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Administrative data

Description of key information

LD50 (oral) > 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

The following data was obtained for the Similar Substance 01. It is expected that the Target substance will present similar acute oral toxicity. Justification for the use of a read-across approach is provided in Section 13 of IUCLID.

Groups of 10 male Wistar rats received single oral doses (3100 or 5000 mg/kg bw) of the test item dissolved in water and were observed for 14 days. Rats dosed with 3100 mg/kg bw tolerated the treatment without clinical signs or mortality. All 10 rats dosed with 5000 mg/kg bw showed sedation and poor general condition within 2 to 6 days after application of the test item, 4/10 died.

Therefore, the LD50 (oral) is > 5000 mg/kg bw.

Justification for classification or non-classification

The CLP Regulation (EC) No. 1272/2008 defines acute toxicity 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 of the substance is warranted under the CLP Regulation (EC) No. 1272/2008.


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