Toxicity of disodium sebacate

Investigations of the acute toxicity of disodium sebacate after oral, i.p. and i.v. administration were carried out on 220 Wistar rats (110 males and 110 females) and 204 New Zealand rabbits (102 males and 102 females). No oral acute toxicity was found. On the contrary LD50 +/- s.e. of 5500 +/- 830 mg/kg b.w. and 6000 +/- 850 mg/kg b.w. were found respectively for rats and rabbits after i.p. sebacate administration. When sebacate was given i.v., the median lethal dose +/- s.e. was 560 +/- 86.5 mg/kg b.w. for rats and 1400 +/- 267.2 mg/kg b.w. for rabbits. Similar results were obtained in corresponding groups of animals (in total 220 rats and 204 rabbits) given oral, i.p. and i.v. saline solutions with added glucose in order to obtain the same value of osmolarity and sodium ion concentration. The above results appear indicative of low toxicity of disodium sebacate, and suggest that the toxic effects found could be due to the sodium content of the compound administered. Similarly, subacute and chronic toxicity was investigated in forty rats and forty rabbits (twenty males and twenty females) fed disodium sebacate incorporated into pellets. When compared to the control animals, no significant differences in biological parameters (clinical, chemical and haematological values, growth curves and histological findings for the different organs) were observed in the test groups during the treatment period. In addition, fetal toxicity, teratogenicity and neonatal toxicity were investigated in twenty female rats and twenty female rabbits. Sebacic acid did not show any teratogenic effect and the development of the fetuses was regular.