Registration Dossier

Administrative data

Description of key information

Only one acute oral toxicity (limit test; Val 4; no guideline followed) and one acute dermal toxicity (limit test; Val 4; no guideline followed) studies are available. In both studies, the LD50 was greater than 2000 mg/kg bw in male and female SD rats (TNO-CIVO, 1990). 

Key value for chemical safety assessment

Additional information

- Acute oral toxicity

In the available study, the test substance (prepared in 20% maize oil [w/v]) was administered to 5 rats per sex by gavage at 2000 mg/kg bw (limit test). Animals were observed for 14 days after treatment (no further details available). No deaths, clinical signs of toxicity or treatment-related macroscopic lesions were observed. Therefore, the LD50 is greater than 2000 mg/kg bw after acute oral administration to rats.

 

- Acute inhalation toxicity

No data available. Given the very low vapour pressure of the test substance, human exposure via inhalation is probably not relevant.

 

- Acute dermal toxicity

In the available study, the test substance (prepared in 20% maize oil [w/v]) was applied to skin sites of 5 rats per sex for 24 hours at 2000 mg/kg bw (limit test). Animals were observed for 14 days after treatment (no further details available). No deaths or clinical signs of toxicity were observed. Therefore, the LD50 is greater than 2000 mg/kg bw after acute dermal treatment of rats.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available experimental test data is reliable and suitable for the purpose of classification under Directive 67/548/EEC. Based on the data, classification for acute toxicity is not warranted under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.

 

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008. Based on the data, classification for acute toxicity is not warranted under Regulation (EC) No.1272/2008.