Submitter name: DuPont

Submission date: 10/15/1992

Was the submission provided under the Compliance Audit Program (CAP)?

• Yes

Chemical testing

Human health effects

Initial submission

No

ACUTE TOXICITY:

• Study Type
  • Acute oral toxicity (AOT)

• Protocol/guideline
  • Other: Not reported

• Year Study Performed 1973

• Was the Study
  • Measured

• Duration of Study 14 days

• Species
  • Rat

• Strain ChR-CD

• Sex of Organisms
  • Male

• Number of Organisms per Group 10

• Test Substance Purity Not reported

• Vehicle Water

• Dose/Concentration 500, 550, 575, and 600 mg/kg

• Route
  • Oral

• Exposure period Single exposure (gavage)

• Results based on critical effect The following mortalities were observed: 0/10 (500), 1/10 (550), 4/10 (575), and 7/10 (600). Clinical signs included irregular respiration, lacrimation, prostration, pallor, belly-to-cage posture. Weight loss was observed at 600 mg/kg and transient weight loss for 2-14 days was observed at 500, 550, and 575 mg/kg. Histological changes for animals dosed at 550, 575, and 600 mg/kg that died included necrosis of the stomach and duodenal mucosa, pancreas, liver, lymphocytes of the thymus, lymph nodes, and spleen. Additionally, edema of the submucosal stomach and lung were noted, as well as, kidney abnormalities, testicular hemorrhage, and cardiac and gastric muscle atrophy were observed. In surviving rats, stomach lesions (polymorphonuclear leukocytes, hyperplasia of squamous epithelium, increase in fibrous connective tissue, focal atrophy of the stomach muscle) were observed. No histopathological changes were observed in the 500 mg/kg group. Based on the results, the submission sponsor finds that the oral LD50 is 585 mg/kg in male rats.

• Study Results LD50 = 585 mg/kg