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Description of key information

The median lethal dose of FAT 40840/A TE after single oral administration to female rats, observed over a period of 14 days is:
LD50 (female rat): greater than 2000 mg/kg body weight

Key value for chemical safety assessment

Additional information

Two groups, each of three female HanRcc:WIST (SPF) rats, were treated with FAT 40840/A TE by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was diluted in vehicle (purified water) at a concentration of 0.2 g/mL and administered at a dosing volume of 10 mL/kg. The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs within the first 30 minutes and approximately 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Mortality/viability was recorded at approximately 30 minutes, 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically. All animals survived until the end of the study period. A slightly ruffled fur was recorded in two females 3 hours post-dose and persisted up to the 5- hour reading. Soft feces were observed in all animals 5 hours after treatment. Discolorated purple feces or purple/black feces were recorded in all animals 5 hours after treatment and persisted up to test day 2. The body weight of the animals was within the range commonly recorded for this strain and age. For Group 1 no macroscopic findings were recorded at necropsy. All animals of Group 2 were found with an enlarged spleen at necropsy.

The median lethal dose of FAT 40840/A TE after single oral administration to female rats, observed over a period of 14 days is:

LD50 (female rat): greater than 2000 mg/kg body weight

Justification for classification or non-classification

FAT 40840/A E is not classified since the LC50 cut-off value for classification is 2000mg/kg