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Administrative data

Description of key information

oral LD50 in rats > 15000 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:
15 000 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

The evaluation of Acute toxicity of the substance has been based on a study conducted on the Similar Substance 01. The complete hypothesis and justification for the read across approach has been attached in section 13.

Despite the key study was not carried out according to a OECD Guideline, but to an internal method, the test turns out to be sufficiently detailed (even if pathology was not performed). Groups of 5 male and 5 female rats were treated with various single doses of the compound, diluted in distilled water by gavage. Symptoms and mortality after administration were recorded during an observation period of 8 days.

The acute oral LD50 in rats was established to be greater than 15000 mg/kg.

Justification for selection of acute toxicity – oral endpoint

The test results/procedures described do not totally comply with a testing guideline (OECD 401) but they are sufficient in quantity and quality to permit an evaluation of the effects of the test substance.

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 15000 mg/kg bw.

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