Potassium 1,2-bis(2-ethylhexyloxycarbonyl)ethanesulphonate

Endpoint summary

Description of key information

Data are available for the corresponding sodium salt of the substance, docusate sodium. These data are used for read-across to the substance registered. Both oral and dermal acute toxicity were tested in various studies with docusate sodium and formulations, demonstrating that LD50 values were above the limit dose of 2000 mg active ingredient/kg bw. LD50 values are  approximately 3000 mg/kg bw for acute oral toxicity in rats and 2525 mg/kg bw for acute dermal toxicity in rabbits.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Dose descriptor:

LD50

Value:

3 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Dose descriptor:

LC50

Value:

20 000 mg/m³ air

Acute toxicity: via dermal route

Endpoint conclusion

Dose descriptor:

LD50

Value:

2 525 mg/kg bw

Additional information

Data are available for the corresponding sodium salt of the substance, docusate sodium. These data are used for read-across to the substance registered.

A key study for acute oral toxicity was performed in rats with a 70% docusate sodium formulation (Elementis, Mürmann 1988a); the study was conducted according to OECD 401, and was considered to be reliable, adequate and relevant. The limit dose was reached for the active ingredient. LD50 was > 3000mg/kg body weight, corresponding with>2100 mg active ingredient/kg bw.The body weight evolution was not influenced during the 14-day observation period. All animals showed red brown lips and a slightly harsh skin 20-30 minutes after administration; one animal showed diarrhoea 3-7 hours after administration. After 24 hours the skin was very harsh and the animals showed a squatting attitude; 4 animals showed diarrhoea and 3 had a dirtily brown skin. After 48 hours, the skin was still slightly harsh and after 72 hours all animals were without poisoning symptoms. Dissection at the end of testing showed only 1 animal with a partial bulge of the stomach mucosa. All treated animals were free from poisoning symptoms after 72 hours.

Supportingacute oral toxicitystudies with lower reliability levels were collected with different formulations. In the various rat acute toxicity studies, LD50 values were either above tested doses, or fellbetween 3.0 and 4.5 g/kg bw, therefore exceeding the limit dose.

The LD50 of a 66% docusate formulation in the rat was >2000 mg/kg bodyweight, corresponding to > 1320 mg active ingredient/kg bw. There were no clinical observations, effects on body weight and macroscopic findings (Elementis, Discroll 1966). 

·The LD50 of a 70% docusate formulation was > 2000 mg/kg bw, corresponding with >1400 mg active ingredient/kg bw (Cognis, Potokar 1984). There was no mortality, but symptoms of a temporarily harsh skin and diarrhoea appeared. The internal organs of the animals were inconspicuous.

In a study with a 100% formulation, doses given were 5, 2.5, 1.25 and 0.625 g/kg bw (Cytec, American Cyanamid 1966). A mortality of 5/5 at 5 g/kg and 1/5 at 2.5 mg/kg bw resulted in an oral LD50 of 3.08 g/kg bw. Clinical signs of depression with varying intensity and diarrhoea were observed at all doses, but reversible by day 4 after dosing.

In a study with a product formulation of 20% docusate solutions were given at 25.2, 22.4, 17.8 and 14.1 ml/kg bw, corresponding doses were approximately 5.0, 4.5, 3.5 and 2.8 g/kg bw (Cytec, McGinty 1976a). A mortality of 5/5 at 5.0 g/kg bw, 3/5 at 4.5 mg/kg bw and 1/5 at 3.5 g/kg bw (and 0/5 at 2.8 g/kg bw) resulted in an oral LD50 of 4.2 g/kg bw. Animals became prostrate and lethargic; at necropsy,yellow fluid was observed through the gastrointestinal tract of those found dead.

In a key study foracute dermal toxicity, rabbits were dosed at 10000 mg/kg bw on a 10% body surface area (Cytec, McGinty 1977). Clinical observations included signs of skin irritation (fissuring, desquamation, coriaceousness, pulling fur out), however no signs of intoxication or gross pathological findings were noted ; there was no mortality (LD50 >10000 mg/kg bw). In another study, dermal dosing with a test formulation in male rabbits at 1263, 2525 and 5050 mg/kg bw resulted in mortality at 2525 (1/2) and 5050 (2/2) mg/kg bw; the LD50 was therefore 2525 mg/kg bw. Clinical observations included severe edema, moderate erythema with subsequent eschar formation. No gross pathological examination was performed. The study was of lower reliability and disregarded, but confirmed that LD50 was higher than the limit dose (Dow, Rohm-Haas 1974).

Intoxication due toacute inhalation exposureof industrial workers or even the acute inhalation exposure as such is very unlikely for sulphosuccinates due to their substance properties and the risk management measures that are already implemented. Additional acute inhalation toxicity tests would therefore neither lead to a better risk assessment, nor improve the safety of applications. Data were found in literature with an LC50 of 20 mg/L, which is above the limit dose (ECB, 2000; BUA, 2004). As there were only very few details, the study was not taken into account. On the basis of the argumentation summarized above, further acute inhalation toxicity testing is waived.

In summary, both oral and dermal acute toxicity were tested in various studies with docusate sodium and formulations, demonstrating that LD50 values were above the limit dose of 2000 mg active ingredient/kg bw. Therefore, there is no need for classification and labeling.

 

Justification for classification or non-classification

As the LD50 values were above 2000 mg/kg bw, classification for acute toxicity is not warranted.