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EC number: 254-184-4
CAS number: 38900-29-7
See attached documents.
Dermal application of Fatty acids
C18-(unsaturated) lithium salts to the dorsal surface of Parental male
and female rats at dose levels of 100, 300, and 1000 mg/kg bw/day did
not result in any adverse reproductive effects or any definitive test
article-related changes in the development or survival of the offspring.
In addition, results from the clinical
pathology evaluations and neurobehavioral testing did not reveal any
definitive effects that could be attributed to treatment at the dose
levels tested. Test article-related dermal changes were limited to local
effects at the test site for Parental animals at 300 and 1000 mg/kg
bw/day, which showed a decreasing trend following cessation of dosing in
the designated recovery animals. Microscopic evaluation of the skin at
the test site showed minimal to moderate erosion/ulceration, epidermal
hyperplasia and exudate, minimal to mild acute to subacute/chronic
inflammation and minimal edema, which confirmed the macroscopic
findings. At recovery necropsy, test article-related microscopic
findings in treated skin in animals at 1000 mg/kg bw/day were
morphologically similar, although they occurred at a lower incidence and
severity indicating partial resolution of these findings following the
recovery period. Microscopic findings of splenic extramedullary
hematopoiesis and thymic lympoid depletion noted at 1000 mg/kg bw/day
were considered to be secondary adaptive responses to parturition and
localized dermal effects.
Systemic effects were limited to changes
in body weight and organ weight at 1000 mg/kg bw/day, the highest dose
In summary, there were no treatment
related effects at any dose level on any of the reproductive parameters
evaluated in this study, or in any of the developmental parameters
evaluated. Based on these daya, the NOAEL for developmental toxicity was
>1089.75 mg/kg bw/day and the NOAEL for reproductive toxicity was also
>1089.75 mg/kg bw/day.
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