Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Additional information

This substance was tested for acute oral and inhalation toxicity. The aqueous dispersion was tested (approx. 20% solids and 80% water) was administered directly without correction for active ingredient in an acute oral up/down study in rats. In this study, the material was not toxic and the LD 50 was determined to be > 5000 mg aqueous dispersion/kg or > 1000 mg a. i. /kg of the substance. In another acute oral up/down LD50 study, female mice were administered the test substance formulation and the LD50 was determined to be > 5000 mg aqueous dispersion/kg. A correction for active solids was made and an additional dose was administered with no mortality resulting from > 2000 mg a. i. /kg. Due to animal welfare considerations, no further oral administrations at higher corrections were made and the LD50 can be estimated to be > 2000 mg a. i. /kg. An acute inhalation toxicity study was conducted on the substance according to OECD 436, acute toxic class method. In this study, 0/3 male and 1/3 female rats died at a measured aerosol concentration of 126 mg total solids/m3, and 2/3 male and 2/3 female rats died at a measured aerosol concentration of 263 mg total solids/m3.  It was concluded that the 4-hour LC50 of the substance in rats was between 126 and  263 mg total solids/m3 as measured aerosol (MMAD ~2.3 μm), indicating the material may be toxic with inhalation of respirable particulate; the vapor is not expected to be toxic.

Justification for classification or non-classification

This substance is not classified for acute oral toxicity according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, as the LD50 was estimated to be >2000 mg a.i./kg in mice.

 

No acute lethality study was conducted via the dermal route of exposure; therefore, this endpoint cannot be classified.

 

An inhalation LC50 determination according to the acute toxicity class method has been conducted that indicates the 4-hour LC50 is between 126 and 263 mg total solids/m3 as measured, respirable aerosol. Accordingly, the substance is classified at Cat 2 (H330: Fatal if inhaled) according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008. Additionally, although no histopathological evaluation was conducted on animals exposed to the test substance via inhalation, several structurally-related, multi-constituent fluorinated phosphate esters (see Chapter13 in IUCLID for additional information) have shown clinical signs of respiratory distress, gross pathological changes and adverse histopathological effects in the lungs and/or larynx following acute inhalation at measured aerosol concentrations between 8 and 98 mg/m3. The clinical signs and gross/anatomic pathology observed among these related fluorinated phosphate esters are consistent with local epithelial injury, however, none of these related substances are corrosive or exhibit remarkable irritation to skin or mucous membranes in guideline studies. Given the potential for respiratory tract injury for related fluorinated phosphate esters at relatively low exposure concentrations, the test substance is classified as STOT Single Exp. 1 (H370: Causes damage to organs; lungs and larynx via inhalation) according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.