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Diss Factsheets

Administrative data

Description of key information

The acute oral median lethal dose (LD50) of the Precursor PD 206 in the female SD rats was estimated to be > 2000 mg/kg bw  according to OECD guideline 425.

Key value for chemical safety assessment

Additional information

The purpose of this study was to assess the toxicity of the test article following a single oral dose to the rat. Initially one female Sprague Dawley rat was dosed at 2000 mg/kg. No mortality was observed at 2000 mg/kg and in accordance with the guideline the study continued with the dosing of another four females at 2000 mg/kg. Mortality checks were made at least once daily. Clinical observations were recorded prior to dosing, as well as at 30 minutes. 4 hours post-dose, and daily thereafter through Day 15. Body weights were recorded on the day of dosing (Day 1), and on Days 8 and 15. All rats were euthanized by C02 asphyxiation and necropsied on Day 15.

For the dose of 2000 mg/kg, no mortality was observed in any of the animals. Based on the results of this study, the oral LD50 for PD 206 in rats was estimated to be greater than 2000 mg / kg.

Justification for classification or non-classification

Precusor PD 206 should not be classified as acute oral toxicity according to EU CLP regulation and DSD criteria.