US Environmental Protection Agency
Office of Pesticide Programs

Prenatal Developmental Toxicity
July 2002

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    U.S. Environmental Protection Agency

        Office of Pesticide Programs

      Electronic Submission Guidance
Standard Format for Electronic Submission of
   Supplemental Data Files in Support of


   Prenatal  Developmental

        Toxicity Studies
             July 31, 2002

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Standard Format for Electronic Submission of Supplemental Data Files                  July 31, 2002
in Support of Prenatal Developmental Toxicity Data.

The following formats and instructions are designed to be used as an example or guide for
registrants to format electronic files for submission of animal toxicology data to the USEPA
Office of Pesticide Programs for review in support of registration and re-registration of
pesticides.  They are based upon, and are intended to be consistent with, similar guidance
published by the Food and Drug Administration (FDA).

The USEPA Office of Pesticide Programs has identified SAS Transport as the preferred means
of supplying the supplemental data. SAS Transport Format, published by the SAS Institute,
allows data to be translated to other commonly used formats without the need for other programs
from the SAS Institute or other specific vendors. It is compatible with widely used spreadsheet
and statistical software. Additionally, SAS transport files can be readily transferred to common
database applications.

There are two SAS transport file formats: The open source version 5 XPORT and proprietary
version 6 CPORT.  In keeping with federal guidelines, OPP is specifying use of version 5
XPORT. Technical specifications for the XPORT Transport format may be found on the SAS
Institute web site under Technical Document TS-140.

The following data definition tables, developed jointly by OPP and Bayer Corp., should be used
when submitting supplemental toxicity data.  If changes are made to the data definition, an
updated data definition table should be supplied in PDF format and include variable name, a
description of the variable, type of variable, and codes used. A single transport file should be
supplied for each dataset.

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Standard Format for Electronic Submission of Supplemental Data Files
in Support of Prenatal Developmental Toxicity Data.
July 31, 2002
                               Table of Contents
• • • • Dataiet ;;•:•:•;••;••;••
MORTAL
SIGNS
WEIGHTS
FOOD
MACRO
UTCARCWT
MATED
PREGSTAT
RE PRO DAT
FETDAT
FETEXT
FETVISC
FETSKEL
FETSKJ
PLANCENTA
Other
	 Description of Qataset 	 -%
Mortality information.
Clinical signs.
Body weights.
Food consumption.
Gross pathology findings (Macroscopic examination of
tissues).
Uterine weight, carcass weight, adjusted body weight gain.
Animals mated.
Pregnancy status.
Reproduction data:
No. Corpora Lutea,
No. Implantations,
No. Live fetuses,
No. Dead fetuses,
No. Resorptions - Early, Late.
Individual fetal data.
Individual fetal findings - External.
Individual fetal findings - Visceral.
Individual fetal findings - Skeletal.
Individual fetal findings - Skeletal incompletely evaluated
litters.
Placental findings.
Other datasets as needed.

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Standard Format for Electronic Submission of Supplemental Data Files in Support of Prenatal Developmental Toxicity Data.



                          Mortality Data for Each Animal (MORTAL.V5X)
July 31, 2002
Variable
STUDYNUM
SPECIES
ANIMLNUM
SEX
DOSEGP
DOSETEXT
DOSEVAL
DTHSACST
DTHDESC
WEIGHT
UNIT
EXCLUDE
EXCCODE
EXCDESC
Label
Study number
Animal Species
Animal number
Sex
Dose Group
Dose Group Representation
Numeric Dose Value
Death or Sac Status
Description of Death or Sac Status
Terminal body weight
Unit of measurement
Is This Record Excluded from Summaries?
Exclusion Code
Exclusion Description or Reason
Type
Char
Char
Char
Char
Num
Char
Num
Num
Char
Num
Char
Char
Char
Char
Codes and Comments

M = mouse,
R = rat,
D = dog

F = female
Use 0, 1, 2, 3, 4, etc. in ascending order from control.
PPM, MG/KG etc. plus dose level (e. g. 50 MG/KG)
In 50 MG/KG example above, DOSEVAL would equal 50.

Use to define DTHSACST codes


'YES' if record should be excluded.
Blank (" ") if record should NOT be excluded.
(if codes are used)
Text Description

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Standard Format for Electronic Submission of Supplemental Data Files in Support of Prenatal Developmental Toxicity Data.



                            Clinical Signs for Each Animal (SIGNS.V5X)
July 31, 2002
Variable
STUDYNUM
SPECIES
ANIMLNUM
SEX
DOSEGP
DOSETEXT
DOSEVAL
DAYS
SIGN
START
SEVERITY
EXCLUDE
EXCCODE
EXCDESC
Label
Study number
Animal Species
Animal number
Sex
Dose Group
Dose Group Representation
Numeric Dose Value
Day of Clinical Sign
Clinical Sign
Days on Drug Sign First Seen
Severity
Is This Record Excluded from Summaries?
Exclusion Code
Exclusion Description or Reason
Type
Char
Char
Char
Char
Num
Char
Num
Num
Char
Num
Char
Char
Char
Char
Codes and Comments

M = mouse,
R = rat,
D = dog

F = female
Use 0, 1, 2, 3, 4, etc. in ascending order from control.
PPM, MG/KG etc. plus dose level (e. g. 50 MG/KG)
In 50 MG/KG example above, DOSEVAL would equal 50.




'YES' if record should be excluded.
Blank (" ") if record should NOT be excluded.
(if codes are used)
Not Observed, etc.

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Standard Format for Electronic Submission of Supplemental Data Files in Support of Prenatal Developmental Toxicity Data.



                         Body Weights for Each Animal (WEIGHTS.V5X)
July 31, 2002
Variable
STUDYNUM
SPECIES
ANIMLNUM
SEX
DOSEGP
DOSETEXT
DOSEVAL
DAYS
WEIGHT
UNIT
EXCLUDE
EXCCODE
EXCDESC
Label
Study number
Animal Species
Animal number
Sex
Dose Group
Dose Group Representation
Numeric Dose Value
Day of Measurement
Body weight
Unit of weight measurement
Is This Record Excluded from Summaries?
Exclusion Code
Exclusion Description or Reason
Type
Char
Char
Char
Char
Num
Char
Num
Num
Num
Char
Char
Char
Char
Codes and Comments

M = mouse,
R = rat,
D = dog

F = Female
Use 0, 1, 2, 3, 4, etc, in ascending order from control.
PPM, MG/KG etc. plus dose level (e. g. 50 MG/KG)
In 50 MG/KG example above, DOSEVAL would equal 50.


G = gram, KG = kilograms, etc.
'YES' if record should be excluded.
Blank (" ") if record should NOT be excluded.
(if codes are used)
Not Measured, etc.

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Standard Format for Electronic Submission of Supplemental Data Files in Support of Prenatal Developmental Toxicity Data.



                        Food Consumption for Each Animal (FOOD.V5X)
July 31, 2002
Variable
STUDYNUM
SPECIES
ANIMLNUM
SEX
DOSEGP
DOSETEXT
DOSEVAL
DAYS
FFED
FLEFT
PREVFED
DAYDIFF
UNIT
EXCLUDE
EXCCODE
EXCDESC
Label
Study number
Animal Species
Animal number
Sex
Dose group
Dose Group Representation
Numeric Dose Value
Day of measurement
Food Fed
Food Left
Previous Day's Food Fed
Number of Days From Previous Measurement
Unit of Measurement
Is This Record Excluded from Summaries?
Exclusion Code
Exclusion Description or Reason
Type
Char
Char
Char
Char
Num
Char
Num
Num
Num
Num
Num
Num
Char
Char
Char
Char
Codes and Comments

M = mouse,
R = rat,
D = dog

F = Female
Use 0, 1, 2, 3, 4, etc. in ascending order from control.
PPM, MG/KG etc. plus dose level (e. g. 50 MG/KG)
In 50 MG/KG example above, DOSEVAL would equal 50.





G = gram, KG = kilograms, etc.
'YES' if record should be excluded.
Blank (" ") if record should NOT be excluded.
S, NM, O, etc. (if codes are used)
Spiller, Not Measured, Outlier, etc.

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Standard Format for Electronic Submission of Supplemental Data Files in Support of Prenatal Developmental Toxicity Data.



                     Macroscopic Findings for Each Animal (MACRO.V5X)
July 31, 2002
Variable
STUDYNUM
SPECIES
ANIMLNUM
SEX
DOSEGP
DOSETEXT
DOSEVAL
OBS_DATE
ORGANNAM
MACRO
MODIFIER
GRADE
EXCLUDE
EXCCODE
EXCDESC
Label
Study number
Animal Species
Animal number
Sex
Dose Group
Dose Group Representation
Numeric Dose Value
Date of Observation
Name of organ
Macroscopic findings
Modifier
Grade or severity of abnormality
Is This Record Excluded from Summaries?
Exclusion Code
Exclusion Description or Reason
Type
Char
Char
Char
Char
Num
Char
Num
Char
Char
Char
Char
Char
Char
Char
Char
Codes and Comments

M = mouse,
R = rat,
D = dog.

F = female.
Use 0, 1, 2, 3, 4, etc. in ascending order from control.
PPM, MG/KG etc. plus dose level (e. g. 50 MG/KG).
In 50 MG/KG example above, DOSEVAL would equal 50.


Do not include comments associated with findings. Full details
for abnormal findings should be described in study report.


'YES' if record should be excluded.
Blank (" ") if record should NOT be excluded.
(if codes are used.)
Text Description.

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Standard Format for Electronic Submission of Supplemental Data Files in Support of Prenatal Developmental Toxicity Data.
July 31, 2002
     Uterine Weight, Carcass Weight, and Adjusted Body Weight Gain for Each Animal
                                      (UTCARCwtVSX)
Variable
STUDYNUM
SPECIES
ANIMLNUM
SEX
DOSEGP
DOSETEXT
DOSEVAL
UTERWT
CARCWT
WTCHG
ADJWTCHG
EXCLUDE
EXCCODE
EXCDESC
Label
Study number
Species
Animal number
Sex
Dose Group
Dose Group Representation
Numeric Dose Value
Uterus Weight
Carcass Weight
Weight Change Day 0 to 20
Adjusted Weight Change Day 0 to 20
Is This Record Excluded from Summaries?
Exclusion Code
Exclusion Description or Reason
Type
Char
Char
Char
Char
Num
Char
Num
Num
Num
Num
Num
Char
Char
Char
Codes and Comments

M = mouse,
R = rat,
D = dog.

F = Female.
Use 0,1,2, 3, 4, etc, in ascending order from control.
PPM, MG/KG etc. plus dose level (e. g. 50 MG/KG).
In 50 MG/KG example above, DOSEVAL would equal 50.




'YES' if record should be excluded.
Blank (" ") if record should NOT be excluded.
(if codes are used.)
Text Description.

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Standard Format for Electronic Submission of Supplemental Data Files in Support of Prenatal Developmental Toxicity Data.



                                     Animals  Mated (MATED.V5X)
July 31, 2002
Variable
STUDYNUM
SPECIES
ANIMLNUM
SEX
DOSEGP
DOSETEXT
DOSEVAL
DATEPREG
EXCLUDE
EXCCODE
EXCDESC
Label
Study number
Species
Animal number
Sex
Dose Group
Dose Group Representation
Numeric Dose Value
Date Pregnant
Is This Record Excluded from Summaries?
Exclusion Code
Exclusion Description or Reason
Type
Char
Char
Char
Char
Num
Char
Num
Num
Char
Char
Char
Codes and Comments

M = mouse,
R = rat,
D = dog..

F = female.
Use 0,1,2, 3, 4, etc, in ascending order from control.
PPM, MG/KG etc. plus dose level (e. g. 50 MG/KG).
In 50 MG/KG example above, DOSEVAL would equal 50.

'YES' if record should be excluded.
Blank (" ") if record should NOT be excluded.
(if codes are used.)
Text Description.
                                                     10

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Standard Format for Electronic Submission of Supplemental Data Files in Support of Prenatal Developmental Toxicity Data.



                                Pregnancy Status (PREGSTAT.V5X)
July 31, 2002
Variable
STUDYNUM
SPECIES
ANIMLNUM
SEX
DOSEGP

DOSETEXT
DOSEVAL
DATEPREG
SCHEDSAC
ACTDEATH
DELTYPE
PREGSTAT
DELDATE
EXCLUDE
EXCCODE
EXCDESC
Label
Study number
Species
Animal number
Sex
Dose Group

Dose Group Representation
Numeric Dose Value
Date Pregnant
Scheduled Sac Date
Actual Death Date
Delivery Type
Pregnancy Status
Date of Delivery
Is This Record Excluded from Summaries?
Exclusion Code
Exclusion Description or Reason
Type
Char
Char
Char
Char
Num

Char
Num
Num
Num
Num
Char
Char
Char
Char
Char
Char
Codes and Comments

M = mouse,
R = rat,
D = dog.

F = female.
Use 0, 1, 2, 3, 4, etc, in ascending order from control.

PPM, MG/KG etc. plus dose level (e. g. 50 MG/KG).
In 50 MG/KG example above, DOSEVAL would equal 50.






'YES' if record should be excluded.
Blank (" ") if record should NOT be excluded.
(if codes are used.)
Text Description.
                                                    11

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Standard Format for Electronic Submission of Supplemental Data Files in Support of Prenatal Developmental Toxicity Data.
July 31, 2002
                               Reproduction Data (REPRODAT.V5X)
Variable
STUDYNUM
SPECIES
ANIMLNUM
SEX
DOSEGP

DOSETEXT
DOSEVAL
CORLUTEA
IMPLANTS
FETUS_L
FETUS_D
RESORP_E
RESORP_L
MALES
FEMALES
EXCLUDE
EXCCODE
EXCDESC
Label
Study number
Species
Animal number
Sex
Dose Group

Dose Group Representation
Numeric Dose Value
Number of Corpora Lutea
Number of Implantations
Number of Live Fetuses
Number of Dead Fetuses
Number of Resorptions - Early
Number of Resorptions - Late
Number of Males
Number of Females
Is This Record Excluded from Summaries?
Exclusion Code
Exclusion Description or Reason
Type
Char
Char
Char
Char
Num

Char
Num
Num
Num
Num
Num
Num
Num
Num
Num
Char
Char
Char
Codes and Comments

M = mouse,
R = rat,
D = dog.

F = female.
Use 0, 1, 2, 3, 4, etc, in ascending order from control.

PPM, MG/KG etc. plus dose level (e. g. 50 MG/KG).
In 50 MG/KG example above, DOSEVAL would equal 50.








'YES' if record should be excluded.
Blank (" ") if record should NOT be excluded.
(if codes are used.)
Text Description.
                                                   12

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Standard Format for Electronic Submission of Supplemental Data Files in Support of Prenatal Developmental Toxicity Data.



                                  Individual Fetal  Data (FETDAT.V5X)
July 31, 2002
Variable
STUDYNUM
SPECIES
ANIMLNUM
DOSEGP

DOSETEXT
DOSEVAL
IMPNUM
LOCATION
FETNUM
FETSEX
RESORP_E
RESORP_L
DEAD
FETWT
PLACWT
FIXATION
EXCLUDE
EXCCODE
EXCDESC
Label
Study number
Species
Dam (Litter) number
Dose Group

Dose Group Representation
Numeric Dose Value
Implant Number
Implant Location
Fetus number
Fetus sex
Early Resorption?
Late Resorption?
Dead Fetus?
Fetal Weight
Placental Weight
Fixation Type
Is This Record Excluded from Summaries?
Exclusion Code
Exclusion Description or Reason
Type
Char
Char
Char
Num

Char
Num
Num
Char
Num
Char
Num
Num
Num
Num
Num
Char
Char
Char
Char
Codes and Comments

M = mouse,
R = rat,
D = dog.

Use 0, 1, 2, 3, 4, etc, in ascending order from control.

PPM, MG/KG etc. plus dose level (e. g. 50 MG/KG).
In 50 MG/KG example above, DOSEVAL would equal 50.

Right or Left.

M = male,
F = female.
0=No, 1=Yes.
0=No, 1=Yes.
0=No, 1=Yes.
Unit = grams.
Unit = grams.
S = Skeletal, V = Visceral.
'YES' if record should be excluded.
Blank (" ") if record should NOT be excluded.
(if codes are used.)
Text Description.
                                                      13

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Standard Format for Electronic Submission of Supplemental Data Files in Support of Prenatal Developmental Toxicity Data.



                         Individual Fetal Findings - External (FETEXT.V5X)
July 31, 2002
Variable
STUDYNUM
SPECIES
ANIMLNUM
FETNUM
FETSEX
DOSEGP

DOSETEXT
DOSEVAL
OBSDATE
DAYS
ORGAN
OBS
MODIFIER
EXCLUDE
EXCCODE
EXCDESC
Label
Study number
Species
Dam (Litter) number
Fetus number
Fetus sex
Dose Group

Dose Group Representation
Numeric Dose Value
Observation Date
Nominal Day of Observation
Organ Name
Observation
Modifier
Is This Record Excluded from Summaries?
Exclusion Code
Exclusion Description or Reason
Type
Char
Char
Char
Num
Char
Num

Char
Num
Num
Num
Char
Char
Char
Char
Char
Char
Codes and Comments

M = mouse,
R = rat,
D = dog.


M = male,
F = female.
Use 0, 1, 2, 3, 4, etc, in ascending order from control.

PPM, MG/KG etc. plus dose level (e. g. 50 MG/KG).
In 50 MG/KG example above, DOSEVAL would equal 50.





'YES' if record should be excluded.
Blank (" ") if record should NOT be excluded.
(if codes are used.)
Text Description.
                                                    14

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Standard Format for Electronic Submission of Supplemental Data Files in Support of Prenatal Developmental Toxicity Data.



                        Individual Fetal Findings -Visceral (FETVISC.V5X)
July 31, 2002
Variable
STUDYNUM
SPECIES
ANIMLNUM
FETNUM
DOSEGP

DOSETEXT
DOSEVAL
OBSDATE
DAYS
ORGAN
OBS
MODIFIER
EXCLUDE
EXCCODE
EXCDESC
Label
Study number
Species
Dam (Litter) number
Fetus number
Dose Group

Dose Group Representation
Numeric Dose Value
Observation Date
Nominal Day of Observation
Organ Name
Observation
Modifier
Is This Record Excluded from Summaries?
Exclusion Code
Exclusion Description or Reason
Type
Char
Char
Char
Num
Num

Char
Num
Num
Num
Char
Char
Char
Char
Char
Char
Codes and Comments

M = mouse,
R = rat,
D = dog.


Use 0, 1, 2, 3, 4, etc, in ascending order from control.

PPM, MG/KG etc. plus dose level (e. g. 50 MG/KG).
In 50 MG/KG example above, DOSEVAL would equal 50.





'YES' if record should be excluded.
Blank (" ") if record should NOT be excluded.
(if codes are used.)
Text Description.
                                                    15

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Standard Format for Electronic Submission of Supplemental Data Files in Support of Prenatal Developmental Toxicity Data.



                        Individual Fetal Findings - Skeletal (FETSKEL.V5X)
July 31, 2002
Variable
STUDYNUM
SPECIES
ANIMLNUM
FETNUM
DOSEGP

DOSETEXT
DOSEVAL
OBSDATE
DAYS
SKELSYS
OBS
LOC1
LOC2
EXCLUDE
EXCCODE
EXCDESC
Label
Study number
Species
Dam (Litter) number
Fetus number
Dose Group

Dose Group Representation
Numeric Dose Value
Observation Date
Nominal Day of Observation
Skeletal System
Observation
1st Location
2nd Location
Is This Record Excluded from Summaries?
Exclusion Code
Exclusion Description or Reason
Type
Char
Char
Char
Num
Num

Char
Num
Num
Num
Char
Char
Char
Char
Char
Char
Char
Codes and Comments

M = mouse,
R = rat,
D = dog.


Use 0, 1, 2, 3, 4, etc, in ascending order from control.

PPM, MG/KG etc. plus dose level (e. g. 50 MG/KG).
In 50 MG/KG example above, DOSEVAL would equal 50.






'YES' if record should be excluded.
Blank (" ") if record should NOT be excluded.
(if codes are used.)
Text Description.
                                                    16

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Standard Format for Electronic Submission of Supplemental Data Files in Support of Prenatal Developmental Toxicity Data.



                                Placental  Findings (PLACENTA.V5X)
July 31, 2002
Variable
STUDYNUM
SPECIES
ANIMLNUM
FETNUM
DOSEGP

DOSETEXT
DOSEVAL
OBSDATE
DAYS
OBS
MODIFIER
EXCLUDE
EXCCODE
EXCDESC
Label
Study number
Species
Dam (Litter) number
Fetus number
Dose Group

Dose Group Representation
Numeric Dose Value
Observation Date
Nominal Day of Observation
Observation
Modifier
Is This Record Excluded from Summaries?
Exclusion Code
Exclusion Description or Reason
Type
Char
Char
Char
Num
Num

Char
Num
Num
Num
Char
Char
Char
Char
Char
Codes and Comments

M = mouse,
R = rat,
D = dog.


Use 0, 1, 2, 3, 4, etc, in ascending order from control.

PPM, MG/KG etc. plus dose level (e. g. 50 MG/KG).
In 50 MG/KG example above, DOSEVAL would equal 50.




'YES' if record should be excluded.
Blank (" ") if record should NOT be excluded.
(if codes are used.)
Text Description.
                                                    17

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