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. 2024 May 15;22(5):e8747. doi: 10.2903/j.efsa.2024.8747

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:
  • GD 0, G3 and G4;

  • GD 7 and 14, G2, G3 and G4;

  • GD 20, G2 and G3

Body weight during lactation n.a. Mean body weight on:
  • LD 1, G2, G3 and G4;

  • LD 4, G2 and G3;

  • LD 7, 14 and 21, G2, G3 and G4

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
  • Mean pH value: G4;

  • Specific gravity: ↑G4

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.