28-Day oral (gavage) and 13-week (dietary) toxicity studies of DHA canola oil and DHA canola meal in rats

Omega-3 (omega 3) fatty acids are a family of polyunsaturated fats. Two of the omega 3 long-chain polyunsaturated fatty acids (LC-PUFA), eicosapentaenoic acid (EPA, omega 3, 20:5 Delta 5,8,11,14,17) and docosahexaenoic acid (DHA, omega 3, 22:6 Delta 4,7,10,13,16,19) are sourced primarily from fish. Higher consumption, limited fishing quotas and other environmental factors (e.g., heavy metals) have warranted a need for alternative sources. Nuseed offers a genetically engineered canola (Brassica napus) event,1 DHA canola (OECD Unique Identifier NS-B5empty setempty set27-4), which has been modified to introduce a pathway for production of the (omega 3 LC-PUFAs DHA and EPA from oleic acid (OA) in the seed oil. To accomplish this, genes were sourced from marine microalgae and common yeast then incorporated into canola to produce DHA canola, one of the first land-based production systems for (omega 3 PUFAs. Safety was evaluated in part by conducting a repeated dose 28-day toxicity study and a dietary 13-week toxicity study using CD (R) IGS [Crl:CD(SD)] rats. In the 28-day study, conventional and DHA canola oil were administered orally (via gavage); no treatment-related adverse effects were observed. The 13-week toxicity study was subsequently conducted where DHA canola oil and meal were administered by dietary admixture. No adverse effects were noted in clinical observations, clinical pathology, or histopathology. These studies support the food and feed safety of DHA canola oil and meal.

Automated summary

Omega-3 fatty acids, particularly EPA and DHA, are mostly sourced from fish, but environmental factors and limited fishing quotas have led to the development of alternative sources like genetically engineered DHA canola by Nuseed. Safety assessments through animal studies support the safety of DHA canola oil and meal for food and feed purposes.