10000 MG/M3       24          186          0           0

                  20000 MG/M3       24          184          0           0

K-7

APPENDIX K – STATISTICIANS REPORT (CONT’D)

                                       head - individual

                                   HEAD:  Retina fold; Right

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          181          0           0

                   2000 MG/M3       24          179          1           1

                  10000 MG/M3       24          186          0           0

                  20000 MG/M3       24          184          0           0

                       External Variations and Malformations - combined

                                          All Fetuses

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          358          2           2

                   2000 MG/M3       24          362          1           1

                  10000 MG/M3       24          369          1           1

                  20000 MG/M3       24          366          1           1

                       External Variations and Malformations - combined

                                         Alive Fetuses

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          358          2           2

                   2000 MG/M3       24          362          1           1

                  10000 MG/M3       24          369          1           1

                  20000 MG/M3       24          366          1           1

                               External Malformations - combined

                                          All Fetuses

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          358          2           2

                   2000 MG/M3       24          362          1           1

                  10000 MG/M3       24          369          1           1

                  20000 MG/M3       24          366          1           1

K-8

APPENDIX K – STATISTICIANS REPORT (CONT’D)

                               External Malformations - combined

                                         Alive Fetuses

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          358          2           2

                   2000 MG/M3       24          362          1           1

                  10000 MG/M3       24          369          1           1

                  20000 MG/M3       24          366          1           1

                                     external - individual

                         EXTERNAL: Cleft palate (confirmed internally)

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          358          0           0

                   2000 MG/M3       24          362          1           1

                  10000 MG/M3       24          369          0           0

                  20000 MG/M3       24          366          0           0

                                     external - individual

                                 EXTERNAL: Fetus discolored red

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          358          0           0

                   2000 MG/M3       24          362          2           2

                  10000 MG/M3       24          369          0           0

                  20000 MG/M3       24          366          0           0

 NOTE:  This is an observation and is not included in the combined categories.

                                     external - individual

                                   EXTERNAL: Filamentous tail

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          358          1           1

                   2000 MG/M3       24          362          0           0

                  10000 MG/M3       24          369          0           0

                  20000 MG/M3       24          366          0           0

K-9

APPENDIX K – STATISTICIANS REPORT (CONT’D)

                                     external - individual

                                    EXTERNAL: Malrotated paw

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          358          1           1

                   2000 MG/M3       24          362          0           0

                  10000 MG/M3       24          369          1           1

                  20000 MG/M3       24          366          1           1

                                     external - individual

                                     EXTERNAL: Microstomia

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          358          0           0

                   2000 MG/M3       24          362          1           1

                  10000 MG/M3       24          369          0           0

                  20000 MG/M3       24          366          0           0

                       Visceral Variations and Malformations - combined

                                          All Fetuses

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          181          4           4

                   2000 MG/M3       24          179          1           1

                  10000 MG/M3       24          186          1           1

                  20000 MG/M3       24          184          1           1

                       Visceral Variations and Malformations - combined

                                         Alive Fetuses

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          181          4           4

                   2000 MG/M3       24          179          1           1

                  10000 MG/M3       24          186          1           1

                  20000 MG/M3       24          184          1           1

K-10

APPENDIX K – STATISTICIANS REPORT (CONT’D)

                               Visceral Malformations - combined

                                          All Fetuses

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          181          4           4

                   2000 MG/M3       24          179          1           1

                  10000 MG/M3       24          186          1           1

                  20000 MG/M3       24          184          1           1

                               Visceral Malformations - combined

                                         Alive Fetuses

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          181          4           4

                   2000 MG/M3       24          179          1           1

                  10000 MG/M3       24          186          1           1

                  20000 MG/M3       24          184          1           1

                                     visceral - individual

                                ABDOMEN/THORAX:  Hydronephrosis

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          181          3           3

                   2000 MG/M3       24          179          1           1

                  10000 MG/M3       24          186          1           1

                  20000 MG/M3       24          184          1           1

                                     visceral - individual

                               ABDOMEN/THORAX:  Hydroureter; Left

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          181          1           1

                   2000 MG/M3       24          179          0           0

                  10000 MG/M3       24          186          0           0

                  20000 MG/M3       24          184          0           0

K-11

APPENDIX K – STATISTICIANS REPORT (CONT’D)

                       Skeletal Variations and Malformations - combined

                                          All Fetuses

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          177         14          28

                   2000 MG/M3       24          183         16          32

                  10000 MG/M3       24          183         15          30

                  20000 MG/M3       24          182         16          35

                       Skeletal Variations and Malformations - combined

                                         Alive Fetuses

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          177         14          28

                   2000 MG/M3       24          183         16          32

                  10000 MG/M3       24          183         15          30

                  20000 MG/M3       24          182         16          35

                                Skeletal Variations - combined

                                          All Fetuses

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          177         13          27

                   2000 MG/M3       24          183         16          32

                  10000 MG/M3       24          183         15          30

                  20000 MG/M3       24          182         16          35

                                Skeletal Variations - combined

                                         Alive Fetuses

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          177         13          27

                   2000 MG/M3       24          183         16          32

                  10000 MG/M3       24          183         15          30

                  20000 MG/M3       24          182         16          35

K-12

APPENDIX K – STATISTICIANS REPORT (CONT’D)

                               Skeletal Malformations - combined

                                          All Fetuses

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          177          2           2

                   2000 MG/M3       24          183          2           2

                  10000 MG/M3       24          183          0           0

                  20000 MG/M3       24          182          0           0

                               Skeletal Malformations - combined

                                         Alive Fetuses

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          177          2           2

                   2000 MG/M3       24          183          2           2

                  10000 MG/M3       24          183          0           0

                  20000 MG/M3       24          182          0           0

                                     skeletal - individual

                         SKELETAL/RIBS (Anlage):  Multiple hypoplastic

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          177          3           5

                   2000 MG/M3       24          183          3           4

                  10000 MG/M3       24          183          4           7

                  20000 MG/M3       24          182          4           6

                                     skeletal - individual

                            SKELETAL/RIBS (CE8):  Well-formed; Right

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          177          0           0

                   2000 MG/M3       24          183          1           1

                  10000 MG/M3       24          183          0           0

                  20000 MG/M3       24          182          0           0

K-13

APPENDIX K – STATISTICIANS REPORT (CONT’D)

                                     skeletal - individual

                          SKELETAL/RIBS (L1):  Rudimentary lumbar ribs

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          177          3           3

                   2000 MG/M3       24          183          5           5

                  10000 MG/M3       24          183          4           6

                  20000 MG/M3       24          182          5          11

                                     skeletal - individual

                             SKELETAL/RIBS (L1):  Well-formed; Left

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          177          0           0

                   2000 MG/M3       24          183          1           1

                  10000 MG/M3       24          183          0           0

                  20000 MG/M3       24          182          1           1

                                     skeletal - individual

                          SKELETAL/RIBS (T13):  Short Last; Bilateral

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          177          0           0

                   2000 MG/M3       24          183          0           0

                  10000 MG/M3       24          183          0           0

                  20000 MG/M3       24          182          1           1

                                     skeletal - individual

                    SKELETAL/RIBS:  Rib anlage supernumary ossification site

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          177          1           2

                   2000 MG/M3       24          183          1           2

                  10000 MG/M3       24          183          1           1

                  20000 MG/M3       24          182          2           6

K-14

APPENDIX K – STATISTICIANS REPORT (CONT’D)

                                     skeletal - individual

                      SKELETAL/STERNEBRAE (Anlage):  Multiple hypoplastic

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          177          3           5

                   2000 MG/M3       24          183          1           2

                  10000 MG/M3       24          183          1           3

                  20000 MG/M3       24          182          2           2

                                     skeletal - individual

                  SKELETAL/STERNEBRAE (Between V and VI): Site of ossification

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          177          0           0

                   2000 MG/M3       24          183          1           1

                  10000 MG/M3       24          183          0           0

                  20000 MG/M3       24          182          0           0

                                     skeletal - individual

                           SKELETAL/STERNEBRAE (III):  dumbbell centra

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          177          0           0

                   2000 MG/M3       24          183          0           0

                  10000 MG/M3       24          183          1           1

                  20000 MG/M3       24          182          0           0

                                     skeletal - individual

                            SKELETAL/STERNEBRAE (IV):  Bifid centra

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          177          0           0

                   2000 MG/M3       24          183          1           1

                  10000 MG/M3       24          183          1           1

                  20000 MG/M3       24          182          0           0

K-15

APPENDIX K – STATISTICIANS REPORT (CONT’D)

                                     skeletal - individual

                          SKELETAL/STERNEBRAE:  Hypolastic sternebrae

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          177          0           0

                   2000 MG/M3       24          183          1           1

                  10000 MG/M3       24          183          1           1

                  20000 MG/M3       24          182          0           0

                                     skeletal - individual

                        SKELETAL/STERNEBRAE:  Sternebrae, asymetric form

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          177          0           0

                   2000 MG/M3       24          183          1           1

                  10000 MG/M3       24          183          1           1

                  20000 MG/M3       24          182          1           1

                                     skeletal - individual

                          SKELETAL/STERNEBRAE:  Unossified sternebrae

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          177          2           3

                   2000 MG/M3       24          183          1           1

                  10000 MG/M3       24          183          0           0

                  20000 MG/M3       24          182          2           3

                                     skeletal - individual

                       SKELETAL/VERTEBRAE (CE):  Multiple bones malformed

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          177          0           0

                   2000 MG/M3       24          183          1           1

                  10000 MG/M3       24          183          0           0

                  20000 MG/M3       24          182          0           0

K-16

APPENDIX K – STATISTICIANS REPORT (CONT’D)

                                     skeletal - individual

                               SKELETAL/VERTEBRAE (CE): Presacral

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          177          0           0

                   2000 MG/M3       24          183          1           1

                  10000 MG/M3       24          183          0           0

                  20000 MG/M3       24          182          0           0

                                     skeletal - individual

                          SKELETAL/VERTEBRAE (L):  One less presacral

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          177          0           0

                   2000 MG/M3       24          183          1           1

                  10000 MG/M3       24          183          0           0

                  20000 MG/M3       24          182          0           0

                                     skeletal - individual

                               SKELETAL/VERTEBRAE (L):  Presacral

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          177          1           1

                   2000 MG/M3       24          183          0           0

                  10000 MG/M3       24          183          0           0

                  20000 MG/M3       24          182          0           0

                                     skeletal - individual

                          SKELETAL/VERTEBRAE (S4):  Unossified centra

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          177          1           1

                   2000 MG/M3       24          183          0           0

                  10000 MG/M3       24          183          0           0

                  20000 MG/M3       24          182          0           0

K-17

APPENDIX K – STATISTICIANS REPORT (CONT’D)

                                     skeletal - individual

                       SKELETAL/VERTEBRAE (T5 Anlage):  Misshapen centra

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          177          1           1

                   2000 MG/M3       24          183          0           0

                  10000 MG/M3       24          183          0           0

                  20000 MG/M3       24          182          0           0

                                     skeletal - individual

                           SKELETAL/VERTEBRAE (T5):  Misshapen centra

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          177          1           1

                   2000 MG/M3       24          183          0           0

                  10000 MG/M3       24          183          0           0

                  20000 MG/M3       24          182          0           0

                                     skeletal - individual

                       SKELETAL/VERTEBRAE:  Bifid centra vertebral anlage

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          177          0           0

                   2000 MG/M3       24          183          2           2

                  10000 MG/M3       24          183          1           1

                  20000 MG/M3       24          182          2           2

                                     skeletal - individual

                          SKELETAL/VERTEBRAE:  Bifid vertebral centra

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          177          7          12

                   2000 MG/M3       24          183          6          14

                  10000 MG/M3       24          183          8           9

                  20000 MG/M3       24          182          7           9

K-18

APPENDIX K – STATISTICIANS REPORT (CONT’D)

                                     skeletal - individual

                 SKELETAL/VERTEBRAE:  Dumbbell-shaped vertebral centra anlage

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          177          0           0

                   2000 MG/M3       24          183          3           9

                  10000 MG/M3       24          183          5           5

                  20000 MG/M3       24          182          2           2

                                     skeletal - individual

                         SKELETAL/VERTEBRAE:  dumbbell vertebral centra

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          177          0           0

                   2000 MG/M3       24          183          0           0

                  10000 MG/M3       24          183          3           3

                  20000 MG/M3       24          182          0           0

                                     skeletal - individual

                    SKELETAL/VERTEBRAE:  Hypoplastic vertebral anlage centra

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          177          3           3

                   2000 MG/M3       24          183          4           8

                  10000 MG/M3       24          183          4           8

                  20000 MG/M3       24          182          5           8

                                     skeletal - individual

                       SKELETAL/VERTEBRAE:  Hypoplastic vertebral centra

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          177          0           0

                   2000 MG/M3       24          183          1           1

                  10000 MG/M3       24          183          1           1

                  20000 MG/M3       24          182          0           0

K-19

APPENDIX K – STATISTICIANS REPORT (CONT’D)

                                     skeletal - individual

                      SKELETAL/VERTEBRAE:  Multiple vertebral bones absent

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          177          1           1

                   2000 MG/M3       24          183          0           0

                  10000 MG/M3       24          183          0           0

                  20000 MG/M3       24          182          0           0

                                      skeletal - combined

                                SKELETAL/RIBS:  Supernumary ribs

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          177          3           3

                   2000 MG/M3       24          183          6           6

                  10000 MG/M3       24          183          4           6

                  20000 MG/M3       24          182          5          11

                                      skeletal - combined

                          SKELETAL/STERNEBRAE:  Hypoplastic sternebrae

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          177          2           3

                   2000 MG/M3       24          183          2           2

                  10000 MG/M3       24          183          1           1

                  20000 MG/M3       24          182          2           3

                                      skeletal - combined

                         SKELETAL/VERTEBRAE:  Extra presacral vertebrae

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          177          1           1

                   2000 MG/M3       24          183          1           1

                  10000 MG/M3       24          183          0           0

                  20000 MG/M3       24          182          0           0

K-20

APPENDIX K – STATISTICIANS REPORT (CONT’D)

                                      skeletal - combined

              			SKELETAL/VERTEBRAE:  Hypoplastic vertebral

anlage centra (combined)

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          177          3           3

                   2000 MG/M3       24          183          8          18

                  10000 MG/M3       24          183          9          14

                  20000 MG/M3       24          182          7          12

                                      skeletal - combined

                  SKELETAL/VERTEBRAE:  Hypoplastic vertebral centra (combined)

                                   dams       fetuses      dams       fetuses

                     DOSE        examined    examined    affected    affected

                      0 MG/M3       24          177          8          13

                   2000 MG/M3       24          183          6          14

                  10000 MG/M3       24          183         10          12

                  20000 MG/M3       24          182          7           9

K-21

APPENDIX L - HISTORICAL CONTROL DATA FOR ANNANDALE, NJ FACILITY

SUPPLIER: Charles River Laboratories, Inc.

FEED: PMI Certified Rodent Chow (5002 Meal)

STUDY          NUMBER	STUDY DATES	SUPPLIER LOCATION/AREA	SPECIES/STRAIN NUMBER OF LITTERS/FETUSES	% PREGNANT	DOSING ROUTE/CARRIER

9A	May 9, 2000 –

June 2, 2000	Raleigh, NC/R04	Crl:CD®(SD)IGSBR VAF/Plus	25/398	100 Oral/Corn Oil

9B	May 9, 2000 –

June 2, 2000	Raleigh, NC/R04	Crl:CD®(SD)IGSBR VAF/Plus	25/401	100 Oral/Corn Oil

10	May 19, 2001 –

June 15, 2001	Raleigh, NC/R04	Crl:CD®(SD)IGSBR VAF/Plus	24/359	96 Inhalation/Air

L-1

APPENDIX L - HISTORICAL CONTROL DATA FOR ANNANDALE, NJ FACILITY (CONT’D)

 (UTERINE IMPLANTATION DATA)

	NUMBER

OF LITTERS

LIVE

MALE

FEMALE

RESORPTIONS

IMPLANTS

CORPORA LUTEA

DEAD

FETUS/ IMPLANTS

RESORPTIONS/ IMPLANTS

F/I TRANSFORMED

HIGH

16.04	7.84	8.436	0.58	16.48	17.16	0	0.97	0.4	79.840760

LOW

14.96	7.54	7.42	0.44	15.50	16.42	0	0.97	0.03	78.883958

STUDY #

	10	24	14.96	7.54	7.42	0.58	15.50	16.42	0	0.97	0.04	78.883958

STD

3.07	2.90	2.55	0.83	3.18	3.41	0	0.05	0.05	5.408551

(N)

24	24	24	24	24	24	24	24	24	24

9(B)	25	16.04	7.84	8.20	0.44	16.48	17.16	0	0.97	0.03	79.840760

STD

2.24	1.57	1.91	0.77	2.02	1.93	0	0.05	0.05	5.232909

(N)

25	25	25	25	25	25	25	25	25	25

9(A)	25	15.92	7.56	8.36	0.52	16.44	16.88	0	0.97	0.03	79.294360

STD

1.53	1.69	1.60	0.71	1.42	1.48	0	0.04	0.04	4.836482

(N)

25	25	25	25	25	25	25	25	25	25

L-2

APPENDIX L - HISTORICAL CONTROL DATA FOR ANNANDALE, NJ FACILITY (CONT’D)

 (UTERINE IMPLANTATION DATA)

	NUMBER

OF LITTERS	R/I TRANSFORMED	D/I TRANSFORMED	DEAD/ IMPLANTS	PRE IMPLANT LOSS	POST IMPLANT LOSS	MALFORMATIONS	VARIATIONS	AFFECTED

HIGH

11.402500	7.455	0	5.10	3.30	0.17	0.70	0.80

LOW

10.159600	7.103	0	2.50	2.80	0.08	0	0.50

STUDY #

	10	24	11.402500	7.455	0	5.1	3.3	0.17	0.70	0.80

STD

5.349722	1.087	0	12.6	5.4	0.38	0.80	0.80

(N)

24	24	24	24	24	24	24	24

9(B)	25	10.159600	7.117	0	3.9	2.8	0.08	0.00	0.50

STD

5.232766	0.478	0	7.0	5.0	0.40	0.00	0.80

(N)

25	25	25	25	25	25	25	25

9(A)	25	10.706120	7.103	0	2.5	3.1	0.12	0.10	0.60

STD

4.836645	0.318	0	4.3	4.3	0.33	0.40	0.70

(N)

25	25	25	25	25	25	25	25

L-3

APPENDIX L - HISTORICAL CONTROL DATA FOR ANNANDALE, NJ FACILITY (CONT’D)

 (FETAL BODY WEIGHTS)

	NUMBER

OF LITTERS	MALE	FEMALE

HIGH

5.75	5.50

LOW

5.41	5.16

STUDY #

	10	24	5.75	5.50

STD

0.35	0.34

(N)

181	178

9(B)	25	5.41	5.16

STD

0.45	0.39

(N)

196	205

9(A)	25	5.61	5.31

STD

0.38	0.37

(N)

189	209

L-4

APPENDIX L - HISTORICAL CONTROL DATA FOR ANNANDALE, NJ FACILITY (CONT’D)

 (EXTERNAL DATA)

STUDY #	10	9(B)	9(A)

NUMBER OF LITTER	24	25	25

NUMBER OF FETUSES	359	401	398

% STUNTED - F	0	1.25	0

% STUNTED - L	0	16.00	0

	% EXT. VAR. - F	0	0	0

% EXT. VAR. - L	0	0	0

	% EXT. MAL - F	0.28	0	0.50

% EXT. MAL. - L	4.17	0	8.00

	Cleft Palate - F

	Cleft Palate - L

	Malrotated hindpaw - F	0.28

0.50

Malrotated hindpaw - L	4.17

8.00

	NOTE:    	F - Fetus

	               	L - Litter

		Blank entries for an observation indicate that the observation was not present in that study

L-5

APPENDIX L - HISTORICAL CONTROL DATA FOR ANNANDALE, NJ FACILITY (CONT’D)

 (INTERNAL DATA)

STUDY #	10	9(B)	9(A)

NUMBER OF LITTERS	24	25	25

NUMBER OF FETUSES	178	197	201

% VIS. VAR. - F	0	0	1.00

% VIS. VAR. - L	0	0	4.00

	% VIS. MAL. - F	1.69	1.02	0.50

% VIS. MAL. - L	12.50	4.00	4.00

	Hydrocephaly - F

	Hydrocephaly - L

	Microphthalmia - F

0.51

	Microphthalmia - L

4.00

	Retinal fold  - F	1.12

Retinal fold - L	8.33

Heart: Misshapen - F

	Heart: Misshapen  - L

	Subclavian artery: Abnormal origin  - F

	Subclavian artery: Abnormal origin - L

	Subclavian artery: Retroesophageal  - F

	Subclavian artery: Retroesophageal - L

	Adrenal(s): Discolored  - F

	Adrenal(s): Discolored - L

	Renal pelvis(es): Dilated - F

	Renal pelvis(es): Dilated - L

	Hydronephrosis - F

	Hydronephrosis - L

	Ureter(s): Convoluted - F

	1.00

Ureter(s): Convoluted - L

	4.00

NOTE:  	F - Fetus

	               	L - Litter

			Blank entries for an observation indicate that the observation was not present in that study

L-6

STUDY #	10	9(B)	9(A)

NUMBER OF LITTERS	24	25	25

NUMBER OF FETUSES	178	197	201

Hydroureter - F	0.56	0.51	0.50

Hydroureter - L	4.17	4.00	4.00

Umbilical artery: Left of urinary bladder - F

	Umbilical artery: Left of urinary bladder - L

	NOTE:  	F - Fetus

	               	L - Litter

			Blank entries for an observation indicate that the observation was not present in that study

L-7

APPENDIX L - HISTORICAL CONTROL DATA FOR ANNANDALE, NJ FACILITY (CONT’D)

 (SKELETAL DATA)

STUDY #	10	9(B)	9(A)

NUMBER OF LITTER	24	$	$

NUMBER OF FETUSES	181	$	$

% SKEL. VAR. - F	8.84	$	$

% SKEL. VAR. - L	50.00	$	$

	% SKEL. MAL. - F	0	$	$

% SKEL. MAL. - L	0	$	$

	Skull bone(s): Hypoplastic - F

	Skull bone(s): Hypoplastic - L

	Skull bone(s): Unossified - F

	Skull bone(s): Unossified - L

	Forepaw: Advanced - F

	Forepaw: Advanced - L

	Forepaw: Unossified - F

	Forepaw: Unossified - L

	Sternebrae: Asymmetric form - F

	Sternebrae: Asymmetric form - L

	Sternebrae: Bifid - F

	Sternebrae: Bifid - L

	Sternebrae: Hypoplastic - F

	Sternebrae: Hypoplastic - L

	Sternebrae: Unossified - F	1.10

Sternebrae: Unossified - L	8.33

Vertebral centra: Bifid- F	1.10

Vertebral centra: Bifid- L	8.33

NOTE:  	F - Fetus

	               	L - Litter

	               	$ - Not examined

		Blank entries for an observation indicate that the observation was not present in that study

L-8

APPENDIX L - HISTORICAL CONTROL DATA FOR ANNANDALE, NJ FACILITY (CONT’D)

 (SKELETAL DATA)

STUDY #	10	9(B)	9(A)

NUMBER OF LITTER	24	$	$

NUMBER OF FETUSES	181	$	$

Vertebral centra: Dumbbell/8-shaped - F	1.10

Vertebral centra: Dumbbell/8-shaped - L	8.33

Vertebral centra anlage: Bifid - F

	Vertebral centra anlage: Bifid - L

	Rib(s): Hypoplastic - F

	Rib(s): Hypoplastic - L

	Rib(s): Misshapen - F

	Rib(s): Misshapen - L

	Rib(s): Rudimentary lumbar - F	5.52

Rib(s): Rudimentary lumbar - L	25.00

Rib(s): Well formed lumbar - F

	Rib(s): Well formed lumbar - L

	Rib(s): Short last thoracic - F

	Rib(s): Short last thoracic - L

	Rib(s): Thick/wavy - F

	Rib(s): Thick/wavy - L

	Pelvic girdle: Hypoplastic - F

	Pelvic girdle: Hypoplastic - L

	Hindpaw: Advanced - F

	Hindpaw: Advanced - L

	Hindpaw: Unossified - F

	Hindpaw: Unossified - L

NOTE:    	F - Fetus

	                	L - Litter

	                	$ - Not examined

		Blank entries for an observation indicate that the observation was not present in that study

L-9

APPENDIX M – FEED AND WATER ANALYSES

FEED ANALYSES

M-1

APPENDIX M – FEED AND WATER ANALYSES (CONT’D)

WATER ANALYSES

M-2

APPENDIX M – FEED AND WATER ANALYSES (CONT’D)

WATER ANALYSES (CONT’D)

M-3

APPENDIX M – FEED AND WATER ANALYSES (CONT’D)

WATER ANALYSES (CONT’D)

M-4

APPENDIX M – FEED AND WATER ANALYSES (CONT’D)

WATER ANALYSES (CONT’D)

M-5

APPENDIX M – FEED AND WATER ANALYSES (CONT’D)

WATER ANALYSES (CONT’D)

M-6

APPENDIX M – FEED AND WATER ANALYSES (CONT’D)

WATER ANALYSES (CONT’D)

M-7

APPENDIX M – FEED AND WATER ANALYSES (CONT’D)

WATER ANALYSES (CONT’D)

M-8

APPENDIX M – FEED AND WATER ANALYSES (CONT’D)

WATER ANALYSES (CONT’D)

M-9

APPENDIX M – FEED AND WATER ANALYSES (CONT’D)

WATER ANALYSES (CONT’D)

M-10

WHOLE-BODY INHALATION DEVELOPMENTAL TOXICITY STUDY IN RATS

WITH GASOLINE WITH MTBE VAPOR CONDENSATE MRD-00-713: 171334

 PAGE

Page   PAGE  1  of   NUMPAGES  267

  PAGE  1

Whole Body Inhalation Developmental Toxicity Study in Rats

With Gasoline Vapor with MTBE Condensate  (MRD-00-713):  171334

 PAGE

Whole Body Inhalation Developmental Toxicity Study in Rats

With Gasoline Vapor with MTBE Condensate  (MRD-00-713):  171334

I-  PAGE  5

 PAGE

Miran

Miran

Pump

Pump

 OUT

IN

IN

OUT

IN

OUT

GC

GC

Line inlet

Select Stream

Disconnect

Stream Vent