Registration Dossier

Administrative data

Description of key information

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:
LD50
Value:
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

Additional information

Acute oral toxicity

An acute oral toxicity study was performed treatingfive male and five female rats with test substance. The study was conducted according to the recommendation of the OECD Guideline 401 (1981). No death occurred after a single administration of 5000 mg/kg which corresponds to the maximum administrable dose level.

A slight hypokinesia was observed after treatment but the behaviour and body weight gain of the animals were not influenced by the treatment.

The macroscopic investigations revealed no lesion in the animals sacrificed at the end of the observation period.

The oral LD50 value of the substance in rats was established to exceed 5000 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 > 5000 mg/kg bw), no classification for acute oral toxicity is warranted under the CLP Regulation (EC 1272/2008).