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PAUL A. TAYLOR. PhD. PRESIDENT CHARLES J. SOOERQUIST. Ph D VICE PRESIDENT ANTHONY S. WONG. Ph.D. VICE PRESIDENT RUBY A. ULRICH secretary/treasurep California. Analytical Laboratories, Inn. 401 NORTH 16th STREET SACRAMENTO. CALIFORNIA 95314 (916) 444-9602 STUDY REVIEW PRESENCE OF CHEMICALS ASSOCIATED WITH PVC/CPVC PLASTIC PIPE IN POTABLE WATER FOR CALIFORNIA PIPE TRADES COUNCIL TDO0T80Z SEPTEMBER 1980 BfG06904 r SUMMARY OF REPORT Chemical components of glues and primers used to install PVC and CPVC pipe have been found to leach into water contained in the pipe. 2. Regulatory agencies -- including the U.S. EPA and the California Department of Health Services -- have not established Maximum Contaminant Levels for these chemicals. The California Department of Health Services has proposed guidelines to estimate a Maximum Acceptable Level based on existing permissible occupational exposure levels (TLV's). 3. The Montgomery Consulting Engineers study for the Department of Health Services and plastic pipe manufacturers is deficient in that unrealistic pipe joint configurations and average gallon/day flow rates were used. 4. All four of the reviewed studies contained examples wherein levels of glue and primer components exceed the proposed California Department of Health Services Maximum Acceptable Levels in water. This is true for data from samples collected under continual use and. initial occupancy conditions. These data should be carefully and cautiously interpreted. It would appear that unless the new occupants reflush their plumbing system, they could be exposed to levels of con taminants up to 40 times the Maximum Allowable Concentrations during initial occupancy. 1. INTRODUCTION At the request of the California Pipe Trades Council, California Analytical Laboratories, Inc. has agreed to review pertinent documents as they apply to the potential hazards associated with the use of CPVC and PVC plastic pipe components for the transport of potable water. These studies include: (1) "Plastic Pipes Study" of James M. Montgomery, Inc. completed for the California Department of Health Services and the plastic pipe and fitting manufacturers, August 1980. (2) Wang and Bricker Study (Bull. Environ. Contam Toxicol., 23,620 (1979)). (3) California Analytical Laboratories, Inc. report dated May 15, 1980. (4) California Analytical Laboratories, Inc. report dated June 10, 1980. BFG06906 2. BACKGROUND Under the direction of Dr. Charles J. Soderquist, we have attempted to address the following points: (1) how scientifically valid are the studies which have been conducted; and (2) what extrapolations can be made and reasonable conclu sions drawn from these studies, particularly the James M. Montgomery report, in conjunction with the known toxicological properties of the identified contaminants, to determine whether the levels found represent a health risk under normal water-use conditions. The reviewed studies focus on the leaching of glue components from glued ("welded") PVC or CPVC joints. The leach ing of vinyl chloride monomer from PVC (poly vinyl chloride) pipe is not at issue. Commerical glues and primers are known to contain or more of the following organic solvents: methylethyl ketone (MEK), tetrahydrofuran (THF), cyclohexanone (CYH), and dimethylformamide (DMF). 0810004 3. TOXICOLOGY The true health hazard of any chemical, man-made or natural, can not be assessed solely in terms of its toxicity, as established by acute (single, lethal dose) and chronic (low dose, long term) trials using laboratory animals. Other factors, including route of exposure (dermal, oral, inhalation), duration of exposure and the susceptability of the person (age, health) must be considered. For example, while a large oral dose of the toxicant ethyl alcohol can be lethal to an adult, long term (chronic) exposure to low doses may result not in death, but liver deterioration. A comparable low level dose may, on the other hand, cause severe effects or death to a child or an unborn fetus. Substances which show carcinogenic potential are considered hazardous at any dosage (the Delaney law). While regulatory agencies such as the Food and Drug Administration (FDA) have rigid protocols for establishing acceptable contamination levels ("residue" levels) for noncarcinogenic substances which have been intentionally added (as pesticides) to consumable crops, other agencies (e.g. U.S. Environmental Protection Agency [EPA]) must deal with uninten tionally added substances for which appropriate toxicity and exposure data often do not exist. In the case of potable water, BFG06908 A S0U0T80 EPA has established Maximum Contaminant Levels for a select set of substances. Water which exceeds the limit for any single substance is considered non-potable. Only six organic chemicals" are currently regulated. (See Table I below) . "" TABLE I Chemical Maximum Contaminant Levels for Organic Chemicals in Water a/ mg/L (ppm) allowed -- endrin lindane methoxychlor toxaphene 2,4-D silvex 0.0002 0.004 0.1 0.005 0.1 0.01 a/ California Department of Health Services, Title 22 The Occupational Safety and Health Administration (OSHA) has collected a large volume of data on the effects of chemicals, mainly organic solvents, on worker health. To protect the health of workers who are continually exposed to chemicals as a result of their occupation, levels of these chemicals in the workplace environment (air) are limited to certain maximum acceptable values, called Threshold Limit Values (TLV's). 9UOOT80Z BFG06909 5. If a chemical (e.g. an organic solvent such as THF or DMF) is found as a contaminant in a potable water supply, the establishment of an acceptable (safe) level is more difficult. It is not generally possible to monitor the level of contaminant in water and correlate its effects over a long period of time in order to decide what level could be deemed safe--effects of low level exposure may take years to manifest as a chronic disease or disorder. The California Department of Health Services (CDHS) Hazard Alert System has adopted the policy that, in the absence of more directly applicable data, TLV's set by Cal/OSHA for workplace environ ments will be used to estimate safe levels in water. A flow chart of the arithmetic extrapolation procedure is attached. (Document #2). In brief, the procedure converts the TLV levels into drinking water levels by assuming an (arbitrary) safety factor of 100. That is, since CDHS does not know what a "safe" level of THF in water is, they must base their estimate on known effects (inhalation TLV's), extrapolate to exposure via ingestion (drinking water) and then only allow one-hundredth of that amount due to the uncertainties in their procedure. The calculation results--Maximum Acceptable Levels or MAC values-- for dimethylformamide (DMF), methyl ethyl ketone (MEK), tetrahydrofuran (THF) and cyclohexanone (CYH) are summarized in Table II. Additional information relative to the toxicity of these four compounds is attached. (Attachment #9). BFG06910 6. ^ n o n ie n :* TABLE II Estimated Maximum Acceptable Concentrations in Water Compound TLV (mg/m3) MAC (mq/L, ppm) --^ DMF MEK THF CYH 30 590 590 200 0.30 6.0 6.0 2.0 a/ Cal/OSHA b/ Assumes 10 Kg child consuming 1 liter 'of water per day and a lung retention factor of 1.0. v / . vs .I*. 0310008 7. PVC SOLVENT STUDIES Study A. James M. Montgomery Of the documents under question, the most exhaustive study completed to date is that of the James M. Montgomery group for the Hazard Alert System (CDHS, Berkeley) and for Hoge, Fenton, James and Appel, Inc., Attorneys at Law, who represent the PVC pipe manufacturers. (Attachment #1)-. We have reviewed this report based on our experience with projects of this type and with the analytical methodologies employed. While the contractor appears to have done an adequate job in providing the data required by the experimental protocol, certain design and analytical deficiencies appear. These are addressed in three parts. 1. There is some question as to whether a controlled laboratory study is an appropriate mode of evaluation. Generally, a laboratory simulation of a "real-world" phenonema is carried out only when the "real-world" is not accessible. Examples of PVC/CPVC plumbing already do exist and could have been monitored-- monitoring certainly should be considered as a future goal. BfG069V2 8. 2.Our criticisms of the methodology are: (a) Lack of data for the composition of the primers and glues limits the opportunity to compare the THF-MEK-CYH-DMF values for any particular study, and casts doubt on the validity of the entire ex periment by opening the possibility that glues with low THF-MEK-CYH-DMF or different content were used. While this data is apparently being collected by the contractor (see Attachment #la) , it is essential / ^J.n our view, to verify that the composition of the glues and primers used is typical of all glues commercially available. Glues containing twice the amount of THF would be expected to cause twice the level of leached THF in water. (b) The "kinetic" study is of no use because: .(1) contrary to what would be expected, levels of some contaminants decrease with time; and (2) use of an alternate pipe design (2", capped) and different brands of glue/primer preclude any com parison to the "static" and "usage" studies. It would have been helpful to be able to use the kinetic >_data to predict the contaminant levels in the "usage" ^s-'-'test which would result from increased (greater than - -i'i'overnight) stagnation time. BFG06913 9 ;:.V-3T-Kt ^ "* (c) Insufficient detail is provided concerning the determination of DMF, particularly the precision and accuracy of analysis. In our experience, this < analysis is difficult and not reproducible. Con sidering that DMF is the most toxic of the four solvents, good analytical data for low levels of contamination are essential. sz 3. Our final criticism involves the experimental design of the "usage" study, which was intended to simulate consumer exposure to domestic, potable water potentially containing leached solvents. We feel that the design of the "usage" study insufficiently modeled typical plumbing and water use regimes and certainly did not adequately assess any "worst case" situations. The following specific criticisms apply: (a) The ratio of feet of pipe to number of glued joints was 2.375. Typical 2-bath, 1400 square ^***<1 v .*** foot tract houses in Sacramento, California, have ratios near 1.2--that is, more glued joints and more glue per foot of pipe than was used in the study. (Attachment #4). (b) The average gallon/day flow through the single system was 350, while 250 gallon/day appear --' to be more typical of total (i.e., multi-outlet) 10. BFG06914 fanuly-of-four use (see Attachment #5) JjUW ci /-- -- flow rates (perhaps 50 gallon/day or less) would i seem more typical for a single outlet. (c) Most tap water consumption occurs at kitchen and bathroom faucets. Typical plumbing at a kitchen sink involves up to ten cemented joints (or more if accessories such as a dishwasher are -^Sised) in the four feet of pipe immediately preceeding -v,,, .N .X*' the tap outlet, yielding a pipe foot-cemented joint ratio of 0.40, about six times as many glued joints per foot than that used in the study. Thus, it would be expected that the level of contaminants * in the four feet of pipe preceeding an outlet would exceed those found in the James M. Montgomery study (usage test) by a factor of about six. Considering this factor alone, a consumer who samples (drinks) the initial 250 ml/flow of tap water might be exposed to levels about six times those found in the study. (d) While the choice of a twelve hour (overnight) stagnation time may be appropriate to model daily use, there was no provision in the experimental design to assess prolonged dwell time typical of weekend absence (48 hour stagnation), seldom used outlets (? hour stagnation) or seldom used homes (condominiums, vacation homes). BFG069V5 ^THO TSO In summary, most of the data collected according to the established experimental design, the sampling and analytical methodologies, and the report formats appear scientifically valid. We do find, however, significant deficiencies in the design itself. The "usage" study data, and the "static" tests (Montgomery Tables 3-1 through 3-5, respectively) are repro duced below. 1 BFG06916 P TnnTQ n^ / i ft IS. ^ <W. a izc czc tofiw*9si*^4 w*O9 O -Z 9*0 O O O mm | O C*M tv e v* o S>o S O.^ W> W5 tfl iv HIS ^ 11 99O 9 mm O _ 5 * ift NN w m> in N S. E-E J A M E S M . M O N T G O M E R Y , C O N S U L T IN G E N G IN E E R S , IM G . 555 East Walnut Street, Pasadena.California 91101/(213/ *96-9141/(213) 681-4255 Cable Address: Montgomery Pasadena California Telex: 67-5420 TAIII.E 3-2 TE TIt A IIY ItltO K U II AN CONCENTIIA THIN IN STATIC TEST SYSTEMS , ^ SJS5 roi hin ! In ts s Ifvts is ; 5 IS H IS s' \fZ2 "inZ "c^*e -- to* o 6w a* z $ 1 tw W ' o o l \ *a> > *s 9* u e >*-* i *o e -* 2 > U*- V* mm D OO 9S o5 I.-tJ t*o* 9 ^\ Gft . rio At 9 ^ s fi mm ft * ft. ^ tSi " 816909^ ST0OT8OS J A M E S M . M O N T G O M E R Y , C O N S U L T IN G E N G IN E E R S , IN C . 555 East Walnut Street, Pasadena. California 91101/(213/ 796-9141/(213) 681-4255 Cable Address: Montgomery Pasadena California Telex: 67-5420 6v690Di9 o aat > >a a 3(A 01 50) 5 c 1 m tf) s: o o: 3 oa3 2 0 TJ Cft aat 30> O* o> a o 2 H G) 0 l m o 31 3< 0 0z (A C q z G) Jl Z G) Z m n 2 0) i Z io I 9TOOT802 c& ft * > e S"C Oefr S IA IS P 3. c (A 9 S? Ml e rs so *9900 09 ^ t* * au#-sc S9 s N> o fw* (A*- O O i z9 zz n - <M N S l pu M^ls 7? "R. 5 I np gI [jon Oft 15 &| ^ < O IS :jcxnj * } Q ; &I2.ll I!A ^J* CYCLOHEXANONE OONCEMTIIATIOM IN STATIC TEST 6YSTEMS 06909i& a0> a icrr c. > Z0 aa> 3<tao 2 m to 5(U c3Csr 2 m <n 02* 3 2<0 0 0 3 a 3 Xa (aa/1> 031 O 0(0aaX3tft))t 0 Z 0 O0*1 0 O. 2 O 3 u> 02> <0 0 m 3) < \ 3 -- <0 to w 0 0 z<x5 <o>3 m ctb ro A. q 0 zro u zna0>3 AtCfXJl (9 Z n n a a z 0 1001802 91 z6ft 3z r: ?S Tr& 2<; w *r -- -e L ( I?' < tifecn ? I l? i- i, 15 zzzz a;;: St? I* ~ f}z?r ! 9 n rr zz zz s::: ;S n; 15 2 zzzzr zz :::: rz 9C oe i^ ? ~ " L" o^r Si Ztn --Z s r8A z2 :1 e& e II,N IH M E U IY Itn ilM AM IDE C O IIC E N TII ATKM IN STATIC TEST SYSTEMS o? ci j; >* 5 *c e Cl Q 2 2 -O. 2C << 2 -1 2 0S 40 Qu >* s> & _ CJ ~5 HQ "S ?< g* M fi 2 in dou l js. ts* 2 H40 2 >- > -- -- 40 5 H f1 a 40 >s ="^ 4- T a2 32 rc 0= .. 2 2< 2 0w =2 < >2 2M **.l a2 u2 2P 0G or Wn = >. 3 AC OS CJ a 2 m eca > T3 -v O -- ci a 2 sa -- j: *S03 IfC 5* 3 (M b a 2 es SO ro min e* e cl A a ^c 2 2 O 40 P < cs o s -- <3 i>. =a Psl r a 5a co o a -< W 2 O uw i >. s a a ea a rJ (-4 pM fn 2 CO 4* --e a > e o e a a aa a o m HM 2 40 - _eo "a 3 o A* (M o rt m o(VJ a 2 a c- O x tx 4} e S) 1L 4J JC A 40 JJ 1) 2 V Mot SJ -- > 0 c uA X S a y A u u2 y >* r* U 2 a v* 5 W a 3-7 17. ' o 0810018 0 z to a a uz 5 z liCOnM u CD to z0 r> CM 5 oCM in 3 o> tSi (I) Z aC*>D. CO 0X 0 Q> 0 o 9> ffl c2k_ o 2 cwo -- 0 o 0 z0 (5 h 0 0 O tco *(0a0DA> & c 0 tVPooO) a eQ> 2 <oD o05 c o 2 to V1f)t w lit 2 5--,, tn to LU "O < <3 m 4mT* BIS O ^G0692V B 1 Study B. Wang and Bricker The work of Wang and Bricker (Attachment #6) showed that a plumbing system consisting of about 80 feet of 1.5 inch diameter PVC pipe, presumably plumbed in the usual fasliion, continued to leach MEK and THF even after eight months of continual (40 gallons per day) use. Their Table I data is reproduced below. Bull. Environm. Conum. Toxicol. 23.020-623 (1979) 2-Butanone and Tetrahydrofuran Contamination in the Water Supply' T. C. Wang and J. L. Bricker Harbor Branch Foundation, Inc^ HR J, Sox J96. Ft. Piarca, Fla. 33450 MEX (2-butanone) and THF (tetrahydrofuran) were found in high concentrations in our laboratory's water outlets 6 mo after PVC (polyvinyl chloride) pipe instal lation. Subsequent analysis confirmed that the solvents from the PVC pipe cement used to join the tubing were leaching into our water supply. Water samples were taken at various residence times in the pipe to observe the solvents' leaching kinetics. TCBLS 1. Concentration (ppm) of MQC and THF in Water Samples at various Residence Times in the PVC Pipe Residence Time (h) 0 4 8 16 24 48 64 72 96 Saiples taken 6 mo after pipe installation HEX. A\C L o 0.4 0.6 1.8 2.2 3.9 4.5 -- 4.5 THF 0 1.0 1.7 (tf !12 jl3 - Sanples taken 8 mo after pipe installation THF 00 0.1 0.7 - 0.6 2.4 1.1 3.7 2.1 6.8 - 2.2 - BFG06922 t: GT00T80 Study C. ' California Analytical Labs, Report, May 1980 This report (Attachment #7) consisted of results of sampling a new house in Lancaster, California, which had been partially plumbed with CPVC pipe. MEK, THF, and CYH were found at levels of up to 92 ppm. 'sU n it Study D. California Analytical Labs Report, June 1980 Samples were collected from a newly plumbed CPVC system at Mercy Hospital, Sacramento, which apparently had never been flushed. MEK and THF were found at levels up to 240 ppm. (See Attachment #8). 19. 0810020 SUMMARY OF PVC SOLVENT STUDIES THF and MEK were found in all four studies, and DMF was found in two of the four. This certainly indicates that leaching of glue components is a real phenomena. / Consumer exposure to domestic water contaminated by transport through CPVC pipe should be assessed under two separate conditions. First, what exposure levels will result from continual, typical use conditions. Second, what exposure levels will result during the initial occupancy of the house. These situations are assessed below. For the first case, we assumme that the CPVC plumbing has been flushed and in use for some period of time. The Montgomery "static" tests for THF indicate that levels in excess of the MAC values are obtained even after six flushes over 19 days of leaching. The Montgomery "usage" study, when corrected for a more typical pipe feet to cemented f joint ratio as we propose (Table IV), yields concentrations very close to the MAC values after 10 days of use iidering the other experimental design problems which we have pointed out (excessive flows, inadequate stagnation), these data should be interpreted as representing minimum levels to be expected 3 10810021 Jb & 5 >1 & 00 oo oCN o VO VO V V o tn En rs CN O<N LH in ovo rH V ".i* VO O in ctn CN 20810022 in a real-world situation. This observation is borne out by the other two relevant studies, which are based on samples taken from in-use PVC/CPVC systems, and yielded samples containing excessive levels of contaminants, particularly THF. Data from all three studies are summarized for comparison to the estimated MAC values obtained from the California Department of Health Services procedure (Table V). For the second case, we assume that a CPVC system has been cured, pressure tested (1-2 days stagnation), flushed with up to three volumes of water, and then left unused for some period of time. For example, a contractor performs these steps, the dwelling is sold, and the new occupants move in two weeks after any water use has occured. The Montgomery static test data (Tables 3-1 through 3-4) and the California Analytical Lab Report of June, 1980 represent this use pattern; data is reproduced in Table VI for comparison to the MAC values. It would appear that unless new occupants reflush their plumbing system, they could be exposed to levels of contaminants up to 40 times the Maximum Allowable Concentrations during initial occupancy. ? 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' to c O in c in <N V 4J o / z (inD p o 0) o 0 H ft to (U o H > H 0) CO JZ 44 otO <D P rH to T3 >C 3 X to CO fOt 01 01 ft -H ,,--. 'O O3 4-> 44 4 N O' tO CO E V 44 PC c a m > -h ft r-H rH ' .0 tH H U CO H X 6 I W oV4 <uu Ob ft c w toI O -P n> CI2 tO p nPHs Q a f(t0 oE u \ Ql >i ft 3 s *4 44 0 0) CO H E JX 44 O O 0) ID Cji-H 01 c 44 44 tn 3 o1 O 44 CN 44 CO "" CO c o -H ol 44 <u ns *H H E Q 44 P ns C E <u HoU X -H C id h o s <u ID rH o O' o CO CN ooo vo vo <N o Hi c to c -H Eto 44 ffXtt ft X h X ft u ft X Q c o u o 44 c <0 E 44 >H (0 a <u Q to H c p o H H rH to u 0 44 O' c 'C o u oto T3 a) . 44 44 i--toi aXt 3 44 o rH Q) Uto W<u \ to I ui 0) 44 0 z 30 A ve ra g e o f fo u r CPVC p lu m b in g re g im e s a f t e r an i n i t i a l 3 -vo lu m e flu s h fo llo w e d by tw o weeks o f s ta g n a tio n . See M ontgom ery T a b le s 3-1 th ro u g h in te x t. 20S10025 IT roI DOCUMENTS 1. James M. Montgomery, Consulting Engineers, Inc. "Hazard Alerty System, California Department of Health , Services, Plastic Pipes Study, Draft Report"; August, 1980. A letter of August 29, 1980 from Kenneth Reich to Marc Lappe' accompanied. 2. Marc Lappe', California Department of Health Services/ Department of Industrial Relations -- Hazard Alert System letter to Mr. Ray Leonardini; May 22, 1980. 3. Beverlee A. Myers, California Department of Health Services letter to Mr. Donald Terner, Director of Housing and Community Development, Sacramento; January 28, 1980. 4. X; Plumbing plan for 2 bath house from Luppen and Hawley, Inc., Sacramento, California. Plan received from Mr. John Gorman, California Pipe Trades Council. 5. Tom Johnson, Department of Housing and Community Development, Division of Codes and Standards, memorandum of May 27, 1980. 6. T.C. Wang and J.L. Bricker, "2-Butanone and Tetrahydrofuran Contamination in the Water Supply," Bull. Environm. Contam. Toxicol., 23, 620 (1979). 7. California Analytical Laboratories, Inc., report #11501 to Raymond Leonardini of May 15, 1980. 8. California Analytical Laboratories, Inc., report #11614 to Raymond Leonardini of June 10, 1980. 9. / / Marc Lappe' letter to Mr. Myron Moskovitz and accompanying SNARL on trichloroethylene and toxicity data for other chemicals of February 14, 1980. 11 9200TS0: BFG06929 C. APPENDIX Not all of the documents referred to in the text are reproduced here. Total pages for these documents number over 100. Interested parties may contact either the Calif ornia Department of Health Services or the California Pipe Trades Council for a copy of: 1. The Montgomery Report; 2. Plumbing plan for 2-bath house; 3. California Department of Housing and Community Development memo; 4. Wang Study; 5. EPA SNARL on trichloroethylene. The other documents are reproduced in the following pages. 26. 20810027 JTATt OF CALIFORNIA--HEALTH AND WELFARE AGENCY/AGRICULTURE AND SERVICES AGlnCV EOMUHO C. SHOWN J*.. Cn(m DEPARTMENT OF HEALTH SERVICES/DEPARTMENT OF INDUSTRIAL RELATIONS HAZARD ALERT SYSTEM (HALTS) 2251 BERKELEY WAV BERKELEY, CA 94704 May 22, 1980 Mr. Ray Leonardini 717 K Street Suite 510 Sacramento, CA 95814 Dear Ray: You asked me to provide you and other labor representatives with the methodo logy we plan to use in evaluating the safety of any observed solvents, PVC, monomer, plasticizer or other organic chemicals or metal ions in water carried by plastic or metal pipes. For non-mutagens and non-carcinogens (refer to letter to Myron Moskovitz of Februairr 13 sent under separate cover) we will determine water-borne pemissable exposures based on equivalent doses permitted in workplace settings. This means that if a worker is permitted to be exposed to 200 ppm of methyl ethyl ketone (MEK) daily for a 40 hour work week, we will calculate the amount of MEK he or she would likely absorb in the course of those five days of work, incorporating an appropriate lung retention and body weight factor. Having obtained this absorption value (expressed as mg/kg) we will then com pute an equivalent amount for the most vulnerable member(s) of the population, specifically newborns and children, by extrapolating from the adult value to a child value using a body weight conversion--a standard pharmacology pro cedure. We will then calculate a permissable dose by using a safety factor of 100 and assuming that one liter of water is ingested per day for a child, and two liters for an adult. This process is shown schematically in the accompanying table. If an agent is found in the leaching study water that has other than acute toxic effects, i.e., teratogenic, carcinogenic and/or mutagenic effects, a more rigorous risk estimation process will be needed. In general we will follow the procedures used by EPA in preparing SNARL documents, a copy of which is enclosed for TCE. We are presenting this information to you in written fora to corroborate our orally expressed position at earlier meetings. However, we wish to emphasize that these methodologies provide only broad guidelines for our evaluation. Should, for example, a solvent or a metal be shown to have chronic neuro toxicity, we would want a more stringent safety factor than the "100" one we have proposed. You will also note the similarity in our approach to that used in the January 20, 1980, letter to Mr. Temer from Beverlee Myers. 8Z00TS0 2- - Any comments you or your toxicological consultants might wish to make would be welcome; however, any responsibility for the most suitable evaluation pro cess rests with HALTS and its staff. You will be notified as a further courtesy should we introduce any modifications of the general approach out lined here. Your comments or questions regarding either our rationale or the actual methodologies to be used are welcome. Sincerely, Enclosure ml :vk Marc Lappe', Ph.D. Chief, Hazard Alert System 0S100Z9 BFG06932 Table I ---------------------- -------- 1.! Current or Recommended TLV (TWA.) (mg/m^) i multiplied by 2. Volume of Air Inhaled by worker per work day (mg/day) multiplied by 3. Work Week (assume 40 hours) or 5 days multiplied by 4. Retention Factor (, equals 5. 1 Amount of Substance Absorbed [ by worker per week (mg) divided by 6. Weight of worker (assume 70 kg) equals 7. Bose on body weight basis (mg/kg) divided by 8. Seven day week equals 9. Daily dose on body weight basis (mg/kg) multiplied by 10. Child or newborn body weight divide by 11. Safety factor (100) equals 12. Maximum allowable dose child or newborn (mg) divide by 13. Volume of water consumed per day (assume one literJ equals 14. Maximum allowable concentration in water (mg/1) an appropriate confidence interval IZ 0810030 445-12-'.a o i Dor.ald Turner, Director Housing and Cothiunity Development 921 Tenth Street Sacramento, CA 95814 ram i Office of the Director OaU i Sub|jct: Consideration of Health Hazards Associated with Use of PVC Pipe Cements As requested, the Department of Health Services has reviewed information related to possible health hazards associated with polyvinyl chloride (PVC) ' pipe. The Department oust adopt the position that it cannot support the use of PVC pipe until it is shown that residues of solvents used to join PVC pipes do not enter drinking water in amounts significant to health. The Department has reviewed literature related to the effects on. water quality from PVC pipe. The Environmental Protection Agency reports Indicate that there is little release of*the carcinogenic vinyl chloride monomer from the ' pipe into drinking water.1.2 Under appropriate controlled conditions of manufacturc, the pipe Itself appears to be safe for carrying drinking water. Of greater concern to the Department are the primers and solvent cements used to join PVC pipe. These include tetrahydrofuran (THF), dimcthylformamide (DKF), cyclohexanone, and methyl-eciwl-kecone (1EC). MEK Is neurotonic', particularly in the presence of certain other ketones, and DHF is hepatotoxlc, an effect potentiated by ethanol. Decently, the Threshold Limit Values (TLV's) h^ve been reduced for both cyclohexanone (from 50 ppm to 25 ppm) and for OKF (to 10 ppm) . Both MEK and TUP have been shown to leach into water that is left standing in the pipes,3 and It is reasonable to assise, until proven otherwise, that the other two solvents, DMF and cyclohexanone, do also. There are, at presene, no water quality criteria standards known to the Department which sec acceptable levels for these chemicals in drinking water. The Department has decided as an a priori margin of safety, ehac the dose absorbed in drinking water per week by Che population should be less chan one - one-hundredth (10"2) of the TLV/TWA, the level that GSHA allows the industrial worker to bresche at the worksite per week. -- 0810031 Health Division JAN2812S0 f.J / Mr. Donald Turner -2- This should be considered cho smallest acceptable margin ef safety because exposures to these chemicals In drinking water affects: 1. the general population; and consequently a much larger number of people than just the worker population with industrial or installation exposure; and I 2. high risk groups In the population;, e.g., pregnant women and infants. Calculations presented in the Appendix may demonstrate that these chemicals may enter drinking water in amounts that could be of health significance. According to these calculations, a developing child could be exposed to DKF at levels 1/3 the TLV/TWA industrial exposure (on a per kilogram basis) and to cyclo hexanone at 1/10 the TLV/TWA industrial exposure, "ven with the compounds MEX and THF the exposure would be l/60th the TLV/TWA -- certainly not a broad margin of safety. Exposure of adults to DMF and cyclohexanone would also lack an adequate safety margin. The brain of the fetus or developing infant is more susceptible to neurotcxic agents chan is chat of the adult. Given these calculations and discussion, the Department of Health Services must adopt the position thac it cannot support the use of PVC pipe until it is shown that residues of these solvents do not enter drinking water in amounts significant to health. If further discussion of this subject is desired, you may contact Dr. Donald Lyman, Deputy Director, Public and Environmental- Health Division, Department of Health Services, (916) 445-1102. Beverlee A. Myers Director Attachment C00T802 i\i APPENDIX A study recently reported in the Bulletin of Environmental Contamination and Toxicology.3 reports chat water from PVC pipea installed 6 months earlier gave the following levels of KEX and THF as affected by the time the water resided in the pipes before use: Residing Time (hours) 0 HEX (ppm) 0 THF SsssiL 0 t 4 0.4 1.0 8 0.6 1.7 16 1.8 5.8 24 2.2 8.9 48 3.9 12.0 64 4.5 13.0 96 4.5 13.0 Since no water qualitycriteria are available for these chemicals, limits for these substances are estimated from quantities respired by a worker breathing in an atmosphere at the TLV for a work week; Quantities of DMF, THF, HEX, and cyclohexanone absorbed by a 70 kg worker breathing each substance at the TLV 8 hours per day: A. DMF: ! TLV for DMF is 10 ppm (30 ag/M?) Breathing 10 M3 per 8 hour day, he will be exposed to and potentially absorb: 300 mg DMF or 4.3 mg/kg/day or 21.4 mg/kg/work week 20810033 BFG06936 -2- B. THF or HEK: TLV for THF and KEK is 200 ppm (590 mg/U^) Breaching 10 per 8 hour work day, he will be exposed Co and potentially absorb: 5900 mg TUF or MEX/day or 84.3 mg/kg/day or 421 ng/kg/vork week C. Cyclohexanone: TLV for cyclohexanone will be 25 ppa (100 ng/M^) t By the same reasoning: ^ 1000 ag cyclohexanona/day or 14.3 mg/kg/day or 71.4 mg/kg/work week How to estimate water exposure: If drinking water contains 1 ppa of substance For 70 kg person drinking 2 liters/day 2 ag/day Intake or 0.03 mg/kg/day or 0.2 mg/kg/7-day week For 10 kg child drinking 1 liter/day 1 ag/day intake or 0.1 ag/kg/day or 0.7 rg/kg/week If drinking water contains 10 pom of substance 20 ag/day Intake or 0.29 mg/kg/day or 2 mg/kg/7-day week 10 ag/day Intake or 1 ag/l;g/day or 7 ag/kg/week It 1a apparent that water ranging from 1 ppm Co 10 ppm of DMF would expose an Infant (on a per kilogram basis) from 1/3 Co 1/30 the limit of DMF an adult Bay be exposed to in a week at work. By the same reasoning the infant would b exposed to from 1/10 to 1/100 the cyclohexanone limit and from 1/60 to 1/600 the THF and MEK. limit. These exposures are unacceptably high and do not afford the 10~^ margin of safety the Department considers necessary. References: 1. Preliminary Assessment of Suspected Carcinogens in Drinking Hater, O.S.E.P.A., December 1975. 2. Dressman, R.C., McFarren, E.F.: Determination of Vinyl Chloride Migration from Polyvinyl Pipe Into Water; J. Amer. Water Works Assoc. 70:l:29-30, t 1978. 3. Wang, T.C., Bricker, J.L.: 2 Butanone (methyl-ethyl-ketone) end tetra- hydrofuran (THF) in the Water Supply; Bull. Environ. Contam " :ol. 23:620-623, 1979. ... . ". > PAUL A TAYLOR PK.O. PRESIOENT ANTHVOIONYhSllWMOQNCGN. !F CHARLES J SOOEROUIST. Pri.O OIR OF ENVIRONMENTAL CHEMISTRY JERRY L. WILSON. Pi SENIOR CHEMIST SECRETARY California Analytical Laboratories, Inc. 401 NORTH iem STREET SACRAMENTO. CALIFORNIA 95814 (9i444^602 June 10, 1980 Lab No. 11614 Submitted: 6/5/80 Ray Leonardini 717 "K" St. Suite 510 Sacramento, CA 95814 Nine water samples received in 40 mL septum-capped vials. Analysis for organic contaminants. The following samples were collected by Dr. C.J. Soderquist of California Analytical Labs on June 5, 1980. Sample I.D. 1. 70-1 -- Hospital new basement, capped CPVC line; initial effluent 2. 70-2-- flow Hospital new basement, capped CPVC line; after about 1 pint 3. 70-3-- flow Hospital new basement, capped CPVC line; after about 3-5. gallons 4. 70-4- Hospital new basement, capped CPVC line; after installation of hose bib and 5 mi full flow 5. 70-5-- system Hospital, 1st floor, incoming water 6` before tie-in to CPVC 6. 70-6-- Hospital, new basement; same as sample 4 after 30 minutes stagnation 7. 70-7-- Hospital drinking fountain in old basement .8 70-8-- Hospital, new basement; same as sample 4 after 43 minutes stagnation 9. 70-9-- Hospital, new basement; same as sample 4 after 144 minutes stagnation Selected samples were analyzed for methyl ethyl ketone (MEK), tetrahydrofuran (THF) and cyclohexanone by direct aqueous injection using flame-ionization gas liquid chromatography and for halogenated volatile organics using purge/trap Coulson gas-liquid chromatography. Results are attached. c- Charles Dir. of ijSV Sodermiist, PhD iromental Chemistry n n n /iT r/i^ PAUL A TAYLOR. Ph 0. PRESIDENT ANTHONY S WONG. Ph C vir.i pur sior.N? ChaplES J SOOEROUIST. Ph D DIR OF ENVIRONMENTAL CHEMISTRY JERRY L. WILSON. Ph O SENIOR CHEMIST SECRETARY California Analytical Laboratories, Inc. *01 NORTH 18th STREET SACRAMENTO. CALIFORNIA 9581* <9ie>444^a *JlWe 10, 1980 Lab No. 11614 Submitted: 6/5/80 Ray teonardini 717 "K" St. Suite 510 Sacramento, CA 95814 Nine water samples received in 40 mL septum-capped vials. Analysis for organic contaminants. The following samples were collected by Dr. C.J. Soderquist of California Analytical Labs on June 5, 1980. Sample I.D. 1. 70-1 -- Hospital, new basement, capped CPVC line; initial effluent 2. 70-2-- flow Hospital, new basement, capped CPVC line; after about 1 pint 3. 70-3-- flow Hospital, new basement, capped CPVC line; after about 3-5. gallons 4. 70-4-- Hospital, new basement, capped CPVC line; after installation of hose bib i 5 minutes full flow 5. 70-5-- system Hospital, 1st floor, incoming water 6' before tie-in to CPVC 6. 70-6-- stagnate Hospital, new basement; same as sample 4 after 30 minutes 7. 70-7-- Hospital drinking fountain in old basement 8. 70-8-- stagnate Hospital, new basement; same as sample 4 after 43 minutes 9. 70-9-- Hospital, new basement; same as sample 4 after 144 minutes staanation Selected samples were analyzed for methyl ethyl ketone (MEK), tetrahydrofuran (THF) and cyclohexanone by direct aqueous injection using flame-ionization gasliquid chromatography and for halogenated volatile organics using purge/trap Coulson gas-liquid chromatography. Results are attached. L | BFG06939 Charles Di r. of Soderquist, PhD iromenta1 Chemis try 20310035 Ray Leonardini Lab No. 11614 June 10, 1980 page 2 Sample TABLE I ,JCt_ , JyCtC* tiCL. ^ ____________ mq/L (ppm) found_____________ __________ MEK TH'F~ cyclohexanone 11614-1 C :9,3 d1 ' ^ <r v: ' -f 3J V *. .. ' . 3 -19 . *___ ^ ""^19 v*`; -8.7 4J 9` , __ ; ? -U 5 ' <1.0 <1.0 5 v * ><!' '^<1.0 y a O. -. 1 <1.0 8 "- <1.0 9- '` <1.0 l- '* 2'' * **- 240 260 160 <1.0 <1.0 <1.0 <1.0 <1.0 <1.0 <5.0 <5.0 <5.0^ <5.0 ( <5.0 1 <5.0 ' <5.0 <5.0 <5.0 ! 9COOT80: BFG06940 to TABLE II Compounds for which entries are made below were detected by the purge/trap technique with Coulson gas-chromatography. All others were absent at the stated detection limit. ,Vo x'~ - 'c Ujr ' ' DDb found COMPOUNDS 11614-1* 11614-3* 11614-5* 11614-9 Dichlorodifluoromethane Chioromethane Vinyl chloride Bromomethane Chioroethane T richiorof1uoromethane Diehloromethane 1.1- Diehloroethylene 1.1- Diehloroethane trans-1,2-Dichloroethylene Chloroform I 1.1.2- Trichloro-2,2,1-trifluoroethane 1.2- Dichloroethane 1,1,1-Trichloroethane Carbon Tetrachloride Dibromomethane B romodich1o rome thane 2.3- Dichioropropy1ene} 1.2- Dichloropropane T rich1oroethylene cis-1,3-Dichloropropylene 1.1.2- Trichloroethane Dibromochloromethane / 1.2- Dibromoethane Bromoform Tetrachloroethylene 1.1.2.2- Tetrachloroethane Chlorobenzene 2.7 14 0.83 1.2 2.1 1.5 10 8.7 0.20 0.72 1.7 60 54 .i 4.0 3.8 *****\ 1 Detection limit: 0.5 ppb 0.5 ppb 0.5 ppb 0.5 ppt NOTE: The bracketed pairs cannot be distinguished by this technique. * Contains.unidentified compounds at the low ppb level. 20810037 Raymond J,. Leonardini Lab No. 11501 May 15, 1980 Page 2 CAL I.D. 11501-1 -2 -3 -4 -5 -6 -7 -8 -9 -10 -11 -12 -13 -14 Sample description 63-la 63-lb 63-2 63-3 63-4a 6 3-4b 63-5 63-6 63-7 63-8 63-9 63-10 63-11 63-12 South side hose bib 1120 hrs. South side hose bib (duplicate) 1120 hrs. South side hose bib after approx. 3 minutes flow 1125 hrs. West side (south end) hose bib after approx. 0.5 minute flow 1130 hrs. North side hose bib after approx. 5 minutes flow 1135 hrs. North side hose bib after approx. 5 minutes flow (duplicate) 1135 hrs. South side hose bib after approx. 18 minutes flow (BROKEN) West side (south end) hose bib 1420 hrs. West side (south end) hose bib after approx. 0.5 minutes 1420:30 hrs. West side (south end) hose bib after approx. 1 minute 1421 1" West side (north end) hose bib 1427 hrs. West side (north end) hose bib after aoprox. 1 minute 1428 h South side (by garage) hose bib 1431 hrs. South side (by garage) hose bib after approx. .1 minute 1432 METHODS: Various analytical approaches were used to determine the nature and level of contaminants present in the water collected from the house. A. FID-GLC determination of THF, DMF, MEK and cyclohexanone. Samples were analyzed by di rect aqueous injection for THF (tetrahydrofuran), DMF (dimethyl formamide), MEK (methylethylketone) and cyclohexanone by flame-ionization gas-liquid chromatography (10 foot, 20% SP-1000 column) against authentic samples of these compounds. DMF gave a poor response to the analysis; its presence or absence was not accurately determined. Results are given in Table I. B. Coulson-GLC determination of volatile, halogenated organics. Samples were analyzed by the purge-trap technique using Coulson gas-liquid chromatography (10 foot, 0.2% Carbowax 1500 on Carbopak C Column). Results are given in Table II. C. FID-GLC and ECD-GLC determination of phthalate esters. Samples were analyzed for phthalate esters (e.g., dimethyl-, diethyl-, dibutyl-, butyl benzyl-, diethylhexyl- and dioctyl phthalates) by extraction with toluene and with carbondisulfide. The toluene extracts were examined by electron capture gasliquid chromatography (6 ft. 1.5% OV-17/1.95% QF1 column) and the carbondisulfide extracts by flame-ionization gas-liquid chromatography (3% SP-2250 column). Results of the FID analysis are given in Table III. D. GC/MS confirmation. Certain samples were examined by gas-chromatography mass-spectrometry to confirm the presence of suspected contaminants. Both the purge/trap (for volatiles) and extract injection (for phthalates) techniques were used. 2o^>ico^c DISCUSSION: GC-MS analysis of sample 11501-4 confirmed that THF, MEK and' cyclohexanone were present. GC-MS analysis of the toluene extract of sample 11501-1 confirmed the presence of diethyl hexyl phthal ate.. Samples collected from the south side hose bib, which is the furthest sampling point from the incoming (north side) source, contained high levels of MEK, THF and cyclohexanone and low levels of carbontetrachloride, tri chloroethylene and tetrachloroethylene. Samples collected from the incoming (north side) source contained no detectable amounts of these contaminants; only those volatiles which are common to chlorinated water were present (Table II). Data of three sets of samples can be interpreted in terms of time-of-flow. In two cases, an increase in contaminant levels is apparent after some flushing: Sample 11501-2, collected just after 11501-1, and sample 11501-12 collected about one minute after 11501-11. A decrease in contaminant levels following prolonged flow is apparent from comparison of sample 11501-3 (3 minutes flow) to 11501-1 and -2 and from samples 11501-9 and -TO to sample 11501-8. It is obvious from these comparisons that the potential hazard to a consumer will be dependent upon the pattern of water use in the home. Analysis for phthalate esters indicated that diethyl hexylphthalate was present in the two samples examined (Table III). It would appear from this limited data that diethylhexylphthalate was present at an elevated level in the south side sample. However, the sample vials and sampling protocol used in this study were intended for volatile organics and do not represent the best protocol available for semivolatile organics--especially for the ubiq-: uitous phthalates. Further work would be necessary to confirm the validity of this preliminary assessment. rau BfG06943 O fO O TSO t CAL I.D. 11501-1 -2 -3 -4 -5 -6 -7 -8 .. ^-9 -10 -n -12 -13 -14 MEK 5.5 <0.5 3.1 <0.5 <0.5 Broken 4.1 <0.5 <0.5 0.5 1.3 3.6 <0.5 ND = Not Determi ned TABLE I ma/L (ppm) found THF cyclohexanone 2.7 92"-, < jj 'NO 1 .o ss. 2---'"^-*' no ; 24^)^5 0.5< Mfi. *-7<~ 11,1 <0 5 5 f r J' 1.4 ND ND 37 <0.5-"* 'V2`:,' <0.5 5.0 Xfo) /1,I! /Wi" 5 5 3/J7S ^ 'w,/ 0.6 ^ 0.8 NO ND ND ND ND ND U: S .w -r - ft 25r' | ' Vr y *r UJ'f >* - J ri 5 2. O DMF <5.0 . ND ND <5.0 ND ND <5.0 ND ND ND ND ND ND 20810041 BFG06944 TABLE II Compounds for which entries are made below were detected by the purge/trap technique with Coulson gas-chromatography. All others were absent at the stated detection limit. COMPOUNDS 11501-2 11501-5 Dichlorodifluoromethane Chioromethane Vinyl chloride Bromomethane Chioroethane Trichiorof1uoromethane Diehloromethane 1.1-Dichloroethylene 1.1-Diehloroethane trans-1,2-Dichloroethylene Chloroform 1 1.1.2-Trichloro-2,2,l-trifluoroethane 1.2- Dichloroethane 1,1,1-Trichioroethane Carbon Tetrachloride Dibromomethane B romodich1o romethane 2.3-Dichloropropylene'} 1.2-Dichloropropane Trichloroethylene cis-1,3-Dichloropropylene }1.1.2-Trichloroethane Dibromochloromethane 1.2- Dibromoethane Bromoform Tetrachloroethylene 1.1.2.2-Tetrachloroethane Chlorobenzene 140 ppb 14 ppb 16 ppb 2.5 ppb 3.5 ppb 6.0 ppb 74 ppb 20 ppb 3.6 ppb nfTO nrv Detection limit: 0.5 ppb NOTE: The bracketed pairs cannot be distinguished by this technique. BFG06945 Samde 11501-1/-2 composite 11501-5/-6 composite TABLE III diethylhexylphthalate 0.11 mg/L (ppm) 0.02 mg/L (ppm BFG06946 C EPARTMENT OF HEALTH SERV. MA2AR0 ALERT SYSTEM (HALTS). *I5i WAV haakclcy. ca m704 iS/DEPARTMENT OF INDUSTRIAL .LATIONS February 14, 1380 Mr. Myron. Moskovitz Chairman Coniirf R3lon on Housing & Community Development 921 10th Street SAcramento, CA 93S14 Deer Mr. Moskovitz: wanted to provide you and the Housing and Development Committee a interim progress report on the work of the HALTS unit on the issue of potential health hazards for plastic pipe. To date, the HALTS staff have completed an initial review of the complete toxicology literature on each of the major solvents; initiated field measure-* meats on worker exposures to solvent cements or primers while installing pipe; and commenced planning with industry to do a full-scale test of FVC pipe to determine hov much solvent, if any leaches from pipe under a full range of operating conditions. 1. Toxicology The attached. Appendix summarizes briefly the major toxicological features of the solvents. I wish to emphasize chat such data provides only a baseline against which to measure worker exposures and leached solvent. By themselves, such toxicity information provide little or no guidance for policy determi nations. Only actual measurements of exposure data will suffice for our review. Our evaluation will thus be based on data measured in the workplace or in the pipe itself. These tests will be conducted under conditions set by Che Department with the cooperation of industry representatives as outlined below (see 3). Every effort will be made to ensure that the test conditions meet the concerns of all factions involved, consistent with goad study design and abjective scientific analysis. 2. Worker Hazard Evaluations Field measurements are going forward at a number of sites given to us by workers or their representatives with the objective of deriving "worst-case" scenarios for exposure. Preliminary dara vased on MEK exposure in a closed site suggests that even under such extreme conditions workers may not be exposed to levels that pose major health risks. I would emphasize the very preliminary nature of such a finding, and again stress chat our final report (due Kay 1, 1980) will embrace as full a range of worker exposure as is practicable. 3. Field Test of Leaching BFG06947 Hr. Woakxrrf.cz --2-- In order to resolve the contradictory and largely anecdotal reports of the safety of potable water transported through plastic pipe, HALTS ha reached agreement with Hr. J. J. Bluaenkrantz of the R,. & G. Sloane Mfg. Company of Sun Valley, California, to conduct a full series of tests of water carried by plastic pipe under supervision, of the Department's staff and the most rigorous test conditions possible. Again, "worst possible" test conditions will be assessed with maximum numbers of fittings per unit length of pipe; "sloppy" solvent technique; "aggressive" (ie high solvency) water; and maximum temperatores used as well as appropriate "normal" condition and, hopefully, iron pipe controls. 4, Comments .^ Our findings to date, based on extensive contacts with industry (including Monsanto and Dupont representatives) lead us to believe acht Che issue of worker safety and solvent leaching has been inadequately studied. To cite but one specific case, a call to Dr. Robert Olson of St. Louis University School of Medicine revealed that his conclusions on worker safety (communicated in e telegram dated 1/23/80) were based on theoretical calculations rather than field measurements. Similarly, calls to industry references on solvent safety vis a vis leaching (Continental Water Co., Indianapolis, Indiana and 1 Paso, Texas) yielded no contacts who had actually measured solvent amounts in water. Tn view of the the dearth of usable data on actual exposures and our previous concerns about potential health effects, we believe that the original study ^ outlined in our letter of December 13, 1979, should now be conducted. We have begun the necessary tests and study designs- and fully expect to have definitive results and evaluations available for your committee by May 1, 1980. I hope the Committee considers this prospect in its deliberations February 26. The resolution of probable health effects prior to the expanded use of plastic pipe would seem to us to be in everyone's best interest. Sincerely, Enclosure cc: Donald Lyman Beverlee Myers Louis Pappan ml:vk M__________ . Director, HALTS BFG06948 Appendix I General Summary Toxicity of PVC-Plpe Cement Solvents Exclusive of Carcinogenicity I. Specific Solvents A. Methyl Ethyl Ketone (MEK, butaaoue) 1* Central Nervous System Depression MZX belongs to the class of hydrocarbon solvents chat have central nervous sys tem (CNS) depressant (i.e. anaesthetic or narcotic) effects. The precise potency of HEX in this regard is unknown, but it is generally considered weak. Estimates of Che minimum exposure level chat might produce narcotic effects range from 300 eo 600 ppm. Since MEX produces mucosal irritation beginning for some persons at 100 ppm, and the 200 ppm threshold value was established to protet against irri tation, it is generally believed chat this provides a buffer against CNS effects. However, neurobehavloral effects such as decreased reaction times occur before or at lover levels Chan obvious CNS depression. It is possible that prolonged expo sure to near-threshold levels (100 - 200 ppm) of MEX would result in measurable deficits in performance, but this has not been studied. . 2. Neurotoxicity A number of solvents related to MEX have been shown to cause nerve damage in men and usually also in experimental animals. Most prominent are n-hexane and methyln-buttyl ketone (MBK) both of which are metabolized to a six carbon molecule, 2,5hexanedione, Che active neurocoxin. Other probable oeuratoxins formed from the metabolism of ketones are also six-carbon molecules. MEX is' a four-carbon molecu eh*g is metabolized to 2-butanol, 3-hydroxy-2-butanone and 2,3-butanediol.^ Other possible metabolites include acetaldehyde, acetone, methanol and ethanol.^ There is no reason to suspect any of these four carbon or shorter molecules would re sult in nerve damage (peripheral neuropathy) as a result of occupational exposure to HEX. In support of this position, an-tmal data suggests that HEX alone does not produce peripheral neuropathy. Rats exposed continuously to MEX at 1,125 ppm for five months shoved no evidence of neurotoxicity.3 (However, this study showed that MEK potentiated the neurotoxic effect of M3K. in rats, a finding that was not confirms in cacs.)^ There is little evidence that MEK alone can produce peripheral neuropathy in hums Allan et al^ reported chat workers in a plant exposed to SEX alone shewed no evi dence of neuropathy, while these exposed to MSX did. However, it is relevant of solvent mixtures chat or.s worker developed a r.nuropac: after exposure to MEX and THE, neither of which is to t-i r. iutczoxu; - Three workers in a shoe factory vic.y cutaneous exr.osvra to MT" tr.i toluene '-vlao not known to be neurotoxic) developed ?er ithc.-ei .roput.nes. 0810046 BFG06949 Case reports have suggested. chat KEK might poccnclate the neurotoxlc effects o MBK* a-hexane2, and. methyl i-butyl kecoue,9 although such poteaciatioa is iapoa- to prove in. such cases. Ia summary, there is no convincing evidence thee MESC alone produces nerve damage, a conclusion generally supposed by data from an estimated 3,000,000 workers who are exposed to MEK in the U.S. There may be potentiation of other neurotoxins. Although none of Che other components under consideration here are known neurocoxins, because of one previous case report with THF and because such effects may be evidenced only after long-term exposure, this possibility must be con sidered whenever MEX is used in combination with other solvents. A. specific recommendation in this regard will be made after a full review of the composition of solvents in use and actual field measurement of combined exposures Is made. References 1. DiVencenzo, G.D. ec al., Toxicol, and Appl. Pharmacol. 36:511522, 1976 2. Berg, E.F., Ana. Ophthal. 3:1351-53, 1971 3. Saida, . et al., J. neuropathol. Exp. neurol, 35:201-25, 1976 4. Spencer, F.S. and Scgaumberg, H.H., Tox. Appl. Pharmacol. 37&30111, 1976 5. Allen, N. et al.. Arch. Neurol. 32:209-18, 1975 6. 71ader, F., Nouv. Presse. Med. 4:1813-14, 1975 7. Dyso, P.M., Clin. Tox. 13:371-76, 1978 8. Altenkirch, H.G. et al., J. Neurol. 214:137-52, 1977 9. AuBuchon, J. et al.. Lancet 2:363-4, 1979 BFG06950 s trn n T Q n 'y B. Tecrahyd.ro Cur,-- 1. CHS Depression This has been seen apparently only with high-level exposure to aninala e.g. 1025,000 ppm. It is unclear as to vhat the basis for Che TLV of 200 ppm. is. THF is the most volatile of the four solvents. 2. ffeurocoxcry fiefer to above far case report of nerve damage with use of a mixture of 602 THF adhesive with HEX solvent (MEK ref. 9). A pipefitter worlcing with THF, cyclo hexanone and acetone developed parosmia (unpleasant sensation of smell) and hyposmia (decreasedsensitivity of smell), although exposure levels were not reported.! it is uncertain as to whether this might he a common but .under re ported condition or an isolated case. C. Cyclohexanone 1. CHS Depression Evidence of CHS depression was seen in rabbits exposed to 190 ppm for prolonged periods. Cyclohexanone is a mucosal irritant at 75 ppm, and so the TLV is 25 ppt Given this and very low volatility, there is low risk for this toxicity with bos uaeage. 2. Other There is no evidence that cyclohexanone is nesrotoxic, but few animal studies examined the peripheral nervous system. The rabbits exposed to 190 ppm in the 1943 study showed some animals with liver and kidney damage. There are no report of such in humans. Refer to above (THF ref. 1) for case of disturbed olfactory function with exposure to cyclohexanone and THF. References 1. Emmett, E.A., Brit. J. Indust. Med. 33:196--8, 1976 2. Treon, et al., J. Ind. Hyg. Toxicol. 25:323-47, 1943 BFG06951 t: c oo W GO 0. Dimethyl for^amlde (DMF) 1. Gastrointestinal Exposure to repeated Inhalation of DM? results in damage to multiple organs in experimental animals, particularly liver and pancreas.Repeated exposure to 100 ppm resulted 4-- some animals with mild liver necrosis. Thus Che TLV is set at 10 ppm. Liver injury and abdominal pain possibly caused by pancreatitis has been reported in case reports of workers.-* Where che level of exposure was reported it appeared to be excessive. However, OSHA is currently investigating a plant situation where a series of cases of liver damage have been associated with the use of DM?. This investigation Is just beginning. Conclusions regard-* Lng the potential hepacocoxlclty of DMF in the workplace should be held pending the outcome of this study. 2. Alcohol Interaction Alcohol is metabolized to acetalcehyde, a potent vasodilator and qnlte toxic, which is Chen metabolized by acetaldehyde dehydrogenase to a less toxic substance, acetec Disulflram (antabuse") is used to. treat alcoholics as it inhibits the metabolism of acetaldehyde, resulting in a reaction of cutaneous flushing, headache, nausea, vomiting and hypotension. When severe, it has been fatal, but is usually simply extremely unpleasant. DMF, through its metabolite n-methylfocaamide, also inhibits acetaldehyde dehydrogenase, and has resulted in ehis reaction with alcohol in hv..:an anti animals. The amount of DMF necessary to produce this reaction is unknown. In. an-tmaim exposure to 1,000 ppa DMF for three days at 4 hr/day significantly incra-.se' acetaldehyde levels after alcohol administration in rats.^ However, a "no effect" exposure level was not determined.. Nineteen of 102 workers exposed to up to 200 ppof DMF noted reactions upon drinking alcohol.^ One worker had a reaction following exposure to 30 ppm for four hours, plus possible cutaneous exposure.^ Although ther are no reports of this reaction with exposure below che TLV of 10 ppm, in order to determine its frequency all workers exposed to any level should be warned of this, and T- possible reactions reported. References 1. Hassman, V., Brit. J. Ind. Med. 13:51-54, 1956 2. Clayton, U.W. ec al., Am. Hyg. Assoc. J. 24:144-54, 1963 3. Potter, H.P.* Arch. Environ. Health 27:340-1, 1973 4. Peter Infante, personal communication. 5. Eanasona, G.G. ec al., Tox. Appl. Pharmacol. 39:461-72, 1977 6. Lyle et al, Brit. J. Ind. Med. 36:63-6, 1979 7. Chirens, C.P. Lancet 1:331, 1978 BFG06952 JoO GO Oo C