Document ExjJXZrVqeMybXx1ko2pOR6QR
APR-22-97 TUE 01:08 PH HUNT INGDON 11FE SC 1ENCES FAX NO, 908 873 3992
P. 01/22
TOTAL NUMBER OF PAGES INCLUDING THIS PAGE; If this transmission is unsatisfactory please contact us by telephone at (908)
ATTENTION OF: Or. J. Knaak
COMPANY:
Occidental Chemical Corporation
Dallas, TX 75244
CC: Dr. Hasmukh Shah <2s. Wendy Sherman^
Chemical Manufacturers Association
Arlingon, VA 22209
FROM: DATE:
Raymond E. Schroede-r 22 April 1997
MESSAGE;
Study No. 96-4080 - Vinyl Chloride Combined Inhalation Two-Generation Reproduction and Developmental Toxicity Study in CD Rats
This fascimile includes the following summary data for the above referenced study for your review (Study Weeks -1 through 14);
Tables 1. Summary of Cl ini cal'Observations 2. Mean 8ody Weights - Premating Period 3. Mean Body Weight Change during Premating Period (Weeks 0-10) 4. Mean Food Consumption - Premating Period 5. Mean Body Weights - Mating and Post-mating Periods (Males) 6. Mean Food Consumption - Post-mating Period (Males)
Appendix A. Methodology and References
Please contact me with any questions.
Best; Regards, ^ . (_y
Raymond E. Schfoeder Study Director
CMA 118725
APR-22-97 TUE 01:08 PH HUNTINGDON LIFE SCIENCES FAX NO. 908 873 3992
?. 02/22
STUDY NO. 96-4080 VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION
AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
Slam Resort
Submitted to:
Chemical Manufacturers Association Chemstar Department 1300 Wilson Blvd. Arlington, Virgiana 22209
Attn: Hasmukh c. Shah, Ph.0.
Date: 22 April 1997
CMA 118726
APR-22`9? TUE 01:08 PH HUNTINGDON LIFE SCIENCES FAX NO. 908 873 3992
P. 03/22
* Of ANIMALS examined
NORMAL WITHIN NORMAL LIMITS
OSNL APPEARANCE EARS SWOLLEN/RED BILATERAL
DERMAL -pENERAL ULCERATION - CERVICAL
ALOPECIA SXTREM]T1ES/SNOUT
ALOPECIA - GENERAL
YELLOW ANO-GEN1TAL STAINING
UNAUDITED
DRAFT
7 1-t TABLE 1 VINYL CHLORIDE COMBINED INHALATION TWO*GENERATION REPRODUCTION
AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
96-4080
WEK; I
r 30 I! 30 in 30 IV 30
SUNMARY Of CLINICAL OBSERVATIONS - MALES
1 2 3 4 5 6 7 8 9 10 11 T2 13 U
30 30 SO 30
30 30 30 30
30 30
30 30
30
30 30 30
30 30
30
JO
30 30
30 30
30 30 30 30
30 30
30 30
30
30 30 30
30 30
SO 30
30
SO
30 30
30 30
30 30
30 30
30 30
30 30 30 30
1 30 II 30
III 30 IV 30
29 29 29 29 30 29 28 26 30 29 28 28 30 JO 29 28
29 27 27 25 26 27 27 26 2* 26 24 23 27 27 27 27
2? 23 23 23 23 23 26 26 26 26 26 25 26 24 23 24 24 23 29 28 2S 26 26 26
I0
ua
in o
IV 0
0 0 0 0 0 o a o ooo ooo
0 0 0 o 0 ooo ooo 0 0 0
0
a
00
oo
00
oo
ooo ooo 0 0 1 ooo ooo ooo
I0 11 0 III 0 IV o
I0 It 0 in 0 IV 0
I0
na
III 0 IV 0
I0 II 0 111 0 IV 0
01 1 1 1 1 T 1 1 1 T 1 1 1 00000000 00 0000 000 0 00000 0 0 00 0 0000000o00 0000
0a0000 1 1 000o00 0 T 1 2 2 1 1 1 111112 0 0 0 0 0 0 0 1 110 1)1
0000 0 000 0oooao
ooo 0 0 0 000 0 o a o o
0 0 1 1 1 1 1 1 1 1 0 0 01
ooo
OOO
ooo ooo
00 0 ooo
0 0
0 0
0 0
00 00
0000000000 0000
00 00 0 000 0 0 00 0 0
0 0
0 0
0 0
0 0
0 0
0 0
0 0
0 0
0
o
0
o
0 1
0 0
0 0
0 0
CMA 118727
APR-22-97 TUE 01:08 PH HUNTINGDON LIFE SCIENCES FAX NO, 908 873 3992
P. 04/22
# OF ANIMALS EXAMINED
UNAUDITED
T 1-2 TABLE 1 Ceoot.J
DRAFT
VINYL CHLORIDE COMBINED INHALATION TUO-GENERATION REPRODUCTION
AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS
4080
SUMMARY OF CLINICAL OBSERVATIONS - MALES
WEEK: -1
1 2 3 4 5 6 7 8 9 10 11 12 13 K
I 30 II 30 III 30 IV 30
30 30 30 30 30 SO 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 SO 30 30 30 30 30 30 30 30 30 SO
OCULAR
LACK [MAT I ON UNILATERAL
CHROMODACRYORRHEA -
unilateral
CHROMOOACRYORRHEA BILATERAL
LACK I NATION - BILATERAL
ORAL/BUCCAL INCISORS MALOCUUOED
I0 ii a in o iv o
io ao HI 0
IV 0
I0
II o III 0
IV 0
I0 uo
III 0 IV 0
I0 II 0 in o
IV 0
1 00 0 0
0 ao oo
ooaoo
oooio
10 0 0
0 110
0 000
0 .1 1 0
1 0 0 0 0 10 12
o u o o i 1113
0 00 0 0 0 Z 0 0
0 0 12 1 1111
0 00 0 00
a oa ooo
000 ooo 1 a oo oo oo 1 00 0 ooo 0 0 0
ooo ooo ooo ooo
ooo ooo ooo ooo
ooo ooo ooo
ooo
110 0 0 0 0 111 1 00 0 0
0 00 0 1
00 32 00 12
0 01 2 22 0 00 112
0 0 ooo 0 0 ooo 0 0 ooo 0 0 ooo
0 0 ooo 0 0 U 00 0 0 a ao 0 0 0 01
0 0 0 00 22 3 3 5 5 5 4 4 0 0 0 1 1 1 0 1 113 3 3 2 0 1 2 2 2 4 3 3 12 3 3 3 3
0 0 1 23 33 3 0 0 2 2 2 2
CMA 118728
APR-22-97 TUE 01:08 PM HUNTINGDON LIFE SCIENCES FAX _NQ. 908 873 3992
P, 05/22
# OF MI HALS EXAMINED
UNAUDITED DRAFT
T 1-3
TASLE 1 (cont.)
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION
AND DEVELOPMENTAL TOXICITY StUOT IN CD RATS
SUMMARY OF CLINICAL OBSERVATIONS - MALES
WEEK: -1
l 30 11 30 III 30 IV 30
1 2 3 4 5 6 7 8 9 10 11 12 13 14
30 30 30 3D 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 10 30 SO 30 30 30 30 30 30
INCISORS SROKEN/MISS1NG
I0
II 0 III 0
IV 0
000000 1 1 1 22233 0000 000001 0000
00000033 232233 00000000 1 Z2222
96-4080
CMA118729
APR-22-97 TUE 01:08 PH HUNTINGDON LIFE SCIENCES Fffl NO. 90.8 873 3992
P. 06/22
# OF animals examined
UNAUDITED T 1-4 DRAFT
TASLE 1 (cont.) VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION
AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS
96-4080
WEEK: -1
SUMMARY OF CLINICAL OBSERVATIONS - FEMALES 1 2 3 4 5 6 7 8 9 10 11 12 13 14
l 30 II 30 III 30 IV 30
30 30 30 30 30 30 30 30 30 SO 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30
30 30 30 30 30 30 30 30 30 30 30 JO
normal
WITHIN NORMAL LIMITS
1 30 U 30 III 30 iv 30
GENL APPEARANCE
EARS SWOLLEN/RED BILATERAL
I JI HI
IV
DERMAL-GENERAL ALOPECIA EXTREMITIES/SNOUT
ALOPECIA - GENERAL
I
It III
IV
i n m
IV
OCULAR LACRIMATION - UNILATERAL
CKROMOOACRYORRHEA UNILATERAL
i ii
in
IV
I
II
11!
IV
30 30 30 30 30 30 30 30 30 30 29 29
29 29 30 30 29 29 28 27
28 28 28 26 30 30 30 30 2& 28 28 28 25 26 25 25
26 26 27 26 26 28 28 28 27 25 27 28 28 26 27 25 24 23 22 21
CMA118730
APR-22-97 TUE 01:09 PM HUNTINGDON LIFE SCIENCES FAX NO. 908 873 3992
P, 07/22
# OF ANIMALS EXAMINED
unwuiliO
draftT 1-5
TABLE 1 (cont.)
Ul!
VINYL CHLORIDE COMBINED INHALATION TWO-GENERATION REPRODUCTION
AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
WEEK: -1
I 30 II 30 III 30 IV 30
SUMMARY OF CLINICAL OBSERVATIONS - FEMALES
I2 3
30 JO 30 30 30 30 30 30
30 30 30
30
A5 6 7 8 9
30 30 30 30 30 30
30 30
30 30 30
30
30 30 30 30 30 30
30 30
30 30 30
30
TO II 12 13 14
30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30
98-4080
CHROMOOACRYORRHEA ` BILATERAL
LACRIMATION - bilateral
QRAL/BUCCAI, INCISORS MALOCCIUDED
10
II 0 III 0
iv 0
10 II 0 III 0 IV 0
0
0 0
o
00
00 00
ao
0 0 1 11
0 00 00 ooooo 0 00 00
111111
0000 00 00 00 0 0
0 0 1111
0 0
0 0
00 00
00 00
ooooo ooooo
ooooo ooooo
0
0 0
0
0 0 0
0
0 0 0
0
1 0 0
0
1 0 0
0
0 0 0
0
ORAL SORE
INCISORS SROKEN/MISSING
MASS!31
CMA 118731
APR-22-97 TUE 01:09 PH HUNTINGDON LIFE SCIENCES___ FAX NO, 908 873 3992
P, 08/22
--
/ 3 wy L CHLORIDE COMBINED INHALATION TUG-GENERATION REPRODUCTION
AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
UNAUDITED
L/IV Arl
'
STat SYMBOL;
WEEK
BODY WEIGHT IN GRAMS MALES
DOSE LEVEL: PPM
0.0000
10.0000 100.0000 1100.0000
A-L-
-1 MEAN 161.0
S.D.
9.3
N 30
161.0 9.3 30
161.1 9.4 30
160.9 9.4 30
A-L -
0 MEAN 233.3
S.D.
11.6
N 30
237.7 IS.3 30
236.6 12.6 30
234.3 14.0 30
A-L-
1 MEAN 274.5
S.D.
13.4
N 30
279.6 19.0 JO
277.8 14.S 30
272.4 16.6 3o
A-L*
2 MEAN 314.2
S.D.
16.5
H 30
322.1 23.5 30
321.7 17.9 30
318.3 20.5 30
A-L'
5 MEAN 348,8
S-D.
18.0
N 30
357.7 27.2 30
357,2 20.4 30
348.0 25.3 SO
A-L
4 MEAN 375.3
S.O.
22.4
N 30
384.2 32.8 30
382.3 25,5 30
374.7 27.8 30
A-L-
5 MEAN 401.8
S.O,
25.1
N 30
412.1 36.2 30
409.2 28.0 30
405.5 30.1 30
A-L '
6 MEAN 417.1
S.S.
32.7
N 30
432.4 38.8 30
426.1 29.2 30
424.5 33.3 30
CMA 118732
APR-22-97 TUE 01:09 PN HUNTINGDON LIFE SCIENCES FAX NO, 908 873 3992
P. 09/22
UNAUDITEDj 2-2
*6*4080
v,,,`"
DRAFT
ST AT STMSOl ;
WEEK
BOOr WE HINT IN oPams MALES
OOSE LEVEL; PPM
0.0000
10.0000
4"L*
7 MEAN 435.9
S.D.
31.6
N 30
452.3 41.1 30
A-L-
a MEAN 447. A
S.D.
32.4
N JO
465.0 42.1
30
A-L-
9 mean 462.6
S.D.
36.6
N 30
482,0 46.4 30
A-l-
10 MEAN 478,9
S.D.
IS.6
M 30
498.8 46,7 30
100.0000 1100.0000
447.3 31.0 30
447,6 37.0
30
460.8 32.9 30
477.6 34.8 30
463.5 37.0 30
477.8 38.9 30
492.5 35.7 30
490.6 39.2
SO
CMA 118733
APR-22-97 M 01=09 PN HUNTINGDON LIFE SCIENCES FAX NO, 908 873 3992
P, 10/22
UNAUDITEDT 2-3
'6*4080
n"L draft
S TAT SYH8QL:
WEEK
FEMALES DOSE LEVEL: PPM
0.0000
10.0000
A-l*
*1 MEAN 116.5
S,D.
6.0
N 30
116.2 6.1
30
A-L*
0 MEAN 15S.0
S.D.
7.5
N 30
158.5 9,1
so
A-L-
l MEAN 177.1
S ,D,
6.7
N 30
173.8 9.5 30.
a-l*
2 MEAN 106.4
S.D,
11.9
N 30
197.3 10.4
30
A-L-
2 MEAN 213.2
S.D.
12.3
H 30
209.8 10.J SO
A-L-
4 MEAN 225.6
5.0.
15.3
N 30
222.0 10.7
30
K-J*
5 MEAN 241.6
S.O.
14.7
N 30
236.6 10.5 30
a-l*
6 MEAN 250.7
i.D.
15.5
N 30
247.8 U.8 30
100,0000 1100,0000
116.S 5.7 30
116.7 5.8 30
156.3 9.3 30
157.0 7.7 30
178.1 12.1 30
175.8 9.3 30
199.1 14.1 30
197,1 11.7 30
214.4 16.6 50
212.2 12.7 30
226.7 17.4 30
223.0 13.1 30
241.5 19.4 30
236.4 13.0 30
252. 1 20.7
30
247.5 13.8 30
CMA 118734
APR-22-97 TUE 01:09 PH HUNTINGDON LIFE SCIENCES FAX NO. 90B 873 3992
P, 11/22
T 2-4
96-4080
TABLE 2 (cont,)
VINYL CHLORIDE COWTWO INNALATION TWO-GENERATION REPRODUCTION
AND DEVELOPMENTAL TOXICITY STUDY IN CO RATS
UNAUDITED
DRAFT
5TAT SYMBOL:
wEEK
BODY WEIGHT IN GRAMS females
DOS! LEVEL: PPM
0,0000
10.0000 100.0000 1100,0000
A-w
7 MEAN 258.5
S.O.
15.8
H 30
2S3.4 14.3 30
259.6 20.7 30
253.1
14.2 30
A-l-
3 MEAN 264.8
S.O.
16.4
N 30
259.5 14.0
30
265.4 21.4 30
258.2 15,9 30
A-LA
9 MEAN 274.3
S.O.
15.4
N 30
10 MEAN 280.6
S.O,
17.9
N 30
266.5 16.5 30
271.6 16.4 30
272.8 22.2 30
279.7 23.6 30
265.4 15.5 30
271.0 16.9 30
CMA 118735
APR-22-97 TUE 01:09 PH HUNTINGDON LIFE SCIENCES FAX NO. 908 873 3992
P, 12/22
V!
STAr SYMBOL;
T 3-1 TABLE 3
800Y WEIGHT CHANG! PROH WEEK MALES
DOSE LEVEL 1 PPM
0
96-4030
UNAUDITED DRAFT
WEEK 0.0000 igjaao loc.ccoo 1100.0000
A-!.
10 MEAN S.O.
245.6 34.4
261.t 37.5
255.9 31.8
256.3 31.6
N 30 30 JO 30
CMA118736
APR-22-97 TUE 01:09 PH HUNTINGDON LIFE SCIENCES
908 873 3992
P. 13/22
T
,.f TABZtE 3 (COST )
1 "`SISSS,;^
0
DRAFT
STAT SYMBOL:
800V WEIGHT CHANGE FSOM WEEK
FEMALES DOSE LEVEL! PPM
0
WggK
0.0000
10.0000 100.0000
1100.0000
AL-2
10 MEAN S.O.
K
122.6 16.2
30
115-1 13-8 30
123.4 21.0 30
114.0 14.6 30
CMA 118737
APR-22-97 TUE 01:10 PH HUNTINGDON LIFE SCIENCES FAX NO. 908 873 3992
P. 14/22
r 4-i
96*4080
TABLE 4 v'tNYL chloride combined inhalation TWO-GINERATION REPRODUCTION
AND DEVELOPMENTAL TOXICITY STUDY IN CD RATS
UNAUDITED
draft
STAT SYH60L-.
Al-0
FOOD CONSUMPTION G/KG/DAY MALES
DOSE LEVEL; PPM
WEEK
0.0000
0 MEAN 122.6
S.D. N
6.2 29
10.0000
125,1 4.4 30
100.0000
* 127.1
5.1 30
1100.0000
124.8 6.6 30
A-lA*L-U+ A*L-Ot
I MEAN S.D. N
98,3 4.8 30
2 MEAN S.D. N
86.7 6.3 30
3 MEAN S.D. H
78.5 3.2 30
98,8 4,0 30
89.3 3.9 30
79.1 3.5 30
99.5 4.9 30
r* 91,2
4.3 30
00
82.1 3.8 30
97.0 4.8 30
89.1 4,7 30
80.3 3.8 30
A L '
u mean
S.O. N
72.7
3.1 JO
72.J 3.9 30
73.3 3.2 30
73.2 3.5 30
AL*
AL-0
AL
i MEAN S.D. N
66.6 2.7 30
6 MEAN S.D. N
62.6 4.6 30
7 MEAN S.D, M
60.2 3.7 30
69.5 3.5 29
66.0
3.4 29
61.0 2.3 30
70.3 3.5 JO
65.0 6.0 30
9 62.4
3.5 30
71.4 3.8 30
45.6
3.9 30
*
62.3 3.5 30
CMA118738
APR-22-97 TUE 01:10 PM HUNTINGDON LIFE SCIENCES FftX NO, 908 873 3992
''"'l
STAT SVMBOL: a-l-
K*v r
A'L-0
y
issTa"
POOO consumption G/KG/OAT MALES
DOSE LEVEL; PPik
^6"4080
UNAUDITED
draft
WEEK
0.0000
8 mean
S.O. N
sr.3 3.3 30
9 mean S.D. N
36.0 3.3 30
10 MEAN S.O. N
34.A 2.3 30
10.0000 100.0000 1100.0000
58.1 3.4 30
36.1 2.7 30
39.1 2.4 30
57.4 6,2 29
58.4 3.0 30
am
59.4 4,0 Jo
55.6 2.9 29
56.6 3.1 29
35.2 3.9 30
CMA 118739
APR-22-97 TUE 01:10 PM HUNTINGDON LIFE SCIENCES FAX NO. m 873 3992
P. 18/22
T 4*3 WNYL CHL^r0*^*0 'NH4lAno"?w^ENB(WTIQN REPRODUCTION
AKO DEVELOPMENTAL TOXICITY STUDY IN CO RATS
unaudited
STAT SYMBOL:
WEEK
FOOD CONSUMPTION G/K8/DAY
FEMALES OOSB LEVEL: PPM
0.0000
10.0000 100.0000 1100.0000
DRAFT
A*l-
0 MEAN 131.8
S.O.
5.9
N 29
133.5 9.4 29
134.9 7.8 28
154.9 8.0 26
al-
1 MEAN 107.4
S.O.
S.2
N 30
104.3 5.4 28
109.2 3.7 29
105.4 6.7 27
<.
2 MEAN
S.O. N
103.6 10.3 50
103.9 5.5 30
105.9 9.5 30
103.9 8.6 30
a-l-
3 MEAN S.O. N
94.3 5.2
30
94.7 6.2 30
96.9 5.8 30
96,9 6.5 29
A*L*
MEAN S.O, u
90.3 5.6 30
89.0 4.9 30
92.2 5.9 30
90.4 5.9 30
`0* 4
5 MEAN S.O. M
35,8 4,3 30
MEAN
S.O,
N
79.4 3.4 29
MEAN s.o,
N
77.4
5.9
30
87.6 5.6 30
**
84.9 5.7 30
76,5 5.7 30
87.6 7,0 30
84.7 9,0 30
76.5
5.0
30
87.1
r.s
30
*
85.0 3.9 30
77,7 6.1
30
CMA 118740
APR-22-97 TUE 01:10 PM HUNTINGDON LIFE SCIENCES FAN NO, 908 873 3992
P. 17/22
Wnh Chloride combined
^AUDITEDm wtiommi toxrcm ^Tf"2* "PROOUeT,OM
STM SVM30L : A-L*
A-L-
a+l*
FOOO CONSUMPTION $/Ka/0Ay
FEMALES
OOSS LEVEL: PPM
MEEK
0.0000
S MEAN
S.D. N
74.9
5.3 30
9 MEAN S.D. N
71.9 5,7 30
10 MEAN
S.D. H
47.1 6.3 39
10.0000 100.0000
74.3 5.0 30
75.3 5.3 30
70.9 3.3
30
73.1 7.0 30
43.5 6.5 30
70.1 5.0 30
`
1100.0000
76.5 5.9 SO
74.4 6.1
28 ** 72.2 5.1 29
Dm
CMA 118741
APR-; >2-97 TUE OHIO PH HUNTINGDON LIFE SCIENCES FAX NO. 908 873 3992
P. 18/22
VWL
STAT SYMBOL:
MEEK
r j.t
tcor WEIGHT IN GRAMS
MALES OQSg LEVEL: PPM
96-4080
UNAUDITED
draft
0.0000
10.0000
100.0000 HOO.OOOO
L' L1-LL-
ii MEAN 479.3
S.O.
36.6
N 30
12 MEAH 488.2
S.D.
37,2
N 30
U MEAN S00.6
S.O.
39.6
N 30
14 MEAN 508.0
S.O.
43.0
N 30
499.7 49.8 30
512.0 51.0 30
523.7 51.3 30
523.1 33.7 30
493.6 34.4 30
502.1 36.8 30
511.5 45.6 30
520.3 41.9 30
493.7 38.1 30
505.8 38.7 30
518.2 39.4 30
520.3 42.9 30
CMA 118742
APR-22-97 TUE 01:10 PM HUNTINGDON LIFE SCIENCES FAX NO. 908 873 3992
P. 19/22
r 6-i 96'4080
VINYL CHL^Dl!.F?'8,Ne> INHALATION TWO'GENERATION AEPRODL/Crmu
ANP DEVELOPMENTAL TOXICITY STUDY ,n CB^A?|
rW
UNAUDITED DRAFT
FOOD CONSUMPTION Q/K&/DAY
MALES DOSE LIVELi PPM
STAT SYMBOL;
weiK
a. oooo 10.0000 100.0000 1100.0000
K-JA+L-0+
13 MEAN
S.B. N
AS.A 9.S 30
H MEAN S.O. N
SO.8 3.1
29
50.2
7.5 30
49.9
3.8 30
51-1 3.8
30
* 53.0 3.9
29
51.0
3.6
30
51.2
3.0 30
CMA 118743
APR-22-97 TUE 01:10 PM HUNTINGDON LIFE SCIENCES FAX NO, 908 873 3992
P. 20/22
UNAUDITED
Vinyl
DRAFT
A-l 96-4080 Appendix A Chloride Combined Inhalation Two-Generation Reproduction
and Developmental Toxicity Study in CD Rats
Methodology and References - Statistical Analysis
Parameters analyzed statistically for this status report: body weights and food consumption
MULTIPLE GROUP ANALYSIS STAT SYMBOL
No Sio D3Q.Q5 paQ.Ql Parametric
A-
A A*
L-
L L+ Q Q+ * **
STATISTICAL STATEMENT
No statistical differences among the means (parametric ANOVA). The means differ significantly (parametric ANOVA). The response is not linearly related to the dose levels. The response is linearly related to the dose levels. The response shows a lack of fit. Significantly different from control (Dunnett 's).
CMA 118744
APR-22-97 TUE 01:10 PM HUNTINGDON LIFE SCIENCES FAX NO, 908 873 3992
P. 21/22
UNAUDITED
draftA-2
Appendix A (cant.)
96-4080
Vinyl Chloride Combined Inhalation Two-Generation Reproduction
and Developmental Toxicity Study in CD Rats
Methodology and References - Statistical Analysis
MULTIPLE GROUP ANALYSIS STAT SYMBOL
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Nonparametric K-
K K+
JJ J+
NT
STATISTICAL STATEMENT
No statistical differences among the means (Kruskal-Wallis, nonparametric). The means differ significantly (Kruskal-Wallis nonparametric). There is not an ordered response to dosage. There is an ordered response to dosage. Significantly different from control (Dunn's Rank 5um). Not tested due to lack of variance.
Statistical evaluation of equality of means was made by the appropriate one way analysis of variance technique, followed by a multiple comparison procedure if needed. First, Bartlett's test was performed to determine if groups had equal variance. If the variances were equal, parametric procedures were used; if not, nonparametric procedures were used. The parametric procedures were the standard one way ANOVA using the F distribution to assess significance. If significant differences among the means were indicated, Qunnett's test was used to determine which means were significantly different from the control. If a nonparametric procedure for testing equality of means was needed, the Kruskal-Wallis test was used, and if differences were indicated a summed rank test (Dunn) was used to determine which treatments differed from control.
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A-3 96-4080 Appendix A (cont.)
Chloride Combined Inhalation Two-Generation Reproduction and Developmental Toxicity Study in CD Rats
Methodology and References - Statistical Analysis
A statistical test for trend in the dose levels was also performed. the parametric case (i.e., equal variance) standard regression techniques with a test for trend and lack of fit were used. In the nonparametric case Jonckheere's test for monotonic trend was used.
In
The test for equal variance (Bartlett's) was conducted at the 1%, two-sided risk level. All other statistical tests were conducted at the 5% and 1%, two-sided risk level.
References for these techniques are Snedecor, G.W., and Cochran, W.G., Statistical Methods, 6th edition, Iowa State University Press (1967); Hollander, M. and Wolfe, O.A., Nonparametric Statistical Methods. John Wiley and Sons, New York (1973); Dunnett, C.W., J. Am. Sto. Assn. Vol. 50 (1955) and Biometrics. Vol. 20 (1964).
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