Registration Dossier

Administrative data

Description of key information

OECD 423, rat, oral: LD50 > 2000 mg/kg bw; LD50 cut-off > 5000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
2 000 mg/kg bw
Quality of whole database:
GLP Guideline study with no restrictions.

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

There is a reliable GLP guideline study (OECD 423) available assessing acute toxicity via the oral route (Latour, 2016). The most relevant route of exposure based on handling experience had been chosen for testing. Two subsequent groups of 3 female rats were treated with the limit dose of 2000 mg/kg bw by oral gavage. No mortality occurred. Hunched posture and/or piloerection were noted for the animals on Day 1 and/or 2. No effects on body weight gain were observed during the course of the study. The animals were sacrificed after the observation period of 14 days and subjected to necropsy. No internal abnormalities were found at the macroscopical post mortem examination.

Based on these results, the LD50 was established to exceed 2000 mg/kg body weight. According to the OECD 423 test guideline the LD50 cut-off was considered to exceed 5000 mg/kg body weight.

Justification for selection of acute toxicity – oral endpoint
There is only one study available.

Justification for classification or non-classification

According to the criteria of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments) and Regulation (EC) No 1271/2008 on classification, labelling and packaging of items and mixtures (including all amendments) the test item does not have to be classified for acute toxicity via the oral route. The available data is conclusive but not sufficient for classification.