Registration Dossier

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
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
5 000 mg/kg bw

Additional information

ACUTE ORAL TOXICITY

The substance was tested for acute toxicity by oral route administration. Five male rats were tested at concentration of 5000 mg/kg b.w and other five male were used as vehicle control. No mortalities was registered. The LD50 to male rats was found to be greater than 5000 mg/kg bodyweight.

ACUTE DERMAL TOXICITY

The test substance was administered to 10 male rats by skin route at a dosage level of 5000 mg/kg bodyweight. Animals similary treated using water alone served as control. The substance was prepared as a aqueous suspension and administered by spreading evenly over the prepared skin. There were no mortalities. The LD50 in rats observed over period of 14 days was found to be greater than 5000 mg/kg bw.

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).