Registration Dossier

Administrative data

Description of key information

The test item was tested for acute oral toxicity according to OECD 423. The LD50 was estimated to be > 2000 mg/kg bw in male and female rats. 
The test item was tested for acute dermal toxicity according to OECD 402. The LD50 was estimated to be > 2000 mg/kg bw in male and female rats.

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
Quality of whole database:
GLP and guideline compliant study.

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:
GLP and guideline compliant study.

Additional information

Acute oral toxicity

The aim of the study was to investigate acute toxic effects of the test item after a single peroral administration to Sprague-Dawley rats according to the OECD 423. Administration of 200 and 2000 mg/kg bw were performed once per gavage to 3 males and 3 females, respectively. No clinical signs of toxicity and no mortality were observed within the observation period of 14 days. The LD50 was estimated to be > 2000 mg/kg bw.

Acute dermal toxicity

The aim of the study was to investigate acute toxic effects of the test item after a single dermal administration to rats according to the OECD 402. Administration of 2000 mg/kg bw were performed once under semi-occlusive conditions to 5 males and 5 females, respectively. No mortality and no signs of clinical toxicity were observed within the observation period of 14 days. The LD50 was estimated to be > 2000 mg/kg bw.

Acute inhalation toxicity

There is no study available for acute inhalation toxicity.


Justification for selection of acute toxicity – oral endpoint
GLP and guideline compliant

Justification for selection of acute toxicity – dermal endpoint
GLP and guideline compliant study.

Justification for classification or non-classification

No mortality and no toxic effects of the test item were observed during the study period. The test item is therefore classified as "not acute toxic" after oral application according to the Directive 67/548/EEC (DSD) and the Regulation (EC) No 1272/2008 (CLP).

No mortality and no toxic effects of the test item were observed during the study period. The test item is therefore classified as "not acute toxic" after oral application according to the Directive 67/548/EEC (DSD) and the Regulation (EC) No 1272/2008 (CLP).

There is no study available for acute inhalation toxicity.