Registration Dossier
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EC number: 236-007-2 | CAS number: 13093-17-9
Endpoint summary
Administrative data
Description of key information
Acute oral toxicity: The oral LD50 in female Wistar rats was estimated to be greater than 2248 mg/kg bw (equivalent to 2000 mg active ingredient/kg bodyweight) in a study conducted according to OECD Guideline 420 and EU Method B.1 bis (Bradshaw, 2013).
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 toxicity: oral
Bradshaw (2013) investigated the acute oral toxicity via the oral route (fixed dose method) (K1study). Following a sighting test at dose levels of 338 mg/kg and 2248 mg/kg (equivalent to 300 and 2000 mg/kg active ingredient/kg bodyweight, respectively), a further group of four fasted females was given a single oral dose of test item, as a solution in distilled water, at a dose level of 2248 mg/kg bodyweight (equivalent to 2000 mg active ingredient/kg bodyweight).
The acute oral median lethal dose (LD50) of the test item in female Wistar strain rat was estimated to be greater than 2248 mg/kg bodyweight (equivalent to 2000 mg active ingredient/kg bodyweight).
No mortality was observed. At 338 mg/kg (equivalent to 300 mg active ingredient/kg bodyweight) no signs of systemic toxicity were noted during the observation period (1 animal) . At 2248 mg/kg (equivalent to 2000 mg active ingredient/kg bodyweight) no signs of systemic toxicity were noted during the observation period of the initial treated animal.
Hunched posture was noted up to one hour after dosing in four females of the additional group and persisted up to four hours after dosing in one of these females. Noisy respiration was also noted in one animal of the additional group from four hours after dosing to day 2. The animal showed expected gains in bodyweight over the observation period. No abnormalities were noted at necropsy.
Justification for selection of acute toxicity – oral endpoint
Only one study is available for this endpoint. The LD50 is considered to be greater than 2000 mg/kg bw.
Justification for classification or non-classification
According to the available data and the criteria of the CLP and DSD Regulation, cerium tetranitrate should not be classified for acute oral toxicity.
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