Acute and subacute in vivo safety assessment of developed chitosan derivatives for food applications.

The acute and subacute studies of two chitosan derivatives was conducted by oral administration on Swiss albino
mice. Chitosan soluble derivatives were prepared by depolymerization method using potassium persulfate. 13C
NMR data have revealed that Low Molecular Weight Chitosan (LMWC) has higher (~70%) ‘acetylated’ residues
and Self Assembled Chitosan Microparticles (SAMC) consists of ‘deacetylated’ residues. For acute toxicity study,
a single dose of two concentrations 2000 and 5000 mg/kg bw of the chitosan derivatives (LMWC, or SAMC) was
given orally to healthy mice. Results indicated that the LD50 value for chitosan derivatives was greater than 5000
mg/kg bw. In the sub-acute toxicity studies, administration of concentrations 1000 and 2000 mg/kg bw dose of
chitosan derivatives (repeated daily dose for 28 days) also did not reveal any toxicological changes in clinical
observations, viz. relative organs, body weight, food consumption, biochemical parameters studied, antioxidant
markers, and histopathological studies has been compared with control group. Together, present systematic
study supports the oral administration of non-viscous and soluble chitosan derivatives (LMWC & SAMC) will
have no toxicity may be safe to use in food and pharma applications.