Document MJ1eeJwBGvZ95LEo1DEpp09LL
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AR226-3015
Study Title
Approximate Lethal Dose (ALD) of H-21095 in Rats Laboratory Project ID
Haskell Laboratory Report Mo. 290-95
Author M. Scott Karr
Study CoBpleted On
April 19. 1995
Performing Laboratory
Haskell
E. I. du Font de Newnirs and Company
Laboratory for Toxicology and Industrial Elk^on Road, P. 0. Box 50
Newark, Delaware 19714
Medicine
Medical Research No.
Company Sanitized. ] psse 1 of 6
Substance Tested; Synpnygs/Codes;
CTMStAL ItffORHATIOH
DuPoDt BUl 2W-M
Physical Form; Composition;
Transparent tan liquid
H-21095 contains:
Contaminantsi
Purityi CAS Registry No.;
Sponsor;
Study Initiated - Completed: In Life Phase Initiated - Completed:
None 30X
None available DuPont Specialty Chemicals
E. I. du Pont de Nemours and Company
Vilaington, Delaware 3/13/95 - A/19/95
3/U/95 - 4/5/95
2 - net
Approxiaatc Lethal Dose (ALP) of B-21095 ia 9stts
SUMMARY
MPMt
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KM 29G-45
H-21095 vas administered as a sing'e oral dose by inti-agastric intubation to nale cats. No deaths and no clinical signs of toxicity irere observed during this study. Under the conditions of this test, the ALD vas creator than 11,000 g/kg of body weight. This substance is considered t" be very low in toxicity (ALD greater than 5000 ng/kg) when administered as a single
oral dose.
Work by;
Toxicology Technician
Reviewed and Approved for Issue: ^UdU <3. ^P^JU.L^^_____^/ ^/^S 7JTracy A. Filliben
Study Director
TF/alv
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SlUS
DuPont BIA 290-95
INTRODUCTION
The
purpose
of
this
test
was
to
determine
an
approximate
lethal do of
The KLD vac
Hde-2fi1n0e9d5 washentheadlmoiwneisstterdeodseasadamisniinsgteleredorwalhicdhosecautosed--dIeearthat3e.ither on the day
of dosing or within 1A days post exposure.
MATERIALS AND METHODS
A- Animal Husbandry
Kale Crl:CD*BR
rats,
approximately
7 weeks old, were received from North Carolina. Rats vere
Charles
River
Breeding
Laboratories, Raleigh, stainless steel, wire-mesh
cages.
Bach rat
housed
singly
in suspended, unique identification
number
which
was
recorded on a card water-insoluble
vas assigned a
affixed to tic cage.
The rats 3 digits
were tail-marked, using a of the animal number. Purina
Certified
marker, with Rodent Chov*
the last
#5002 and
water
were
available
ad
llbitum.
Baskell
Laboratory
has
an
animal
health
monitoring program. This Laboratory Veterinarian.
progran
is
monitored
and
administered by the
analyzed for total
bacterial
counts
and
Water samples are periodically for the presence of conforms,
lead,
and
other
contaminants. and cage racks
are
Additionally,
samples
from fr-eshly washed cages
to assure adequate sanitation
by
the
cagevashers.
periodically analyzed Data from this program
are
maintained
separately
from study records. specified
Animal
fead
is
certified
by the manufacturer and to be free of a
to meet
list of
specified
nutritional requirements
contaminants. On the basis
of
these
analyses, there is no evidence in the feed or water In
suggesting
that
contaminants were
have interfered
present with the
results
of
this
study.
amounts which may
Rats
were quarantined,
weighed,
and
observed
for general health for rooms were maintained
one week prior to testing. Animal light/12-hour dark cycle.
Environmental
aoproxiBately on a timer-controlled, 12-hour -onditlons of the rooms were targeted
for a
temperature of 23"C t 1"C outside these ranges
and
relative
humidity
of 50X + and/or
10!!;.
brief
Excursions duration and
did'not
adversely
were of SB&II magnitude
affect the validity of the study.
B. Protocol
S-21095
was
mixed
with
deionized
water and administered to 1 In the absence of visible
rat
per
dose
rate
by
intragastric
intubation. the test substance
was
assuaed
to
be
stable
evidence to the contrary, under the eoad.'.tions of administration.
Dose rates administered ranged
froa
2300
to
11,000
Bg/kg
of
body
veizht in increenf
670 ag/feg. The
of appcoxiakfly docinf day --
502. Additionally, 1 ret dva&ys 1d4ovseads atet st day 15. Pollovinf
test day 1$ pcs (exposure adttini&trstlofl of the tesi
substance,
rats were observed Cor clinical observed at least ^ tine* a
signs of toxicity. Rats verc weighed ind the 14-day observation period.
Observations for
veek throughout
ortality were aade daily
throughout
the study.
Pathological
examinations ot test animals were not Derforaed.
C. Records Retention
A71
raw
data
and
the
final
report
will
be
stored
in
the
archives of du Font
HdeasHkoenlol uLrsabaonrdatoCroympfaonry, TNoexwicaorklo.,gyDealanwd aIrne dourstirnialtheMeDduiPcoinnet , REe.coIrd. s
Hanagenent Center, Wilining^cp, Delavare.
RESULTS
A. Dosage and Mortality Data The dosage regimen and the mortality resulting over the 15-day test
period are detailed below.
Dosage
WW
670
2300
3400
5000
7500
11,000
Dose Volume
iEk)
1.! 3.7 1.6
2.6 3.8 5.4
Mixture Concentration
(mg/mL) 150
150
500
500
500
500
Initial Body
Weight (g)
256 243 241 262 252 245
Mortality
No No No No No No
B. Clinical Signs No clinical signs of toxicity were observed during' this study.
DufORt ltt&2>0-5
CONCLUSIOH
Under the conditions of this study, the ALD for H-21095 ma (raxr etum
11,000 w/kff of body weight. This substance is considered to be vry lov in
loxiclty (ALO fr--ter than 5000 Kg/kg) when adainistered as a single oral doe to ale rats.
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