Registration Dossier

Administrative data

Description of key information

LD50 > 2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

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

The acute toxicity of the test item was investigated following a single oral administration (10 ml/kg in 0.5% carboxymethylcellulose in water) to the Sprague Dawley rat (6 female animals/group) followed by a 14-day observation period, according to the OECD guideline 423.

A first sub-group of 3 female animals was initially dosed at 2000 mg/kg (step 1). No mortality occurred and a second sub-group of animals, similarly composed, was then dosed at the same dose level (step 2) bringing the group size up to 6 animals.

In both steps mortality did not occur and clinical signs were limited to piloerection (Day 1 and 2) and brown staining on the cage tray (Day 2). Recovery occurred by Day 3.

At the end of the observation period, changes in body weight were within the expected range for this strain and age of animals.

The animals were killed at the end of the observation period and all animals were subjected to necropsy examination.

No external or internal abnormalities were observed in all the animals dosed at 2000 mg/kg (step 1 and 2).

The lack of mortality demonstrates the LD50 to be greater than 2000 mg/kg body weight.

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, therefore, the substance is not classified for oral acute toxicity according to the CLP Regulation (EC n. 1272/2008).