Reaction mass of potassium difluoro{[2,2,4,5-tetrafluoro-5-(trifluoromethoxy)-1,3-dioxolan-4-yl]oxy}acetate with potassiumfluoride and potassium carbonate

Endpoint summary

Description of key information

In the absence of experimental data on the registered intermediate, the eye/skin irritation potential of F-DIOX potassium salt was evaluated through the Read Across approach with cC6O4 ammonium salt.
Impurities present in F-DIOX potassium salt are also considered contributing to the classification of the substance.

Additional information

F-DIOX potassium salt is a organic carboxylic acid derivative .

In order to assess the eyes and skin irritation potential of F- Diox potassium salt it was deemed appropriate to use the Read Across approach based on experimental studies performed on cC6O4 ammonium salt by virtue of similarity of chemical structure between F- Diox potassium salt and cC6O4 ammonium salt (CAS no: 1190931-27-1).

F-DIOX potassium salt and cC6O4 ammonium salt are two salts of the same carboxylic acid, they differ only for the cationic part (K+ in F-DIOX potassium salt and NH4+ in cC6O4 ammonium salt). F-DIOX potassium salt readily dissolves in aqueous media and dissociates to the corresponding carboxylic acid in equilibrium with its anion. The dissociation is expected to be similar for F-DIOX potassium salt and cC6O4 ammonium salt. Considering the similarity of chemical structure, a similar biological behaviour is expected betwen the two substances.

An in vitro skin irritation study and an in vitro eye irritation study (BCOP) were performed on cC6O4 ammonium salt. The studies were performed under GLP conditions.

 

In the skin irritation study three tissues of the human skin model EPISKIN were treated with either the test item cC6O4 ammonium salt, the negative or the positive control for 15 minutes. After treatment with cC6O4 ammonium salt the relative absorbance values were decreased to 49.2%. This value is slightly below the threshold for irritancy of ≤ 50% and therefore the test item was considered to possess an irritant potential.

In the eye irritation study, performed to assess the corneal irritation and damage potential of cC6O4 ammonium salt using fresh bovine corneas, the test item caused opacity and permeability of the corneas compared with the results of the negative control and therefore cC6O4 ammonium salt was classified as very severe eye irritant.

Considering the similarity of chemical structure between C6O4 ammonium salt and F-DIOX potassium salt, a similar biological behaviour is expected for the two substances.

 

In order to apply the classification according to Regulation (EC) No. 1272/2008, the presence of impurities was considered.

Justification for classification or non-classification

Classification of the Dry substance:

The classification is based on the Read Across approach with cC6O4 ammonium salt above discussed and taking into account the typical concentration of classified impurities present in the dried substance.

 

In addition to the main potassium salt constituent, there are two impurities with a classification for skin and/or eye irritation/corrosion and with a typical content above the cut-off, that need to be taken into account in the calculations: potassium fluoride and potassium carbonate.

F-Diox potassium salt (self-classification based on data on the related ammonium salt):

Skin irritation 2, H315

Eye Damage 1, H318

Potassium fluoride (harmonised classification):

Eye Damage 1, H318

Potassium carbonate (self-classification):

Skin Irritation 2, H315

Eye irritation 2, H319

STOT SE 3, H335

Classification of the registered substance (dried form):

As a result of the application of the rules described in the Regulation (EC) No. 1272/2008 and subsequent revisions the registered substance is classified hazardous as follows:

 

Skin Irritation Category 2, H315: Causes skin irritation

Eye damage 1, H318: Causes serious eye damage.

STOT SE3, H335 : May cause respiratory irritation