Purpose: Safety and toxicity evaluation of a nove liposome-encapsulated rapamycin formulation, intended for autoimmune ocular disorders. Methods: The formulation (60 and 180 µg for subconjunctival and 40 and 440 µg for intravitreal administration) were assessed through micronucleus polychromatic erythrocytes production, and irritability by HET CAM and pyrogenicity testing. Subconjunctival and intravitreal administration of the formulation were performed to evaluate subacute and acute toxicity, respectively. Shapiro Wilk and Kolmogorov-Smirnov tests were applied for normality. Pearson and Spearman Correlation tests for variable comparison. Differences between groups in biochemical and hematological parameters were evaluated by ANOVA test with significance determination by t-Holm-Sidak post-hoc test. A t-test was employed to compare independent, normally distributed variables. Numeric score was assigned to histopathological classification. Data was analyzed by a one way no parametric Kruskal-Wallis and the Mann-Whitney tests. Significance was considered when p<0.05 Results: No significant toxicity directly related to the preparation was detected. Micronucleus count, mucous irritation score, and pyrogenicity were negative. Pathology demonstrated no damage related to the formulation after subconjunctival injection. After intravitreal injection, only lens injury associated with the technique was observed. Retinal function was also conserved in electroretinography. (ERG). Conclusions: The preparation evaluated offers a good toxicity and safety profile when injected in a subconjunctival or intravitreal manner in an animal model. A clinical trial conducted in humans is highly warranted, as it could reveal an alternative immunosuppressive treatment for ophthalmological immune-mediated pathologies.