Registration Dossier

Administrative data

Description of key information

Oral: LD50(rat, f) > 2000 mg/kg bw (OECD 423, GLP)

Dermal: no study available

Inhalation: no study available

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
The available data comprise one study conducted following an OECD Guideline and under GLP conditions, with no or no relevant deviations or deficiencies which may affect the validity and reliability of the study results. Therefore, the available data are sufficient to fulfil the endpoint specific standard information requirements of Regulation (EC) No 1907/2006 (REACH) and are likewise sufficient for the purpose of classification and labelling in accordance with Regulation (EC) 1272/2008 (CLP).

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute oral toxicity

The acute oral toxicity of the substance was tested in rats in a study following OECD Guideline 423 and under GLP conditions. No mortality occurred. No clinical signs and no test item-related changes in body weight were observed. There were no macroscopic necropsy findings. The oral LD50 of the test material in female rats was thus determined to be > 2000 mg/kg bw.

Justification for classification or non-classification

The available data indicate that the substance does not meet the classification criteria for acute oral toxicity in accordance with Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). There is no information available on acute dermal and inhalation toxicity.