### 42982 Federal Register / Vol. 60, No. 159 / Thursday, August 17, 1995 / Notices

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 ThirtySixth 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: ncic@epamail.epa.gov. 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: TSCAHotline@epamail.epa.gov.

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, andremoves cyclohexanone, a previouslydesignated chemical, and 34 previouslyrecommended 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:

ncic@epamail.epa.gov

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 ThirtySixth 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.

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TABLE 

### 1.—THE 

### TSCA S ECTION 

### 4(e) P RIORITY 

### TESTING 

### L IST 

### (MAY 

### 1995)

Report Date Chemical/Group Action

26 May 1990 15 Isocyanates Recommended with intent-to-designate

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-, chloro-, hydroxymethyl diaryl ethers Recommended

30 May 1992 56 Siloxanes Recommended

31 January 1993 24 Chemicals with no dermal toxicity data Designated

32 May 1993 32 Chemicals with insufficient dermal absorption data Designated

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 insufficient dermal absorption data Designated

36 May 1995 12 High Production Volume Chemicals: Solicitation for Use and Exposure Data Recommended

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.—R EVISIONS TO THE 

### TSCA SECTION 

### 4(e) P RIORITY 

### TESTING 

### L IST 

### (N OVEMBER 

### 1994 TO 

### APRIL 

### 1995)

CAS No. Chemical/Group Action Date

High Production Volume Chemicals Solicit use and exposure data 5/95

80–51–3 p,p ′-Oxybis(benzenesulfonyl hydrazide)

81–84–5 Naphthalene dicarboxylic anhydride

99–54–7 3,4-Dichloronitrobenzene

100–29–8 4-Ethoxynitrobenzene

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)benzenesulfonyl chloride

594–42–3 Trichloromethane sulfenyl chloride

### 42984 Federal Register / Vol. 60, No. 159 / Thursday, August 17, 1995 / Notices

TABLE 

### 2.—R EVISIONS TO THE 

### TSCA SECTION 

### 4(e) P RIORITY 

### TESTING 

### L IST 

### (N OVEMBER 

### 1994 TO 

### APRIL 

### 1995)— Continued

CAS No. Chemical/Group Action Date

626–17–5 1,3-Dicyanobenzene

929–06–6 2-(2-Aminoethoxy)ethanol

3089–11–0 Hexa(methoxymethyl) melamine
High Production Volume Chemicals Remove previously recommended chemicals 5/95

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 phosphates Remove previously recommended chemicals 5/95

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(chloromethyl) 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 previously recommended chemicals 5/95

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)phenyl]-1- oxo-2-propenyl]oxy]-N,N,N -trimethyl-, chloride

Propylene glycol ethers and esters Remove previously recommended chemicals 5/95

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 glycol ethers and esters Remove previously recommended chemicals 5/95

3121–67–7 Ethylene glycol methyl ether acrylate

23783–42–8 Tetraethylene glycol methyl ether Other Chemicals

80–07–9 Sulfonyl bis(4-chlorobenzene) Remove previously recommended chemical 5/95

99–65–0 m -Dinitrobenzene Remove previously recommended chemical 5/95

108–94–1 Cyclohexanone Remove previously recommended chemical 5/95

123–72–8 Butyraldehyde Remove previously recommended chemical 5/95

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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

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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 chemicalsfrom the List because they are welltested 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 SIDSprogram and because it contains betachloroalkyl 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

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the framework of the OECD SIDS program (Table 2). However, mdinitrobenzene 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 (CASNo. 137–05–3), 2-propenoic acid, 2-cyano3,3-diphenyl-, 2-ethylhexyl ester (CAS No.6197–30–4) and ethanaminium, 2-[[2-cyano3-[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 intoanimals yields a polymer. In the NTPconducted 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).

### 42988 Federal Register / Vol. 60, No. 159 / Thursday, August 17, 1995 / Notices

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., MoutschenDahmen, M., Degrave, N., Houbrechts, N., and Colizzi, A. ‘‘Genetical hazards of aldehydes from mouse experiments.’’ Mutation Research. 29:205 (1975).

(9) Moutschen-Dahmen, J., MoutschenDahmen, 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 walker.johnd@epamail.epa.gov.

[FR Doc. 95–20422 Filed 8–16–95; 8:45 am]

BILLING CODE 6560–50–F