Registration Dossier
Registration Dossier
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EC number: 954-598-1 | CAS number: -
Endpoint summary
Administrative data
Description of key information
LD50 > 2000 mg/kg bw
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute Oral Toxicity
One test is available on similar substance 1 .
The test was performed according Method B.1 tris: Acute Oral Toxicity - Acute Toxic Class Method.
The test substance was administered in a single dose as a suspension in vehicle given orally via gavage to female Wistar rats.
The test substance administered at the dose of 2000 mg/kg bwcaused no death of animals. Only changes of colour of faeces associated with the colour of the test substance were observed first and second day during the clinical observation after the application. Soft faeces were observed only on the day of the application. No other clinical signs of intoxication were detected during the whole study in all sixanimals administered by the dose 2000 mg/kg/body weight. No pathologic macroscopic changes were diagnosed during pathological examination.
Justification for classification or non-classification
According to the CLP Regulation (EC 1272/2008), substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).
In the case of oral exposure route, the acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories are:
- category 1: ATE ≤ 5 mg/kg bw
- category 2: 5 < ATE ≤ 50 mg/kg bw
- category 3: 50 < ATE ≤ 300 mg/kg bw
- category 4: 300 < ATE ≤ 2000 mg/kg bw
The substance shall not be classified for Oral toxicity if the LD50 resulted in animal test is > 2000 mg/kg (mg/kg bodyweight). According to the CLP criteria n.1272/2008, the test substance is not classified as toxic for the oral exposure as its LD50 is > 2000 mg/kg bw.
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