-------
f
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
-------
These tables also indicate the pesticides for which
new data have been required as a result of EPA regulatory
actions. These include risk/benefit reviews undertaken
because of specific evidence of a hazard (known as
Rebuttable Presumption Against Registration, listed as
"RPAR" in tables) or EPA's regular program for reregister-
ing all previously registered pesticides (in tables,
"Registration Standard" and "Data Call-In"). The reregis-
tration program is hot specifically connected to the IBT
case, but serves the purpose of bringing the data on older
chemicals, including some tested by IBT, up to current
scientific standards. Under the authority of section
3(c)(2)(B) of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) the Agency can require additional
data to maintain a registration, and may suspend a product's
registration if the registrant does not agree to provide
the data or if it is not provided pursuant to an agreement
with the Agency.
Attached is also a list (Exhibit B) of major health
effects studies on pesticides conducted by IBT identifying
which have been found valid or invalid, and which have
been or are in the process of being replaced. This list
covers 801 studies on 140 pesticides. An earlier draft
list of IBT tests prepared by EPA in May 1983 identified
1205 tests on 212 pesticides. The current list has
eliminated duplicative entries, preliminary range finding
and similar tests which were not true health effects
studies, and short-term, acute toxicity tests which
generally do not create a significant data gap and which
will be replaced if needed, through the existing r.eregis-
tration program described above. Thus, the current list
of 801 studies covers health effects considered significant.
to regulatory decisions, such as induction of benign or
malignant tumors (oncogenicity), birth defects (teratogeni-
city), genetic mutations, other adverse reproductive effects,
and neurotoxicity. Of the 801 IBT studies in the pivotal
categories, 594 (74%) have been found invalid. To date,
of the invalid studies, 212 (36%) studies have been replaced
or are in progress, 38 (7%) are under discussion for possible
replacement, and 45 (7%) are of a type no longer required
for registration.
One way to assess the impact of IBT is to consider
the effect of invalid studies on the data base supporting
pesticides used in high volume. Although hundreds of
pesticides are registered, only 25 insecticides account for
85% of the actual pounds of .insecticides used, 32 herbicides
account for 82%, and only 8 fungicides account for 71%
of the volume of those products used. Of these 65 most
heavily used pesticides, only 18 have IBT data in 6ne or
-------
more important categories. Of those 18, all but one also
have non-IBT data available in some or all of the same
cagetories. The exception, prometdn, a herbicide not used
on food crops, has one partially valid IBT study and many
non-IBT acute and subacute studies. Sixteen of these high
volume chemicals are the subject of one of the regulatory
procedures described above requiring additional data.
Thus, the data bases for the high volume chemicals to
which people are most likely to be exposed are for the
most part unaffected by the IBT situation, and where there
is an impact, EPA has taken active regulatory steps to
obtain replacement data.
. \
The principal remaining task of the IBT program
is to clarify the status of the invalid studies for which
registrants have indicated they do not intend to provide
replacements, or have not communicated an intention one way
or the other to EPA. Although around 300.studies are in
this category, a significant number (140) of negative and
non-responses Involve discontinued or cancelled products,
or pesticides of such low volume use that registrants may
choose not to invest in further testing needed to maintain
registrations. The replacement status column of Exhibit B
indicates that there are 159 invalid studies (26% of invalid
IBT tests) for which there is negative or no response.
However, as previously noted, most of these chemicals have
non-IBT data available. Exhibit A shows that only five
chemicals still registered and actually used have entirely
IBT data bases. The 17 studies involved with those 5
chemicals constitute 3% of invalid IBT studies. A registra-
tion standard will result in replacement of 6 of these
studies. This leaves only 11 studies or 2% of-the invalid
IBT tests which constitute the sole support of registered .
pesticides, and for'which no regulatory action to generate
replacement data has yet been initiated. Several of these
11 are valid or have at least supplementary value.
This report is being furnished to the registrants
of the affected chemicals for which negative or no responses
have been received concerning replacement of invalid IBT
studies. We are also sending the registrants 3(c)(2)(B)
notifications which require a registrant to make a specific
commitment within 90 days or the registration m.ay be
suspended. In some cases, EPA and a registrant may agree
that a specific study does not need to be replaced.
The IBT case caused serious concern and uncertainty.
about the potential hazards of the hundreds of pesticides
involved, both for EPA and the public. Although it was
advocated by some that all 212 pesticides tested in whole
or in part by IBT be removed from the market pendihg
retesting, that option is not.availab!e under current law.
-------
The regulatory response authorized by FIFRA requires
valid evidence of risk, as opposed to a lack of information,
before removing a product from the market, and allows for
the replacement of inadequate data. As we reach the final
resolution of the IBT problem, it appears that this approach
was appropriate and adequate to deal with this event.
The IBT scandal shook the industry and government
regulators. Obviously, steps had to be taken, not just
to deal with the IBT situation itself, but to ensure that
data providing the foundation of regulatory decisions in
the future are adequately prepared and scrutinized. Thus,
another result of the IBT case was the establishment in
1977 of a joint EPA-FDA audit program to help ensure that
another IBT situation has not occurred and will not in
the future. The lab audit program includes visits to
laboratories to inspect their procedures, facilities and
staff qualifications, and about sixty audits per year of
labs and/or individual pesticide studies to see if the
reported results are supported by the "raw" laboratory
records and data. In the past six years, we have found
the large majority of laboratories to be in compliance
with current standards, and producing scientifically valid
studies. An important effect of the IBT case has been to
make the testing community, the industries which use their
services, and government regulators keenly aware of the
need to maintain high standards of quality control over
health effects testing.
-------
EPA ASSESSMENT OF THE 801 MAJOR IBT TESTS
VALID,
SUPPLEMENTAL
PENDING REVIEW
INVALID
TEST REPLACED
OR IN PROGRESS
NEGATIVE
RESPONSE
NEGATIVE RESPONSE:
BUT REGISTRATION
CANCELLED. PRODUCT
DISCONTINUED. NO
PRODUCT REGISTERED
IN U.S.. OR NO CURRENT
PRODUCTION
REPLACEMENT UNDER DISCUSSION
TYPE OF TEST NO LONGER REQUIRED
NO RESPONSE
NO RESPONSE:
BUT REGISTRATION
CANCELLED, PRODUCT
DISCONTINUED. NO
PRODUCT REGISTERED
IN U.S.. OR NO CURRENT
PRODUCTION
STUDIES WITH NO AND
NEGATIVE RESPONSES
REQUIRING REGULATORY
ACTION
INVALID IBT STUDIES
PROVIDING SOLE
SUPPORT FOR
REGISTRATION
INVALID IBT STUDIES
ON PESTICIDES WHICH
ALSO HAVE NON-IBT
STUDIES .
-------
EPA ASSESSMENT OF EFFECT OF IBT DATA
ON 65 LARGEST USE PESTICIDES*
PESTICIDES
WITH NO IBT DATA
PESTICIDES WITH
SOME IBT DATA
IBT PESTICIDES
THAT WERE THE
SUBJECT OF RPAR.
DATA CALL IN, OR
REGISTRATION STD.
TWO PESTICIDES WITH
SOME IBT DATA BUT
WITH NO PREVIOUS
REGULATORY ACTION
*25 INSECTICIDES ACCOUNTING FOR 85% OF POUNDAGE USED.
32 HERBICIDES ACCOUNTING FOR 82% OF POUNDAGE USED,
AND 8 FUNGICIDES ACCOUNTING FOR 71% OF POUNDAGE USED,
IN 1980.
-------
SUMMARY STATISTICS: IBT
TOTALS
38 COMPANIES
140 -.CHEMICALS
801 STUDIES
STUDY VALIDATION STATUS
131 16%VAUD
44 6% SUPPLEMENTAL
32 4% PENDING
594 74% INVALID
801 100%
INVALID STUDY REPLACEMENT STATUS
212 36% STUDY REPLACED OR IN PROGRESS
38 6% REPLACEMENT UNDER DISCUSSION
45 8% STUDY NO LONGER REQUIRED
116 20% NEGATIVE RESPONSE BUT PRODUCTS ARE CANCELLED,
DISCONTINUED, NOT REGISTERED IN THE U.S., OR HAVE
NO PRODUCTION.
24 4% NO RESPONSE BUT PRODUCTS ARE CANCELLED, DISCONTINUED
NOT REGISTERED IN THE U.S., OR HAVE NO PRODUCTION,
86 14% NEGATIVE RESPONSE AND INVALID
73r 12% NO RESPONSE AND INVALID
594 100%
IBT STUDIES PROVIDING SOLE SUPPORT FOR REGISTRATION
17 3% IBT STUDIES PROVIDE SOLE SUPPORT FOR REGISTRATION
-6 1% CHRONIC STUDIES GENERATED BY REGISTRATION STANDARD
11 2%
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OP
PESTICIDES AND TOXIC SUBSTANCES
ADDITIONAL BACKGROUND ON THE IBT REVIEW PROGRAM
In 1976, during a routine lab inspection of one of IBT's
facilities, FDA discoverd deficiencies in the manner in which
studies were being conducted and discrepancies between those
studies and their raw data. In 1977, EPA placed a moratorium
on registration actions involving data developed at IBT as a
result of this information. In the same year, EPA notified
registrants that they were required to audit the raw data
and validate both those IBT studies which were pivotal to the
data base of pesticides already registered and all those
which were supporting new registration actions.
In 1978 a joint EPA/FDA audit of IBT's two other
facilities uncovered problems similar to those discovered
during the initial audit. In March of that year EPA required
registrants to submit to EPA the raw data for the IBT studies
so that a review of registrant audits could be conducted.
EPA referred this case to the Department of Justice for
investigation in April 1978. At approximately the same time,
the U.S. and Canada' were negotiating an agreement to share
the task of spot checking registrants' audits of IBT studies.
Through these checks, however, it became apparent that
registrants' audits routinely overlooked some areas of concern.
As a result, Canada and the U.S. agreed to review each audit
and study.
Mutual agreement was reached as to which studies would
be reviewed by each country. It was also decided that each
country would accept the other's determination as to validity.
However, due to differences in data requirements, each country
would independently evaluate whether studies met their
regulatory requirements, and determine the need for replacement
studies.
-------
After two years experience of the review program
a decision was made to reconsider past policies regarding
IBT data. A policy statement reflecting decisions made as a
result of this analysis was sent to registrants in July 1980.
The decisions were: 1) that the moratorium on registration
actions was lifted unless a valid IBT study was essential to
the approval of a specific action, 2) that registrants would
be required to fill data gaps resulting from invalid IBT
studies, 3) minor data gaps would be considered through
normal registration channels, 4) if the entire data base was
invalid, EPA would consider cancellation action, and 5) if
previously unreported adverse effects were discovered, the
study would have to be replaced, and in addition the Agency
would consider initiating either an intensive risk/benefit
review, or formal hearings on a chemical's registration
status.
The IBT Review Program consisted of validation review,
evaluation review, and data gap review. Validation review
was designed to determine whether the information in the
final report was supported by the raw data. Evaluation of
whether a study met Agency guidelines for studies used to
support registration, was performed on studies determined
to be valid or at least reliable enough to supplement other
valid data. Data gap review was a search through a chemical's
entire data base to determine which invalid studies needed
to be replaced.
Because our experience with data gap review proved it
to be extremely time consuming, options for completing the
IBT program more expeditiously were considered. As a result,
several policy changes were adopted and conveyed to registrants
in a letter in April 1982 which stated: 1) that acute IBT .
studies would^no longer be reviewed through the IBT program.
Instead, they'would be reviewed through normal registration
channels; 2) that studies which were considered invalid
because the registrant initially chose not to audit them,
would not be reviewed by the Agency and our presumption would
be that they had to be replaced; 3) that EPA would no longer
perform a data gap review of a chemical's data base to
determine if other studies existed to replace the IBT studies,
instead we would assume that replacement was necessary unless
the registrant could convince us otherwise; and 4) that EPA
would not review an IBT study if the registrant identified a
replacement and agreed to have the IBT study considered
i nvalid. .
The review stage of the IBT program is essentially
complete. The remainder of the program consists of obtaining
replacement studies and tracking commitments to repl.ace
studi es.
-------
EXHIBIT A
THE DATA BASE FOR INDUSTRIAL BIO-TEST CHEMICALS
-------
Exhibit A quantitatively presents the data base of the
chemical compounds for which studies were conducted by
Industrial Bio-Test Laboratories. The 1ST studies are
designated by the letter 0. Studies in the EPA data base
done by labs other than IBT are designated by the letter
X.
The studies are arrayed across six categories of chronic
effects. These chronic effects are: oncogenicity, terato-
genicity, mutagenicity, reproductive effects, neurotoxicity,
and other chronic effects.
Some of the chemicals in this exhibit appear to have no
IBT studies because the studies conducted for these chemicals
by IBT were all in the acute categories. The chemical names
used are those that were listed in the IBT records. There
is no designation of the validity or invalidity of the IBT
studies presented. Specific information of thiss nature is
in Exhibit B.
Exhibit A also notes any ongoing regulatory activity
that will generate chronic data ror these chemicals.
The types of regulatory activity that cause the generation
of data are: the registration standard program, the data
call in program, the rebuttable presumption against
registration program, and any special action employing
the 3c2b provision of the Federal Insecticide, Fungicide,
Rodenticide Act. There are approximately 2830 chronic
studies indicated in this data base.
-------
CHEMICAL COMPOUNDS TESTED BY INDUSTRIAL BIO-TEST LABORATORIES;
A QUANTITATIVE PRESENTATION OP STUbiES SUBMITTED TO EfrA BY IBT AND OTHER LABORATORIES.
CHEMICALS
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REGULATORY ACTIVITY TO
GENERATE CHRONIC DATA
Accel
Alanap
Alar
Ametryn
. As u lam
Atrazine
Avadex
Avenge
Azodrin
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Bacillus. thurin
X
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Registration Standard
Data Call In
Data Call In
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Registration Standard
Data Call In '
Data Call In
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0 - IBT
-------
CHEMICAL COMPOUNDS TESTED BY INDUSTRIAL BIO-TEST LABORATORIES:
A OUAHT1TAT1VH PRiJSbNTATlOH OP STUDIES SUBMITTED TO EPA BY IBT AND OTHER LABORATORIES.
CHEMICALS
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REGULATORY ACTIVITY TO
GENERATE CHRONIC DATA
Barban .
Bardike
Baygon
Bifenox
Binapacryl
Bladex
Bolero
(thiobencarb)
Brodifacoum
(Talon)
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- TRT
-------
CHEMICAL COMPOUNDS TESTED BY INDUSTRIAL BIO-TEST LABORATORIES;
A QUANTITATIVE PRESENTATION OT STUDIES SUBMITTED TO EPA BY IBT AND OTHER LABORATORIES.
CHEMICALS
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REGULATORY ACTIVITY TO
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CGA- 12223
Chipco-RP260l9
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Chloropropham
Chlorothalionil
Chloropyrifos
; Chloropropylate
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**
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Data Call In
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RPAR Data Call In
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Discontinued Prndiirt'y
-------
CHEMICAL COMPOUNDS TESTED BY INDUSTRIAL BIO-TEST LABORATORIES;
niUANTITATIVH PRESENTATION OP STUDIES SUBMITTED TO EPA BY IBT AND OTHER LABORATORIES. .
CHEMICALS
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Ciodrin
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(Profenofos)
Cycle
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Cyprazine
Dasanit
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0 IBT
-------
CHEMICAL COMPOUNDS TESTED BY INDUSTRIAL BIO-TEST LABORATORIES:
A OUANTITATIVFTEES^TATION OT STUDIES SUBMITTED TO EPA BY IBT AND OTHER LABORATORIES. .
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Dicamba
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-------
CHEMICAL COMPOUNDS TESTED BY INDUSTRIAL BIO-TEST LABORATORIES;
A QUANTITATIVE PRESENTATION OF StUblES SUBMITTED TO EPA BY IHT AND OTHER LABORATORIES.
CHEMICALS
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Drepanon
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-------
CHEMICAL COMPOUNDS TESTED BY INDUSTRIAL BIO-TEST LABORATORIES;
A" QUANTITAT1VB~TRESENTAT10N OF STUDIED SUBMITTED TO EPA BYTffT AND OTHER LABORATORIES.
CHEMICALS
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Gossyplure
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-------
CHEMICAL COMPOUNDS TESTED BY INDUSTRIAL BIO-TEST LABORATORIES;
A QUANTITATIVE PRESENTATION OF STUDIES SUBMITTED TO EPA BY 1ST AND OTHER LABORATORIES.
CHEMICALS
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MCPA
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-------
CHEMICAL COMPOUNDS TESTED BY INDUSTRIAL BIO-TEST LABORATORIES:
A QUANTITATIVE PRESENTATION OF STUDIES SUBMITTED TO EPA BY FBT AND OTHER LABORATORIES.
CHEMICALS
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REGULATORY ACTIVITY TO
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Methazole
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Methoprene
Metolachlor
Mocap
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Monitor
(Methamidophos)
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00
XX
X
X
00
X
X
0
0
X
000
XX
XX
XX
X
X
0
0
XX
X
0
0
xxxxxxxx
0
xxxxxxxxx
0
X
0
XX
0
X
0
0
X
xxxxxxxxx
XX
XX
X=ll
0=7
XXXXXX
000
xxxxxxxx
0000
00000
XXXXXX .-
xxxx
XXX
0
0
00
XXX
00000
xxxx
Not registered in -U.S.A.
Data. Call In
Registration Standard
Registration Standard
Registration Standard
Registration Standard
1
»-. ' ;
Data Call In
0
IBT
-------
CHEMICAL COMPOUNDS TESTED BY INDUSTRIAL BIO-TEST LABORATORIES;
A QUANTITATIVE PRESENTATION OF STUDIES SUBMITTED TO EPA BY IBT AND OTHER LABORATORIES. .
CHEMICALS
u
»-«
55
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OH
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HI
X
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REGULATORY ACTIVITY TO
GENERATB CHRONIC DATA
Nemagon
Nemefene
Norea
«
Omadine
Omite-Comite
Orthene
(Acephate)
' Oxadiazon
, Paraquat
pqNB
Penncap E
(ethyl parathion
X
XXX
X
xxxx
o
X
X
XXX
XX
1
0
xxxxxxx
00000000
xxxx
0
XX
00 .
xxxx
xxxxx
xxxxxx
X
xxxx
X
00
X
X
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X-16
xxxxx
xxxx
XX '
00
0
X
X
xxxx
000
xxxxxxx
xxxx
XX
.
xxxxx
0
X=12
00000
X
0
X=37
0
XX
X
0
000
XX
000
XX
xxxx
000
XXX
xxxx
0
X=14
X
'
Data Call In
Discontinued Product i
Data Call In !
i
i
i
, i
.
Data Call In
i
Date Call In |
*.
»
I
0
-------
CHEMICAL COMPOUNDS TESTED BY INDUSTRIAL BIO-TEST LABORATORIES;
A QUANTITATIVE PRESENTATION OF StUbltiS SUBMITTED TO EPA BY IBT AND OTHER LABORATORIES,
CHEMICALS
u
w
o
o
u
§
fc
HI
u
HI
o
fc
HI
u
w
u
p
1-4
fc
QH
OU
IMP.
fc
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u
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REGULATORY ACTIVITY TO
GENERATE CHRONIC DATA
Penncap M.
(methyl parathio
Permethrine
Phorate
Phosalone
Phosphamidon
Picloram
Pik Off
Piperonyl
Butoxide
! Plictran
Polyram
O
x=:u
X
X
X
0
X .
X
XXX
xxxxxxx
X
xxxx
XX
0
0
xxxxx
0
XX
X
XX
X=23
XX
xx '
0
.
t
XXX
X-13
X
XXX
000
XXX
0
X
XXX
XX
0
X-22
X-21
X=16
0
X=12
XXXXXXX
000000
XXX
XXX
0
X»l2
.
X
0
X
000 .
0
X=9
X=9
X
hon .
'.
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< :
Data Call In
Registration Standard
. i
Data Call In '
Data Call In j
Mot Registered j
i
Data Call In i
i
i
Data Call In :
IBT
-------
CHEMICAL COMPOUNDS TESTED BY INDUSTRIAL BIO-TEST LABORATORIES;
A QUANTITATlVjrFRESTNTATlON OT StUblfiS SUBMITTED TO EPA BY IHT AND OTHER LABORATORIES,
CHEMICALS
u
w
o
o
u
JC
o
u
w
13
o
fc
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u
14
a
u
»-4
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o
00
ocw
IX U,
WM<
PJW
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w
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REGULATORY ACTIVITY TO
GENERATE CHRONIC DATA
PPG 124
Profluralin
Prometon
Prometryn
Propham
Prowl
i
Pyrethrin
Rabon
Ramijod
Randox
X
xxxxxx
xxxxx
X
XXX
0
0
0
X
XXX
X
00
XX
0
X
00
0
X
X
xxxx
XXX
xxxxx
X
0
X
0
X
XX
X
xxxxxx
xxxxxx
xxxxx
00
0
.
0
xxxxx
XXX
t
X
X
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0
X=10
0
xxxxxxx
000
P
t . >
. I
Data .Call In
i
Data Gall In . j
1 ' ' "' ' ^
/ ;
o . IBT
-------
CHEMICAL COMPOUNDS TESTED BY INDUSTRIAL BIO-TEST LABORATORIES;
A QUANTlTAnVB~PTtE5BNTAT10N OP StUDttiS SUBMITTED TO EPA BY IBT AND OTHER LABORATORIES.
CHEMICALS
as
ui
o
8
ac
o
u
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w
u
1
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u
M
as
o
£31/1
OH
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X
O
H
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tn
13
HU.
ow
REGULATORY ACTIVITY TO
GENERATE CHRONIC DATA
Resmethrin
Ronnel
Rydex
(Prodiamine)
Santophen
Sectrol
Sencor
Simazine
Sodium Azide
Sodium Bromide
Sodium Chlorate
XXXX
X
0
X
X
0
XX
0
xxxxxx
000
XX
0
0
X
00
xxxxxxx
XXX
000.
X
0
XXXX
0
0
X
xxxxxxx
0
XX
xxxxx
1
XXX
XXX
0'
0
X=9
XX
XXX
0
XXXX
X-25
X=9
X
xxxxx
XX
0000
X=20
0
XXX
xxxxxxx
0
XXX
X
p
.'
»
' k
Discontinued Product
Not Registered :
No Food Use
i
Data Call In
: i .
i
o
-------
CHEMICAL COMPOUNDS TESTED BY INDUSTRIAL BIO-TEST LABORATORIES:
A QUANTITATTVirTHESl-NTATlON OP StUblfiS SUBMITTED TO EPA BY IHT AND OTHER LABORATORIES.
CHEMICALS
u
M
35
w
u
o
u
35
o
fc
*-«
u
1-4
W
o
3
B
i:
»-i
u
M
.35
W
fc
M
U
£>(/!
OH
OU
a:
o
U to
«s
Bw
u«
Pu
ow
REGULATORY ACTIVITY TO
GENERATE CHRONIC DATA
Sumitol
Supracide
Tedion
Terbufos
Terbuthylazine
. Terbutryn
Terrazole
Thidiazuron
ThiOjdan
Thiofanox
X
0
X
X
X
0
XXX
0
X
0
0
XX
0
xxxxxx
0
XX
0
XX
X-14
X
XX
XX
'XXX -
XX
X
X
0
x l
XX
XXX
0
XXX
0
X
XX
0
0
XX
X=26
xxxxxx
xxxx
0
X=9
00
v
xxxxx
0
xxxxxxxx
xxxx
00
XXX
xxxxxxx
0
xxxxxx
00
XXX
o ^.:
9
Discontinued 'Product
Data Call In
Suspended
Data Call In
1
t
Cancelled '
Data Call In
Registration Standard '
1
}
Registration Standard i
V
n _
-------
CHEMICAL COMPOUNDS TESTED BY INDUSTRIAL BIO-TEST LABORATORIES:
A QUANT!TATIVU"lrRHSl!KTATiON OF STUDIES SUBMITTED TO EPA BY IBT AND OTHER LABORATORIES
CHEMICALS
u
-«
se
w
o
o
u
§
fc
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u
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W
u
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55
w
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ou
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wo.
fc
M
U
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g
u
1-4
2
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u)
as
HU«
ow
REGULATORY ACTIVITY TO
GENERATE CHRONIC DATA
Thiophanate
i
Torak
(dialifor)
; Toxaphene
Trial late
Triforine
Triphenyltin
Hydr.
Vapona
fDDVPl '
Velpar
Vendex
i
; Vinyzine
XX
X
X
X
X
X
XXX
000
X
0
XX
xxxxx
XX
XXX
XXX
X=10
X
xxxxxx
0
X
0
X=ll
X
XXX
1
xxxx
0000
xxxx
0
0
XX
xxxxxx
XX
xxxx
xxxx
XX
XX
xxxxxx
000000
XX
0
0
X=70
0
X
xxxxxxxx
000
xxxx
00
00
xxxx
X
xxxxxx
xxxxxx
X»9
p '
Registration Standard
RPAR
Data Call In
. i
i
. . .j
Data Call In 1
' I
Registration Standard i
i
-------
CHEMICAL COMPOUNDS TESTED BY INDUSTRIAL BIO-TEST LABORATORIES;
A qUANTITATIVirnresWTATlON UP StUbttiS SUBMITTED TO EPA BY IBT AND OTHER LABORATORIES
CHEMICALS
u
»-«
55
W
U
8
§
u
w
o
o
s
fc
HI
U
M
W
<
fc
M
U
U
1-4
s
OH
00
OiW
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OW
REGULATORY ACTIVITY TO
GENERATE CHRONIC DATA
Visco 1152
Visco 1153
Vitavax
\
Vorlex
Vydate
foxamyl)
4-Amino-
pyridine
2,4-D
i
X
XXX
X
XX
XX
XXX
XX
0
xxxxx
X-ll
X
X
XXX
xxxx
XX
xxxxx
.
1
0
xxxxxxxx
xxxxx
X
X
X
xxxxxx
00
X
0
XXX
xxxx
»
Registration Standard
Data Call In
.
!
\
0 . TUT
-------
EXHIBIT B
IBT TRACKING SYSTEM REPORT
-------
IBT TRACKING SYSTEM REPORT
CODE DEFINITIONS
VALIDATE: a review designed to' determine if the information
in the final report was supported by the raw data
from the study.
I - Invalid. The information in the final report was not supported
by the raw data from the study.
P - Pending.- The study is still under validation review. j
S - Supplemental. Portions of the study are valid and can be used
independently of the remainder of the study.
V - Valid. The information in the final report is supported by
the raw data from the study.
EVALUATE: a review designed to determine if a study meets Agency
guidelines for studies to be used in support of
pesticide registration.
C, CM - Core minimum. The study meets the regulatory data
requirements to support pesticide registration.
S, CS - Core supplemental, the study is useful to supplement other
studies.
I, CI - Core invalid. "The study does not meet the regulatory data
requirements to support registration. /
P - Pending. The study is still under evaluation review.
NA - Not applicable. The study was not given an evaluation status
if the validation process determined it to be invalid.
REPLACE: the column indicating the replacement status of the study.
Replaced - Study replaced or in progress
Discussion - Replacement study under discussion
Not Req - Study no longer required
No Resp - No response from registrant
Neg Resp - Negative response from registrant
-------
IBT TRACKIMS SYSTEM REPORT
IBOUM
CHEMICAL
COMPANY
ROUTE
TYPE
SPECIES
VALIDATE EVALUATE REPLACE
B-1708
B-4715
C-4716
P-4709
2945
601-4274
611-8169
622-0464
622-3059
622-8164
8560-10525 '
8530-08351
8560-9350
622-6769
8530-8906
59-13
59-13A
59-13B
59-13C
622-5250
622-5252
623-6841
651-5254
8530-9030
8590-10580
8532-10762
8580-10813
8580-9119
^
*
B-2793
B-585
C-721
1017
543
E-8917
A-5372
B-4381
C-4382
A-1884
B-1474
B-2156
C-1475
E-2155
J-1548
J-782
421-5532
621-5533
623-6793
8530-8513
8580-9571
ALAR
AMETRYN
AMETRYN
AMETRYN
AMETRYN
ANTOR
ANTOR
ANTQR
ANTOR
ANTOR
ANTOR
ANTOR
ANTOR
ATRAZINE
ATRAZINE
AVADEX
AVADEX
AVADEX
AVADEX
AVADEX
AVADEX
AVADEX
AVADEX
AVADEX
AVADEX
AVADEX
AVADEX
.AVADEX
AVADEX
AVADEX
BACILLUS THURIN6
BARBAN
BARBAN
BARBAN
BARBAN
BAYGON
BENZADOX
BENZADOX
BENZADOX
BIFENOX
BIFENOX
BIFENOX
BIFENOX
BIFENOX
BIFENOX
BIFENOX
BIFENOX
BIFENOX
BIFENOX
BIFENOX
BIFENOX
BINAPACRYL
BINAPACRYL
BINAPACRYL
BINAPACRYL
UNIROYAL
CIBA GEIGY
CIBA 6EI6Y
CIBA GEIGY
CIBA GEIGY
BFC
BFC
BFC
BFC
BFC
BFC
BFC
BFC
CIBA GEIGY
. CIBA GEIGY
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
SANDOZ
VELSICOL
VELSICOL
vasicoL
vasicoL
CHEMAGRO
GULF
GULF
GULF
MOBIL
MOBIL
MOBIL
MOBIL
MOBIL
MOBIL
MOBIL
MOBIL
MOBIL
MOBIL
MOBIL
MOBIL
FMC
FMC
FMC
FMC
ORAL
ORAL
DERMAL
DERMAL
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
NEURO
NEURO
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
DERMAL
ORAL
ORAL
DERMAL
ORAL
ORAL
ORAL
ORAL
DERMAL
ORAL
ORAL
ORAL
ORAL
PERCUTAN
TERATOLOGY
CHRONIC .
CHRONIC
REPRODUCTION
SUBACUTE
SUBCHRONIC
SUBCHRONIC
SUBCHRONIC
SUBCHRONIC
CHRONIC
CHRONIC
CHRONIC
CHRONIC
SUBCHRONIC
SUBCHRONIC
SUBCHRONIC
SUBCHRONIC
CHRONIC
MUTAGENICITY
REPRODUCTION
TERATOLOGY
CHOLINESTERASE
CHRONIC
SUBACUTE
CHRONIC
CHRONIC
CHRONIC
MUTAGENICITY
SUBACUTE
SUBACUTE
SUBCHRONIC
SUBACUTE
SUBCHRONIC
TERATOLOGY
SUKKRON1C
MUTAGENICITY
CATARACTEGEN
CATARACTEGEN
CHRONIC
CHRONIC
REPRODUCTION
SUBACUTE
SUBACUTE
CHRONIC
SUBCHRONIC
SUBCHRONIC
SUBACUTE
RAT
RAT
DOG
RAT
RAT/RABBIT
RABBIT
DOG
RAT
RAT
RAT
RAT
MOUSE
RAT
RAT
MICE
DOG
RAT
DOG
RAT
RAT
MOUSE
RAT
RABBIT
RAT
DOG
MOUSE
HEN
HEN
RAT
DOG
RAT
RAT
DOG
RAT
RAT
MOUSE
RABBIT
RAT
DOG
RABBIT
RAT
RAT
DOS
MOUSE
HEN
HEN
DOG
RAT
RAT
RABBIT
QUAIL
CAT
RAT
DOG
RABBIT
I
I
I
I
I
V
V
P
I
V
V
V
I
s
s
I
I
I
I
I
I
V
I
V
P
P
V
V
I
I
V
I
I
I
I
I
I
I
I
I
V
V
V
I
I
I
V
I
V
V
I
P
P
P
P
NA
NA
NA
NA
NA
P
NA
NA
NA
NA
NA
NA
NA
NA
NA
P
NA
NA
P
P
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
P
P
P
NA
NA
NA
P
NA .
P
NA
NA
NA. .
NA
NA
REPLACED
DISCUSSION
DISCUSSION
DISCUSSION
NOT F:EQ
NO RESP
REPLACED
NO RESP
REPLACED
NO RESP
NO RESP
NO RESP
NO RESP
REPLACED. .
NO RESP
DISCUSSION
DISCUSSION
DISCUSSION
DISCUSSION
DISCUSSION
DISCUSSION
NO RESP
DISCUSSION
NO RESP
NO RESP
NO RESP
NO RESP
NO RESP
REPLACED
NE5 RESP
REPLACED
REPLACED
REPLACED
REPLACED
REPLACED
NEG RESP
NO RESP
NO RESP
NO RESP
NEG RESP
NO RESP
NO RESP
NO RESP
NEG RESP
NEG RESP
NEG RESP
NO REEP
NEG RESP
NO RESP
NO RESP
NO RESP
NEG RESP
NE£ RESP
NEG RESP
NEG RESP
-------
IBT.MJM CHEMICAL
COMPANY
ROUTE TYPE
SPECIES
VALIDATE EVALUATE , REPLACE:
B-2210-
B-2705
C-1426
C-2209
OPP1
J-238
8530-11112
B-353
C-610
601-5223
621-2095
621-4452
622-2440
622-2440
622-5225
651-2096
651-5143
651-5265
8533-10026
651-7433
3580-10025
C-6581
B-5433
622-5433
K22-6724
622-6726
8531-9996
B-7120
C-7121
611-03366
622-03363
A-8995
A-3886 -
A-4407
B-3422
B-3653
B-4130
B-4339
C-3655
J-4330
J-5536
J-5863
B-2804
B-9267
B-9271
J-139
J-5420
J-5438
P-5397
P-5393
P-5570
WCRF-139
121-5519
622-5998
623-5998
8530-9030
BIHAPACRYL
BINAPACRYL
BINAPACRYL
JINAPACRYL
BINAPACRYL
BLADEX
BLADEX
BOLERO
BOLERO
BOLERO
BOLERO
BOLERO
BOLERO
BOLERO
BOLERO
BOLERO
BOLERO
BOLERO
BOLERO
BOLERO
BOLERO
BROhOPHENOXIM
BRQMOPROPYLATE
BROMOPROPYLATE
BROMOPROPYLATE
BROMOPROPYLATE
BROMOPROPYLATE
BUSAN 74
BUSAN 74
BUT AH
BUTAH
BUTYLTIN OXIDE
BUX
BUX
BUX
BUX
BUX
BUX
BUX
BUX
BUX
BUX
CAPTAN
CAPTAN
CAPTAH
CAPTAN
CAPTAN
CAPTAN
CAPTAN
CAPTAN
CAPTAN
CAPTAN
CAPTAN
CAPTAN
CAPTAN
CARBARYL
FMC
FMC
FMC
FMC
FMC
SHELL
SHEL1
. CHEVRON
CHEVRON
CHEVRON
' CHEVRON
CHEVRON
CHEVRON
CHEVRON
CHEVRON
CHEVRON
CHEVRON
CHEVRON
CHEVRON
CHEVRON
CHEVRON
CIBA C-EIGY
CIBA 6EI6Y
CIBA BEIGY
CIBA 5EIGY
CIBA GEIGY
CIBA GEIGY
BUCKMAN
BUCKMAN
GULF
GULF
CHEVRON
CHEVRON
CHEVRON
CHEVRON
CHEVRON
CHEVRON
CHEVRON
CHEVRON
CHEVRON
CHEVRON
A«ER/ SEED/CHEVRON
AMER SEED/CHEVRON
AMER SEED/CHEVRON
CHEVRON
CHEVRON
AKER SEED/CHEVRON
AMER SEEB/CHEVRON
AHER SEED/CHEVRON
AMER SEED/CHEVRON
AMER SEED/CHEVRON
AMER SEED/CHEVRON
AMER SEED/CAPTAN
AMER SEED/CHEVRON
' MONSANTO
ORAL
ORAL
ORAL
ORAL
ORAL
BERHAL
ORAL
ORAL
ORAL
ORAL
NEURO
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
DERMAL
DERMAL
DERMAL
ORAL
ORAL
ORAL
ORAL
~-
CHRONIC
REPRODUCTION
CATARACTEGEN
CHRONIC
TERATOLOGY
TERATOLOGY
SUBACUTE
SUBACUTE
SUBACUTE
CHRONIC
CHRONIC
REPRODUCTION
TERATOLOGY
MUTAGENICITY
CHRONIC
CHRONIC
TERATOLOGY
MUTAGENICITY
SUBCHRONIC
CHRONIC
CHRONIC
REPRODUCTION
CARCINOGENICITY
CHOLINESTERASE
SUBCHRONIC
SUBCHRONIC
SUBACUTE
SUBACUTE
SUBCHRONIC
SUBACUTE
SUBACUTE
SUBCHRONIC
SUBCHRONIC
CHOLINESTERASE
REPRODUCTION
SUBCHRONIC
DEMYELINATION
TERATOLOGY
TERATOLOGY
REPRODUCTION
CHRONIC
CARCINOGENIC
TERATOLOSr
TERATOLOGY
PROGENY
TERATOLOGY
TERATOLOGY
MUTAGENICITY
REPRODUCTN
TERATOLOGY
DOMINANT LETHAL
DOMINANT LETHAL
CHOLINESTERASE
RAT .
RAT
HEN
DOG
DOG
RABBIT
RABBIT
RAT
DOG . .
RABBIT
.RAT
RAT
RAT
RAT
MOUSE
DOG
DOG
RABBIT
MOUSE
HEN .
HEN
DOG
RAT
RAT .
RAT
MOUSE
.DOG
RAT.
DOG
DOG
RAT
RABBIT
RABBIT
RABBIT
DOG
RAT
RAT
RAT
DOG
HEN
RAT
RABBIT
RAT
RAT
MOUSE
RABBIT
RABBIT
DOG
RAT
RABBT/HAHSTR
HOUSE
CHICKEN
MONKEY
MOUSE
MOUSE
RAT
I
I
I
I
I
I
- I
I
I
I
I
I
I
I
I
I
I .
I
I
V
s
I
.p
I
p
s
I
I
V
I
I
I
I
I
I
I
I
I
I
I
I
I
T
I
I
I
I
I
I
I
I
I
I
I
I
V
. NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA .
NA
NA
NA
NA
. NA
. NA
NA
NA
, V
S
NA
NA
" S
NA
NA
NA
NA
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-------
IBTJWM
CHEMICAL
COMPANY
ROUTE
TYPE
SPECIES
VALIDATE EVALUATE REPLACE
A-7099
A-972
B-1590
B-1591
B-3113
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C-6785
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B-5242
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-------
IBTJUJM
CHEMICAL
COMPANY
ROUTE
TYPE
SPECIES VALIDATE EVALUATE REPLACE
622-7923
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C-3595
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-------
IBTJftJH
CHEMICAL
COMPANY
ROUTE
TYPE
SPECIES
VALIDATE EVALUATE REPLACE
J-471
621-6138
C-2529
B-1254
B-2804
B-5397
C-1272
J-139
J-3681
J-5061
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611-7135
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8580-10430
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-------
IBT.NUM
CHEMICAL
COMPANY
ROUTE
TYPE
SPECIES
VALIDATE EVALUATE REPLACE
B-5349
C-5346
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C-975
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F-8948
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2705
621-01058
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TERATOLOGY
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TERATOLOGY
REPRODUCTION
CHRONIC
SUBACUTE
CHOLINESTERASE
CHRONIC
CHOLINESTERASE
CHOLINESTERASE
PLACENTAL TRANS
CHOLINESTERASE
TERATOLOGY
REPRODUCTION
HUTAGENICITY
REPRODUCTION
TERATOLOGY
RAT
DOG
DOG
DOG
HOUSE
HUHAN
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RAT
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HEN
HEN
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DOG
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RABBIT .
RABBIT
DOG
HONKEY
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RABBIT
RAT
RAT
DOG
RABBIT
RAT
DOG
HOUSE
RABBIT.
RABBIT
-MONKEY
HAMPSTER
RABBIT
RAT
RABBIT
RAT
RAT
DOG
DOG
RAT
HUHAN
RABBIT
RAT
HOUSE
HUMAN
HEN
PHES/DK/QUL
RAT
RAT
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I
V
I
V
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I
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NA
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NA
NA
NA
NA
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NA
NA
NA
P
NA
NA
NA
NA
NA
NA
. NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
S
NA
NA
NA
NA
NA
NA
HA
NA
NA
NA
NA-
NA
NA
DISCUSSICK
NOT REQ
NOT REQ
REPLACED
REPLACED
NO RESP
NOT REQ
REPLACED
REPLACED
REPLACED
NO RESP
NEG RESP
NEC RESP
NEG RESP
NO RESP
NO RESP
NO RESP
NO RESP
REPLACED
NEG RESP
REPLACED
REPLACED
NEG RESP
NEG RESP
REPLACED
REPLACED
REPLACED
REPLACED
REPLACED
REPLACED
NEG RES?
NEG RESP
' REPLACED
REPLACED
DISCUSSION
DISCUSSION
DISCUSSION
DISCUSSION
DISCUSSION
DISCUSSION
DISCUSSION
DISCUSSION
DISCUSSION
DISCUSSION
DISCUSSION
DISCUSSION
DISCUSSION
NO RESP
DISCUSSION
-------
IBT.NUM CHEMICAL
COMPANY
ROUTE
TYPE
SPECIES VALIDATE EVALUATE REPLACE
A-1549
A-2144
A-2443A
B-1020
B-544
B-544
B-549
C-1021
E-547
J-545
J-543
£01-5044
401-4527
423-7503
433-7507
433-7801
451-3917
£51-5275
443-4290
8533-8920
8533-8923
8540-8924
8580-8921
8580-8922
A-2448B
E-1753
J-3920
432-3894
451-3918
8530-9117
A-8424
B-330
B-8424
B-9555
B-9558
B-9540
C-8425
C-9554
E-9541
J-9545
8580-9114
422-5557
411-5554
8540-8881
8580-8882
411-3043
£22-8070
J-4511
424
C-5414
GLYPHOSATE
GLYPHOSATE
GLYPHOSATE
GLYPHOSATE
GLYPHOSATE
GLYPHOSATE
GLYPHOSATE
GLYPHOSATE
GLYPHOSATE
GLYPHOSATE
GLYPKOSATE
GLYPHOSATE
GLYPHOSATE
GLYPHQSATE
GLYPHOSATE
GLYPHOSATE
SLYPHOSATE
GLYPHOSATE
GLYPKOSATE
GLYPHOSATE
GLYPHOSATE
GLYPHOSATE
GLYPHOSATE
GLYPHOSATE
GLYPHOSATE
GLYPHOSATE
GLYPHOSATE
GLYPHOSATE
GLYPHOSATE
GLYPHOSATE
GLYPHOSINE
GLYPHOSINE
GLYPHOSINE
GLYPHOSINE
GLYPHOSINE
GLYPHOSINE
GLYPHOSINE
GLYPHOSINE
GLYPHOSINE
GLYPHOSINE
GLYPHOSINE
GOODRITE 3125
'GOODRITE 3125
GOSSYPLURE
60SSYPLURE
KARUADE
KARUADE
.KPIftCHiDJLEM
HINOSAN
IRGASAN
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO .
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
HONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
CONREL
COHREL
UNIROYAL
UHIROYAL
ynsjCDL
MOBAY
CIBA 6EIGY
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DERMAL
DERMAL
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ORAL
ORAL
ORAL
ORAL
ASSAY
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FIEDING
ORAL
DERMAL
NEURO
DERMAL
ORAL
ORAL
ORAL
ORAL
NEURO
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
DERMAL
SUBCHRONIC
SUBCHRONIC
SUBCHRONIC
SUBCHRONIC
CHRONIC
REPRODUCTION
CARCINOGENICITY
SUBCHRONIC
MUTAGENICITY
CHRONIC
TERATOLOGY
SUBCHRONIC
CHOLINESTERASE
MUTAGENICITY
AMES TEST
RECOMBINATION
REPROIRESIDUE
TERATOLOGY
SUBCHRONIC
MUTAGENICITY
REPRODUCTION
PILOT t CHRONIC
TERATOLOGY
CHRONIC
.
SUBCHRONIC
SUBCHRONIC
SUBACUTE
CHRONIC
CARCINOGENICITY
REPRODUCTION
SUBCHRONIC
CHRONIC
MUTAGENICITY
TERATOLOGY
INUTERO EXPOSURE
SUBACUTE
SUBACUTE
SUBCHRONIC
SUBCHRONIC
J?EPRDDi!CJ.IQN.
MUTAGENICITY
SUBACUTE
RABBIT
RABBIT
RABBIT
RAT
RAT
RAT
MOUSE
DOG
MOUSE
DOG
RABBIT
RABBIT
RAT
RAT/MOUSE
HEN
RABBIT
RAT
MOUSE
RAT
RAT
RABBIT
DOG
RABBIT
QUAIL
SHINE
CATTLE
HEN
HEN
RABBIT
RAT
RAT
RAT
MOUSE
RAT
DOG
DOG
MOUSE
RABBIT
HEN
RAT
DOG
RAT
DOG
DOG
RAT
JEN
MOUSE
DOG
I
I
I
V
I
V
I
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I
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NA
NA
I
NA
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NA
I
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
V
V
V
V
NA
NA
S
NA
NA
S
NA
NA
NA
S
P
P
S
S
NA
NA
M.
NA
NA
REPLACED
. REPLACED
REPLACED
NO RESP
REPLACED
REPLACED
REPLACED
NO RESP
REPLACED
NO RESP
REPLACED
NOT REQ
NOT REQ
NO RESP
REPLACED
REPLACED
NO RESP
REPLACED
REPLACED
NEG RESP
NO RESP
NEG RESP
NEG RESP
NEG RESP
REPLACED
NEG RESP
NEG RESP
NEG RESP
NEG RESP
NO RESP
NO RESP
NEG RESP
NO RESP
NEG RESP
NEG RESP
NO RESP
NO RESP
NEG RESP
NEG RESP
NEG RESP
NO RESP
NO RESP
NO RESP
REPLACED
REPLACED
REPLACED
REPLACED
.NEiR&SP
NEG RESP
NO RESP
-------
IBT.NUM OOICAL
COMPANY
ROUTE
TYPE
SPECIES VALIDATE EVALUATE REPLACE
J-7112
P-7113
622-04047
A-S434
C-1425
J-4915
602-02220
622-04554
622-05273
631-04784
A-6010
B-1182
B-4477
B-5987
C-1181
C-4478
C-5988
E-1184
J-1183
621-1180
621-1122'
622-1185
8533-8849
8533-3850
8533-8851
8533-8852
663-6288
A-7679
A-7680
A-9966
B-3703
C-2312
C-8704
E-2314
621-02311
621-2310
622-02313
633-8181
651-2315
8536-08181
8580-9731
611-4855
621-8138
622-4854
651-8137
T-1604
E-8916
J-105
J-2570
16063
B-8965
C-8966
J-9025
P-8915
B-7369
IRGASAN
IRGASAN
IRGASAN
IRGASAN
IRGASAN
IRGASAN
IRGASAN
IRGASAN
IRGASAN
IRGASAN
LASSO
LASSO
LASSO
LASSO
LASSO
LASSO
LASSO
LASSO
LASSO
LASSO
LASSO
LASSO
LASSO
LASSO
LASSO
LASSO
LASSO
MACHETE
MACHETE
MACHETE
MACHETE
HACKETE
MACHETE
MACHETE
MACHETE
MACHETE
MACHETE
MACHETE
MACHETE
MACHETE
MACHETE
MALONOBEN
MALQNQBEN
HALQNC&EN
MALONOBEN
MBP
MESUP.OL
MESUROL
MESUROL
MESUROL
HETA SYSTOX-R
META SYSTOX-R
META SYSTOX-R
META SYSTOX-R
METHAZOLE
CIBA GEIGY
CIBA GEIGY
CIBA GEIGY
CIBA GEIGY
CIBA GEIGY
CIBA GEIGY
CIBA .GEIGY
CIBA GEIGY
CIBA GEIGY
CIBA GEIGY
MONSANTO
MONSANTO
MOHSANTO
MONSANTO
MONSANTO
HOHSANTQ
HONSHNTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MOHSAHTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
GULF
GULF
GULF
GULF
CHEMAGRO
CKEMAGRO
CHEMAGRQ
CHEMAGRO
CHEMAGRO
CHEMAGRO
CHEMAGRO
CHEMAGRO
VELSICOL
ORAL
DERMAL
ORAL
DERMAL
DERMAL
ORAL
ORAL
DERMAL
DERMAL
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
;
INHALATION
DERMAL
DERMAL
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ORAL
ORAL
ORAL
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NEURO
ORAL
ORAL
ORAL
REPRODUCTION
REPRODUCTION
CHRONIC
SUBACUTE
SUBCHRONIC
SUBCHRONIC
SUBCHRONIC
CHRONIC
SUBCHROHIC
SUBCHRONIC
MUTAGEKICITY
TERATOLOGY
CHRONIC
CARCINOGENICITY.
REPRODUCTION
MUTAGENICITY
MUTAGENICITY
MUTAGENICITY
MUTAGENICITY
SUBCHRONIC
SUBCKRQNIC'
SUBCHRONIC
SUBACUTE
CHRONIC
SUBACUTE
MUTAGENICITY
CARCINOGENICITY
CHRONIC
REPRODUCTION
RECOMBINATION
TERATOLOGY -
REVERSE MUTATION
REPRO i RESIDUE
SUBACUTE
CARCINOGENICITI
SUBACUFE
CARCINGGEHICITY
NEURQTQXICITY
MUTAGENICITY
DEMYLINIATION
REPRODUCTION
CHRONIC
CHRONIC
TERATOLOGY
MUTAGENICITY
SUBACUTE
- RABBIT
RAT
RAT
RABBIT
D06
MOUSE
MONKEY
RAT
MICE
MONKEY
RABBIT
MOUSE
RAT
RAT
DOG
DOG
DOG
MOUSE
RABBIT
RAT
MOUSE
RAT
MOUSE
MICRORGANISM
RAT
MICRORGANISM
RAT
RABBIT
RABBIT
RABBIT
RAT
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DOG .
MOUSE
MOUSE
RAT .
RAT
SALMONELLA
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DOG
RAT
RAT
HOUSE
HOUSE
MOUSE
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RAT
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RAT
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NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
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NA
NA
NA
NA
CI
NA
CI
NA
NA
NA
NA
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NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
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NA
NA
NA
NA-
NA
NA
NA
NA
CI
NA .
NA
NA
NO RESP
NO RESP
NO RESP
NO RESP
NO RESP
NO RESP
NO RESP
NO RESP
NO RESP
REPLACED
' NEG RESP
NOT REQ
NOT REQ
NOT REQ
NOT REQ
NOT REQ
NOT REQ
NO RESP
REPLACED
REPLACED
REPLACED
REPLACED
NO RESP
REPLACED
NO RESP
REPLACED
NO RESP
HOT REQ
NO' RESP
NOT REQ
REPLACED
NEG RESP
NO RESP
NEG RESP
REPLACED
REPLACED
REPLACED
NO RESP
REPLACED
REPLACED
NO RESP
NE5 RESP
NEG RESP
NEG RESP
NEG RESP
NEG RESP
NEG RESP
NEG RESP
NEG RESP
NEG RESP
NO RESP
NO RESP
NO RESP
NO RESP
NO RESF
-------
IBTJflJM CHEMICAL
COMPANY
ROUTE
TYPE
SPECIES VALIDATE EVALUATE REPLACE
C-7370
E-2097A
E-2097B
622-03373
8532-823?
8533-3240
8580-8238
4180
A-1992
6-1645
B-1982
J-1983
A-3773
B-3972
C-3126
C-3749
P-3770
3768
A-3774
622-7925
422-7926
623-7923
(A-6479
B-2442A
8-5485
B-6484
B-6485
C-5468
C-8128
E-9517
1-7081
J-9515
N-9516
P-6255
C-6486
J-64BO
J-9546
J-8908
P-8913
651-03393
B-2804
B-2948
B-3705
C-1012
C-1012
C-1240
C-1446
D-2203
D-2203
E-1022
OPP3
1010
1568
METHAZOLE
METHAZOLE
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HETHAZOLE
METHftZQH
METHAZOLE
METHAZOLE
METHWYL
METHOPRENE
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METHOPRENE
METHOPRENE
METOBROMUROH
METOBRCMURON
METOBRCMURON
METOBROMUROM
HETOBRDMURON
METOBROMURQN
METOBROMURON
METOLACHLOR
METOLACHLOR
METOLACHLOR
MONITOR
MONITOR
MONITOR
MONITOR
MONITOR
MONITOR
MONITOR
MONITOR
MONITOR
MONITOR
MONITOR
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MORESTAN
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NALEIl
NALEB
HALED
HALED
NALEH
HALED
NALEB
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VELSICOL MUTAGENICITY MOUSE
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CIBA GEIGY
CIBA GEIGY
CHEVRON
CHEVRON
CHEVRON
CHEVRON
CHEVRON
CHEVRON
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CHEVRON
CHEVRON
CHEVRON
CHEVRON
CHEVRON
CHEVRON
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CHEMAGRO
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CHEVRON
CHEVRON
CHEVRON
CHEVRON
CHEVRON
CHEVRON
CHEVRON
CHEVRON
CHEVRON
CHEVRON
CHEVRON
CHEVRON
CHEVRON
DERMAL
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DERMAL
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INHALATION
FEEDING
NEURO
NEURO
DIETARY
ORAL
ORAL
ORAL
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ORAL
FEEDING
SUBACUTE
SUBACUTE
SUMCUTE
TERATOLOGY .
TERATOLOGY
SUBACUTE
CHRONIC
CHRONIC
CHRONIC
REPRODUCTION
SUBACUTE
CARCINOGENICITY
CHRONIC
REPRODUCTION
SUBACUTE
CHOLINESTERASE
CHRONIC
CHOLINES1 ERASE
CHOLINESTERASE
CHRONIC '
CHOLINESTERASE
MUTAGENICITY
CHOLINESTERASE
TERATOLOGY
SUBACUTE
REPRODUCTION
SPERMATOGENESIS
MUTAGENICITY
SUBACUTE
REPRODUCTION
CHRONIC
SUBCHRONIC
SUBACUTE
DEMYELINATION
SUBACUTE
CHRONIC
SUBACUTE
CHOLINESTERASE
MUTAGENICITY
NEUROTOX
SUBACUTE
SUBACUTE
RABBIT
RABBIT
RAT
RAT
RABBIT
RABBIT
RAT
DOG
RAT
RAT '
RABBIT
MOUSE
RAT
RAT
RABBIT
RAT
RAT
RAT
DOG
DOG
DOG
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RABBIT
RAT
RAT
RAT
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HEN
DOG
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DUCK/QUAIL
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RAT
RAT
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DOG
DOG
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COU
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MOUSE
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I
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NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
s
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NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
S
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NO RESP
NO RESP
NO RES?
NO RESP
ME? r-ESF
REPLACED
NEG RESP
REPLACED
NO RESP
NO RESP
REPLACED
REPLACED
NEG RESP
NEG RESP
NO RESP
NEG RESP
NEG RESP
NO RESP
NEG RESP
NO RESP
REPLACED
REPLACED
NEG RESP
REPLACED
REPLACED
REPLACED
REPLACED
REPLACED
REPLACED
REPLACED
REPLACED
REPLACED
NEG RESP
REPLACED
REPLACED
REPLACED
REPLACED
NEG RESP
NEG RESP
REPLACED
REPLACED
REPLACED
REPLACED
REPLACED
NEG RESP
REPLACED
NEG RESP
NEG RESP
' REPLACED
NEG RESP
NO RESP
REPLACED
REPLACED
-------
IBTJftIM CHEMICAL
COMPANY
ROUTE
TYPE
SPECIES VALIDATE EVALUATE REPLACE
8580-8991
965(2-62)
965(7-62)
B-1445
965(6-62)
B-9068
J-9024
P-8914
621-6001
421-6002
623-6212
651-6000
C-8798
J'8797
J-940v
C-1772
1771
2476
9/62
9/62
1773
B-1242
B-346
621-4599
622-3088
622-4598
622-5693
622-8049
623-8160
623-sm
632-6372
632-6541
651-4101A
651-4101B
651-4101C
651-4101D
B-1707
663-4206
J-1201
651-05485
A-776
B-1116
B-190
B-2442
B-8733
B-8867
B-9269
B-9272
B-9526
C-8732
C-9527
E-193
J-1378
J-191
636-24?8
HALED
HALED
HALED
HALED
HALED
NEMACUR
NEMACUR
NEMACUR
NEMEFENE
NEMEFENE
NEMEFENE
NEMEFENE
NICOTINE
NICOTINE.
NICOTINE
NOREA
NOREA
NOREA
NOREA
NOREA
NOREA
OMADINE
OMADINE .
QMADINE
OMADINE
OMADIHE
OMADINE
OMADINE
OMADINE
OMADINE
OMADINE
OMADINE
OMADINE
OMADIHE
OMADIHE
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IBTJflJH CHEMICAL
COMPANY
ROUTE
TYPE
SPECIES VALIDATE EVALUATE REPLACE
651-4807
J-2042
J-2493
J-513
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A-33S9
A-3686
B-1350
B-3796
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-------
IBTJflJM CHEMICAL
COMPANY
ROUTE
TYPE
SPECIES VALIDATE EVALUATE REPLACE
T-3035
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1002A
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-------
IBT.NUM CHEMICAL
COMPANY
ROUTE
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SPECIES VALIDATE EVALUATE REPLACE
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-------
IBTJflJM CHEMICAL
COMPANY
ROUTE
TYPE
SPECIES VALIDATE EVALUATE REPLACE
622-2012B
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8531-8338
8533-9630
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SIMAZINE
SIHAZINE
SIHAZINE
SODIUH AZIDE
SODIUM CHLORATE
SODIUH CHLORATE
SUMITOL
SUPRACIDE
SUPRACIDE
TEDION
TERBUFCS
TERBUTHYLAZINE
TERBUTKYLAZINE
TERBUTHYLAZINE
TERBUTHYLAZINE
TERBUTHYLAZINE
TERBUTHYLAZINE
TERBUTHYLAZINE
TERBUTHYLAZINE
TERBUTHYLAZINE
TERBUTHYLAZINE
TERBUTRYN
TERBUTRYN
TERBUTRYN
TERBUTRYN
TERRAZOLE
THIDIAZURON
THIBIAZURON
THIDIAZURON
THIDIftZURON
THIDIAZURON
THIODAN
THIODAN
THIODAN
THIODAN
THIODAN
THIODAN
THIODAN
THIODAN
THIOFANOX
THIOFANOX
THIOFANOX
TORAK '
TORAK
MONSANTO
MONSANTO
3H
CHEMAGRO
CHEHAGRO
CHEMAGRO
CHEMAGRO
CHEHAGRO
CHEMAGRO
CIBA GEIGY
CIBA GEIGY
CIBA GEIGY
CIBA GEIGY
PPG
CIBA GEIGY
CIBA GEIGY
CIBA GEIBY
FHC
AMER CYANIMID
CIBA GEIGY
CIBA GEIGY
CIBA GEIGY
CIBA GEIGY
CIBA GEIGY
CIBA GEIGY
CIBA GEIGY
CIBA GEIGY
CIBA GEIGY
CIBA GEIGY
CIBA GEIGY
CIBA GEIGY
CIBA GEIGY
CIBA GEIGY
OLIK
NORAH
NORAH
NORAM
NORAM
NORAM
FMC
FMC
FMC
FHC
FHC
FMC
FMC
FMC
DIAMOND SHAMROCK
DIAMOND SHAMROCK
DIAMOND SHAMROCK
BFC
BFC
INAHLATION
ORAL .
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
DERMAL
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
DERMAL
DERMAL
DERMAL
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
REPRODUCTION ,
TERATOLOGY
CARCINOGENICITY
SUBACUTE
MUTAGENICITY
TERATOLOGY
TERATOLOGY
TERATOLOGY
SUBCHRONIC
SUBCHRONIC
SUBCHRONIC
CARCINOGENICITY
TERATOLOGY
TERATOLOGY
CHRONIC
REPRODUCTION
TERATOLOGY
TERATOLOGY
SUBCHRONIC
SUBCHRONIC
CHRONIC
CHRONIC
SUBCHRONIC
CHRONIC
REPRODUCTION
TERATOLOGY
TERATOLOGY
SUBCHRONIC
REPRODUCTION
SUBCHROHIC
CHRONIC
ONCOGENICITY
TERMCLQGY
SUBACUTE
SUBACUTE
CHRONIf.
CHRONIC
MUTAGENICITY
REPRODUCTION
SUBCHRONIC
NEUROTOX
NEUROTOX
SUBACUTE
SUBCHRONIC
RAT
RAT
RAT
MOUSE
DOG
MOUSE
RABBIT
RABBIT
RABBIT
RAT
RAT
MOUSE
MOUSE
RAT
RAT
DOG
RAT
MOUSE
RABBIT
RAT
RAT
RAT
RAT
RAT
RAT
RAT
DOG
DOG
RAT
RABBIT
RABBIT
RAT
RABBIT
RAT
DOG
RAT
DOG
RAT
RAT
RAT
HOUSE
RAT
RAT
DOG
DOG
DOG
HOUSE
RAT
HEN
RAT
CHICKEN
CHICKEN
RAT
RAT
P
1
I.
I
V
I
I
I
I
I
I
I
I
I
I
I
V
s
V
I
I
V
I
I
P
I
I
I
P
P
I
V
I
I
I
s
s
V
s
s
V
I
I
I
V
V
V
I
V
I
V
V
I ,
I
NA
NA
NA
P
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
P
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
S
CS
C
CS
S
C
NA
NA
NA
P
P.
CI
NA
V
NA .
P
P
NA
NA
NO RESP
NO P.ESF
REPLACED
REPLACED
NO RESP
REPLACED
REPLACED
REPLACED
REPLACED
. REPLACED
NOT REQ
NEG RESP
DISCUSSION
NOT REQ
NEG RESF
NEG RESP
NO RESP
REPLACED
REPLACED
NEG RESP
NO RESP
' NEG RESP.
NEG RESP
NEG RESP
NEG RESP
NEG RESP
NEG RESP
. NEG RESP
NEG RESP
NEG RESP
NEG RESP
REPLACED
NOT REQ
REPLACED
REPLACED
REPLACED
REPLACED
NEG RESP
NOT REO
REPLACED
NEG RESP
REPLACED
REPLACED .
REPLACED
NO RESP
NOT REQ
REPLACED
REPLACED
NEG RESP
NO RESP
NO RESP
NOT REQ
NEG RESP
NEG RESP
-------
IBTJWM CHEMICAL
COMPANY
ROUTE
TYPE
SPECIES VALIDATE EVALUATE REPLACE
BH056
B-4345
Cr4007
CH350
Er4009
F-7110
F-7493
J-4529
M-6336
N-7310
P-4347
UCRF 153
623-3751
A-7303
A-7848
J-6351
2330
2367
2367
2367
2476
632-6451
A-3149
B-4834 .
C-4835
622-5251
622-5253
623-6842
651-5255
8530-9030.
8580-10581
A-6678
A-6679
J-6676
J-6677
651-2842
651-3023
8532-10763
8530-10814
8580-9120
622-5459
663-5460
B-4634
C-3964
C-4343
611-8069
8532-8071
17721
1563
C-4805
621-6954
623-6955
623-7092
651-7093
TORAK
TORAK
TORAK
TORAK
TORAK
TORAK
TORAK
TORAK
TORAK
TORAK
TORAK
TORAK
TORAK
TORAK
TORAK
TORAK
TOXAPHENE
TOXAPHENE
TOXAPHENE
TOXAPHENE
TOXAPHENE
TOXAPHENE
TRIALLATE
TRIALLATE
TRIALLATE
TRIALLATE
TRIALLATE
TRIALLATE
TRIALLATE
TRIALLATE
TRIALLATE
TRIALLATE
TRIALLATE
TRIALLATE
TRIALLATE
TRIALLATE
TRIALLATE
TRIALLATE
TRIALLATE
TRIALLATE
TRIFORINE
TRIFORINE
TRIPHENYLTIN HYD
TRIPHENYLTIH HYD
TRIPHENYLTIN HYD
TRIVAX
TRIVAX
VAPONA
VAPONA
VEGADEX
VEGADEX
VEGADEX
VEGADEX
VEGADEX
BFC
BFC
BFC
BFC
BFC
BFC
BFC
BFC
BFC
BFC
BFC
BFC
BFC
BFC
BFC
BFC
BFC
BFC
BFC
BFC
HERCULES
BFC
MONSANTO
HONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
HONSANTQ
CHEVRON
CHEVRON
THOHPSON-HAYVARD
THOKPSOH-HAYUARB
THOMPSON-HATIMR5
UHIROYAL
UNIKOYAL
SHELL
SHELL
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
ORAL
ORAL
ORAL
DERMAL
DERMAL
NEURO
ORAL
INHALATION
INHALATION
INHALATION
ORAL
DERMAL
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
NEURO
NEURO
INHALATION
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
-
CHOLINESTERASE
CHRONIC
SUBACUTE
CHRONIC
CHOLINESTERASE
CHOLINESTERASE
CHOLINESTERASE
TERATOLOGY
CHOLINEST1TERATO
REPRODUCTION
REPRODUCTION
TERATOLOGY
REPRO 1 TERATOLO
CHRONIC
SUBACUTE
SUBACUIE
SUBACUTE
REPRODUCTION
SUBCHRONIC
SUBCHRONIC
SUBCHRONIC
CHRONIC
MUTAGENICITY
REPRODUCTION
TERATOLOGY
CHOLINESTERASE
CHRONIC
MUTAGENICITY
SUBACUTE
SUBACUTE
SUBACUTE
SUWXUTE
CHOLINESTERASE
SUBACUTE
SUBACUTE
CHRONIC
REPRODUCTION
MUTAGENICITY
TERATOLOGY
RAT
RAT
DOG
DOG
RAT
HUMAN
HUMAN
RABBIT
MONKEY
RAT
RABBIT
RAT
RABBIT
RABBIT
HEN
DOG
DOG
RAT
GUINEA PIG
RAT
HEN
RABBIT
RAT
DOG
RAT
MOUSE
RAT
RABBIT
RAT
DOG
FISH
FISH
QUAIL
(DUAIL
TJUCK
QUAIL
HOUSE
HEN
HEN
HOUSE
RAT
RAT
DOG
DOG
DOG
RAT
DOG
RAT
DOG
RAT
RAT
MOUSE
RAT
S
I
I
I
I
I
P
1
S
I
I
I
I
I
I
V
I
I
I
I
V
V
I
V
V
I
I
I
I
V
V ..
I
I
V
I
I
1
I
I
V
V
I
I
I
I
I
I
I ,
S
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
P
P
NA
P
P
NA.
NA
NA
NA
P
P
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA .
NA
NA
NA
NEB RESP
NEG RESP
NEG RESP
NEG RESP
NEG RESP
NEG RESP
NEG RESP
NE5 RESP
NEG RESP
NEG RESP
NEG RESP
NEG RESP
NEG >RESP
NEG RESP
NEG RESP,
NEG RESP
NEG RESP
NEG RESP
NEG RESP
NEG RESP
NO RESP
NEG RESP
REPLACED
REPLACED
REPLACED
NEG RESP
NO RESP
NO RESP
REPLACED
NO RESP
NO RESP
REPLACED
REPLACED
REPLACED
NOT RED
NO RESP
NO RES?
NEG RESP
NEG RESP
NO RESP
NEG RESP
NEG RESP
NOT REQ
NOT REQ
NOT REQ
NEG RESP
NEG RESP
NEG RESP
NEG RESP
NEG RESP
NEG RESP
NEG RESP
NEG RESP
NEG RESP
-------
IBTJWM CHEMICAL
COMPANY
ROUTE
TYPE
SPECIES VALIDATE EVALUATE REPLACE.
8530-9030
8532-10744
8580-10582
B-4804
8580-10815
8580-9118
651-6763
A-1159
8560-8838
622-07392
623-07393
VEGADEX
VEGADEX
VEGABEX
VEGADEX
VEGADEX
VEGABEX
VEL
VENDEX
VINYIEKE
VORLEX
VORLEX
2»4-D
4-AMINOPYRIDINE
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
MONSANTO
SANDOZ
SHaL
VEHTRON
Dcy
AVITROL CORP
ORAL
ORAL
ORAL
NE'JRO
NEURQ
NUERO
DERMAL
ORAL
ORAL
DERMAL
CHOLINESTERASE
SUBCHRONIC
CHRONIC
SUBACUTE
SUBACUTE
SUBCHRONIC
REPRODUCTION
SUBACUTE
SUBACUTE
RAT
HOUSE
DOG
RAT
HEN
HEN
HEN
RABBIT
RAT
RAT
RAT
RABBIT
DOG/SUINE
V
I
I
I
V
I
I
I
I
V
V
I
I
NA
NA
NA
NA
NA
NA
NA
NA
P
P
NA
NA
NO RESP
NEG RESP
NEG RESP
REPLACED
NO RESP
NEG RESP
NO RESP
NEG RESF
DISCUSSION
NO RESP
NO RESP
NO RESP
NO RES?
-------