Registration Dossier

Administrative data

Description of key information

Acute toxicity, oral, Wistar rats (according to OECD TG 423, GLP): LD50 (predicted) > 5000 mg/kg bw. No mortality, no clinical signs or necropsy findings were observed after administration of 2000 mg/kg bw test substance (BASF SE, 2011).
Acute toxicity, dermal, Wistar rats (according to OECD TG 402, GLP): LD50 > 5000 mg/kg bw (mortality 0/10); no clinical signs or necropsy findings were observed (BASF SE, 2011).

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

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

Additional information

Acute toxicity, oral:

The acute oral toxicity of the test substance was evaluated in female Wistar rats according to OECD TG 423 under GLP conditions (BASF SE, 2011). Three rats were dosed with 2000 mg/kg bw in a first step. After no mortality was observed within a 14 observation period another 3 rats were dosed with 2000 mg/kg bw. Again no mortality was observed. In addition, no clinical signs, no body weight changes, and no necropsy findings were observed. According to OECD TG 423 an LD50 (predicted) > 5000 mg/kg bw was deduced.

Acute toxicity, dermal:

The acute dermal toxicity of the test substance was evaluated in male and female Wistar rats according to TG 423 under GLP conditions (BASF SE, 2011). Five male and female rats were administered a dose of 5000 mg/kg bw of undiluted test substance (purity > 99%) to the clipped epidermis (dorsal and dorsolateral parts of the trunk) under a semi-occlusive dressing for 24 hours. Afterwards the test side was washed with warm water followed by a 14 day observation period. Because no mortality occurred a LD50 of > 5000 mg/kg bw was deduced. In addition no clinical signs, local effects or necropsy findings were reported.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available data on acute toxicity of the test substance do not meet the criteria for classification, and are therefore conclusive but not sufficient for classification.

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008:

The available data on acute oral and dermal toxicity of the test substance do not meet the criteria for classification, and are therefore conclusive but not sufficient for classification.