Registration Dossier
Registration Dossier
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EC number: 226-323-9 | CAS number: 5351-04-2
Endpoint summary
Administrative data
Description of key information
Oral (Acute toxic class method), rat: LD50: 500 - 2000 mg/kg bw
Key value for chemical safety assessment
Additional information
Acute oral toxicity
In an acute oral toxicity study performed according to EU B.1 modified according to OECD 423, 3 male Wistar rats were administered 2000 mg/kg bw of the test substance (99.6% pure) in olive oil per gavage as the starting dose. As all animals died within the first day, doses of 200 and 500 mg/kg bw were tested subsequently in 3 males and 3 females, respectively. No animal died in these dose groups. All animals were observed for clinical signs for 14 days and necropsied. No signs of toxicity were noted in the low dose groups. Impaired or poor general state, dyspnoea, staggering, piloerection, tremor and exophthalmos were observed in the mid dose group, but all animals were without symptoms at day 2. In the high dose group, impaired and poor general state, dyspnoea, staggering and piloerection were observed before death. Thus, the LD50 is > 500 and < 2000 mg/kg bw. The study is suitable for assessment as it was performed according to guideline under GLP conditions.
Justification for classification or non-classification
Dangerous substance Directive (67/548/EEC)
The available experimental test data are considered reliable and suitable for the purpose of classification. Based on the criteria for classification of Directive 67/548/EEC, as amended for the 28thtime in Directive 2001/59/EC, classification for acute oral toxicity is warranted as “R 22”.
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for the purpose of classification. Based on the criteria laid down in Regulation (EC) No. 1272/2008, as amended for the 2ndtime in Directive EC 286/2011, classification for acute oral toxicity is warranted as “category 4".
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