Registration Dossier

Administrative data

Description of key information

A single dose of the test item was administered by gavage at concentrations up to 3200 mg/kg bw and topically at concentrations up to 10000 mg/kg bw. Mortality occurred at concentrations from 1400 mg/kg bw (orally) or 5000 mg/kg bw (dermally) onward. Signs of toxicity as wells as effects on liver and urinary bladder were recorded in deceased animals. Scheduled sacrificed animals in both studies did not show any adverse findings. The LD50 after oral administration is therefore considered to be 1694 mg/kg bw and after dermal application 6929 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
1 694 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:
6 929 mg/kg bw

Additional information

A single dose of the test item was administered by gavage to female Wistar rats at concentrations up to 3200 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 up to 10000 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.

Mortality occurred at concentrations from 1400 mg/kg bw (orally) or 5000 mg/kg bw (dermally) onward. After oral administration of the substance, there were signs of toxicity about 5 minutes after the intubation. The animals which died showed fatty liver infiltration and dilation of the bladder (starting at 1800 mg/kg) as well as mucous content of the intestine (starting at 2000 mg/kg). Effects on liver and urinary bladder were also observed in deceased animals after topical application (starting at 6400 mg/kg bw). Scheduled sacrificed animals in both studies did not show any adverse findings.

The LD50 after oral administration is therefore considered to be 1694 mg/kg bw and after dermal application 6929 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 considered to be classified for acute oral toxicity under Directive 67/548/EEC. The substance is not considered to be classified for acute dermal or inhalation 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 considered to be classified for acute oral toxicity under Regulation (EC) No. 1272/2008 as amended for the fifth time in Directive EC 944/2013.

The substance is not considered to be classified for acute dermal or inhalation toxicity under Directive 67/548/EEC.