Registration Dossier
Registration Dossier
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EC number: 950-576-0 | CAS number: -
Endpoint summary
Administrative data
Description of key information
In an acute oral toxicity study with female rats, performed according to OECD 423 and GLP principles, a LD50 >2000 mg/kg bw was determined.
The determination of Acute inhalation toxicity and Acute Dermal toxicity is waived based on exposure considerations and the physicochemical and toxicological properties of SHR 1396.
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
An acute oral toxicity study was performed according to OECD 423 test guideline and GLP principles. SHR 1396 was administered by oral gavage to two consecutive groups of three female Wistar Han rats at 2000 mg/kg body weight. No mortality occurred. Hunched posture and/or piloerection was noted for all animals between Days 1 and 5. The mean body weight gain shown by the animals over the study period was considered to be similar to that expected for normal untreated animals of the same age and strain. No abnormalities were found at macroscopic post mortem examination of the animals. Based on these results, a LD50 >2000 mg/kg body weight was determined.
Justification for classification or non-classification
Based on the current available information, the substance does not have to be classified for acute toxicity according to the CLP Regulation.
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