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EC number: 259-134-5
CAS number: 54381-16-7
toxicity of N,N-bis (2-hydroxyethyl)-p-phenylenediamine sulfate was
performed following OECD Guideline 408 (Repeated Dose 90-Day Oral
Toxicity in Rodents).
study was designed to evaluate the toxicity of the test substance, when
administered daily at dose levels of 0, 1, 4 and 20 mg/kg bw/day via
oral gavage to Crl:CD(SD)IGS BR rats for 91 d and to assess the
reversibility of any effects after a 4
Wk recovery period.
total of 140 Crl:CD(SD)IGS BR rats (70/sex) of 6-7 Wk age (source:
Charles River Laboratories, Portage, Michigan), weighing 204-299 g
(males) and 153-194 g (females) were housed individually, in suspended
stainless-steel cages. The animals were maintained under standard
laboratory conditions (temperature: 19-25°C, relative humidity: 30-70%,
10 or greater air changes/h, 12 h light/12 h dark cycle per d). The
animals were fed on certified rodent diet (#8728C, Harlan Teklad); ad
libitum and acclimated to laboratory condition for a period of 7 d.
formulations were prepared weekly, stored in a refrigerator set to
maintain 2 to 8°C and protected from light. For each dose level, the
required amount of test substance was added to a volume of vehicle (0.2%
w/v erythorbic acid in reverse osmosis water) and mixed on a magnetic
stirrer until the formulation appeared to be a solution.
acclimation, animals were randomized into four treatment and one vehicle
control group (containing 15 animal/sex/ group each) using a
computerized blocking procedure designed to achieve body weight balance
with respect to treatment groups. An additional 5 animals/sex were
included in control and high dose groups to assess the reversibility of
any effects after a 4 Wk recovery period.
animals were observed twice daily (a.m. and p.m.) for mortality,
abnormalities, and signs of pain or distress. Cage side observations
were made for each animal once daily. Detailed clinical observations
were performed prior to treatment, on Day 1, weekly thereafter, and on
the day of each scheduled sacrifice. Neurobehavioral observations were
performed weekly; hand-held and open-field expanded clinical
observations were done pre-study and during Weeks 4, 8, and 13; elicited
behavior observations were done prestudy and during Wk 13; and motor
activity data were collected pre-study and during Wk 13. Ophthalmic
examinations were done prior to treatment and during Wk 13. Body weights
were collected twice prior to treatment, on Day 1, and weekly
thereafter. Food consumption data were measured weekly. Vaginal cytology
data were collected once daily for 21 consecutive days, beginning after
Wk 10. Blood and urine samples for hematology, coagulation, clinical
chemistry, urinalysis, and urine chemistry were collected at each
scheduled sacrifice (on Day 92 and Day 120).
Day 92, up to 15 animals/sex/group were anesthetized, weighed, and
necropsied. On Day 120, all surviving animals (recovery group) were
anesthetized, weighed, and necropsied. Each animal sacrificed, or died
during the study was necropsied, selected organs were weighed and
selected tissues collected and preserved. At each scheduled sacrifice,
male reproductive assessment (sperm motility, morphology, and count) was
done by Pathology Associates (PAI). Microscopic examination of tissues
was performed, and a pathology peer review was conducted.
Group 1 (vehicle control) male died on Day 72 from causes unrelated to
treatment (severe, acute pyelonephritis). All other animals survived in
apparent good health until scheduled sacrifice. No treatment-related
clinical observations were noted during the treatment or recovery phase
of the study.
were no test substance-related effects on ophthalmic observations;
effects on neurobehavioral assessment tests; effects on body weights or
body weight changes; effects on food consumption; or effects on vaginal
cytology. Test substance had no effect on clinical pathology test
mean percent sperm motility, caudal epididymal sperm count, and sperm
morphology were not affected by treatment. No
biologically meaningful differences were observed between the study
on the results of the study, the No Observed Adverse Effect Level
(NOAEL) following oral gavage administration of N,N-bis
(2-hydroxyethyl)-PPD Sulf to rats at doses of 0, 1, 4, or 20 mg/kg/day
for 91 d was determined to be greater than 20 mg/kg/day.
repeated dose toxicity study is classified as acceptable, and satisfies
the guideline requirements of OECD 408 method.
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