Submitter name: Eastman Chemical Company

Submission date: 11/30/2018

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

• No

Chemical testing

Human health effects

Initial submission

Yes:

• If yes, provide link to supplement records or template display https://chemview.epa.gov/chemview/proxy?filename=8EHQ-18-21258_377273.pdf

REPRODUCTIVE TOXICITY:

• Study Type

• Protocol/guideline
  • Other: OECD 443

• Was the Study
  • Measured

• Duration of Study Not reported

• Species
  • Rat

• Strain Sprague-Dawley

• Sex of Organisms
  • Female

• Number of Organisms per Group 100 (4 groups of 25 for 0, 7, and 20 mg/kg/day groups); 120 (4 groups of 30 for 60 mg/kg/day group)

• Test Substance Purity Not reported

• Dose/Concentrations

• Dose Frequency Daily (gavage)

• Exposure period Not reported

• Route
  • Oral

• Results based on critical effect In an extended 1 generation reproductive toxicity study animals were administered the test substance by oral gavage. Preliminary data showed mortality in 2 females at 20 mg/kg/day. Adverse clinical signs and dystocia were observed in 5 animals at 60 mg/kg/day. Total litter loss was observed at 0, 20, and 60 mg/kg/day in 3, 1, and 4 animals, respectively, however, these were not considered to be related to the test substance. No findings were observed at 7 mg/kg/day. The study is ongoing.

• Study Results Control: 3 animals with total litter loss; 7 mg/kg/day: no findings; 20 mg/kg/day: 2 mortalities and 1 animal with total litter loss; 60 mg/kg/day: 5 animals with adverse clinical signs and dystocia and 4 animals with total litter loss