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Description of key information

Acute Oral

Under the conditions of this study the estimated acute oral LD50 for male and female rats treated with the test material was determined to be greater than 10.0 g/kg.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
10 000 mg/kg bw

Additional information

Acute Oral

The acute oral toxicity of the test material to rats was investigated under GLP conditions. The study was awarded a reliability score of 2 in accordance with the criteria set forth by Klimisch et al. (1997).

The test material was administered at 10 g/kg by gavage to one group of ten rats (5 per sex) which were fasted for 18 hours prior to dosing. The rats were observed immediately, and at 1 and 4 hours after dosing and daily thereafter for clinical signs and mortality. Body weights were recorded initially and at the time of death. The surviving rats were sacrificed 14 days after dosing by CO2 inhalation and subjected to a gross necropsy.

No mortality was observed at a dose of 10 g/kg. There were no significant clinical signs seen at this dose level. All animals gained weight and no visible lesions were observed in the surviving animals upon terminal necropsy.

Under the conditions of this study the estimated acute oral LD50 for male and female rats treated with the test material was determined to be greater than 10.0 g/kg.

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to acute toxicity via the oral route.