Registration Dossier
Registration Dossier
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EC number: 700-426-3 | CAS number: 502962-81-4
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
Additional information
The following conclusions can be drawn on the basis of a review of available experimental data from physicochemical and toxicological studies on Fatty acids C18-(unsaturated) lithium salts performed according to international technical guidelines and in compliance with GLP in internationally recognised contract research organisations:
o Fatty acids C18-(unsaturated) lithium salts is absorbed via the gastrointestinal tract. This is supported by the observation of signs of systemic toxicity (i.e. hunched posture, pilo-erection, ataxia, noisy respiration, sneezing, increased salivation) at 2000 mg/kg bw, as an aqueous suspension via oral gavage in an acute oral toxicity study in female Wistar rats.
o Fatty acids C18-(unsaturated) lithium salts is absorbed to some degree via the skin. This is supported by the observation of a dose-related, but not statistically significant, increase in stimulation index following topical application of Fatty acids, C18-(unsaturated) lithium salts in an ethanol/distilled water (7:3) suspension in a local lymph node assay.
o In addition, in the dermal combined repeat dose toxicity study with a reproduction/developmental toxicity screening study in rats, systemic effects (statistically significant decrease in body weight) were noted at the highest tested dose of 1089.75 mg/kg bw.
No available data allow conclusions to be drawn regarding distribution, metabolism or excretion of fatty acids C18-(unsaturated) lithium salts.
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