Registration Dossier

Administrative data

Description of key information

LD50 (oral, rat) > 2000 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:
2 000 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.

Similar Substance 01 was tested for acute toxicity in a limit test, according to the EU Method B.1. Three female and three male Wistar rats were administered 2000 mg/kg bw of the test item, and were subsequently observed for mortality, clinical signs and body weight change for 14 days, after which time all surviving animals were sacrificed and subjected to necropsy.

No mortality, clinical signs or body weight change were observed during the study period including the observation period. No macroscopic signs were observed at necropsy. Based on these findings, the LD50 (oral) was found to be greater than 2000 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 > 2000 mg/kg bw), no classification for acute oral toxicity of the substance is warranted under the CLP Regulation (EC) No. 1272/2008.