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EC number: 308-783-3
CAS number: 98510-75-9
a subacute toxicity study according to OECD guideline 407 (2008) and EU
method B.7 (2008) C8-10 Alkylamidopropyl
a.i.) was administered to 5Hsd:
Sprague Dawley SDrats/sex/dose
in purified water by gavage at dose levels of 0 (control), 100, 300 and
500 mg/kg bw/day for 28 consecutive days. Control and high dose groups
included 5 additional animals per sex to be sacrificed after 2 weeks of
mortality occurred. No clinical signs and no changes were observed at
the weekly detailed clinical observations. Neurotoxicity assessment did
not reveal any treatment-related effects. No changes on body weight and
food consumption were noted.
lymphocytosis and monocytosis seen in single females dosed at 300 and/or
500 mg/kg bw/day showed reversibility at the end of the recovery period
or comparability to control data. No toxicological relevant effects in
coagulation and clinical chemistry parameters were observed. No
differences were reported in terminal body weights and organ weights
between treated and control animals and no treatment-related changes
were noted at macroscopic and microscopic observations.
tubules were evaluated with respect to their stage in the spermatogenic
cycle and to the integrity of the various cell types within the
different stages; regular layering in the germinal epithelium was noted.
physiology of the oestrous cycle (oestrous, metestrous, diestrous and
proestrous) was noted in control and treated females. The morphological
changes seen were normal when compared to each “oestrous phase” in the
ovaries, uterus/cervix and vagina.
the basis of the results obtained in this study, the dose level of 500
mg/kg bw/day was considered the NOAEL (No Observed Adverse Effect
NOEL for fertility parameters is 500 mg/kg bw/d.
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