Appendices 1-18 to: Report on the Health Effects of Selected Pesticide Coformulants

Appendices 1-18 to: Report on the Health Effects of Selected Pesticide Coformulants

54 Evaluation

Based on the available knowledge, the critical effect of sodium ligninsulphonate in pesticide formulations is probably the irritative effects that it may cause on the eyes, the skin, and the upper respiratory tract. However, there is no information about the dose levels causing irritation, or whether the irritation was caused by the sodium ligninsulphonate powder or by the chemical in a solution.

Following oral intake of relatively high doses, sodium ligninsulphonate may affect the gastrointestinal tract. Pepsin proteolysis may be inhibited but sodium ligninsulphonate has also been shown to cause ulcers of the colon and stomach in guinea pigs, but not in rats at high doses. Guinea pigs are known to be highly susceptible to ulcerative disease of the colon (Marcus et al. 1974). This may explain the difference in effect on the gastrointestinal tract in rats and guinea pigs. At high doses, the liver and kidney of rats had histological changes, and sodium ligninsulphonate in the faeces irritated the skin at the base of the tail causing lesions, anaemia and an increased leucocyte level.

Following injections, sodium ligninsulphonate inhibited the blood coagulation in dogs and decreased the incidence and amount of thrombus formation in rabbits despite a lack of anti-coagulant effect. In rats, dosed orally with sodium ligninsulphonate, no anti-coagulant effect was noted. The differences in effect on blood coagulation in the different studies could have many explanations. The studies were performed with different species of which some may be more sensitive than others. In addition, different routes of administration were used. The bioavailability of sodium ligninsulphonate is most likely much higher following injection than following oral administration. However, no toxicokinetic data exist for sodium ligninsulphonate to be used for confirmation of this.

No carcinogenic or other chronic studies of sodium ligninsulphonate were found. Therefore it is not known whether sodium ligninsulphonate may cause cancer or other effects following chronic exposure.

Sodium ligninsulphonate did not possess estrogenic activity in a recombinant yeast screen. No data have been found regarding reproductive and developmental effects following exposure by inhalation, oral administration, or dermal contact.

In conclusion, it has been reported that sodium ligninsulphonate may irritate the eyes, skin and upper respiratory tract; however, there is no information about the dose levels causing irritation. Relatively high doses of sodium ligninsulphonate have to be ingested in order to cause toxic effects in short-term studies. In addition, oral intake and injections are not relevant routes of exposure for sodium lignosulphonate in pesticide formulations.

Based on the available data, the main concern regarding exposure to sodium ligninsulphonate in pesticide formulations is the irritation that it may cause. However, it should be noted that no data regarding effects following long-term exposure as well as of reproductive and developmental effects are available.