Registration Dossier

Administrative data

Description of key information

LD50 > 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

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
No studies on the "Acute Oral Toxicity" are available for the substance in itself nevertheless, two studies were conducted with an analogue molecule (Similar Substance 01). Further information are reported in the Read Across justification attached to section 13.

Additional information

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).

In the case of oral exposure route, the acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories are:

- Category 1: ATE ≤ 5 mg/kg bw

- Category 2: 5 < ATE ≤ 50 mg/kg bw

- Category 3: 50 < ATE ≤ 300 mg/kg bw

- Category 4: 300 < ATE ≤ 2000 mg/kg bw

The acute oral LD50 in rats was established to be greater than 2000 mg/kg bw in both tests, therefore the substance is not classified for acute toxicity, according to the CLP Regulation (EC n. 1272/2008).