Registration Dossier

Administrative data

Description of key information

A 28 Day Oral study has been conducted on FC-770 and two 90 Day Inhalation studies has been conducted on analogs of FC-770. The NOAEL in the 28 day study is 1000 mg/kg-day and the molecular weight adjusted NOAEL values for the 90 Day studies are is 59020 ppm and 66170 ppm.

Key value for chemical safety assessment

Additional information

In the 28 Day Oral study, animals were dosed at 250, 500 and 1000 mg/kg-day. At 1000 mg/kg-day, no effects were noted for body weight gain, food consumption, organ weight changes, gross pathology, neurobehavior, clinical chemistry or hematology. The NOAEL was determined to be 1000 mg/g-day, which was the highest dose tested.

In the first 90 day study, the analog substance (Perfluorohexane) was tested at nominal concentrations of 5000, 15000 and 50000 ppm. There were no toxicologically significant treatment-related signs of mortality, clinical signs of toxicity, bodyweight, food consumption, ophthalmoscopy, biochemistry, macroscopic pathology, organ weights and microscopic pathology. No effects of exposure were observed. From this study, a no observed adverse effect level (NOAEL) of 49821 ppm (molecular weight adjusted to 59020 ppm) (the highest measured dose) was determined.

In the second 90 day study, the analog substance (Perfluoro-N-methylmorpholine) was tested at 4971, 15094, and 49589 ppm.There were no toxicologically significant treatment-related signs of mortality, clinical signs of toxicity, bodyweight, food consumption, ophthalmoscopy, biochemistry, macroscopic pathology, organ weights and microscopic pathology.The No Observed Adverse Effect Level for the test article under the conditions of the study was 49589 ppm (molecular weight adjusted to 66170 ppm).

Justification for classification or non-classification

The results of these tests do not meet the requirement to classifyFC-770 as dangerous.