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EC number: 240-642-0 | CAS number: 16587-71-6
Acute oral toxicity: a study similar to OECDTG401: LD50 = 4700 mg/kg bw
Acute inhalation toxicity LC50 route to route extrapolation = 12200 mg/m3
Acute dermal toxicity: a study similar to OECDTG402: LD50 = 4700 mg/kg bw
A pre-guideline study, equivalent to OECD guideline 401, was performed to identify the acute oral toxicity of the test substance. In this study 10 rats (sex unspecified) were administered with 3.2, 4.0, 5.0 and 6.3 g/kg bw. 3/10, 6/10 and 9/10 animals died in the 7 day observation period after exposure to 4.0, 5.0 and 6.3 g/kg respectively. Directly after dosing stimulation and ataxia (uncoordinated movements) were seen. Enteritis (inflammation of the gut) was seen at gross pathology. Under the conditions of the test, the acute oral LD50 for the test substance in rat was determined to be 4700 mg/kg bw. Based on these results, the test substance is not considered to be acute harmful.
A pre-guideline study, equivalent to OECD guideline 402, was performed to identify the acute dermal toxicity of the test substance. In this study 6 rabbits (sex unspecified) were administered 3.2, 4.0, 5.0 and 6.3 g/kg bw test substance on the skin. 1/6, 5/6 and 6/6 animals died in the 7 day observation period after exposure to 4.0, 5.0 and 6.3 g/kg respectively. Clinical signs was ataxia and hemorrhagic enteritis during gross pathology. Under the conditions of the test, the acute dermal LD50 for the substance in rabbits was 4700 mg/ kg bw. Based on these results, the test substance is not considered to be acute harmful.
Acute oral toxicity
Acute inhalation toxicity
The acute inhalation toxicity for the substance can be derived using data on the acute oral toxicity using the following methodology: CLP guidance (2017; 22.214.171.124.8. Example 8, page 264): using the extrapolation formula 1 mg/kg bw = 0.0052 mg/L/4h. The LD50 of the substance for acute oral toxicity is 4700 mg/kg bw. This value can be converted to 24.44 mg/L or 24.44 g/m3. Taking into account the inhalation absorption as 100% and oral absorption 50%, the acute inhalation toxicity would become 12.22 g/m3 = 12220 mg/m3. The maximum saturated vapour concentration for the substance is 287 mg/m3 (4.2 Pa (vapour pressure) x 168.28 (MW)) / (8.3 (R, gas constant) x 297 (°K)). This means that the substance cannot reach a concentration higher than 287 mg /m3. The extrapolated inhalation LC50 cannot be reached because it exceeds the saturated vapour pressure by more than a factor of 42.
Acute dermal toxicity
Based on the available information classification and labelling for acute oral, dermal and inhalation toxicity is not warranted in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008 and its amendments.
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