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Administrative data

Description of key information

LD50 (oral, rat) > 5000 mg/kg b.w

LD50 (dermal, rat) > 5000 mg/kg b.w

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 adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Additional information

ACUTE ORAL TOXICITY

The oral acute toxicity study was performed according to an internal method: a group of male white rats was treated with a single dose of 5000 mg/kg b.w. test substance, diluted with DMSO and administered by oral intubation.

The acute oral LD50 of the substance in rats was found to be more than 5000 mg/kg b.w..

ACUTE DERMAL TOXICITY

The dermal acute toxicity study was performed according to an internal method: a group of male white rats was treated with a single dose of 5000 mg/kg b.w. by dermal route. Gauze pads with the test substance were applied for 4 hours on the skin of the back of animals and the treated skin areas were not washed after the exposure.

The acute dermal LD50 of the substance in rats was found to be more than 5000 mg/kg b.w.

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

In the case of dermal exposure route, the acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories are:

-Category 1: ATE ≤ 50 mg/kg bw

-Category 2: 50 < ATE ≤ 200 mg/kg bw

-Category 3: 200 < ATE ≤ 1000 mg/kg bw

-Category 4: 1000 < ATE ≤ 2000 mg/kg bw

The acute oral and dermal LD50 in rats were found to exceed 5000 mg/kg bw in both cases.

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