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Description of key information

OECD 401, LD50 (oral, rat) > 5000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
5 000 mg/kg bw

Additional information

Acute oral toxicity: an experimental study equivalent to OECD Guideline 401 (1981). Sprague-Dawley rats were administered either 4000 or 5000 mg test item/kg bw (5 female and 5 male animals per dose) and monitored for mortality, clinical symptoms and body weight changes for 15 days, then subjected to gross pathological examination.

The LD50 resulted equal to 5000 mg/kg bw. Based on the read across considerations same results apply to the target substance.

Justification for classification or non-classification

According to Annex I: of the CLP Regulation (EC No. 1272/2008), substances can be allocated to one of four hazard categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria shown in the table below. Acute toxicity values are expressed as (approximate) LD50 (median lethan dose) values for exposure by the oral and dermal routes.

Table 1: Acute toxicity hazard categories defining the respective categories.

Exposure route   Danger Warning
Category 1 Category 2 Category 3 Category 4 No classification
Oral (mg/kg bw) LD50≤ 5 5 < LD50 ≤ 50  50 < LD50 ≤ 300 300 < LD50 ≤ 2000 LD50 > 2000

Based on the available studies, the substance is not classified for acute oral toxicity