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EC number: 259-134-5
CAS number: 54381-16-7
Group (Recovery )
Epididymal count (million sperm/gram)
toxicity of N,N-bis (2-hydroxyethyl)-p-phenylenediamine sulfate was
performed following OECD Guideline 408 (Repeated Dose 90-Day Oral
Toxicity in Rodents). Analysis on fertility parameters as sperm motility
on male and vaginal cytology. Hence, this study was considered to be
relevant for toxicity to reproduction assessment.
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. A
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).
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. 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).
Furthermore, vaginal cytology and sperm
analysis were performed.
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 20 mg/kg/day. No toxicity on reproductive
apparatus or fertily was observed.
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