### NOTICES

[6560-01] ENVIRONMENTAL PROTECTION AGENCY
[FRL 884-73

TOXIC SUBSTANCES CONTROL

Second Report ofthe Interagency Testing Committee; Receipt and Request forComments


### AGENCY: Environmental Protection Agency (EPA).
ACTION: This Notice requests com- ments on the Interagency Testing Committee's recommendations of chemicals for priority consideration for testing.
SUMMARY: The Interagency Testing Committee established under section 4(e) of the Toxic Substances Control Act (TSCA) has transmitted to the EPA its Second Official Report. This Report identifies additional chemical substances and mixtures which the Committee recommends to EPA for priority consideration for promulgation oftesting rules under section 4 of the Act. The Committee's recommen- dations revise and update recommen- dations made in the Commttee's Initial Report. The Second Report appears in its entirety following this Notice. The Agency invites interested persons to submit comments on the Report.
BACKGROUND: Section 4 of TSCA authorizes the EPA Administrator to promulgate regulations requiring testing of chemicals to develop data relating to the risks which-such chemicals may'present to human health and the environment.

Section 4(e) established an Interagency Testing Committee and directed the Committee to recommend to the Administrator chemical substances and mixtures for priority consideration for test rulepromulgation by October 1, 1977. The Committee's initial recommendations were published in the FEDERAL REGISTER on October 12, 1977 (42 FR 55026). Section 4(e) also directs the Committee to revise the list every six months as necessary. The Second Report recommends the addition ofchemicals and groups ofchemicals to the Committee's initial list and includes the Committee's reasons for each addition. The Agency is required to initiate rulemaking for these chemicals within 12 months of their inclusion on the priority list or to publicly state its reasons for not doing so. AvAnABILrry

The Committee's report making these revisions appears in the FEDERAL REGISTER following this notice. Those persons who received the Committee's initial report will bemailed this report automatically within twoweeks. Other persons wishing to receive copies should call or write to: John B. Ritch, Jr., Director, Industry Assistance Office, Office of Toxic Substances, EPA,Washington, D.C. 20460. Call toll free 800-424-9065; in Washington, D.C. call 554-1404.

In developing its recommendations, the Committee relied almost exclusively on published or other generally available information. A number of general references were given in the Committee's initialreport.

In addition, references for specific chemicals being added to the list at this time will be included in the dossiers which the Committee will transmit to EPA in thenext few weeks.
REQUEST FORCOMMENTS

EPA invites interested persons to submit comments on the Committee's

new recommendations. In view of the statutory deadline for Initiating rulemaking (or stating reasons for not doing so), the Agency requests that comments be submitted no later than July 21, 1978.

Comments should bear the identifying notation OTS-040004 and should .be submitted to Joan Urquhart; U.S. Environmental Protection Agency, Office of Toxic Substances (TS-788), Federal Register Section, 401 M Street SW., Washington, D.C. All written comments will be available for public inspection in Room 623 EastTower, at the same address, between 8:30 a.m. and 4:30 p.m., weekdays.

Dated: April 14, 1977.
WAuEN R. Mum, ActingAssistant Administrator forToxicSubstances.

Toxic SUBSTANCES CONTROLACT, 

### INTERAGENCY TESTING COMMTTE, Washington,D.C., April10, 1978. 

### HoN.DOUGLAS 

### M. COSTLE, Administrator, Environmental Protection Agency, Washington,D.C.

DEARMR. CosTLE: In-accordance withthe requirements of the Toxic Substances Control Act, the TSCA Interagency Testing Committee is now recommending the addition of eight designated entries to the Section 4(e) Priority List. These revisions and the Committee's reasons for recommending them are presented in the enclosed document entitled, "SecondReport ofthe TSCA Interagency Testing Committee to the Administrator, Environmental Protection Agency." The representatives of the statutory member agencies are in consensus on theserevisions.

Also, the report contains two special rec- ommendations which bear on the activities of the Environmental Protection Agency. First, it is recommended that EPA consider taking the initiative inthe development ofa comprehensive survey of health and environmental effects testing facilities in the United States. And secondly, your agency is encouraged to Join In the effort to provide increased training support In the fields of mammalian and environmental toxicology, pathology, occupational health and epidemiology as these fields relate to the need for greater numbers of qualified personnel tomeetthe increasing demandfor testing,

The Committee has not yet completed Its review of all of those chemical substances and categories of substances Identified during our Initial activities in 1977. This review Isto continue andwill be asubject of future Committee reports. In addition, can. didate chemicals recommended bythe Committee members or public comment will be reviewed by the Committee as such Informationismade available.

We trust that this report will be ofvalue to EPA as it continues to carry out the Toxic Substances Control Act, Sincerely,
MARvI E.STEPMnsoN, Chairperson,TSCA Interagency TestingCommittee

SECOND REPORT OF THE 

### TSCA INmEAcEoY

TEsTING COMME To THE ADMIvUSTInA. TOR, ENVIRONMENTAL PROTI s0o AoENCY


### APRIL 1978

CONTENTS


### CoLrnTri MEmrmEsIP Acknowledgments Summary

CHAPTER 1. INTRODUCTION 

### 1.1 Committee establishment and responsi. bilities. 1.2 Initialreport. 1.3 Cominittee activities duringthis report- ingperiod. 1.4 Future activities ofthe committee.

CHAPTER 2. CONsIDERATION OFAVAILABILITY OF TESTING FACILITIES AND PERSONNIIEL

CHAPTER 3. RECOMMENDATIONS OFTHE
COMMITT=R 

### 3.1 Substances and categories of substances recommended for testing. 3.2 Reasons for recommending testing of the additional substances and categories ofsubstances. 3.2.A Acrylamide. 3.2.B Aryl phosphates. 3.2.C Chlorinated naphthalenes. 3.2.D Dichloromethane. 3.2E Halogenated alkylepoxides. 3.2.F Polychlorinated terphenyls. 3.2.G Pyridine. 3.2.H 1,1,1-trichloroethane.

TSCA INTERAGENCY TFmrNo CoMIr. 

### Statutory MemberAgencies

COUNCIL ON ENVIRONMENTAL QUALITY 

### CarrollLeslieBastian NathanJ.Karch,.Alternate

DEPARiTMENT OF COLIRCE 

### Orville E.Paynter Bernard Grelfer,Alternate

ETVIRONIENTAL PROTECTIONAGENCY 

### WarrenR.Muir JosephJ.Merenda, Alternate

NATIONAL SCIENCEFOUNDATION 

### Marvin E.Stephenson,Chairperson Carter Schuth, Alternate

NATIONAL INSTITUTE OFENVIROIIENTAL HEALTH SCIENCES 

### HansL Falk

FEDERAL REGISTER, VOL 43, NO. 76-WEDNESDAY, APRIL 19, 1970 

### 16*684

### NOTICES

WarrenT. Piver,Alternate

NATIONAL INSTITUTEFOROCCUPATIONAL AFETYAND W'4ALTH
JeanG.French, ViceChairperson VeraW.Hudson,Alternate

NATIONAL CANCER INSTITUTE
JamesM. Sontag

OCCUPATIONAL SAFETY AND HEMBVI ADMINISTRATION JosephK. Wagoner FredW.Clayton, Alternate

Liaison Agencies

DEPARTMENT OFD ESE SeymourL.Friess

FOODAND DRUG AD!IUSTRATIONi
AllenH.Helm Winston deMonsabert

DEPAIR.MENr OF rTHE INERIOR Charles R.Walker Raymond 

### E.Corcoran

U.S. cONSUMRPRODUCT SAFETY corMaSSON

RobertM. Hehir JosephMcLaughlin

Committee Staff

Executive Secretary:.CarolA. Mapes Secretary:.PhyllisD.Tucker

AcKNOWioaN'TS

The Committee wishes to acknowledge the important contributionsofthe many Individuals and groups who have significantly aidedusin ourwork.TheseInclude:

The Federal agencies who have cooperatedby providing support through the liaison members;

Clement Associates, Inc., technical supportcontractor,

The National Science Foundation, for funding and managing the technical support contract and the National Institute of Environmental Health Sciences, for assist

### ingin thatfunding;

Former Committee members: Sidney R. Gaiter,Department of Commerce; William
M. Upholt, Environmental Protection Agency; Norbert P.Page,National Institute for Occupational Safety and Health; Grover C. Wrenn, Occupational Safety and Health Administration.

EPA staffmembers who assisted theCommittee in a variety ofactivities, and particularly: Donald G. Barnes, Office of Tonic Substances; John W.Lyon, Office ofGeneralCounsel; Ralph C.Northrop,Jr.,Office of Toxic Substances.

The numerous e-perts who prepared presentations and materials forthe Committee; and

The many individuals and organizations who rezponded to the Committe's Initial Report to the Administrator, 

### ravironmentalProtection Agency.

SUBmMARY
A central provision of the Tonic Substances Control Act (TSCA, Pub. 

### I. 9d-469)

concerns the testing of chemical substances and mixtures which are used in commerce
or may represent an unreasonable rLsis of injury to humanhealth orthe environment. The Actprovides forcontinuing advicefrom certainFederal agencies having common Interests in Identifyingchemical substance or mixture. for testing.Accordingly, theTCA& Interagency Testing Committee, which Is composed ofrepresentatives fromthosecon. cerned Federal agencies, regularly provide3
to the Administrator of the Environmental Protection Agency (EPA) recommendations

on chemicals and mixtures to which theAdministratr should give priority con.-deration for the promulgation of testing rules.

As a result ofIts deliberations during the past six months, the Committee has elected
torevise theTSCA Section4(e)PriorityILIt by the addition of four Individual substances and four categories of substances. The Committee considers these additions to be of the same priority as the previouly designated entries. Thechemical substance,

or categories being designated for addition to the Priority List and the testing recommendatlons are presented alphabetically es follovs

SubstanceorCatoryand Testing Recommended AcrylamIde-Carclnogenlc- Ity, mutagenlclty. teratogenlcity, environmental effects andepldemiological study.

Aryl phos-phates-Carcinogen!clty, mutagenlclty, teratogeniclty. other chronic effects, environmental effects and eptdemlological study.

Chlorinated naphthalene--CarinogenIcity, mutagenIcity, teratogenIcIty, other chronic effects, environmental effects and epldemiological study.

-Dlchloromethane--Carcinogena€lty. mutagenlcity, teratozenlclty, other chronic effects, environmental effects and epldemiological study.

Halogenated alkyl cpoxlders-Carcnogenicity, mutageniclty, teratogenilcity, other chronic effects, and epldemlological study.

Polychlorinated terphenylz-CarcinogenIcIty, mutacenicity, teratogeniclty, other chronic effects,and environmental effects.

Pyrldlne-Carclaogenlcity, mutagenlcity, teratogenicity, other chronic effects environmental effects and epldcmlologlcal study.

l,1,l-Trlchloroethane

- Carcinogenicity, mutagenlity, teratogenlcity, other chronic effects, and epidemnlological study.

A set of dossiers containing Information

on the additional entries designated to the Priority LitY711 be forwarded to the EPA Administratorwithin a fewweeks.

SzcoD RErorr oF mm TCA INea-m;cy



### Trsrrz ComrIuTI= To Tac AnrINsruATop, E moloe;==X Pjsorrcre 

### Aon--Cr, Arar 1978

GHAPM 1.INTUODUCTION
1.1 Committee Establishment and R. sponsiliict The Toxic Sub-tances Control Act (Pub. L. 94-469) estblbbh the TSCA Interagency Testing Committee under Zectlon 4(e). The Commltte h- the continuing re-ponsibIlity to Identify and recommend to theAdminitrator ofthe Znvironmental Protection A.ency (EPA) chemical substances or mlxture7 which should be tested to determine their hazard
to human health or the environment. The
statute requires that the Committee conid.

errevision to Its previous recommendat!on3
atleast every slx months.

The Committee has eight statutory mem- bers appointed bytheFederal agenie3 Iden. tifled for membership In Section d(el(2A) ofthe Act, a number of alternate mimb.sr

as permitted bySection 4(e)(2LBil), andIIason members from several Federal agencde with programs related to the control of tonic substunces. Current Committee mem- bers, alternates, and tal-on representatives

are identified at the beginning of this report.



### 1.2 Initial Repo t In July 1977,the Committee published a Preliminary List of 330 chemical substances and categories of such substance3 Including background Information describing the methods used by the Committee In making those selections (Reference No. 1). ThePreliminary Listcontains substances and categorles selected primarily

on the basis of their potential for human
exposure and environmental relese.Subsequently, the chemicals on the Preliminary List and chemicals added to thePreliminary Ist on the basis of public commentz and Committee recommendations were screened further by the Committee. The screening process was based primarily on the chemicls potential for causing adverse human and/or environmental effects but also conddered their exposure potential. Available dataon these chemicals were re7fewed with regard to: potential for carcinogenic, mutagenic. teratogec
, andchronic toxic effect4 their ability toboaccumulate or cause deleterfous environmental effects; and pozsible tonic Lmpuritis. A scoring syztem was used In thL- process which took Intoaccount both available inforation and the lack ofit for thee factors. The Committee further nar- rowed the it of substances end categories underconzlderatlon onthebasisofIts scientifli Judguinct and the scozing results, and requested Its technical contractor to prepare dossiers on these chemicals. The Co=-
rnttee was able toreview about one-half of these substance3 and categories aidedby information In the dossfer Four individual chemicals and six categories of chemical substans v.ere selected forincluzion inthe Initial Report to the Admnistrator, Envlronmental Protection Agency (Reference 1to. 2) datedOctober 1, 1977.

In additionto the liting ofthe chemical d-Ignated by the Committee for cons.derationbyEPA, thereport contabn a detailed d-scriptlon ofthe methods used in develop

### Ing the Commlttea'z Lnitial recommendations Including data sources and methods used for production, release and expo-ure ciores, aswell as biological and environmental corei.Later, on February 7, 1978, a fin3aed sat of supporting do s-Iers on the delgnted entries on the Priority LIst w-z offIcilly tzansmitted to the AdminL-trator.

1.3 CommitteeActirltiesDuring 27:ts Fartir FerozL Since 

### cDmpletion of Its 

### I!ntl recommendations In October1977, the Committee has continued to consIder 

### IndlvIduaI chercal substances and mixtures Identified for In-depth consideration by the screening proce:s mentioned in the preceding section.

This revw b- given -;ecWc cansider

### atlon tothe 

### factor, described in T3CA S='- tlon 4eX1(KA) and other relevant facto Identifled by the Committee. 1e.;dfy allable Inferm-.ton on th=e factors 

### and the lmowlcdge and professional judent Ofthe Committee members havebeen employed to select additMonal entries to the-TZCA Sectlon 4(e) Priorlty Lst-. On the basis ofthe

raer ofmore,butnot al ofthepre-.auy requestcd ds:iFer, the Committe nc7 recomamending the add ion of four chamical subs=ta

. and fourcateg-orie ofchemical sub-tanc= to the4(e) PrioritylsTz.



### 1.4 FaturcActfritiez oftheCommitteaIn the courzse ofde-eloping Itz thirdrapot the



### FEDIAL RECISTEP, VOL 43, KO. 76-WEDIZZDAY, APIL 19, 197" 

### 16685

### NOTICES

Committee expects to continue reviewing those dossiers inhand and considernew dossiers on additional chemicals and groups.

CHAPTER 2. CONSIDERATION OF AVAILABILITY OF TESTING FACILITIES AND PERSONNEL 

### Section 4(e)(1)(A) of TSCA requires that the Committee consider, among other factors, the reasonably foreseeable availability of facilities and persQnnel for carrying out the testing on the substances or mixtures recommended to the Administrator for priority cqnsideration. The Committee con- cludes that testing capabilities are presently adequate to carry out the recommended health effects and environmental tests on the chemicals listed in Table 1. However, the concerns expressed bythe Committee in its first report (Reference No. 2, p. 55048) regarding the limited national capabilityfor conducting long-term tests for environmental effects arereiterated.

The expansion of testing facilities by industry, contracting laboratories, and universities seems to be proceeding at a satisfactoryrate, especially inthe area ofhealth effects testing. Estimates indicate a significant increase in facilities over the next five years. While this is encouraging, the Committee is aware that the increasing requirements of various government agencies are creating competition for the same testing facilities and personnel. Therefore, the projected need and capacity for health and en- vironmental effects testing is somewhat uncertain and should be more accurately sur- veyed. The Committee recommends that EPA assume the leadership in the development of a comprehensive survey of availability of current Federal and private health effectstesting facilities in the United States and the projected annual capacity of suchfacilities during thenext five years. In those cases where testingis likely to involve animal bioassay, the survey should include

an evaluation ofthe capacity to provide ap-- propriate and sufficient populations of test species.

Of paramount concern to the Committee is the availability ofqualified personnel. All indices contained in the Report of the Second TaskForce forResearchPlanning in the EnvironmentalHealthSciences (Refer-

ence No. 3) indicate a current and future shortage of research professionals in the fields of mammalian and environmental toxicology, pathology, occupational health, addepidemiology. There will be a dearth of professionals and supporting tecbnical'personnel in these various skills for many years unless increased training efforts occur at the national level The Committee notes that several Federal agencies are involved in augmenting training support and recom- mends that EPA join in these efforts in a significant way.

There is also a need to maintain viable basic research programs in toxicology and other related health fields. This basic need should not be neglected in order to assure short-term gains in thepractical application of the present state of the art. Because of the interdisciplinary nature of toxicology. and environmental health research, the educational training for some of the disciplines can be provided only byfacilities with personnel engaged in this type of research. The Committee believes that the Civil Service Commission could do much to stimulate interest in these professions by creating professional series andregisters for such

scarce categories as toxicologists, pathologists, epidemiologists and other scientific fields in environmental protection. Recogni- tion of these environmental health professions by the Commission could encourage students to investigate careers in fields thus far hidden as Federal employment opportunities. It is concluded that such an action by the Commissionwould havethe effect ofincreasing the available scientific manpower in these specialty fieldsboth in the Government and in industry where the demand for such personnel exists.

CHAPTER3. RECOMMENDATIONS OFTHE cotuTrEE
3.1 Substances and Categories of Sub-
stances Recommendedfor Testing. On the basis ofthe review and evaluation ofchemical substances whichwas carried outaccording to the methods and procedures described in Sections 1.2 and 1.3, the Committee is revising the TSCA Section 4(e) Priority List to add certain substances and categories of substances for which specific testing is recommended. The Priority List and the date each item was placed on the List

are givenin Table 1. The testing recommen- dations and reasons for such recommendations are indicated in Section 3.2 for the

new entries. Supporting dossiers ofinformation are being prepared in final form and will be forwarded to the Administrator, EPA, at an early date.

All additions to the List are designated chemical substances and categories of chemical substances which the Committee has determined require the Administrator's action under TSCA Section 4(a) within twelve months. The Committee considers these addition to be of the same priority as the previously designated entries. In recom- mending a category of chemical substances for testing (e.g., the aryl phosphates), the Committee recognizes that certain chemicals which are members ofthe category may have been tested previously for an effect of

concern. For those chemicals no additional testing may be warranted if the results of previously completed tests are Judged adequate for assessing the effect of concern. The Committee also recognizes that tho definition and inclusive limits of a given listed category of substances may require additional specification or change in speclfication as the testing rule is developed, Unless stated otherwise, the chemical substance recommended for testing should be the product to which the population Is ex- posed.

3.2 Reasonsfor Recommending Testing oftheAdditionalSubstancesand Categories ofSubstances. In accordance with tho re- porting requirements of the Act, the Committee has listed in the following sections the test recommendations and reasons for recommending testing for those entries being placed on the Priority List at this time. Table 2 presents a summary of the testing recommendations for each addition to theList.

TABLE 1.-The TSCA Section4(e)Priority List,byAlphabetical Arrangement

Designated entry Date ofentry

Acrylamide

................................... ........ April 1978. Alkyl epoxides

.............. October 1977. Alkyl phthalates

......................... .October 1977, Arylphosphates

............. April 1978. Chlorinatedbenzenes, mono-and dl- October 1977. Chlorinatednaphthalenes

.................. April 1978. Chlorinatedparaffins

.......................... October 1977. Chloromethane

............. October 1977. Cresols

............... . October 1977, Dichloromethane

.................... April 1978. Halogenated alkylepoxides

................ April 1978. Hexachloro-1,3-butadlene

................... October 1977. Nltrobenzene

......................................... October 1977. Polychiorinated terphenyls

................ April 1978. Pyridine

............................................... April 1978, Toluene

.................................................. October 1977, 1.1,1-trichloroethane

......... April 1978. 

### Xylenes

.................................................. October 1977.

TABLE 2.-Summaryoftestingrecommendationsby the TSCA4.InteragcncY Testing Committee

Carcino- Muta- Terato- Other Environ- Eplide- Substance orcategory genicity genicity genicity chronic mental miology effects effects rtudy

Acrylamide

................ . ......... X X X

..................... X X Arylphosphates

.................... . X X X X X X Chlorinatednaphthalenes

.. X X X X X X Dichoromethane

................... X X X X X X Halogenated alkyl epoxides.. X X X X

............... X Polychlorinated terphenyls.. X X X X

...... Pyridine

............... . X X X X X X 1,,1-trichloroethane

. .. X

............ .

3.2.A Acryamlde. Testing recommendations: Carcinogenicity,

mutagenicity, teratogenicity, environmen-, tal effects, andepidemiology. Substance Identification: CAB No. 79-06-1.

R msONS FOR REcoMMENDATIoNs Production, release, and exposure, The 1976 U.S. production of acrylamide monomer Is estimated at 64 million pounds, and indications point to a high growth rate of around 12 percent for the next decade. Eighty percent of the acrylamide produced is used captively inpolymer production for water treatment, papermaking and wastewater clarification. About 5 percent Is used in chemical grouts as the acrylamide
monomer, forsoil stabilization and sewer re- habilitation. The remainder s consumed in

FEDERAL REGISTER, VOL 43, NO. 76-WEDNESDAY, APRIL 19, 1978 

## 16686

### NOTICES

other chemical syntheses. Otheruses areIn the paper and paperboard Industry, coalindustry, mining and ore benefication indus try,and secondary oilrecovery Industry.

Acrylamide release to the environment (usually ending up in surface and ground water) occurs at manufacuring sites, soil 

### grouting sites,polymer application sitesand In handling. General population, low-level 

### exposure to acrylamide s likely to occur wherever polyacrylamides are utilized. No data are available on release rates into the environment or actual concentration levels. NIOSH 

### estimates that 20.000 workers are 

### potentially exposedintheworkplace.

Carcinogenicity. Acrylamide hasnotbeen tested for carciongenicity. Because ofwidespread low-level exposure tothe population, acrylamide should be tested for carcinogen- Icity.



### mutagenicity.Althoughtheresultsoftwo independently reported Ames tests were negative, the Committee believes that additional tests, employing other systems, are required to evaluate the mutagenic poten- 

### tial ofthischemical.

Terutogenict. Transplacental transport of acrylamide was demonstrated in rats; therefore, It should be tested conclusIvely 

### forteratogenicity.

Environmentcaeffectsa Inview ofthe high 

### degree of neurotoxicity and neuropathy caused by cumulative exposure and the extensive use ofthis material In waste water treatment and soil grouting, Studies should be initiated to determine the degree of leaching ofthe monomerfrom thepolymer with water and various solvents. Further, 

### the potential for environmental exposures to the aquatic ecosystem, movement In sofl solution andleachate from soil waste must bedetermined forbiological effects onplant 

### and animallife.

Ep&joogy.No epidemiological reports
onacrylamidehave beenfoundIn theliterature.Studiesare needed toprovide information on human exposure toacrylamide and to determine the relationship between airborne concentrations and observed effects

on humans.
3.2.B Arylphosphates. Testing recommendations: carcinogeniclty.

mutagenicity, teratogenicIty, other chronic effects, environmental effects, and epi- demiology. Category identification: This category con-

sists of phosphate esters of phenol or of alkyl-substituted phenols. Tri-aryl and mixed alkyl and arly esters are Included. buttrl-alkyl estersare excluded.

Rnmsos FoaRmooimaxrOS Production, releas, and exposur. As a category, the aryl phosphates areproduced in quantities exceeding 65 million pounds/ year. Several individual arYl phosp hates, such as tritolyl phosphate and triphenyl phosphate, have annual production greater than 10millionpounds.Aryl phosphates 

### re widely usedasplasticizers Inpolyners (prin- cipal y in polyvinyl chloride) andIn hydru- liefluids andhighpressurelubrican3t Such

uses provide opportunity forex-tenive occu- pational exposure to theze compounds beyond that encountered in their manufacture. NIOSH estimates that over 2 miluton workers are so exposed. Because of the nature of their uses,most ofthe arlphcsphates manufactured willultimately be re- leased Into theenvironment, althoughthose 

### used as plasticizers may be released quite slowly. Persistence of aryl phosphates In the environment for significant pertods a. least ontheorder ofmonths) isindicatedby theavailable data.

Carcinogenfctz, With the exception of several tests of Inadequate duration uing trIphenyl phosphate, the carclnoenlc potential ofaryl pohosphates has notbean as. sessed. Carcinogeniclty testing should be performed on aryl phosphates having substantinl human exposure and/or environ. mentalrelease.

Mutagenfcfty,No mutagenicity te-ti ha been reported for aryl phos-hate3. Such testing should be performed because of the potential ofthese substances forwidespread environmental release andhuman exposure.

Teratogentcfty. No teratogenicity testing hasbeen reported forarylphovpha.-. Such testing should be conducted for aryl phosphates having substantial human exposure and/orenvironmental release.

Oierchroniceffccb. The neurotoxicityof certain ryl phosphates Is well documented, TheCommittee recommends that aryl phosphates be tested for chronic effects with special emphasis onneurotoxtc activift.

Envfronmenta effccL% Available data, although limited, indicate a potential for persistence of aryl phosphates In the aquatio environment, as well as a potential for their bloaccumulation in aquatic specles. There Ievidence of chronic toxicity of aryl phoophate hydraulle fluids to fish. Several aryl phosphates potentiate the toxic effects of organophosphate pesticides on Insects and

one (trl-o-cresyl phosphate)has beenshown
to potentlate such effects In nontarget or- gantss Including mam ls. In view ofthis, the environmental fate and effects on aquatic and terrestrial systems should be evaluatedfor arylphosphate.

Epmfoogy. Because of the large-:cale production andpotential for substantial cc. cupational exposure of certain aryl phonphates, the Committee recommends that* epidemiological studiesbe conducted.
3.2.C Chlorinated Naphthlensc. Testing recommendations: Carcinot-gncilty.



### mutagencIty, teratogenicIty, other chronic effects, environmental effecta, and ep.- demiology. Category identification: Thin category can-

sists of chlorinated derivatives of naph. thalene (empirical formula CtHCi,' wherex+y=8).


### Rsson RzC0==MJM0N3
Producton,

### res, and exposure. Available data indicate a production volume on the order of millions of pounds annually. These products have both moderately d. persive uses (e.g., lubricating and cutting oll additives) and enclosed uses (e.g., dielectic for automotive ,capacitors). Althourh NIOSH has estimated that cveralthou.and workers are, exposed to these compound., littleI- known about the ultimaterele=s of these materials from the workplac-, durin, product ue,oras a result ofdispo- l



### Healthieffect,% Ail1 studies and nl! of human exposure reveal that thc:e com- pounds are biologically active, with rcsprts of dermatological (e.g., chorace) and sy,- temlc (liver) effects. To date, there ara no reported data on the carcnogeniclty, muta. genleity, or teratogenicity of thcse com. pounds. Thus, there Is a need to conduct such studies, as well as to Investgate mora thoroughly the chronic effects ofthez2 in. tends. Epldenilologlcal studles choutl t2 undertaken -whereappropriate.

Environmentalrffect_ Little lnformation

on the ecological effects of these matcvrlls 13 available, but the detection of chlorinated naphthalene3 In stream sedimentz,fsh, and fish-eating birds point to their dispersal.
pers- ence, and bloaccumulation In the food cbam. Therefore, testing Is needed to obtain data for Judging the environmental effects ofthese chemicals.
3.2D DfchorometArre, Testing recommendations: Carcinogenicity.

mutagenicity, teratogenolty, other chronto effects, environmental effects, and epldemiology. Substance Identiffcation: CASNO. '75-09-2.

RzasoxsroaRrcomwz-wAxo.s
Productior rele e, ard expourt. The 1976 US. production of dlchloromethane (also known as methylene chloride) exceeded 00 million pounds,,a 12percent increase

over the 1972 level. An averge 9 percent annual growth rate I- projected over the
next several years as this chemical enter. markets dominated by fluorochlorocarbons in the past. Approximately / ofthe volume produced 13 thought to be released to the environment through activities atIndustrial site,_ Inhomes and elsewhere. NIOSH 

### estmated that 2.5 million workers are exposed
to this material at their place ofwork. Its

ue In an array of aerosol spray products andother household products brings a large fraction of the general population intocontact with thischemical.

C4rdrcoenicity.No carcinogenicity test data were found Inthe searched literature. There Is sufficient concern based for the Committee torecommend this chemical for such teatinga. The Committee is aware of
two studies currently under way, however, whose results may be Judged adequat to obviate the needforadditionaltesting.

Muta -enficty. No mutagenIcity test data have been reported. Such studies should be conducted In view of the widespread expocure to this chemical and its demonstrated bioloalml activity.



### Terato3icWt. One study ha reported euMvoal findings of abnormalit es In the 

### oWfe ofpregnant ratn andmiceexposed

to this chcmicaL Additlonal testing Inecded toaw3 thispotential hazard

Otherchronfe ecs.t Iaboratory Investgations and case studies have reported that dlobllorometha-e can affect various org-s (e.g., lungs and eye) and "ystems (blood),as eU as behavior. Given the wide-pread u of this chemical und-rmany different conditIers, this information indlcates a need for furthert,-tngEnrniromentaZ ects. Dlchloromethana Is b:ng released In large quanUtIes and Ina broad dLpersion pattern throughout the en- %ironment.Low-Ievl residu2s have been

m asured Inwater, The exact nature ofthis e-posure andIts chroniceffects onthe biotanced to tedetermined.



### EPfrirfolo7 Xpldemloloatcal studies shouldte conductedto ass hm n rislL 

### 3i.213Hl tdthlEies 

### Tesating recommandattons Carcinogani-aty.

mutnuenlolty. tcratoaanIcity, other chronCategory Id.ntiftcaton: This category con-

syzts of hao,-gnated noncyclic aliphatfz hydrocarbons with one or more epa., functional Croup:;.

1rcdU.tiorn, fc%=e, and Exrosure.

### The lI75 

### U.S prcdlzction ofeplchiorohydnina (I-

cbow-2.3-cvozypropana.) exceeded sea maiMED.AL PEGISTC, VOL 43, NO, 76-WEOZ":AV, AtMIL 19, M J 

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### NOTICES

lion pounds. NIOSH estimates that between 50,000 and 140,000 workers are exposed to epichlorohydrin annually. While epichloro- hydrin Is currently the onlywidely used halogenated alkyl epoxide, advertising and trends In the chemical industry lead the Committee to the conclusion that chemicals of this type may find wider use In the future.

Carcinogenicity. Halogenation of an alkyl epoxide enhances its activity as an alkylatIng agent and hence Its biological activity. Halogenated alkyl epoxides also may inhibit detoxifying enzymes in mammals. Equivocal results of recent carcinogenicity studies on eplchlorohydrin further point out the need for testingthis chemical category forpotential carcinogenicity.

Mutageniteity. Epichlorohydrin has been shown to bemutagenic to mice and bacteria. The potential human toxicity of this and other halogenated alkyl expo;ides should be evaluated.

Teratogenicity.No informAtion could be found on the potential for teratogenicity of the halogenated alkyl epoxides and they should bestudied forthis effect.

Other Chronic Effects. Epichlorohydrin has been reported to penetrate human skin and cause systemic effects. This raises con-
cern for other toxic effects and target organ toxicity of all the halogenated alkyl epoxides. Appropriate studies for these effects

are recommended.

Epidemiology.No epidemiological studies of any of the halogenated alkyl epoxides

were found in the literature. Studies are needed to provide information on the effects of human exposure to these compounds.
3.2.F Polychlorinated terphenyl. Testing recommendations: Carcinogenicity,

mutagenicity, teratogenclty, other chronIceffects, environmental effects. Category identificatlon This category con-

sists of the polychlorinated ortho-, meta- andpara-terphenyls.

REASONS FOR RECO=DATIONS Production, Release and Exposure. Although the production of polychlorinated terphenyls was discontinued in the United States in 1972, there has been an increase in imports ofpolychlorinated terphenyls from 160,000 pounds in 1973 to 400,000 pounds in 1975. Polychlorlnated terphenyls are presently used in waxes for investment casting and this use leads to wide environmental dispersion. Residues ofpolychlorinated terphenyls have been found in human fat and milk and in samples ofwater and sludge. In

a group of 27 individuals tested for blood levels ofpolychlorinated terphenyls andpolychorinated biphenyls, the average con- cerntration ofpolychlorinated terphenyls in the blood was greater than that of polychlorinated biphenyls, despite a fargreater industrial use ofpolychlorinated biphenyls in the area of study.

Carcinogenicity. No reports of long-term carcinogenicity studies of polychlorinated terphenyls were found in the searched literature. The Committee recommends that polychlorinated terphenyls be 'tested for carcinogenicity.

Mutagenicity No information on the mu- tageniclty of polychlorinated terphenyls

was found In the see .hed literature. The Committee recomme .ds that mutagenicity
tests beconducted.

Teratogenicity. N information onthe teratogenicity of polychlorinated terphenyls was found in the searched literature. The Committee recommends that teratogenicity tests beconducted.

Other ChronicEffects. Liver, skin and hematopoletic effects have been observed at high level exposures. Effects at lower levels
cannot be characterized from existing data. Chronic studies to evaluate the effects of prolonged exposures are recommended.

EnvironmentalEffects. The limited available data indicate a potential for bloaccumulation. No adequate information Is available on the ecological effects of these chemicals.
3.2.G PYRIDINE. Testing recommendations: Carcinogenicity,

mutagenicity, teratogenicity, other chronic effects, environmental effects, epidemiology. Substance identification: CAS No. 110-86-1.

REAsoNsFORRECOM=EMnATIONS Production,Release, and Exposure. The annual production of pyridine is estimated
to be in excess of '60million pounds, based bn production amounts for 1976. Although the amouht ofpyridine released into the en- vironment is unknown, its production volume and variety of uses raise concern with respect to human exposure. NIOSH es- timates that 249,000 workers may be ex- posed to pyridine.

Carcinogenicity. Only onelimited carcinogenicity study was found in the searched literature. By current standards, the study is Judged inadequate as an evaluation of the carcinogenic potential of pyridine. The Committee, therefore, recommends that ap- propriate carcinogenicity testing be undertaken onpyridine.

Mutagenicity.No mutagenicity studies on pyridine were found in the searched litera-

- ture. Given its known biological activity,

production volume, and human exposure, it is recommended that appropriate mutagenIcitytesting beundertaken on pyridine.

Teratogenicity.Only one limited teratogenicity study was found in thesearched literature on pyridine. It indicated that pyridineproduced abnormalities in chicken em- bryos. An evaluation of teratogene effects shouldbe undertaken in other species.

OtherChronicEffects.The carcinogenicity study cited above Is the only investigation lasting one year or longer found in the searched literature on the possible chronic effects ofpyridine. Short-term studies indicate that pyridine affects the central ner-
vous system and causes degeneration in the liver and kidneys. Chronic effects on these and other systems should be evaluated in appropriate long-term studies.

EnvironmentalEffects. The environmentalrelease ofpyridine may pose a hazard to aquatic biota and terrestrial life. Residues have been detected in water and uptake in plants has been reported. Although a wide range of toxicity has been measured for plant and animal life inshort-term bioassay tests, the results of one longer-term expo-
sure to Daphniamagna indicates a potential for chronic toxicity. More testing Is needed to determine the biological signifi-

cance of residues and the potential effects of long-term exposures on both plant and animal life.

Epidemiology.Pyridine has been reported to have an effect on the central nervous system in humans, as well as to produce injury to the liver and kidney. Given the large number of workers exposd, epidemiological studies should be undertaken. 3.2.H 1,11-Trichloroethane. Testing recommendations: Carcinogenicity,

mutagenicity, teratogenicity, other chroniceffects, epidemiology. Substance Identification: CAS No.71-55-0,

REAsoN roR RECom OA=0119 Production,Release, and Exposure This compound isproduced primarily for use as a cleaning solvent for metals and other materials. 1,1,1-Tricholoroethane (methyl chloroform) has the potential toreplace the chlorinated ethylenes in a variety of solvent formulations used commercially. The U.S. production of this compound totaled approximately 630 million pounds in 1976. Current release rates are not known; however, It Is estimated that over 300 millon pounds of this compound are employed in dispersive

uses which would principally result In re- leases to the atmosphere. The significant adverse effects on the upper atmosphere have been evaluated. Minor amounts may also enter the acquatic and terrestrial environment. NIOSH estimates that about 3,000,000 persons may be exposed to this material inthe workplace.

Carcinogenicity.The currently availablo Information, including recent results from the NCI carcinogenesis bloassay program, indicates that data are not adequate to make ajudgment onthe carcinogenic potential of 1,1,1-trichloroethane. The Committee recommends that thischemical be evaluated with respect to carcinogenicity.

Mutagenicity.The absence of Information

on the mutagenilcity of this compound Indicates that such studies should be undertaken.

Teratogenicity. The Committee concludes that the current available Information on teratogenc effects Is insufficient to judge the hazard potential ofthismaterial. Consequently, it s recommended that appropriate teratogenesis studies be undertaken on 1,1,1-trichloro- ethane.

Other Chronic Effects. There Is Insuffflclent evidence regarding the impact of chronic, low-level exposure to 1,1,1-trichlor. oethane. Chronic effects, with spccific attention to neurological, cardiovascular and renal systems, should be evaluated In appro. priately designed studies.

. EpIdemiology.,No Investigations ofhealth effects in occupational workers exposed to 1,1,1-trichloroethane were found during the Committee's review of this material. Given the large population of workers exposed to this compound, It is recommended that ap. propriate epidemiological investigations be conducted.

1. Preliminary List of Chemical Sub.
stances forFurther Evaluation,Toxic Substances Control Act Interagency Testing Committee, July 1977.

2. InitialReportto theAdministrator,Environmental ProtectionAgency, TSCA Interageney Testing Committee, October 1, 1977. Published In the FEveznn REoraxnm, Vol. 42, No. 197, Wednesday, October 12, 1977, pp. 55026-55080. The report and the supporting dossiers also were published by the Environmental Protection Agency, EPA 560-10-78/001, January 1978.

3. HumanHealthand the EnvironmentSome Research Needs, A report of the Second Task Force for Research Planning in Environmental Health Sciences, DHEV Publication No. NIH 77-127, Chapter 10, 1977.

[FR Doe. 78-10573 Filed 4-18-78; 8:45 am]

FEDERAL REGISTER, VOL 43,'NO. 76-WEDNESDAY, APRIL 19, 1978 

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