PMC full text:
Published online 2023 Jun 26. doi: 10.2903/j.efsa.2023.8031
Table C.2
Statistically significant parameter/endpoint | Finding | GMO Panel interpretation |
---|---|---|
Body weight and body weight gain | Decreased (5–20%) in the 3% groups, at some timepoints. | No significant change in body weight at the end of the study. No dose response, not present in the 10% groups. Not an adverse effect of treatment. |
Food consumption and utilisation | Decreased (5–20%) in the 10% groups, at some timepoints. | No significant change in body weight at the end of the study. Not an adverse effect of treatment. |
Motor skills and activity | Increases and decreases at different measurement points in all COT102 groups. | No significant changes in the overall values. Within normal variation for these parameters. Not an adverse effect of treatment. |
Mean cell haemoglobin concentration | Decreased (< 5%) in females of the 10% group. | Small magnitude. No impact on total haemoglobin (higher than controls). Not an adverse effect of treatment. |
Neutrophil count | Decreased in males and increased in females of the 3% groups. | No consistent pattern. No dose response, not present in the 10% groups. Not an adverse effect of treatment. |
Alanine aminotransferase (ALT) activity | Decreased (25%) in the 10% groups. | Decreased ALT is not an adverse finding in isolation. No associated changes (e.g. liver pathology). Not an adverse effect of treatment. |
Sodium levels | Increased (2%) in the 3% groups. | No dose response, not present in the 10% groups. Not an adverse effect of treatment. |
Ovary weight | Increased (12%) in 3% females. | Small magnitude. No associated pathological changes. No dose response, not present in the 10% group. Not an adverse effect of treatment |
Spleen weight | Decreased (5%) in females and increased (15%) in males of the 10% groups. | No consistent pattern across the sexes. Small magnitude with no associated changes in pathology or haematology. Not an adverse effect of treatment. |