Registration Dossier
Registration Dossier
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EC number: 629-754-4 | CAS number: 210988-99-1
Endpoint summary
Administrative data
Description of key information
The oral LD50 in the rat was determined to be greater than 2000 mg/kg.
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 a GLP-compliant acute oral toxicity study performed according to the Acute Toxic Class method (OECD 423), a dose of 2000 mg/kg bw of the test item (preparation in corn oil Ph.Eur.) was administered by gavage to two test groups of three fasted Wistar rats each. No mortalities occurred. Impaired general state and piloerection in all animals occurred within the first 3 days after administration. The body weight of the animals in both test groups increased within the normal range throughout the study period with two exceptions in the first test group. In these two animals the body weights were within the normal range during the first week, but stagnated during the second week. This effect is observed at times in the rat strain used, because in the required age range the female animals have already reached the phase of slow growth. There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period (6 females). The acute oral LD50 was calculated to be > 2000 mg/kg bw.
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008. Based on the data, classification for acute toxicity is not warranted under Regulation (EC) No.1272/2008.
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