Registration Dossier
Registration Dossier
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EC number: 234-054-3 | CAS number: 10519-11-6
Endpoint summary
Administrative data
Description of key information
The oral LD50 was determined to be >5000 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:
- 5 000 mg/kg bw
- Quality of whole database:
- The acute oral toxicity of the test item was determined in a limit test using the acute toxic class method. The study is reliable without restriction (Klimisch 1) as it was GLP-compliant and was conducted according to OECD Guideline 423.
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
The acute oral toxicity of the test item was determined in a limit test using the acute toxic class method (2016). The test item dose (5000 mg/kg bw) was administered at a volume of 10 mL/kg bw in a corn oil vehicle by oral gavage. One female Sprague-Dawley rat was administered the dose in Step 1 and no mortality was observed after 3 days. Based on this result, two animals were administered the same dose and observed for 14 days. The oral LD50 was determined to be >5000 mg/kg bw. The study is reliable without restriction (Klimisch 1) as it was GLP-compliant and was conducted according to OECD Guideline 423.
Justification for classification or non-classification
One key study (Klimisch 1) is available for acute oral toxicity classification (2016). The oral LD50 was determined to be >5000 mg/kg bw in a limit test using the acute toxic class method. Therefore, according to "Guidance on the Application of the CLP Criteria" (ECHA 2015), the test item is not classified for acute oral toxicity.
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