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Description of key information

Key value for chemical safety assessment

Additional information

Justification for classification or non-classification

The acute oral LD50 in the rat was >5000 mg/kg/bw. The dose for each rat was corrected for percent solids. Therefore, the substance does not need to be classified for acute oral toxicity according to the EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008. The classification of the active component is best described as GHS Category 3 for acute toxicity (inhalation) based on the observed lethality in 3/6 rats at a measured dry solids concentration of 700 mg/m3 (representing the fluorinated, active component without water). An LC50 could not be derived from the available data however; the 700 mg/m3 total concentration of the active approximates an LC50. A single 4-hour exposure of rats to an aerosol of the active was associated with degenerative changes in both the larynx and lungs of exposed rats. The nature of the laryngeal injury (as minimal focal necrosis and inflammation of the ventral larynx at the base of the epiglottis) is commonly seen in rats inhaling irritant substances. While this lesion might be ascribed to a species specific response, based on the presence of necrosis (with ulceration in occasional animals) the laryngeal changes were considered to be adverse. Further, the pulmonary lesions were characterized by haemorrhage and inflammation (mostly neutrophils) within alveoli, thickening of alveolar septa by inflammatory cell infiltrates (mostly neutrophils) and perivascular inflammation. These lesions were considered to be adverse based on the increased severity and incidence of these findings at 98 mg/m3 (0.098 mg/L) relative to controls. Both laryngeal and pulmonary changes were reversible over a 2-week recovery period. The no observable adverse effect level (NOAEL) was 24 mg/m3. Based on the above findings, the substance is classified as T; R23 (Toxic by inhalation) according to EU Directive 67/548/EEC, Cat 3 (H331; Toxic if inhaled) by EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, and STOT-SE Cat 1 according to CLP.