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Assessment of the Toxicokinetic Behaviour

There are no studies available in which the toxicokinetics of sodium prop-2-enesulphonate have been investigated.

 

Sodium prop-2-enesulphonate (molecular weight of 144.12 g/mol) is a white solid (powder), which is soluble in water (measured water solubility: 714 g/l at 20 °C (See 4.8: “Water Solubility”). The log Pow is -3.5 at 20 °C (See 4.7 “Partition Coefficient”), indicating that accumulation of sodium prop-2-enesulphonate is unlikely.

 

Absorption

 

In an acute oral toxicity study, rats were administered sodium prop-2-enesulphonate by gavage. Mortality was reported in one animal at the highest dose tested; sporadic clinical signs of toxicity were observed; therefore bioavailability of sodium prop-2-enesulphonate after oral administration is indicated (BASF AG 1975). Furthermore, on one hand the highly water-soluble substance should dissolve readily into the gastrointestinal fluids while on the other hand, absorption of very hydrophilic substances by passive diffusion may be limited by the rate at which the substance partitions out of the gastrointestinal fluid (ECHA guidance document 7c, 2008).

 

In an acute dermal toxicity study in rats, sodium prop-2-enesulphonate did not cause any signs of systemic toxicity (BASF SE 2010). In a local lymph node assay, performed to detect skin sensitisation in mice, no indications of systemic availability after dermal application was detected (Harlan CCR 2010). Additionally, since the water solubility is above 10 g/L and the log Pow is below 0 the substance may be too hydrophilic to cross the lipid rich environment of the stratum corneum. Dermal uptake for this substance will be low (ECHA GD 7c, 2008). Taken together, the experimental data and considerations of the physical-chemical properties of the substance, dermal uptake of sodium prop-2-enesulphonate in humans is considered as very limited and the dermal exposition is considered as negligible for hazard assessment.

 

Sodium prop-2-enesulphonate itself has a very low vapour pressure of < 0.01 Pa at 25°C (calculated from EPIWIN, BASF SE 2009, see chapter “vapour pressure”). In an inhalation study of the dissolved substance with a saturated vapour atmosphere, none of the 12 tested rats showed clinical signs indicative for systemic availability after inhalation exposure. Therefore, there is only a low potential for toxicity via the inhalation route.

 

Metabolism

 

Potential metabolites were calculated by OECD toolbox 1.00. Here, the simulator tools for liver, GI tract and skin provided oxidized and hydrolyzed products of sodium prop-2-enesulphonate as potential metabolites.

 

Studies on genotoxicity (Ames Test, gene mutation in mammalian cells in-vitro, micronucleus assay in-vitro) gave no indication reactivity of sodium prop-2-enesulphonate or its metabolites under the test conditions (i.e. no increased mutagenicity or cytotoxicity with metabolic activation).

 

Excretion

 

The potential metabolites as well as the parent chemical have a molecular weight lower than 500 u and are considered as soluble in water. Therefore, sodium prop-2-enesulphonate and its metabolites are expected to be excreted predominantly via the urine (ECHA GD 7c, 2008).