Registration Dossier
Registration Dossier
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EC number: 305-488-1 | CAS number: 94552-41-7
Endpoint summary
Administrative data
Description of key information
Based on the results the read across study, the oral LD50 value of the test substance, 'C18-unsatd and C22-unsatd. AAP EDM-ES' is considered to be > 2350 mg a.i./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:
- 2 350 mg/kg bw
- Quality of whole database:
- Good quality
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
A study was conducted to determine the acute oral toxicity of the read across substance, 'C11-unstad. AAP TMA-MS (purity: 47%)', according to the study similar to OECD Guideline 401.In the study, 5 male and 5 female Sprague-Dawley rats were given a single dose of the test substance at a dose of 5000 mg/kg bw (limit test). The test substance was formulated in water and applied in a volume of 10 mL/kg bw. Animals were subsequently observed for 14 consecutive days. There were no deaths following a single oral dose of the test substance. Except of ruffled fur on the day of treatment, the animals were free of clinical/ toxicological signs during the entire observation period of 14 d. Necropsies were performed on all animals at the end of the 14 d observation period. In one animal a slight thickening of the stomach mucosa could be observed. Necropsies of all other animals showed no test compound related macroscopic findings in the cranial, thoracic and abdominal cavity. Under the study conditions, the oral LD50 value of the test substance was determined to be >5000 mg/kg bw (i.e., equivalent to > 2350 mg a.i./kg bw) (Meisel, 1983). Based on the results of read across study, similar oral LD50 value is considered for the test substance, 'C18-unsatd. and C22-unsatd. AAP EDM-ES'.
Justification for classification or non-classification
Based on the results of the read across study, the test substance, 'C18-unsatd and C22-unsatd. AAP EDM-ES' is concluded not to warrant classification for the acute oral toxicity according to the EU CLP criteria (Regulation 1272/2008/EC).
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