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EC number: 946-959-7
CAS number: -
The testing was performed according Method B.1 tris: Acute Oral Toxicity - Acute Toxic Class Method, Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008. Only one study is available (GLP, Klimish score 1)
The aim of the study was to investigate acute toxic effects of the test substance, Acid Black 227, after a single oral administration to Wistar Han rats.
The testing was performed according Method B.1 tris: Acute Oral Toxicity - Acute Toxic Class Method, Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008.
The test substance was administered in a single dose as a suspension in vehicle (Aqua pro iniectione), given orally via gavage to female Wistar rats. The volume of administered suspension was 1 ml/100 g body weight of animals.
The dose level of 2000 mg/kg was used as the starting dose, because no toxicity of the test substance was estimated on the basis of the information from Sponsor.
The dosing was performed sequentially in two groups of three females: group No. 1 - using the starting dose of 2000 mg/kg of body weight. No death of females caused this dose, dose of 2000 mg/kg of body weight was sequentially applied for confirmation to group No. 2.
The test substance administered at the dose of 2000 mg/kg caused no death of animals. Only changes of colour of faeces associated with the colour of the test substance were observed during the clinical observation from the first to the third day after the application. No other clinical signs of intoxication were detected during the whole study in all six animals administered by the dose 2000 mg/kg/body weight.
No pathologic macroscopic changes were diagnosed during pathological examination.
According to the study results the value of LD50 of the test substance, Acid Black 227, for female rats is > 2000 mg/kg of body weight.
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