Registration Dossier
Registration Dossier
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EC number: 943-406-1 | CAS number: -
Endpoint summary
Administrative data
Description of key information
OECD 423, rat, oral: LD50 > 2000 mg/kg bw; LD50 cut-off > 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:
- 2 000 mg/kg bw
- Quality of whole database:
- GLP Guideline study with no restrictions.
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
There is a reliable GLP guideline study (OECD 423) available assessing acute toxicity via the oral route (Latour, 2016). The most relevant route of exposure based on handling experience had been chosen for testing. Two subsequent groups of 3 female rats were treated with the limit dose of 2000 mg/kg bw by oral gavage. No mortality occurred. Hunched posture and/or piloerection were noted for the animals on Day 1 and/or 2. No effects on body weight gain were observed during the course of the study. The animals were sacrificed after the observation period of 14 days and subjected to necropsy. No internal abnormalities were found at the macroscopical post mortem examination.
Based on these results, the LD50 was established to exceed 2000 mg/kg body weight. According to the OECD 423 test guideline the LD50 cut-off was considered to exceed 5000 mg/kg body weight.
Justification for selection of acute toxicity – oral endpoint
There is only one study available.
Justification for classification or non-classification
According to the criteria of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments) and Regulation (EC) No 1271/2008 on classification, labelling and packaging of items and mixtures (including all amendments) the test item does not have to be classified for acute toxicity via the oral route. The available data is conclusive but not sufficient for classification.
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