Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Additional information

Four groups each of 25 male and 25 female Crl:CD-1(ICR)BR mice were exposed to target concentrations of 0, 10, 50 or 150 ppm hexafluoropropene (HFP) for 6 hours/day, 5 days/week for a period of approximately 90 days. Mean body weights and body weight gains for male and female mice were unremarkable and not affected by exposures to the test material. No differences in food consumption were noted for male or female mice during the study. Elevated levels of water consumption were observed in mice exposed to 150 ppm; these differences were statistically significant for female mice. Statistically significant observations of blue skin color to the abdomen were observed in male mice exposed to 50 or 150 ppm. The relationship of this observation to the test material is not clear. Hematology conducted in mice showed no effects that were related to HFP exposures. The notable effects in mice were the microscopic lesions observed in the kidneys of mice exposed to 50 of 150 ppm. The kidney lesions included regeneration of the inner cortical tubules, cytomegaly of tubular epithelium, and tubular epithelial necrosis.The No Observed Adverse Effect Level (NOAEL) for 90 days of repeated inhalation exposure to HFP in mice is 10 ppm. The NOAEL following 28 days of recovery is also 10 ppm. At recovery, cytomegaly and kidney nephropathy were present in male mice.

Rats were less sensitive to HFP related health effects than mice. Four groups each of 20 male and 20 female Crl:CDBR rats were exposed to target concentrations of 0, 10, 50 or 150 ppm HFP for 6 hours/day, 5 days/week for a period of approximately 90 days. Low mean lymphocyte count was observed in males exposed to 150 ppm. This effect was not observed following 28 days of recovery. There was no hematology or pathology support to consider the single observation of reduced mean lymphocyte count as adverse. Other non-adverse or non-biologically significant effects were observed in the 50 and 150 ppm exposure groups. These included increased levels of fluoride in the urine, increased urine volume, decreased urine osmolality and increased water consumption and elevated levels of serum sodium in the male groups exposed to 50 or 150 ppm.

The following information is taken into account for any hazard/risk assessment:

NOAEL = 61.4 mg/m3 (10 ppm)

Value used for CSA (route: inhalation):

NOAEL: 61.4 mg/m³ (10 ppm)

Justification for classification or non-classification

Based on the results of repeated inhalation studies, the substance is classified as Specific Target Organ Toxicity Repeated Exposure Category 2 (Kidney) according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.