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EC number: 701-354-5
CAS number: -
A combined 28 day repeated dose study with screening for reproductive
and/ or developmental effects was performed according to OECD/EC
guidelines and GLP principles. Sodium Cocopropylenediamine Propionate
was administered by daily oral gavage to male and female rats at dose
levels of 50, 150 and 500 mg/kg bw/day. Males were exposed for 2 weeks
prior to mating, during mating, and up to termination (for 29 days).
Females that delivered offspring were treated for 2 weeks prior to
mating, during mating, during post-coitum, and at least 13-15 days of
lactation (for 60-70 days). Females that failed to deliver pups were
treated for 40-42 days. In females at 150 mg/kg bw/day and in both
females and males at 500 mg/kg bw/day , test item-related microscopic
findings were observed in the mesenteric lymph node. These findings
consisted of foamy macrophage foci at 150 mg/kg bw/day in females and at
500 mg/kg bw/day in males and females which were considered non-adverse,
and of multifocal necrosis in a single female at 500 mg/kg bw/day which
was considered adverse.
No reproduction toxicity was observed up to the highest dose level
tested (500 mg/kg bw/day). No treatment-related changes were noted in
any of the reproductive parameters investigated in this study (i.e.
mating and fertility indices, precoital time, number of implantations,
estrous cycle, spermatogenic profiling and histopathological examination
of reproductive organs).
Based on the adverse effects on mesenteric lymph nodes (seen in 1/10
females) at 500 mg/ kg bw/ day, a No Observed Adverse Effect Level
(NOAEL) for Sodium cocopropylenediamine propionate of 150 mg/kg bw/ day
was established. The NOAEL for reproduction was established to be at
least 500 mg/kg bw/day, as no adverse effects were seen up to and at
this dose level.
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