The
EDMVS'

Draft
Work
Plan
Presentation
to
the
EDMVS,

June
5,
2002
Purpose
of
Today's
WorkPlan
°
Show
progress
of
EDSP
°
Provide
the
status
of
each
assay
°
Project
what's
next
Tier
I
Screening
Battery
recommended
for
consideration
by
EDSTAC
°
Steroidogenesis
°
Pubertal
­
female
°
Fish
Screen
aka
short
term
fish
reproduction
°
Amphibian
Metamorphosis
°
Estrogen
/
Androgen
receptor
binding
°
Hershberger
°
Uterotrophic
Alternative
Assays
recommended
for
consideration
by
EDSTAC
Tier
I
°
Aromatase
°
Pubertal
male
°
Adult
14
 
day
intact
male
Tier
?

°
In
Utero
through
Lactation
Tier
II
Assays
recommended
for
consideration
by
EDSTAC
°
Mammalian
2­
generation
°
Avian
2­
gen.
Reproduction
°
Amphibian
Development
and
Repro.

°
Invertebrate
(
Mysid)
Lifecycle
°
Fish
Lifecycle
Steroidogenesis
(
Tier
I)

Milestone
Current
Status
°
DRP/
Protocol
 
June
02
°
Prevalidation
­
sectional
testes
optimization
Today,
Aug
03
­
cell
based
(
H295R)
In
ORD
Lab
°
Validation
­
multi­
chemical
to
lab
Aug
03
­
inter­
lab
to
lab
Aug
03
 
June
03
=
complete,
date
presented
to
EDMVS
Pubertals
 
m&
f
(
Tier
I)

Milestone
°
DRP
equivalent
°
Prevalidation
­
Single
Dose
Study
­
Multi­
chemical
&
multi­
dose
Protocols
­
Multi­
chemical
&
multi­
dose
Studies
data
to
EDMVS
Aug
03
­
Restricted
Feeding
Study
°
Validation
(
inter­
lab)
Current
Status
 
Dec
01
 
Dec
01
 
Dec
01
In
lab
 
July
02
To
lab
Aug
03
Fish
Screen
(
Tier
I)

Milestones
Current
Status
°
DRP/
Protocol
 
Mar
02
°
Prevalidation
­
ShortTerm
Fish
Repro.
in
FHM
 
Mar
02
­
Short
term
fish
repro.
In
FHM
w/
multi­
chemicals
In
lab

­
Comparative
Study
Plans:
 
Mar
02
­
Comparative
Studies:
To
EDMVS
Aug
03
Vitellogenin
Methods
(
FHM,

Medaka,
Zebrafish)
In
lab

Fathead
Minnow
Assays
In
lab

°
Validation
(
inter­
lab)
depends
on
OECD
Amphibian
Metamorphosis
(
Tier
I)

formerly
Frog
Thyroid
Milestone
Current
Status
°
DRP/
Protocol
 
July
02
°
Pre­
validation
­
prometamorphosis
protocol
demonstration
proj.
Dec
03
­
optimization
studies
TBD
°
Validation
(
inter­
lab)
in
2005
\
ER
/
AR
binding
(
Tier
I)

ICCVAM
°
Scientific
Expert
Panel's
May
2002
retrospective
validation
°
Expert
Panel
Final
Report
Sept
2002
°
EDMVS
Updated
by
ICCVAM
July
02
°
EDSP:
AR
in
lab
(
preval)
Aug
02
 
Sept
03
°
EDSP:
ER
in
lab
(
validation)
May
02
 
May
04
Aromatase
(
Tier
I)

Milestones
Current
Status
°
DRP
/
Protocol
 
Mar
02
°
Prevalidation
­
placental
microsomal
assay
Today
&
Aug
03
compare
bovine,
human,
porcine
­
cell
based
assay
Today
&
Aug
03
­
comparison:
microsomal
&

recombinant
&
multi
chem
Today
&
Aug
03
°
Validation
(
inter­
lab)
to
lab
Sept
03
In
Utero

Lactation
(
Tier
?)

Milestone
Current
Status
°
DRP
 
Dec
02
­
Protocol
review
 
Mar
02
°
Prevalidation
­
Protocol
Demo
report
due
8/
03
­
Multi­
chem
study
TBD
°
Validation
(
inter­
lab)
TBD
Tier
II
Assays
Mammalian
2­
generation
(
Tier
II)

Milestone
Current
Status
°
DRP/
Protocol
­­

°
Prevalidation
One­
gen.
Ext.
Protocol
 
Dec
02
Propylthiouracil
Study
 
July
02
One­
gen
Ext.
study
Tomorrow
°
Validation
(
inter­
lab)
TBD
Avian
2­
gen.
Reproduction
(
Tier
II)

Milestone
Current
Status
°
DRP/
Protocol
 
Fall
03
°
Prevalidation
­
Avian
Dosing
Study
Plan
 
Mar
02
­
Avian
Dose
Study
in
lab
­
Protocol
demo
future
°
Validation
(
inter­
lab)
future
Amphibian
Dev.
&
Repro.
(
Tier
II)

Milestones
Current
Status
°
DRP/
Protocol
proj.
Dec
04
°
Prevalidation
­
protocol
demo
future
­
multi­
chem
study
future
°
Validation
(
inter­
lab)
future
Mysid
Lifecycle
(
Tier
II)

aka
Invertebrate
Chronic
Milestones
Current
Status
°
DRP/
Protocol
 
July
02
°
Prevalidation
­
protocol
demo
Proj.
Dec
03
­
multi­
chem
study
future
°
Validation
(
inter­
lab)
future
Fish
Lifecycle
(
Tier
II)

aka
Fish
Chronic
Milestones
Current
Status
°
DRP/
Protocol
 
Dec
02
°
Prevalidation
­
protocol
demo
future
­
multi­
chem
study
future
°
Validation
(
inter­
lab)
future
August
19­
21,
2003
°
Fish
Screen
­
Comparative
FHM
assays
­
comparative
vitellogenin
Medaka,

Zebrafish,
FHM
°
Aromatase
°
Steroidogenesis
°
Pubertals
male
and
female
°
Strain
/
Species
Discussion
Oct
2003
°
Avian
DRP
°
In
Utero
through
lactation
protocol
demonstration
results
Spring
2004
°
Amphibian
Dev.
&
Repro.
DRP
(
Tier
II)

°
Avian
Dosing
Study
°
Amphibian
Screen
transferable
protocol
°
Fish
Screen
multi­
chemical
results
°
Fish
Screen
Phase
1B
(
OECD)
