TABLE F.2 Parameters examined in animals of the parental (P) generation. Only statistically significant changes are reported; ‘–’: no statistically significant changes were observed; Dose groups: G1: 0, G2: 16,000, G3: 20,000, G4: 25,000 mg/kg feed. Unless specified differently, the reported values for the respective parameters are within the historical control ranges.
| Parameters examined | P generation | P generation |
|---|---|---|
| Males | Females | |
| Mortality | – | – |
| Clinical signs | – | – |
| Behavioural examination during lactation | – | – |
| Body weight during pre‐mating period | Changes in mean body weight and body weight gain, but not dose‐related | |
| Body weight during gestational period | n.a. | Mean gestational body weight on:
|
| Body weight during lactation | n.a. | Mean body weight on:
|
| Feed consumption during pre‐mating period | Mean feed consumption: during week 6, ↑G4 | Mean feed consumption: during week 10, ↑G3 and G4 |
| Haematology | Absolute eosinophil count: ↓G3 and G4 | – |
| Clinical biochemistry | – | – |
| Urinalysis |
|
– |
| Thyroid hormone levels | – | – |
| Oestrous cycle data | n.a. | Mean oestrus cycle duration: ↑G2 and G4 |
| Sperm parameters | Sperm with abnormalities: ↑G3 and G4 | n.a. |
| Necropsy and gross pathology | – | – |
| Organ weight | – | Absolute and relative thyroid+parathyroid weights: ↓G3 |
| Histopathology | – | – |
| Pre‐coital time | – | –, but longer than anticipated for Sprague–Dawley rats |
| Litter size | n.a. | –, but a dose‐related trend ↓ was observed |
| Post‐implantation loss | n.a. | –, but a dose‐related trend ↑ was observed |
Abbreviations: ‘–’, statistically not significant; ↑, increase; ↓, decrease; G, dose group; GD, gestational period; LD, lactation day; n.a., not applicable.