Registration Dossier

Administrative data

Description of key information

An Acute Toxicity in the Rat- Acute Toxic Class Method was the key study conducted for BMS 296796-02.The study was conducted in 2000 according to OECD Method # 423 and in accordance with GLP. The study material is well characterized and the study assigned a reliability rating of 1 (reliable without restriction). The study is considered valid and the acute median lethal dose (LD50) was estimated as being greater than 2000 mg/kg bodyweight.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
2 000 mg/kg bw

Additional information

The animals were observed for deaths or overt signs of toxicity 1/2, 1, 2 and 4 hours after the final dose and subsequently once daily for fourteen days.  At the end of the observation period the animals were subjected to gross pathological observations. There were no deaths. All animals showed expected gains in bodyweight over the study period. No abnormalities were noted at necropsy.

Justification for classification or non-classification

The results of this study are considered valid as the key study was assigned a reliability rating of 1, conducted in accordance with GLP and followed an OECD guideline. The study is considered valid and the acute median lethal dose (LD50) was estimated as being greater than 2000 mg/kg bodyweight. The test material would not be classified as toxic according EU regulations.