Registration Dossier
Registration Dossier
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EC number: 220-942-8 | CAS number: 2944-06-1
Endpoint summary
Administrative data
Description of key information
LD50 (oral)> 2000 mg/kg bw (rats)
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
In the Key study, the test item was evaluated for acute oral toxicity in Sprague Dawley rats as per OECD Guideline No. 423. The test item was administered by oral gavage as a single dose of 300 mg/kg bw to three female rats in Step-I and 2000 mg/kg bw in Step-II. In Step-I and Step-I confirmation, the animals were dosed with 300 mg/kg body weight did not reveal any clinical signs of toxicity and mortality. In Step-II and Step-II confirmation, the animals dosed with 2000 mg/kg body weight did not reveal any clinical signs of toxicity and mortality.
All the animals were observed for clinical signs of toxicity and mortality at 20 to 30 min, 1 hr (±10 mins), 2 hrs (±10 mins), 3 hrs (±10 mins) and 4 hrs (±10 mins) post dosing on Day 1 and once daily thereafter for clinical signs of toxicity and twice daily for mortality during the 14 days observation period. Body weight was recorded on day 1 before test item administration and on day 8 and 15 during the observation period. The survived animals were necropsied.
No changes were observed in body weight and percent change in body weight with respect to day 1 at 300 mg/kg body weight and 2000 mg/kg body weight. All the surviving animals revealed physiologically normal increase in the body weight. No gross pathological changes were observed in any of the surviving animals.
LD50 cut off value for the test item is 5000 mg/kg body weight, while the LD50 was found to be higher than 2000 mg/kg bw.
Justification for classification or non-classification
The available experimental test data from acute oral toxicity study is used for the assessment of classification of the substance.
LD50 (oral) > 2000 mg/kg bw.
Based on the available data the substance is not classified as harmful/toxic according to the CLP Regulation (EC) No. 1272/2008.
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