Potassium 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctanesulphonate

Endpoint summary

Description of key information

Acute oral toxicity (OECD 420, fixed dose method): LD50 between 300 and 2000 mg/kg bw

Acute dermal toxicitity (OECD 402, acute dermal toxicity): The LD50 was determined to be higher than 2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Additional information

Acute oral toxicity (OECD420)

The acute oral toxicity of the test substance was assessed according to the Fixed dose Method (OECD guideline 420) and GLP principles. In this study one female Wistar (RccHan®:WIST) rat was dosed with 300 mg/kg bw test substance by gavage. Since no toxicity was observed, an additional female was treated with 2000 mg/kg bw and subsequently, since no mortality occurred within 5 days, 4 additional females were treated at this dose. However, the first animal dosed at 2000 mg/kg bw and one female of the main study were found dead on study days 7 and 5, respectively. As a consequence, and seeing that the rest of the animals were showing the same clinical signs and a body weight loss between days 1 and 8, it was considered necessary to sacrifice them for welfare reasons. Therefore, it was necessary to administer another four animals at 300 mg/kg in order to complete de main study at this dose level. No deaths occurred in this dose group during the 14 -day observation period. In the animals treated at 2000 mg/kg bw piloerection and/or hunched posture were observed in all animals between day 4 and their sacrifice. The initially dosed female also showed decreased activity, hypothermia, abnormal gait, reduced body tone and pallor on day 7, just before the animal was found dead. In addition, a body weight loss of 13-23% was observed in all the animals in this dose group that survived until day 8 of study. Gross pathology revealed enlarged kidneys in all animals. Additionally, one of them showed stomach with reddish area in mucosa. No other macroscopic findings were recorded at necropsy. In the animals treated at 300 mg/kg bw, no clinical signs, effects on body weight or gross pathology observations were found. Therefore, under the conditions of the test, the acute oral LD50 for the test substance in rat was determined to be between 300 and 2000 mg/kg bw (Envigo 2017). Based on these results, the test substance is considered to be acutely harmful (category 4).

Acute dermal toxicity (OECD402)

The acute dermal toxicity of the test substance was assessed according to OECD guideline 402 and GLP principles. In this study, initially, two males and two females Sprague Dawley (Sprague Dawley®SD®) rats were treated by dermal route on a single occasion at 2000 mg/kg under semi-occlusive conditions. After 24 hours the test substance was removed with distilled water. As no mortality was observed, this dose was administered in the main study. For the main study, five males and five females were treated on a single occasion at 2000 mg/kg. The observation period was 14 days. All animals were examined for clinical signs in the first 30 minutes after dermal application and 1, 2, 3 and 5 hours after on day 1 and once daily during test days 2-15. Administration area was also examined before administration and once daily from day 2 until the end of study. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined Macroscopically. All animals from the main study survived until the end of the observation period. It was determined that body weight were within the range commonly recorded in rats of this strain and age. No clinical signs, local alterations (in administration area) and macroscopic findings were observed during the course of the study.

Since no mortality was recorded after administration of the tested substance at the dose of 2000 mg/kg, the LD50 was found to be higher than the above-mentioned dose when administered by dermal route to rats (Envigo 2018)

Justification for classification or non-classification

Based on the available information, classification and labelling of the substance for acute oral toxicity as category 4 (H302, harmful if swallowed) is warranted in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008 and its amendments. Classification and labelling for acute dermal toxicity is not warranted.