Registration Dossier
Registration Dossier
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EC number: 944-856-1 | CAS number: -
Endpoint summary
Administrative data
Description of key information
LD50 > 5000 mg/kg bw
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
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
There are no experimental available data of the target substance, thus the information on the Similar Substance 01 was taken into account. Similar Substance 01 is a monocostituent substance with the same chemical structure of one of the two costituent of the target substance. The differences occurring between the two substances are not expected to significantly impact the Acute Oral Toxicity,therefore the Read Across is considered as representavive and appropriate (details in the document attached to the IUCLID section 13).
Two studies are available for the assessment of acute administration by oral route.
In the key study the substance was tested for acute toxicity by oral route to male and female Wistar rats. The LD50 was greater than 5000 mg/kg bw (3900 mg/kg bw based on active ingredient) for male and female rats. No signs of intoxication were observed.
In the supporting study the substance was administered by gavage to rats at a dose rate of 20 ml/kg; equivalent to 5000 mg/kg bw. No clinical symptoms were recorded and no deaths occurred during the 14 day observation period. At autopsy no changes in organs or tissues caused by the administration of the test compound were seen. The LD50 was greater than 5000 mg/kg bw.
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
No symptoms has been registered and no mortality has been observed in all studies. The LD50 is higher than 3900 mg/kg b.w, therefore no classification for acute toxicity oral is warranted under the CLP Regulation (EC n. 1272/2008).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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