Cinc eines centrades per a les operacions europees regulades.

FINAL STUDY REPORT

Acute oral toxicity study of NX-417 in Wistar Han rats (acute toxic class method)

Test guideline

The study was performed according to OECD Guideline for the Testing of Chemicals No. 423, Acute Oral Toxicity: Acute Toxic Class Method (adopted 17 December 2001), without deviation.

Statement of GLP compliance

This study was conducted in compliance with the OECD Principles of Good Laboratory Practice (as revised in 1997).

Test system

Species	Rat
Strain	Wistar Han (RccHan:WIST)
Sex	Female, nulliparous and non-pregnant

Route and administration

Route of administration: oral, by gavage. Vehicle: Corn oil (Batch CO-2291), dose volume 10 mL/kg body weight.

Three sequential steps of three females each: 300 mg/kg bw (Step 1), 300 mg/kg bw (Step 2) and 2000 mg/kg bw (Step 3).

Conclusion

The acute oral LD50 cut-off value of NX-417 in female Wistar Han rats is 500 mg/kg body weight. NX-417 meets the criteria for classification as Acute Toxicity Category 4 (H302: Harmful if swallowed).