Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
Reaction mass of bis(polysubstituted hexanoic acid) bis(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) diphosphate and bis(polysubstituted hexanoic acid) 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl phosphate and polysubstituted hexanoic acid bis(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) hydrogen diphosphate and polysubstituted hexanoic acid bis(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) phosphate and polysubstituted hexanoic acid 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl hydrogen phosphate
EC number: - | CAS number: -
Endpoint summary
Administrative data
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
