Registration Dossier

Administrative data

Description of key information

oral
rat: LD50 > 2200 mg/kg bw, no mortalities (GLP, OECD 401, BASF 1991)
dermal
rat: LD50 > 2000 mg/kg bw, no mortalities (GLP, OECD 402, BASF 1991)

Key value for chemical safety assessment

Additional information

oral

In an acute oral toxicity limit test following GLP requirements and according to OECD test guideline 401, groups of five fasted, young adult Wistar rats per sex were given a single oral dose of Keroflux ES 3241 (purity not reported) in olive oil at a dose of 2200 mg/kg bw in 5mL/kg bw and observed for 14 days (BASF AG 1991). No mortalities, unregular body weight changes or necropsy findings were observed. Dyspnoe, staggering, piloerection, impaired general state and apathy were the observed reversible clinical signs.The oral LD50 is therefore considered to be >2200 mg/kg bw.

dermal

In an acute dermal limit test following GLP requirements and according to OECD test guideline 402, groups of five young adult Wistar rats per sex were dermally exposed to Keroflux ES 4132 (unchanged; purity not reported) for 24 h under semiocclusive conditions at a dose of 2000 mg/kg bw. Animals then were observed for 14 days. No mortalities, unregular body weight changes, clinical signs, local effects or necropsy findings were observed. The dermal LD50 is therefore considered to be >2000 mg/kg bw.

inhalative

no route of exposure

Justification for classification or non-classification

No classification for acute oral or dermal toxicity according to 67/548/EEC and UN-GHS, respectively, is warranted since no specific signs of toxicity were observed at doses of 2200 or 2000 mg/kg bw.