship to these known 
rodent carcinogens may be sufficient to predict their ability to cause 
cancer in rodents.
    1,2-Ethanediyl tetrakis(2-chloro-1-methylethyl) phosphate (CAS No. 
34621-99-3), oxydi-2,1-ethanediyl tetrakis(2-chloroethyl) phosphate 
(CAS No. 53461-82-8) and 2-chloro-1-methylethyl bis-(2-chloropropyl) 
phosphate (CAS No. 76649-15-5). The ITC is removing these chemicals 
from the List, because their 1989 production volumes were each less 
than 1 million pounds and because they all contain beta-chloroalkyl 
phosphate substructures similar to those contained in tris(2-
chloroethyl) phosphate and tris(1,3-dichloro-2-propyl) phosphate and 
this substructural relationship to these known rodent carcinogens may 
be sufficient to predict their ability to cause cancer in rodents.
    d. Sulfonyl bis(4-chlorobenzene). In its 35th Report, the ITC 
removed 25 sulfones from the Priority Testing List (59 FR 67596, 
December 29, 1994). For the remaining sulfone, sulfonyl bis(4-
chlorobenzene) (CAS No. 80-07-9), the ITC determined that most of the 
screening test data that would be required under the OECD SIDS Program 
had been developed.
    Sulfonyl bis(4-chlorobenzene) shares structural and functional 
relationships with other sulfonylbenzenes. The NTP has performed a 
number of short-term toxicity and metabolism studies and has developed 
a physiologically-based pharmacokinetic model for sulfonyl bis(4-
chlorobenzene). The NTP is planning to perform a two-species rodent 
carcinogenicity assay to further evaluate structure-activity 
relationships and to determine the effectiveness of shorter-term tests, 
including a 13-week subchronic toxicity test in rats and mice, to 
predict and model the carcinogenic response. The ITC is removing 
sulfonyl bis(4-chlorobenzene) from the Priority Testing List because 
most of the screening test data have been developed and because the NTP 
will be conducting health effects testing (Table 2).
    e. m-Dinitrobenzene. m-Dinitrobenzene (CAS No. 99-65-0) was 
recommended for testing in the 28th Report (56 FR 41212, August 19, 
1991). It is being removed as a discrete entry from the Priority 
Testing List because it is scheduled for future review within 

[[Page 42987]]
the framework of the OECD SIDS program (Table 2). However, m-
dinitrobenzene will remain on the List as a member of a category of 
chemical substances designated by the ITC in its 32nd Report for dermal 
absorption testing to develop data needed by the Occupational Safety 
and Health Administration (58 FR 38490, July 16, 1993).
    f. Cyanoacrylates. In its 35th Report, the ITC removed seven 
cyanoacrylates from the Priority Testing List (59 FR 67596, December 
29, 1994). The ITC is removing three cyanoacrylates from the List 
because 1989 production volumes were less than 1 million pounds per 
year and there are currently no U.S. Government data needs. These 
three cyanoacrylates, listed in Table 2, are 2-propenoic acid, 2-
cyano-, methyl ester (CAS No. 137-05-3), 2-propenoic acid, 2-cyano-
3,3-diphenyl-, 2-ethylhexyl ester (CAS No. 6197-30-4) and 
ethanaminium, 2-[[2-cyano-3-[4-(diethylamino)phenyl] -1-oxo-2-
propenyl]oxy]-N,N,N-trimethyl-, chloride (CAS No. 64992-16-1).
    For the remaining cyanoacrylate, listed in Table 2, 2-propenoic 
acid, 2-cyano-, ethyl ester (CAS No. 7085-85-0), the ITC considered the 
available screening data, the information from a TSCA section 8(e) 
submission and the ongoing attempts by the NTP to test this chemical. 
The ITC determined that few of the screening data that would be 
required under the OECD SIDS program had been developed. The common 
name for this chemical is ethyl cyanoacrylate.
    The TSCA section 8(e) submission that the ITC considered was for an 
adhesive product that contained 95% ethyl cyanoacrylate (EPA, 1989). 
The submitter stated that ``a customer which uses [a] cyanoacrylate 
adhesive among other chemicals reported that three pregnant women [had] 
experienced premature childbirths,'' and ``two [of the] premature 
babies died and one continues on life support.'' The submission noted 
the similarity between the affected women's exposure/working 
relationships.
    The NTP has attempted to test ethyl cyanoacrylate in laboratory 
animals. Injection of ethyl cyanoacrylate into animals yields a 
polymer. In the NTP-conducted tests, where polymerization was not 
considered, ethyl cyanoacrylate was not mutagenic in the Ames test or 
in rodent bone marrow micronucleus tests. The NTP subchronic and 
chronic studies have not been initiated because of the high reactivity 
of the chemical and the resulting difficulties in implementing the 
delivery of an effective concentration of the unpolymerized chemical to 
the test animals. Ethyl cyanoacrylate is being removed from the 
Priority Testing List because the TSCA section 8(e) submission suggests 
that there may be a need to examine exposure controls and because the 
practical problems which may prevent effective health effects testing 
are being evaluated by the NTP.
    g. Propylene glycol ethers and esters. Propylene glycol ethers and 
esters were recommended for developmental toxicity and reproductive 
effects testing in the 28th Report (56 FR 41212, August 19, 1991). 
Based on the recommendations of the Consumer Product Safety Commission 
(CPSC), the Food and Drug Administration, and the National Institute 
for Occupational Safety and Health, the ITC revised the TSCA section 
4(e) Priority Testing List by removing 29 of the 38 propylene glycol 
ethers and esters originally recommended and adding two new propylene 
glycol ethers in its 31st Report (58 FR 26898, May 5, 1993). The ITC 
recommended these 11 propylene glycol ethers and esters for an 
information solicitation to obtain consumer use data. After publication 
of the 31st Report, the EPA promulgated TSCA section 8(a) and 8(d) 
rules for the chemicals in that Report (58 FR 68311, December 27, 
1993). After receiving comments from the CMA's Propylene Glycol Ethers 
Panel, the EPA stayed these TSCA section 8(a) and 8(d) rules for 
propylene glycol ethers and esters. After the stay was published (59 FR 
14115, March 25, 1994), the ITC initiated a dialogue with the CMA's 
Propylene Glycol Ethers Panel and obtained recent production volume and 
consumer use data for nine of the recommended propylene glycol ethers, 
and esters and three others that were not recommended in the 31st 
Report.
    As a result, eight of the propylene glycol ethers and esters listed 
in Table 2 are being removed from the Priority Testing List because the 
U.S. Government consumer use data needs stated in the 31st Report were 
satisfied.
    Tripropylene glycol diacrylate (CAS No. 42978-66-5) is being 
removed from the propylene glycol ethers and esters listed in Table 2 
because another CMA panel supplied commercial use information that 
suggests consumer exposure to this compound is likely to be limited.
    Dipropylene glycol (CAS No. 110-98-5) is being removed from the 
propylene glycol ethers and esters listed in Table 2 because a 
dipropylene glycol mixture (CAS No. 25265-71-8) is being tested by the 
NTP.
    Dipropylene glycol methyl ether (CAS No. 20324-32-7) is being 
removed from the propylene glycol ethers and esters listed in Table 2 
because the CMA provided consumer use data. However, this chemical will 
remain on the Priority Testing List as a member of a category of 
chemical substances designated by the ITC in its 35th Report for dermal 
absorption testing to develop data needed by the Occupational Safety 
and Health Administration (59 FR 67596, December 29, 1994).
    The CPSC will review data submitted by the CMA in response to the 
ITC's recommendation, as part of a project on glycol ethers in consumer 
products. The ITC is including a summary of use data received from the 
CMA for the propylene glycol ethers and esters in the public docket for 
this 36th Report and forwarding a copy to the Chemical Control Division 
in EPA's Office of Pollution Prevention and Toxics.
    h. Methyl ethylene glycol ethers and esters. In its 31st Report (58 
FR 26898, May 5, 1993), the ITC revised the TSCA section 4(e) Priority 
Testing List by removing 8 of 10 methyl ethylene glycol ethers and 
esters recommended in the 28th Report (56 FR 41212, August 19, 1991). 
Ethylene glycol methyl ether acrylate (CAS No. 3121-67-7) and 
tetraethylene glycol methyl ether (CAS No. 23783-42-8) were retained on 
the List in order to obtain consumer use as well as TSCA section 8(a) 
and 8(d) data. In addition, ethylene glycol methyl ether acrylate was 
retained on the List because of its developmental effects (30% 
mortality and 100% intrauterine deaths at term in all 14 litters of 
mice exposed to 650 mg/kg by gavage during gestation days 7-14) as 
reported by Hardin et al. (1987).
    The reported 1989 production volume for both compounds, obtained 
from the 1990 TSCA Inventory Update Rule, was less than 1 million 
pounds each. Information submitted by the CMA suggests that consumer 
exposures to the two chemicals are expected to be limited. The ITC is 
removing ethylene glycol methyl ether acrylate and tetraethylene glycol 
methyl ether from the methyl ethylene glycol ethers and esters listed 
in Table 2 because production volumes were less than 1 million pounds 
and consumer exposures are expected to be limited.
    i. Cyclohexanone. The Occupational Safety and Health Administration 
requested that the ITC designate cyclohexanone in its 35th Report to 
obtain adequate dermal absorption data (59 FR 67596, December 29, 
1994). The ITC is removing cyclohexanone (CAS No. 108-94-1) from the 
Priority Testing List because adequate dermal absorption data to 
estimate a dermal absorption rate were identified in a study published 
in 1994 after the 35th Report was transmitted to the EPA Administrator 
(Mraz et al., 1994). 

[[Page 42988]]


References

    (1) CMA. Letter from Geraldine V. Cox, Vice President-Technical 
Director, Chemical Manufacturers Association, Washington, DC, to 
TSCA Document Processing Center (October 24, 1989).
    (2) CMA. Letter from Gordon D. Strickland, Vice President-
Technical Director, Chemical Manufacturers Association, Washington, 
DC, to John D. Walker, Executive Director, ITC (August 24, 1993).
    (3) CMA. Letter from Barbara O. Francis, Associate Director, 
CHEMSTAR Panels, Chemical Manufacturers Association, Washington, DC, 
to John D. Walker, Executive Director, ITC (February 22, 1995a).
    (4) CMA. Letter from Barbara O. Francis, Associate Director, 
CHEMSTAR Panels, Chemical Manufacturers Association, Washington, DC, 
to John D. Walker, Executive Director, ITC (May 9, 1995b).
    (5) EHRT. ``Butyraldehyde: Sperm morphology vaginal cytology 
evaluations in rodents.'' Contract No. NO1-ES-3-5026, Study No. 
SMVCE-86-055. Submitted by Environmental Health Research and Testing 
for National Toxicology Program. Cincinnati, OH (1986).
    (6) EPA. Status report for a cyanoacrylate adhesive product. EPA 
Document Control No. 8EHQ-0989-0821 S. Microfiche No. OTS0521301.
    (7) Hardin, B.D., Schuler, R.L., Burg, J.R., Booth, G.M., 
Hazelden, K.P., MacKenzie, K.M., Piccirillo, V.J. and Smith, K.N. 
``Evaluation of 60 Chemicals in a Preliminary Developmental Toxicity 
Test.'' Teratogenesis, Carcinogenesis, and Mutagenesis. 7:29-48 
(1987).
    (8) Moutschen-Dahmen, J., Moutschen-Dahmen, M., Degrave, N., 
Houbrechts, N., and Colizzi, A. ``Genetical hazards of aldehydes 
from mouse experiments.'' Mutation Research. 29:205 (1975).
    (9) Moutschen-Dahmen, J., Moutschen-Dahmen, M., Houbrechts, N., 
Colizzi, A. ``Cytotoxicity and mutagenicity of two aldehydes: 
crotonaldehyde and butyraldehyde in the mouse.'' Bulletin de la 
Societe Royale des Sciences de Liege. 45:58-72 (1976).
    (10) Mraz, J., Galova, E., Nohova, H. and Vitkova, D. ``Uptake, 
metabolism and elimination of cyclohexanone in humans.'' 
International Archives of Occupational Environmental Health. 66: 
203-208 (1994).
    (11) Walker, J.D. ``Chemical Selection by the TSCA Interagency 
Testing Committee: Use of Computerized Substructure Searching to 
Identify Chemical Groups for Health Effects, Chemical Fate and 
Ecological Effects Testing,'' Science of the Total Environment: Vol. 
109/110, pp. 691-700 (1991).
    (12) Walker, J.D. ``Estimation Methods Used by the TSCA 
Interagency Testing Committee to Prioritize Chemicals for Testing: 
Exposure and Biological Effects Scoring and Structure Activity 
Relationships''. Toxicology Modeling. Vol. 1, pp.123-141 (1995).

TSCA Interagency Testing Committee

    Statutory Organizations and Their Representatives

    Council on Environmental Quality
      Brad Campbell, Member

     Department of Commerce
      Edward White, Member
      Willie E. May, Alternate

     Environmental Protection Agency
      David R. Williams, Member
      Lois Dicker, Alternate

    National Cancer Institute
      Victor Fung, Member
      Harry Seifried, Alternate

    National Institute of Environmental Health Sciences
      Errol Zeiger, Member
      H.B. Matthews, Alternate

    National Institute for Occupational Safety and Health
      Henryka Nagy, Member
      David A. Dankovic, Alternate

    National Science Foundation
      Linda Duguay, Member

    Occupational Safety and Health Administration
      Christine Whittaker, Member

    Liaison Organizations and Their Representatives
    Agency for Toxic Substances and Disease Registry
      William Cibulas, Member

    Consumer Product Safety Commission
      Val Schaeffer, Member
      Lakshmi C. Mishra, Alternate

    Department of Agriculture
      Clifford Rice, Member

    Department of Defense
      David A. Macys, Member
      James N. McDougal, Alternate

    Department of the Interior
      Barnett A. Rattner, Member, Vice Chair

    Food and Drug Administration
      Edwin J. Matthews, Member
      Raju Kammula, Alternate

    National Library of Medicine
      Vera Hudson, Member

    National Toxicology Program
      NIEHS, Members

    Counsel
      Mary Ellen Levine, Office of General Counsel, EPA

    Technical Support Contractor
      Syracuse Research Corporation

    Committee Staff
      John D. Walker, Ph.D., M.P.H., Executive Director
      Norma S.L. Williams, Executive Assistant, TSCA Interagency 
Testing Committee, U.S. EPA/OPPT (MC/7401), 401 M St., SW., 
Washington, DC 20460, (202) 260-1825, Fax (202) 260-7895, Internet 
[email protected].

[FR Doc. 95-20422 Filed 8-16-95; 8:45 am]
BILLING CODE 6560-50-F