Registration Dossier

Administrative data

Description of key information

Oral: LD50 > 2000 mg/kg bw  for rat (limit test) (OECD 420).
Dermal: LD50 > 2000 mg/kg bw for rabbit (limit test) (OECD 402).
Inhalation: LC50 > 2000 mg/m³ (limit test)

Key value for chemical safety assessment

Additional information

A key study for acute oral toxicity was conducted according to OECD 420 and GLP guidelines in female Sprague-Dawley rats at a dose level of 2000 mg/kg (Sanders, 2007a). There were no deaths, nor any signs of systemic toxicity. The acute oral median lethal dose (LD50) was greater than 2000 mg/kg body weight.

A key study for acute inhalation toxicity was conducted in male and female Sprague-Dawley rats by 4-hour nose-only exposure to 2000+560 mg/m³ under GLP conditions (Dupont, 2005). No notable clinical signs of toxicity were observed in animals immediately following exposure and no animals died. Under the conditions of exposure, the approximate lethal concentration (ALC) and the median lethal concentration are greater than 2000 mg/m³ air. Additional weight of evidence was found in literature, however there were no data on concentration nor were there details on the materials and methods (Klimisch score 4). These data were therefore not used for assessment.

Finally, a key study for acute dermal toxicity was conducted in male and female Sprague-Dawley rats according to OECD 402 and GLP guidelines (Sanders, 2007b). A 24-hour, semi-occluded dermal application of the undiluted test material applied to intact skin at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. There were no deaths, nor any signs of systemic toxicity or dermal irritation. All animals showed expected gains in bodyweight over the study period. No abnormalities were noted at necropsy. The acute dermal median lethal dose (LD50) of the test material in the rat was greater than 2000 mg/kg bodyweight.

Justification for classification or non-classification

As the oral/dermal LD50 and inhalation LC50 values were higher than the limit dose/concentration, classification for acute toxicity is not warranted.