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Description of key information

Acute Oral LD50 is between 300 mg/kg and 2000 mg/kg
Acute Dermal LD50 is greater than 2000 mg/kg

Key value for chemical safety assessment

Additional information

Acute Oral LD50 is between 300 mg/kg and 2000 mg/kg

Acute Dermal LD50 is greater than 2000 mg/kg

The Acute Oral study evaluated the toxicity of ADONA (Batch No. 140499-8/25) in rats according to the OECD 423 (2001) test guideline. Initially, the test article was administered by oral gavage to 3 female Wistar rats at 2000 mg/kg (active ingredient). In a stepwise procedure, additional groups of females were dosed at 300 mg/kg. Clinical signs were recorded daily for 2 weeks. Body weights were measured on days 1 (pre-dose), 8 and 15 post-dose. Necropsies were performed on day 15 post-dose. Three females in the 2000 mg/kg dose group were found dead between days 1 and 2 post-dose. Hunched posture was noted at both dose levels (300 and 2000 mg/kg). Animals in the 2000 mg/kg treatment group exhibited hunched posture, uncoordinated movements, and piloerection. Animals surviving to necropsy (300 mg/kg treatment group) had a normal body weight gains over the 14-day study period. Macroscopic post mortum examination revealed abnormalities in the stomach among the animals that died during the study. No treatment-related abnormalities were found in the surviving animals at termination. Under the conditions of the test, the acute oral LD50 of the test article was between 300 and 2000 mg/kg. According to the Global Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations, the test article should be classified as: harmful if swallowed (Category 4) for acute toxicity by the oral route.

 

The acute dermal toxicity of ADONA was evaluated in rats according to current OECD, EC, EPA and JMAFF guidelines. The test article was administered to Wistar rats by single dermal application (10% of total body surface, covered with an occlusive dressing) at a dose of 2000 mg/kg as the active ingredient for 24 hours. Clinical observations were performed daily and body weights recorded weekly. Necropsies were performed after terminal sacrifice on Day 15. No deaths occurred. Clinical signs included hunched posture, chromodacryorrhoea, piloerection and erythema and scales at the test site. Body weight gains were normal. No macroscopic abnormalities were observed at necropsy. Under the conditions of the study, the acute dermal LD50 of the test article in rats was greater than 2000 mg/kg as the active ingredient.

Justification for classification or non-classification

ADONA meets the DSD criteria for classification as acutely harmful by the oral route (Xn; R22), and it meets the CLP criteria for classification as Acute Tox. 4 (oral).

 

ADONA does not meet the DSD or the CLP criteria for classification as acutely harmful by the dermal route.

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