Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Additional information

Toxicity Description: Rats were exposed via whole-body inhalation to 140, 320, 690, 1090, 1520, 1980, 2220, 2520, 2600, 2870, 3020, or 3440 ppm HFP for 4 hours. Animals were observed for clinical signs, body weight, food consumption, water consumption, urine volume, and urine osmolality for approximately two weeks post-exposure. A pathological exam was conducted at the end of the post-exposure period. Kidney morphology effects were seen at 320 ppm. Kidney function adverse effects were seen at exposures above 320 ppm. Microscopic examination of the tissues from rats exposed above 140 ppm disclosed that the major anatomical change was nephrosis. The lowest level at which an effect was observed was 320 ppm. The observed effects from 320 ppm to 2600 were predominantly healing (reversible) nephrosis. However, at concentrations of 2870 and higher, kidney effects were identified as nephrosis without evidence of reversibility. At 140 ppm, the rats appeared normal in all respects. The 4-hour inhalation LC50 for rats was found to be 3060 ppm. HFP caused damage to the kidneys. In one rat 4-hour inhalation study, respiratory irritation effects (edema and congestion) were observed at concentrations of 1250 ppm and higher. This study is likely the basis for the current EU R37 classification for respiratory irritation. However, the test substance used in the study was contaminated with perfluoroisobutylene (PFIB), which is a known respiratory irritant. In subsequent rat inhalation studies using test substance with controlled PFIB levels, no exposure concentration dependent respiratory irritation was observed.

This substance is a gas, and tests to evaluate dermal and oral systemic toxicity were not feasible.

Dose Descriptor: NOAEL for significant systemic effects resulting from acute inhalation exposure was 140 ppm (859 mg/m3)

 

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

NOAEL = 140 ppm (859 mg/m3) air

Justification for classification or non-classification

Based on the rat 4-hour LC50 of 3060 ppm (18776 mg/m3), and the extent and irreversible nature of the kidney effects at exposures of 2870 ppm and higher the substance is classified as Acute Toxicity Category 4 (Harmful if inhaled) and Specific Target Organ Toxicity – Single Exposure Category 2 (May cause damage to kidneys if inhaled) under EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.