Registration Dossier

Administrative data

Description of key information

Acute oral LD50 rat > 2000 mg/kg bw
Acute dermal LD50 rat > 2000 mg/kg bw
Acute inhalation toxicity: no study required, as the MMAD is > 100 µm

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Acute oral toxicity:

An acute oral toxicity study was performed according to OECD Guideline 420 (Sanders, 2010a). Five female Wistar rats were treated with 2000 mg/kg bw test substance in distilled water by single oral gavage. No deaths occurred, no treatment related changes in bodyweight gain and no other clinical signs of systemic toxicity were observed during the 14 day study period. Based on the study results the oral LD50 in rats was greater than 2000 mg/kg bw.

Acute dermal toxicity:

An acute dermal toxicity study was performed according to OECD Guideline 402 (Sanders, 2010b). Groups of five male and five female Wistar rats were dermally exposed to 2000 mg/kg bw test substance moistened with distilled water for 24 hours under semiocclusive conditions. No deaths occurred. One female showed no gain in bodyweight during the first week and bodyweight loss during the second week. One other female showed bodyweight loss during the first week but expected gain in bodyweight during the second week. The remaining animals showed expected gains in bodyweight over the study period. No other clinical signs of systemic toxicity were observed and no skin irritation was observed. Based on the study results the dermal LD50 in rats was greater than 2000 mg/kg bw.

Justification for classification or non-classification

No classification is warranted according to DSD (67/548/EEC) and CLP (1272/2008/EC) classification criteria for acute toxicity.