Registration Dossier

Administrative data

Description of key information

LD50 (oral, rat) > 2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
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 assessed following oral administration, in Sprague Dawley rats, by the fixed dose method according to the OECD Guideline No.420 (1992) and the Method B.1 bis of the Directive of the Commission of European Communities 92/69/EEC. The substance was administered at the dose of 2000 mg/kg.

None of the animals treated at the dose of 2000 mg/kg died in the course of the Study. The only observations made on the day of treatment and the following day were diarrhoea and the excretion of black-coloured faeces by all the animals. The evolution in bodyweight of all the animals was normal. In the necropsies. there were no macroscopic alterations detected.

The LD50 (oral, rat) was found to be greater than 2000 mg/kg bw.

Justification for classification or non-classification

In the CLP Regulation (EC 1272/2008) acute toxicity is defined as “those adverse effects occurring following oral or dermal administration of a single dose of a substance or a mixture, or multiple doses given within 24 hours, or an inhalation exposure of 4 hours”. A substance can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route. The numeric criteria based on the acute toxicity estimates (ATE) in mg/kg bodyweight are presented in Annex I, Part 3, Table 3.1.1. For acute oral toxicity: "Category 4: 300 < ATE ≤ 2 000".

Based on the available experimental data of acute oral toxicity (LD50 > 2000 mg/kg bw), no classification for acute oral toxicity is warranted under the CLP Regulation (EC) no. 1272/2008.