Registration Dossier
Registration Dossier
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EC number: 204-127-4 | CAS number: 116-15-4
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Additional information
HFP is a gas and guideline testing for irritation or corrosion is not feasible. No skin or eye irritation or corrosion was noted during any of the inhalation exposures. 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.
Justification for classification or non-classification
This substance is a gas and guideline testing for irritation and corrosion is not feasible. No skin or eye irritation or corrosion was noted during any of the inhalation exposures.
The resulting classification under EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 is Specific Target Organ Toxicity – Single Exposure Category 3 (May cause respiratory irritation).
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