Document dQLj6g0bLXavjQkEzr3OzQ720
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MANUFACTURING CHEMISTS ASSOCIATION
1825 CONNECTICUT AVENUE, N.W. WASHINGTON, D. C. 20009 (202) 483-6126
71^
I il'1
September 18, 1974
To: Technical Task Group on Vinyl Chloride Research
Subject: EPA News Release on Vinyl Chloride Emission Controls
Gentlemen:
Distributed herewith are copies of the subject release and Mr. Train's statement at the press conference at which the EPA Task Force report on vinyl chloride was announced. Although his statement does not identify the authority EPA proposes to act under, in his oral comments he did specify that the proposed controls would be promulgated pursuant to section 112 of the Clean Air Act.
Copies of the Task Force Report are being provided MCA, and will be forwarded to members of the TTGVCR as quickly as feasible.
Sincerely,
KDJ/mb Enclosures
Technical Task Group on Vinyl Chloride Research
ASI 000010780
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UNITED 37 A ITS ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OPriCIAL BUSINESS penalty rop private use *od AN COMAi, OPPORTUNITY FMPlOYCR
postacl and ree* paid
U.%. C*W VIBOKME.K T Al_ pnoTCCTION ACtMtY EPA-95
ar^AL I
Arsht
(202) 755-0344
Fitzwater (202) 755-0344
EPA TO SET VINYL CHLORIDE EMISSIONS STANDARD
Environmental Protection Agency Administrator Russell E.
Train announced today that the Agency will establish an air
pollution emission standard for vinyl chloride. Development
of an air standard was one of nineteen recommendations
submitted to the Administrator last week by EPA's vinyl
chloride task force.
The air standard would apply to emissions from the nation's 15 vinyl chloride monomer and the 37 polyvinyl chloride resin manufacturing plants. The Agency is still in vestigating the possible need for a standard applicable to the roughly 8,000 polyvinyl chloride fabricating facilities. (The monomer and resin manufacturing plants account for more than 95 percent of vinyl chloride emissions.)
Train formed the task force last February when it was learned that several workers at vinyl chloride production plants had died from angiosarcoma of the liver, a rare but fatal form of cancer, and that there was an estimated material loss of vinyl chloride and polyvinyl chloride f six percent during the polymerizacion process. Vinyl chloride,
a
(more)
Kmum this sheet If you do NOT wish to roceiee this material 0, or 11 change of address is needed 0 (indicate change, including code).
EPA FORM lEIO-t (hEV. frTJ'
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R-575
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gaseous chemical, has been strongly implicated as a cause of this form of cancer and may increase the risk from other cancers as well.
In accepting the task force recommendations. Train said that EPA would immediately begin "the additional analysis and monitoring necessary for establishing appropriate emis sion controls."
Train said the process of setting an air emission stand ard under the Clean Air Act would probably, require several months of monitoring and other investigations, data collection, public hearings and other required regulatory steps as re4quired by the Act. He also said an environmental impact --statement would be prepared, and public hearings held, to "insure full public participation in the development of this standard."
"I intend to expedite these procedures as much as possible," Train said, "but it's extremely important that our standards and decisions be based on the best scientific data available in order to ensure that the health of our citizens is protected."
The Task Force report released today estimates that "substantial amounts of vinyl chloride -- probably exceeding 200 million pounds annually--- and large quantities of poly vinyl chloride-probably exceeding 50 million pounds -- are being discharged into the environment `during the polyvinyl chloride polymerization process. Most of the vinyl chloride escapes directly into the atmosphere, with lesser amounts dissolved in water effluent streams and entrapped in sludge and solid wastes."
Initial estimates indicate that emissions could be reduced by about 75 percent from polyvinyl chloride resin plants and 90 percent from vinyl chloride plants with a con comitant cumulative increase in the cost of polyvinyl chloride of about four percent. It is estimated that the available control technology, which includes a variety of control * measures applicable to the multiple emission points within the plants, could be in place from within several months to two years after promulgation of appropriate regulations.
In addition to the air standard, eighteen recommendations for EPA action have been made by the task force, including:
--Additional ambient air monitoring at selected sites to support regulatory action under the Clean Air Act;
--More detailed material baiande studi'e's,'"in* cooperation with industry, to more clearly identify leakage points in the manufacturing process;
(more)
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--Monitoring of drinking water supplies which could be contaminated from vinyl chloride discharges from nearby polyvinyl chloride plants;
--Studies around industrial storage and disposal sites and municipal disposal sites to determine the types and quantities of toxic substances leached or discharged out of (a) semi-solid wastes generated by vinyl chloride/polyvinyl chloride facilities or (b) polyvinyl chloride products discarded by consumers.
Recommendations for action by industry encourage all possible steps to (a) tighten up operating and maintenance procedures to reduce emissions from vinyl chloride and poly vinyl chloride facilities and (b) expand research, testing and monitoring activities to improve the base for assessing the risks associated with vinyl chloride.
The task force report also emphasizes a need for the Toxic Substances Control Act. The proposed legislation, under which EPA would set requirements for industry to make pre-market tests of possible dangerous new chemical products, is now before Congress.
The report points out that "many of the considerations and uncertainties that have rpunctuated the vinyl chloride/ polyvinyl chloride deliberations undoubtedly characterize a far broader swath of concerns over high volume industrial chemicals in general, and plastics in particular." The task force report adds that the Toxic Substances Control Act "would provide a mechanism for addressing those products ' using vinyl chloride not now subject to regulation under other laws."
To date, 25 cases of liver angiosarcoma have been identified worldwide in workers exposed to vinyl chloride. In most, but not all of these cases, the workers had been repeatedly exposed to high levels of the gas over a sub stantial number of years. It has also been suggested that vinyl chloride may be implicated in several non-worker deaths from this liver cancer. Whether vinyl chloride is the cause of these deaths is still being investigated.
The Occupational Health and Safety Administration is currently considering vinyl chloride standards to protect workers inside the plants.
The task force report is available from EPA, Room 335V7, 401 M Street, SW., Washington, D.C. 0460.
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ASI 000010783
VINYL CHLORIDE STATEMENT BY THE ADMINISTRATOR
Today's press conference is to announce that I have received the recommendations of our vinyl chloride task force, which was established last February, and that I have directed the Agency to proceed to establish an air pollution emission standard for vinyl chloride under the Cleah Air Act.
m
The air standard will apply to emissions from Vinyl chloride monomer plants and polyvinyl chloride resin manu facturing plants. These account for more than 95 percent of the known emissions of vinyl chloride.
The air standard is just one of several recommendations made by the task force. I have directed that work begin immediately to implement the initial stages of all of the
recommendations. Before getting into these actions, let me briefly summarize our vinyl chloride activities to date.
Beginning last January it was learned that several p
workers at vinyl chloride production plants had died from angiosarcoma of the liver, a rare but fatal form of cancer. The gaseous chemical vinyl chloride has been strongly impli-
cated as a cause of this form of cancer and may increase the*risk from other cancers as well. It was also reported that during the manufacturing process, more than 200 million pounds of the vinyl chloride used was lost each year into
i the environment.
000010784 A SI
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-2I immediately formed an internal task force to assess the overall environmental impact of this chemical and to determine any appropriate regulatory actions. We also took a number of other specific actions to define the prob lem and protect public health. --On April 15, EPA notified the' produderS of all pesticides with aerosols containing vinyl chloride of the need to substitute another propellant--Later that month our Regional Administrators were asked to assess the extent to which vinyl chloride is escaping beyond the confines of the polyvinyl chloride production facilities in their regions; and we released the brand names of pesticides containing vinyl chloride as an aerosol pro pellant. In May and July additional brand names were released, --At the end of April we suspended from sale and re quested a recall of all pesticide aerosols for indoor use containing vinyl chloride. --On May 31, under Section 114 of the Clean Air Act, we requested emission control technology and cost data from . manufacturers of vinyl chloride and polyvinyl chloride. On June 11, I met with leaders of the chemical industry to urge that they take prompt steps to reduce vinyl chloride emissions pending possible establishment of an emission
4.
Standard. They informed me of significant actions already i 1* #
taken or underway.
ASI 000010785
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Data from the manufacturers has been received and re
viewed. The manufacturers have been very cooperative with
us.
The task force report, which you have copies of, con
tains nineteen recommendations. In addition to the air
standard, the recommendations include:-
*'
--Development of a standardized method for monitoring
m
levels of vinyl chloride.
--Additional ambient air monitoring including intensive
sampling at selected manufacturing sites including fabrica
tion plants;
--More detailed material balance studies to identify all
leakage points in the manufacturing process;
*
--Monitoring of drinking water supplies which could be
contaminated from yinyl chloride discharges from nearby
polyvinyl chloride plants;
--Studies around industrial storage and disposal sites
and municipal disposal sites to determine the types and
quantities of toxic substances leached or discharged out of
(a) semi-solid wastes generated by VCM/PVC facilities or
(b) PVC products discarded by consumers.
I have asked that work begin in all of these areas.
I'm certain that as implementation moves forward we may make
some alterations or shifts in'emphasis, but I beli9eve% that | . -r #"' *
the objectives are sound and the recommended programs well
ASI 000010786
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planned. We'll keep you inform d as these efforts progress so that you'll know the various activities underway.
Also, I concur with the task force recommendation which urges industry to expand research, testing, and monitoring activities to improve assessments of the risks associated with vinyl chloride.
* t
Development and formal proposal of a specific air mis-
*
sion standard will take several months due to the need for additional monitoring and research, collection and analysis of data on control technology and the other statutorily required regulatory procedures. It is my intention to ensure full public participation in the development of this standard including the preparation of an environmental impact statement and public hearings.
\
Our initial estimates indicate that emissions could be reduced by about 75 percent from polyvinyl chloride resin plants and 90 percent from vinyl chloride plants with a resulting increase in the cost of polyvinyl chloride of about 4 percent. It is estimated that the best available control technology could be in place from within several months to two years after promulgation of the regulations. Some of it will be installed even sooner because of volun tary industry efforts and the establishment of a worker pro tection standard by Labor's Occupational Safety and Health Administration (OSHA) . Our standard and OSHA'^s probably will require a number of the same control measures.
ASI 000010787
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-5I want to conclude by repeating my statement of Jun 11 that there is no scientific evidence to indicate that vinyl chloride emissions into the atmosphere pose an imminent hazard to people living near the plants. It is clear, how ever, that some hazard does exist and that our population deserves the protection afforded by regulatory action. The public health implications of this chemical and others like it present us with a grave responsibility. We intend to develop our regulations and to conduct the continuing research with full public awareness. I have tried to highlight the task force recommendations today and to emphasize my decision to establish an air standard. Obviously, there are many details left for further discussion. I have asked members of our staff representing
%
the three principal areas of participation in today's recommendation to join me in today's briefing. I would like to introduce Mr. Glenn Schweitzer, Director of the Office of Toxic Substances, Dr. Bernard Steigerwald, Deputy Assistant Administrator for Air Quality Planning and Standards, and Dr. Kenneth Bridboard, Medical Officer with EPA's Special Studies Staff.
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MANUFACTURING CHEMISTS ASSOCIATION
1825 CONNECTICUT AVENUE, N.W. WASHINGTON, D.C. 20009 (202) 483-6126^^^
September 18/ 1974
'V. A. K.
SEP 2 0 1974
To: Technical Task Group on Vinyl Chloride Research
Subject: OSHA Economic Impact Study Report on Vinyl Chloride
Gentlemen:
Distributed herewith are copies of the announcement of the availability of the subject report, appearing in the Federal Register for Friday, September 13. Note that comments on this report will be accepted through Wednesday, September 25.
Sincerely,
KDJ/mb Enclosure
Kenneth D. Johnson, Ph.D. Secretary Technical Task Group on
Vinyl Chloride Research
ASI 000010789
PR POSED RULES
33009
DEPARTMENT OF LABOR .
Occupational Safety and Health Administration
[29 CFR Part 1910]
tDocket No. OSH-30]
VINYL CHLORIDE
Availability of Final Economic Impact Study
On May 10,1074, pursuant to sections 6(b), 6(c), and 8(c) ol the WilliamsSteiger Occupational Safety and Health Act of 1070 (84 Stat. 1593, 1506, 1590 (29 UjS.C. 655, 657)) Secretary of La bor's Order No. 12-71 (36 FR 8754), and 29 CFR 1911, a proposed standard con cerning occupational exposure to vinyl chloride was published In the Federal Register (39 FR 16896). On June 25-28 and July 8-11, 1974, an informal rule making hearing was held on the proposal pursuant to section 6(b) (3) of the Act.
At the dose of the hearing, the pre siding Administrative Law Judge, Gor don J. Myatt, ruled, in accordance with the authority granted him under 29 CFR 1911.16(g), that the record would remain open until August 23,1974 for the receipt of general comments and an additional period after that date solely for the sub mission of written comments on the eco nomic impact study being conducted for OSHA by an independent consultant.
On August 26,1974, a notice was pub lished in the Federal Register (39 FR 30844) announcing the availability of the preliminary report, which examines the economic and technological feasibil ity of compliance with the proposed standard in the monomer, polymer and copolymer producing industries, and in viting comments to be submitted no later than September 6,1974.
Several persons requested additional time to comment on the preliminary re port and also asked for an opportunity to comment on the final economic im pact study when available. Since cer tain portions to be included In the final report were not contained in the pre liminary report, the request for addi tional time to comment on the prelimi nary report and for an opportunity to comment on the final report is granted.
The final economic Impact report win
be avaUable for examination and copying
beginning at 10 am. on September 16,
1974, in Room 230, 1726 M Street NW.,
Occupational Safety and Health Ad
ministration, Washington, D.C. 20210.
This report, although labeled "final
draft" because the independent consult ant may subsequently make minor edi torial corrections, will be treated as the final economic impact report for purposes Of this rulemaking proceeding.
All comments regarding the prelimi nary and final economic impact study should be mailed to the Docket Officer, Docket OSH-36, at the above address, and must be received no later than Sep tember 25, 1974.
Signed at Washington, D.C., this 12th day of September 1974.
Jobs Stenser, Assistant Secretary of Labor. (FJ0OC.74-213B8 Filed 0-13-74:10:43 am]
FEDERAL REGISTER, VOL. 39, NO. 179--FRIDAY, SEPTEMBER 13. 1974
ASI 000010790
MANUFACTURING CHEMISTS ASSOCIATION
1825 CONNECTICUT AVENUE, N.W. WASHINGTON, D. C, 20009 (202) 483-6126
M ^ 2 2 \m
August 21, 1974
To: Technical Task Group on Vinyl Chloride Research
Subject: Interim Report from IBT Laboratories
Gentlemen:
Distributed herewith are copies of the subject report. Note that the 50 and 200 ppm hamsters are now the only groups for which at least tentative identification of tumors have not been made. Also noteworthy is the absence of Zymbal gland tumors in our rats.
Sincerely,
KDJ/mb
Enclosure
cc: Dr. D. P. Duffield Mr. A. W. Barnes Dr. Tiziano Garlanda
Technical Task Group on Vinyl Chloride Research
ASI 000010791
TOXICOLOGY ENVIRONMENTAL SCIENCES CHEMISTRY PLANT SCIENCES MEDICAL SCIENCES
DECATUR RESEARCH
1800 EAST PERSHING ROAD DECATUR, ILLINOIS 62526
August 16, 1974
TELEPHONE S77'2S4
Dr. Kenneth D. Johnson Manufacturing Chemists Association 1825 Connecticut Avenue N. W, Washington, D. C. 20009
Dear Dr. Johnson:
Enclosed are tables summarizing mortality, body weight and gross pathologic findings through the eleventh month of inhalation exposures on the chronic inhalation toxicity study with Vinyl Chloride. I've also included a table giving daily concentration data from the seven-month point to the end of the eleventh month.
Preceding each table is a brief discussion of the data. A complete and. formal eleven-month status summary with full evaluation of this data plus histopathologic data will be submitted shortly.
Sincerely,'
Senior Group Leader Inhalation Toxicity
KS/dm enc.
cc - Dr. T. R. Torkelson J. W. Goode M. I.. Keplinger
ASI 000010792
Hn&tdbUal BIO-TEST ^a&ok. Jed, 9*tc.
1
I. Analytical Concentration Data The daily range and mean of the Vinyl Chloride concentrations in
each chamber from exposure 153 (data previous to this exposure given in seven-month status report) through the end of the eleventh testing month are reported in Table I. The overall average daily vapor concen trations were calculated to be 49.9, 198, 2501 and 2489 ppm for the T-I through T-IV chambers, respectively.
9
000010793 ASI
TABLE I
TEST MATERIAL: Vinyl Chloride (Ethylene Derived)
Chronic Vapor Inhalation Toxicity Study - Albino Rats, Albino Mice and Golden Hamsters
Chamber Concentration Data
Day -rr.ber
Exposure Number
T-I Range
Mean
Chamber Concentration (ppm)
T-II
T-II I
Range
Mean
Rang e
Mean
T-IV Range
Mean
(3 153 . 4 154
. 5 155
156
157
- 0 158
159 ' 160
_3 161
162
163
.5 T64
165 T 166
5 167
4 168
3 169
;o >
170
-9 CMA
171
40 o
172
o
O
o
O Nl
p.
45.5
48.5
47.5
176
214
197
1820
2680
2467
2340 2500
2409
50.5
55.0
51.5
180
242
206
2300
2820
2459
2400
2640
2493
Holiday,, no exposures
43.5
53.5
46.5
180
242
202
2180
3000
2554
2140
2380
2231
46.5
52.5
50.4
154
194
184
2320
2600
2457
2160
2400
2294
36.5
52.5
45.0
138
250
192
1440
2600
2240
2500
3020
2760
44.5
55.0
49.2
130
138
134
2460
2620
2540
2600
2600
38.0
67.5
45.1
124
260
196
2000
3120
2687
1100
2510
2264
47.0
61.0
53.1
130
200
179
2380
2920
2384
2500
3000
2664
47.5
53.0
57.8
150
232
181
2380
2700
2484
2340
2700
2456
50.0
53.5
51.5
180
210
195
2440
2800
2580
2740
3040
2815
47.0
53.0
52.1
184
202
187
2200
2660
2488
2600
2900
2669
46.5
56.0
49.4
190
216
200
2420
2800
2583
2660
2800
2755
47.0
71.0
52.3
184
228
201
2100
2820
2520
2160
2500
2353
42.5
53.0
47.9
180
204
199
2300
2740
2479
2480
2940
2667
38.0
55.5
49.4
180
226
193
2160
2800
2472
2200* 2800
2545
44.0
51.0
47.6
196
215
207
2440
3710
2932
2500
2900
2729
48.0
56.5
53.6
184
216
205
2120
3100
2528
2460
2980
2668
46.0
51.5
49.3
186
198
191
2260
2620
2487
2400
2580
2488
47.0
50.5
48.5
202
214
209
2180
2600
2478
2140
2460
2339
*w is a i- o ia
f'J
TABLE I continued
TEST MATERIAL: Vinyl Chloride (Ethylene Derived)
Chronic Vapor Inhalation Toxicity Study - Albino Rats, Albino Mice and Golden Hamsters
Chamber Concentration Data
Day -rr.ber
Exposure Number
H 173 174
:3 175 : 176 1 177*
5 178
.? 179 : 180 > 181*** 4 182 5 183 t> 184 ' r 185 0 186 1 187 y 188
3 189 * 190 7 </> 191 3 192 t>? 8 193
O o
oNl vO
T-I Rang e
Mean
Chamber Concentration (ppm)
T-II
T-III
Range
Mean
Rang e
44.5
55.5
50.4
46.5
53.0
47.9
48.5
52.5
50.5
45.0
54.5
48.8
47.5
55.0
51.0
47.5
52.5
51.2
44.0
56.0
49.4
Equipment malfunction,
45.5
57.0
51.4
44.0
51.5
50.0
43.0
75.0
57.4
47.0
55.0
50.9
39.0
57.5
48.0
35.0
66.0
48.6
38.0
75.5
49.9
43.0
50.0
47.4
Holiday, no exposures
41.0
50.5
47.5
45.5
58.5
50.2
46.0 41.0
57.0 55.5
50.5 50.5
154 220 180 222 194 206 182 210
--
186 222 164 236 no exposures 188 218 184 212
88 222 172 230 180 214 182 250 170 266 196 224
192 210 192 251 182 214 186 234
197 194 199 198
-
203 201
204 193 171 203 199 209 202 205
198 196 200 215
1500 2100 2380 2320 2440 2420 2560
1900 2320 2000 2300 2140 2140 2140 2160
2300 2160 2320 2380
3340 2560 2780 2760 2780 2700 2740
2760 2500 2640 2720 2400 2888 3240 2560
2620 2540 2620 2880
Mean
T-IV Range
2468 2367 2487 2534 2618 2573** 2645
2340 2480 2460 2320 2560 2580
-
2760 2600 2520 2660 2820 2700
-
2347 2396 2364 2501 2328 2397 2537 2400
1900 2420 2100 2040 2280 2200 2500 2460
2760 2500 2620 2460 2500 2600 2560 2560
2431 2350 2452 2633
-
2240 2380 2420
-
2320 2440 2760
Mean
2532 2512 2496 2536 2673 2640
-
2347 2464 2280 2355 2380 2392 2545** 2524
-
2272 2400 2540
TABLE I continued
TEST MATERIAL: Vinyl Chloride (Ethylene Derived)
Chronic Vapor Inhalation Toxicity Study - Albino Rats, Albino Mice and Golden Hamsters
Chamber Concentration Data
Day N umber
Exposure Number
T-I Rang e
Mean
Chamber Concentration (ppm)
T-II
T-fll
Range
Mean
Rang e
Mean
T-IV Rang e
270 194 27 i 195 274 196 275 197
198 277 199 27S 200 281 201 2S2 202 283 203 284 204 2S5 ,, 205 28S 206 28? 207 290 208 291 209 292 210 295 211
296 5 212 297 w 213
On O O oNl 'O
O'
48.0
54.5
50.1
172
214
204
2260
43.5
50.5
47.3
190
208
200
2140
44.5
51.0
47.9
188
216
202
2180
38.0
56.0
49.5
174
242
198
2160
45.5
52.5
48.9
188
214
199
2320
47.0
56.0
50.3
170
220
201
2280
37.0
52.5
48.3
176
226
200
2220
40.0
56.0
47.5
168
232
204
2360
43.5
54.0
48.2
176
236
202
2120
43.0
54.0
49.7
188
216
206
2340
47.0
57.0
52.5
144
220
194
1400
43.0
58.5
50.3
154
224
199
2100
Equipment malfunction. but animals were exposed
42.5
59.0
48.5
194
206
200
2360
40.0
53.5
45.9
204
218
209
2280
45.5
51.5
49.3
166
220
203
2380
Equipment malfunction, no exposure
46.5
54.5
47.6
186
230
207
2280
43.5
53.0
49.3
200
210
205
2480
Vinyl Chloride gas regulator broken, no exposures
2660 2560 2580 2640 2720 2860 2700 2740 2940 2920 3420 2980
2820 2820 2680
3200 2660
2447 2439 2377 2386 2457 2585 2473 2515 2459 2550 2620 2504
2593 2482 2521
2577 2613
2140 2380 2400 2440 2340 2300 2580 2520 2280 2540 2210 2140
2480 2280 2440
2280 2520
2400 2500 2460 2440 2740 2920 2900 2720 2520 2780 2600 2560
2620 2560 2560
2520 2680
Mean
2270 2408 2440 2440 2564 2656 2672 2600 2413 2640 2478 2397
2528 2424 2516
2428 2585
TABLE 1 continued
TEST MATERIAL: Vinyl Chloride (Ethylene Derived)
Chronic Vapor Inhalation Toxicity Study - Albino Rats, Albino Mice and Golden Hamsters
Chamber Concentration Data
Day Number
Exposure Number
298 214
299 215
302 216
303 217
304 218
305 219
306 220
309 221
310 222
311 223
312 224
315 * 225 316 226
317 227*
318 228
319 229
322 230
323 231
324 325
> uM>
O
232 233
O Ni v>
T-l Range
Mean
Chamber Concentration (ppm)
T-II
T--III
Range_______ Mean__________Range
Mean
Holiday, no exposures
Holiday, no exposures
Vinyl Chloride gas regulator broken
Vinyl Chloride gas regulator broken
45.5, 50.5
48.2
202
226
44.5
52.5
48.6
186
210
45.0
57.5
42.3
190
218
41.5
49.5
45.9
168
192
47.5
55.0
51.0
186
196
44.5
57.5
51.3
160
226
39.0
46.0
42.8
148
172
37.0
52.5
44.2
146
196
46.0
55.0
54.0
182
220
46.5
55.5
50.6
152
242
46.5
52.0
49.2
170
280
44.5
52.0
49.1
192
222
49.5
56.5
52.0
198
222
49.5
62.0
54.9
176
250
49.5
54.5
50.7
200
208
45.5
56.5
49.7
190
206
no exposures
no exposures
218 2140 2460
204
2280
2740
203
2360
2660
185
2080
2500
193
2280
2500
184 1 sam pie only
160
1800
2040
174
1800
2440
208 2080 2500
205
2040
2800
192 1960 2380
201 2440 2620
210
2500
2680
208
2160
2840
204 2220 2620
196
2400
2840
2288 2565 2481 2258 2380 2280 1920 2073 2473 2558 2022 2542 2699 2475 2405 2597
T-IV Range
Mean
2400
2500
2400
2520
2400
2500
2360
2500
2280 2500
1 sam pie only
2640 2960
2500
3100
2400
2620
--
2240 2500 2300 2260 2200 2220
2580 2720 2620 2380 2460 2500
2480 2445 2440 2410 2364 2440 2800 2680 2480
-
2400 2640 2460 2333 2348 2370
i
f i
Day Number
326 329 330 331 332 333
TABLE I continued
TEST MATERIAL: Vinyl Chloride (Ethylene Derived)
Chronic Vapor Inhalation Toxicity Study - Albino Rats, Albino Mice and Golden Hamsters
Chamber Concentration Data
Exposure Number
T-I Range
Mean
Chamber Concentration (ppm)
T-II
T-III
Range
Mean
Rang e
Mean
T-IV Range
Mean
234 235 236* 237* 238 239
48.0
62.0
54.0
170
238
202
Equipment malfunction. but animals exposed
-
-
58.0
200
204
202
53.5
58.5
55.5
186
198
191
56.0
56.0
56.0
206
208
208
47.5
55.0
51.3
185
210
202
2300
2500 2220 2260 . 2160
2760
2580 2500 2380 2600
2576
2540 2376 2300 2556
2520
2760
2576
-
-
1 sample only
1700
2300
-
-
2420 2084
* No exposure in group indicated; animal cages repaired. ** Exposures cut to 5i hours; animal cages repaired. <** Exposures cut to 4i hours; gas chromatograph repaired.
Note: In exposures noted above, the equipment malfunction is referring to a breakdown in the gas chromatograph or sequential sampler valve system-chamber concentrations were believed to be near targets.
3</>> O O o o
I-*
o N >0
00
>4
9nduit\ial B I O - T E S T aJto?L del, Sttc.
7
II. Mortality Data The cumulative monthly mortality data are presented in Table II.
Below is a brief discussion of the data for each species. Rats: With the exception of the T-IV rats (composed of females
only and permitted food ad^ libitum) there is a dose related mortality effect in both sexes at the eleven month point. Although the total number of rats which died in the T-IV group is not as great as in the T-III female group, there was a rapid increase in mortality during the eleventh month in the T-IV group.
Mice: Dose related mortality effects were observed in both male and female mice at the eleven month point.
Hamsters: A significant increase in mortality rate was observed among male and female T-III hamsters during the eleventh month of the investigation. There were no other significant mortality findings.
m ASI 000010799
$Hthubual BfO-TEST
~>eS, Hoc.
8
Month Number
1 2 3 4 5 6 7 8 9 10 11
TABLE II
TEST MATERIAL: Vinyl Chloride (Ethylene' Derived)
Chronic Vapor Inhalation Toxicity Study - Albino Rats, Albino Mice and Golden Hamsters
Summary of Mortality Data - Albino Rats
Accumulative Number of Mortalities at End of Month
Control
T-I
T -II,.'
T--111,0
MF MF MF MF
00000000
0 0 2 0 1 0. 0 0
01201014
02413014
23516134
3462 61 54
44 8 6626 5
4 5 9 7 10 5 10 8
4 6 10 8 11 5 16 15
5
7 11 11 12
9 ' 24
28
7 8 13 13 14 19 34 52
T-IV F
0 0 0 0 0 0 0 1 4 7 17
*
ASI 000010800
^ndust^ial BIO-TEST
ieS, 9nc.
Month Humber
1 2 3 4 5 6 7 8 9 10 11
TABLE II continued
TEST MATERIAL: Vinyl Chloride (Ethylene" Derived)
Chronic Vapor Inhalation Toxicity Study - Albino Rats, Albino Mice and Golden Hamsters
Summary of Mortality Data - Albino Mice
Accumulative Number of Mortalities at End of Month
Control
T-I
T-II
T-III
MF
MF
MF
M
F
00000000
0 003 00 0 0
2064301 0
5 1 19 5 4 1 4 7
8 2 26 6 4 2 8 7
12 2 30 6 8 3 10 9
18 5 31 11 9 12 13 23
18 5 32 14 16 30 30 46
23 8 38 24 37 58 56 75
28 10 42 31 78 82 76 98
30
15
54
46
96
94
100*
100*
* All surviving mice sacrificed
9
V
ASI 000010801 1
Sttdtubtal B I O - T E 5 T JaJtA^u^Uei, D*tc.
)
Month Number
1 2 3 4 5 6 7 8 9 10 11
TABLE II continued
TEST MATERIAL: Vinyl Chloride (Ethylene'Derived)
Chronic Vapor Inhalation Toxicity Study - Albino Rats, Albino Mice and Golden Hamsters
Summary of Mortality Data - Golden Hamsters
Accumulative Number of Mortalities at End of Month
Control
T-I
T-II
T- III
MF MF MF M F
54447 52 5
8 11 10 12
9 16 . 10 11
8 13 12 14 12 18 14 13
9 15 16 16 15 19 15 13
9 18 16 16 16 20 15 15
13 18 16 16 20 21 16 16
13 28 24 19 22 33 18 26
14 28 24 19 23 35 19 28
14 29 24 20 25 36 20 26
14 30 26 20 26 37 23 29
15 31 28 21 26 38 28 36
10
ASI 000010802
1
htduiUial B I O - T E S T Ja&yu. au, 5no.
11
III. Body Weight Data
The mean body weight and weight gain data are presented in Tables III through V. Below is a brief discussion of the data for each species.
Rats: There are no dose related findings. Mice: There appeared to be a drop in body weights of both the males and females of the T-III group during the tenth month of testing. These mice were sacrificed during the eleventh testing month. The other test levels do not indicate any definite adverse effecs. Hamsters: Except for th T-III female hamsters, which revealed a low mean body weight for the eleventh month, there are no significant findings.
W ASI 000010803
-.-x lie
;male
TABLE III
TEST MATERIAL: Vinyl Chloride (Ethylene Derived)
Chronic Vapor Inhalation Toxicity Study - Albino Rats, Albino Mice and Golden Hamsters
Summary of Mean Body Weights - Albino Rats
Mean Body Weights (grams) Month Number:
Group 0 1 2 3 4 5 6 7 8 9* 10 11
Control 205 363 456 498 517 537 . 543 550 559 697 677 689
T-l 209 346 448 491 526 545 554 567 593 651 640 670
T-Il
201 360 457 490 522 549 567 565 . 585 681 663 696
T - III
200 351 453 499 529 550 567 576 581 627 629 680
Control 160 235 275 299 315 320 326 344 356 392 366 380
T-I 168 232 274 297 310 308 323 348 367 357 363 374
T-II
171 242 289 302 313 316 329 342 358 368 362 386
T-II1
165 240 287 303 312 321 329 346 359 359 356 374
T-IV
181 251 282 288 291 314 324 338 348 363 363 384
Gain
484 461 495 480
220 206 215 209 203
03
o
Jt
r
Apparent malfunction of animal weighing machine during month indicated.
3>
o o o
o
o
a> o u
fX ile
err.ale
Group
Control T-I T-II T-III
Control T-I T-II T-III
TABLE IV
TEST MATERIAL: Vinyl Chloride (Ethylene Derived)
Chronic Vapor Inhalation Toxicity Study - Albino Rats, Albino Mice and Golden Hamsters
Summary of Mean Body Weights - Albino Mice
Mean Body Weights (grams) Month Number:
0 1 2 3 4 5 6 7 8 9* 10 11
35 40 41 43 46 43 46 52 49 47 43 47 33 39 39 43 44 42 47 45 47 47 38 48 36 40 38 42 44 42 45 43 44 46 37 44' 36 38 40 43 44 38 45 41 41 43 31 **
29 32 33 35 36 35 38 37 41 40 37 40 30 34 34 37 39 38 40 41 40 40 42 43 28 31 34 35 37 36 38 36 40 39 30 40 28 31 34 35 36 37 37 34 37 39 27 **
o
-4
m vt
Gain
12 15
8 **
t
11
13 12 **
r-xposures \Cere terminated for all mice at the end of the ninth month of the investigation. All surviving T--III mice were sacrificed during the eleventh month of the investigation.
u>
V
Sex Male
Female
TABLE V
TEST MATERIAL: Vinyl Chloride (Ethylene Derived)
Chronic Vapor Inhalation Toxicity Study - Albino Rats, Albino Mice and Golden Hamsters
Summary of Mean Body Weights - Golden Hamsters
Grouo
01
Control T-I T-II T-1II
73 71 63 60
98 90 89 87
Control 77 104
T-I 78 95
T-II
74 94
T-III
69 92
Mean Body Weights (grams) Month Number:
2 3 4 5 6 7 8 9 10 11
110 120 129 130 133 130 138 141 129 126 101 114 120 121 122 128 126 118 115 110
94 99 119 108 120 118 122 117 115 115
91 93 91 88 112 no 115 115 115 114
108 118 120 121 124 125 128 133 119 116
102 112 118 118 122 130 126 125 118 no
99 108 107 106 114 112 116 118 112 112
100 106 106 104 110 118 105 107 103
99
Gain
53 39 52 54
39 32 38 30
tx "
-
it
--
SneLdtoal B I O - T E S T JaUiaivUed, 9nc,
t
! 15
IV. Gross Pathology A summary of tumor data based on gross pathologic findings among all
species is presented in Table VI. This table does not take into account animals that died and postmortem autolysis or cannibalism precluded gross pathologic examination.
V
ASI 000010807
1
3*uJLu&Ual 8 I O - T E S T ^ahviaurUel, 3nc.
16
TABLE VI
TEST MATERIAL: Vinyl Chloride (Ethylene Derived)
Chronic Vapor Inhalation Toxicity Study - Albino Rats. Albino Mice and Golden Hamsters
Summary of Tumor Data Based on Gross Pathologic Findings Among All Species Through 8/14/74
Species Group
Number of Animals Examined
Total Male Female
Tissue Involved (Male/Female) Liver Lung Skin* Kidney
Mice
Control
4
3
1
0/0 1/1 0/0 0/0
T-I
36 12
24
4/9 5/16 2/7 o/i
T-II
133 67
66
45/57 52/39 7/26
5/9
T-1II
121 58
63
48/47 44/45 4/20
7/3
Rats
Control T-I T-II T-III T-IV
0 3 11 52 7
0 3 4 18 0
0 0 7 34 7
0/0 0/0 0/0 2/0 2/0 0/0 0/5 0/4 0/1 7/24 0/6 0/8 0/5 0/0 0/5
0/0 0/0 0/0 0/2 0/0
Hamsters Control
0
0
0
0/0 0/0 0/0 0/0
T-I 0 0 0 0/0 0/0 0/0 0/0
T-II
0 0 0 0/0 0/0 0/0 0/0
T-III
10 7
3
2/2 4/1 1/0 0/0
* Mammary Tumors
m ASX 000010808