Registration Dossier

Administrative data

Description of key information

Acute oral toxicity, LD50: > 2000 mg/kg bw

Acute dermal toxicity: not available

Acute inhalatory toxicity: not available

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 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

Additional information

Acute Oral Toxicity

The acute toxicity of the substance was investigated following a single oral administration to the Sprague Dawley rat followed by a 14-day observation period, according to OECD 423.

No mortality occurred and no clinical signs were observed.

Body weight changes recorded during the study were within the expected range for this strain and age of animals.

No abnormalities were observed at necropsy examination performed at the end of the observation period on animals of both groups.

The lack of mortality demonstrates the acute toxicity expected (ATE) to be greater than 2000 mg/kg body weight.

Justification for classification or non-classification

Acute oral toxicity

According to the CLP Regulation 1272/2008/EC, 3.1.2.1 section, 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 shown in Table 3.1.1:

Oral (mg/kg body weight)

Category 1: LD50 ≤ 5

Category 2: 5 <LD50 ≤ 50

Category 3: 50 < LD50 ≤ 300

Category 4: 300 < LD50 ≤ 2 000

The oral LD50 value is > 2000 mg/kg/body weight.

The substance is not classified for oral toxicity because it doesn't meet the classification criteria of the CLP regulation n.1272/2008.