Registration Dossier

Administrative data

Description of key information

LD50 (oral) > 2000 mg/kg bw (BASF SE, 2015)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
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

In an acute oral toxicity study performed according to the Acute Toxic Class method (OECD guideline 423), doses of 2000 and 300 mg/kg of the test item (preparations in 0.5 % CMC-solution) were administered by gavage to three test groups of three fasted Wistar rats each (2000 mg/kg bw in 6 females, 300 mg/kg bw in 3 females).

No mortality was observed throughout the study period. Clinical signs observed within the first five hours after administration included an impaired general state and piloerection in all animals of the 2000 mg/kg bw dosing group. One animal showed a cowering position. Only one animal of the 300 mg/kg bw dosing group showed an impaired general state and a cowering position while the two other animals were free of any symptoms. The mean body weight of all animals increased within the normal range throughout the study period. There were no macroscopic pathological findings in the animals which were sacrificed at the end of the observation period (9 females). The acute oral LD50 was calculated to be above 2000 mg/kg bw.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. The LD50 was greater than 2000 mg/kg bw. As a result the substance is not considered to be classified for acute oral toxicity under Regulation (EC) No. 1272/2008, as amended for the ninth time in Regulation (EU) No 2016/ 1179.