Registration Dossier

Administrative data

Description of key information

The substance is practically non-toxic after single oral exposure (LD50 rat: > 5000 mg/kg bw) or after single dermal exposure (LD50 rat: > 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:
discriminating dose
5 000 mg/kg bw
Quality of whole database:
The study is GLP compliant and is of high quality (Klimisch score=1)

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:
discriminating dose
2 000 mg/kg bw
Quality of whole database:
The study is GLP compliant and is of high quality (Klimisch score=1)

Additional information

The acute oral toxicity of the substance was low with a LD50 value exceeding 5000 mg/kg bw in rats according to OECD TG 423 (Gillissen, 2010a). A single oral administration of the test substance by gavage to male and female rats at a dose of 2000 mg/kg bw was tolerated without mortalities, clinical signs, effects on body weight gain or gross pathological findings.

The acute dermal toxicity of the substance was low with a LD50 value exceeding 2000 mg/kg bw in rats according to OECD TG 402 (Gillissen, 2010b). Single semiocclusive administration of 2000 mg/kg bw for 24 hours was tolerated without mortalities, clinical signs, effects on body weight gain or gross pathological findings.


Justification for selection of acute toxicity – oral endpoint
Only one study available

Justification for selection of acute toxicity – dermal endpoint
Only one study available

Justification for classification or non-classification

Based on the study results a classification according to Regulation (EC) No.1272/2008 (CLP) is not required.