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Table 1 Oral repeated dose toxicity studies with amorphous silica yielding liver effects

From: Critical review of the safety assessment of nano-structured silica additives in food

Species

Study length

Effect

LOAEL

NOAEL

Reference

Wistar rats

5–8 weeks

Liver atrophy

1000 mg/kg body weight per day

500 mg/kg body weight per day

[29, 30]

Balb/c mice

10 weeks

Fatty liver

1500 mg/kg body weight per day

NA

[31]

Sprague–Dawley rats

12 weeks

Periportal liver fibrosis

810 mg/kg body weight per day

NA

[32]

Fischer rats

103 weeks

Reduced liver weight

1000 mg/kg body weight per day

500 mg/kg body weight per day

[33]

  1. Delivery of particles was by inclusion into the feed. This table proposes LOAEL (lowest observed adverse effect level) and NOAEL (no observed adverse effect level) values that differ from those purported in previous risk assessment reports. Other oral repeated dose studies [25–27] did not elicit adverse effects