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Description of key information

The LD50 (oral route) retained for classification is not equal to 300 mg/kg/day but higher than 300 mg/kg/day (between 300 and 2000 mg/kg/day. 

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
300 mg/kg bw

Additional information

Justification for classification or non-classification

For acute oral:

In the key study, the median lethal dose of Tritolyl Phosphite (BU) after single administration to female rats, observed over a period of 14 days is between 300 mg/kg body weight and 2000 mg/kg body weight. The 300-2000 mg/kg range is within the criteria for category 4 classification. However, Ortho-Tritolyl phosphite is slightly toxic when administered orally to young adult ChR-CD male rats in single doses; its Approximate Lethal Dose (ALD) is 2250 mg/kg of body weight. m,p-Tritolyl phosphite has low toxicity when administered orally to young adult ChR-CD male rats in single doses; its Approximate Lethal Dose (ALD) is 11,000 mg/kg of body weight. Because the classification criteria expects an LD50 value to be used and the unknown correlation to the isomers on the toxicity via oral route, the LD50 value of 300 mg/kg was used for classification.

For acute inhalation: No study found not required for transported intermediates.

For acute dermal: No study found studies are not required for transported intermediates.

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