Registration Dossier

Administrative data

Description of key information

A single dose of the test item was administered orally or dermally to Wistar rats at concentrations of 2000 mg/kg bw. No mortality occurred. Clinical signs of toxicity, i.e. hunched posture, ruffled fur and emaciation were observed after oral administration in male and female animals. Gross necropsy did not reveal any findings. The LD50 is therefore considered to be > 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 adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

A single dose of the test item was administered by gavage to male and female rats at concentrations of 2000 mg/kg bw. The animals were observed for 14 days. Mortality, body weight and clinical signs were recorded continuously. Organ weighing and gross necropsy was performed after scheduled sacrifice.

A single dose of the test item was applied onto skin of male and female Wistar rats at concentrations of 2000 mg/kg bw. The animals were observed for 14 days. Mortality, body weight and clinical signs were recorded continuously. Organ weighing and gross necropsy was performed after scheduled sacrifice.

No mortality occurred in any of the two studies. Clinical signs of toxicity, i.e. hunched posture, ruffled fur and emaciation were observed after oral administration in male and female animals. Gross necropsy did not reveal any findings. The LD50 is therefore considered to be > 2000 mg/kg bw.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for acute toxicity under Directive 67/548/EEC.

                               

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

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for acute toxicity under Regulation (EC) No. 1272/2008.