Registration Dossier
Registration Dossier
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EC number: 947-285-6 | CAS number: -
Endpoint summary
Administrative data
Description of key information
LD50 (oral, rat) > 5000 mg/kg b.w
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 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
No information on the "acute oral toxicity" is available for the Target Substance. However data on Similar Substance 01 has been taken into account for the assessment. More details about the substance similarity are reported in section 13.
The oral acute toxicity study was performed according to an internal method: a group of male white rats was treated with a single dose of 5000 mg/kg b.w. test substance, diluted with DMSO and administered by oral intubation. The acute oral LD50 of the substance in rats was found to be more than 5000 mg/kg b.w.
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 acute oral LD50 in rats was found to exceed 5000 mg/kg bw,therefore the substance is not classified for oral acute toxicity according to the CLP Regulation (EC n. 1272/2008).
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