Registration Dossier
Registration Dossier
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EC number: 614-050-1 | CAS number: 67330-25-0
Endpoint summary
Administrative data
Description of key information
Oral (Rat-Wistar): LD50 males = 1020 mg/kg, LD50 females = 1680 mg/kg (suspended in peanut oil)
[Toxikologisches Institut für Troponwerke, Scientific Report No. 10532, 1981-06-04]
Additionally results of acute toxicity studies with Flufenaminsäurebutylester (Butyl flufenamate) suspended in 1% carboxymethylcellulose are cited in RTECS database (May 2011) and can be found in (Oyo Yakuri. Pharmacometrics (Oyo Yakuri Kenkyukai, CPO Box 180, Sendai 980-81, Japan) V.1- 1967- v. 18, p. 845, 1979 (OYYAA2)):
Oral (rat): LD50 = 510 mg/kg
Oral (mouse): LD50 = 3100 mg/kg
Oral (dog): LD50 > 16000 mg/kg
Oral (rabbit): LD50 = 4800 mg/kg
Dermal (rat): LD50 > 5000 mg/kg
Dermal (mouse): LD50 > 3000 mg/kg
Dermal (dog): LD50 > 1000 mg/kg
Dermal (rabbit): LD50 > 4000 mg/kg
Intraperitoneal (rat): LD50 = 4550 mg/kg
Intraperitoneal (mouse): LD50 = 4100 mg/kg
Intraperitoneal (dog): LD50 = 1500 mg/kg
Intraperitoneal (rabbit): LD50 = 11500 mg/kg
Subcutaneous (rat): LD50 > 5000 mg/kg
Subcutaneous (mouse): LD50 > 10000 mg/kg
Subcutaneous (dog): LD50 = 9300 mg/kg
Subcutaneous (rabbit): LD50 > 10000 mg/kg
Intravenous (rat): LD50 = 650 mg/kg
Intravenous (mouse): LD50 = 610 mg/kg
Key value for chemical safety assessment
Additional information
The acute oral toxicity of Flufenaminsäurebutylester was studied in rats, mice, dogs and rabbits.
The acute oral LD50 for rats was determined to be 1020 mg/kg (males) or 1680 mg/kg (females) (suspended in peanut oil) or 510 mg/kg (suspended in 1% carboxymethylcellulose), respectively.
The acute dermal toxicity of Flufenaminsäurebutylester was studied in rats, mice, dogs and rabbits.
The acute dermal LD50 for rats was determined to be greater than 5000 mg/kg (suspended in 1% carboxymethylcellulose).
The acute intraperitoneal toxicity of Flufenaminsäurebutylester was studied in rats, mice, dogs and rabbits.
The acute intraperitoneal LD50 for rats was determined to be 4550 mg/kg (suspended in 1% carboxymethylcellulose).
The acute subcutaneous toxicity of Flufenaminsäurebutylester was studied in rats, mice, dogs and rabbits.
The acute subcutaneous LD50 for rats was determined to be greater than 5000 mg/kg (suspended in 1% carboxymethylcellulose).
The acute intravenous toxicity of Flufenaminsäurebutylester was studied in rats and mice.
The acute intravenous LD50 for rats was determined to be 650 mg/kg (suspended in 1% carboxymethylcellulose).
Justification for classification or non-classification
Based on the study results Flufenaminsäurebutylester has to be classified according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008 (CLP) as harmful if swallowed (Xn, R22) and as acute oral toxic, category 4 (H302), respectively.
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