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 substance, the potential acute toxicity of F-DIOX potassium salt was evaluated through the Read Across approach with cC6O4 ammonium salt.
Impurities are considered contributing to the classification of F-DIOX potassium salt, classification was determined considering the presence and the concentration of impurities.

Additional information

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

In order to evaluate the potential acute toxicity 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 between the two substances.

An oral toxicity study and a dermal toxicity study were performed on cC6O4 ammonium salt.

 

The results of the oral toxicity study indicate that cC6O4 ammonium salt has a toxic effect on the rat following oral administration of a single dose at a level of 2000 mg(dry salt)/kg. The mortality pattern demonstrates the LD50 to be greater than 300 mg (dry salt)/kg but less than 2000 mg (dry salt)/kg body weight.

The results of the dermal toxicity study indicate that cC6O4 ammonium salt has no toxic effect on the rat following dermal exposure over a 24 hour period at a level of 2000 mg/kg. The lack of mortality demonstrates the LD50 to be greater than 2000 mg/kg.

 

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 salt:

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

 

The hazardous constituents and impurities present and their typical concentration in the dried substance were considered in the classification of the registered substance:

In addition to the main potassium constituent there are two impurities with an acute toxicity classification. Applying the rules of Regulation 1272/2008, only one is above the cut-off for contribution to the classification and needs to be considered, potassium fluoride. For the purpose of the classification of F-Diox Potassium Salt, the harmonised classification of potassium fluoride was taken into account in the calculations, although the registration dossier of the potassium fluoride seems to indicate it is conservative. Thus, the classification of F-Diox Potassium salt is also likely severised.

F-Diox Potassium salt (self-classification, based on data on related ammonium salt)

Acute toxicity - category 4 - H302

Potassium fluoride (Harmonised classification)

Acute oral toxicity - Category 3 - H 301

Acute dermal toxicity - Category 3 - H 311

Acute toxicity inhalation - Category 3 - H 331

Classification of the registered substance:

Applying classification rules of the European CLP Regulation (Council Regulation (EC) No. 1272/2008 and subsequent revisions) and considering the concentrations of hazardous substances present, the registered substance is classified hazardous with the following hazard statements:

Classification : Acute toxicity oral - Category 3

Hazard statement (Oral) : H301, Toxic if swallowed

 

Classification : Acute toxicity dermal - Category 4

Hazard statement (Dermal) : H312, Harmful in contact with skin

 

Classification : Acute toxicity inhalation- Category 4

Hazard statement (Inhalation) : H332, Harmful if inhaled