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

53     Summary

53.1     Description

Sodium ligninsulphonate is a light tan to dark brown nonhygroscopic powder with no pronounced odour. Commercial formulations are mixtures of sodium ligninsulphonates with different molecular weights and wood sugars.

53.2     Toxicokinetics

Systemic effects following oral administration indicate that sodium ligninsulphonate is absorbed following administration by this route.

53.3     Human toxicity

No data have been found.

53.4     Animal toxicity

53.4.1     Single dose toxicity

LD₅₀-values reported for oral administration of sodium ligninsulphonate ranged from 6 g/kg to greater than 40 g/kg for mice and rats, respectively, and the LC₅₀-value for inhalatory administration to rats was reported to be greater than 480 mg/m³.

Sodium ligninsulphonate may irritate eyes, skin, and the upper respiratory tract. It has caused drowsiness and muscle weakness.

At injections of 7.5-15 mg/kg b.w., sodium ligninsulphonate significantly decreased the incidence and amount of thrombus formation in a rabbit model despite a lack of anti-coagulant effect. At higher dosages, an anticoagulant effect of sodium ligninsulphonate was demonstrated in dogs. Within the first 15 minutes behavioural changes were noted in the dogs.

53.4.2     Repeated dose toxicity

Guinea pigs exposed to sodium ligninsulphonate in the drinking water in doses at or above 1700 mg/kg b.w. per day for up to 6 weeks developed ulcers in the upper part of the colon. At higher doses, stomach ulcers as well as weight loss, diarrhoea and deaths also occurred.

In a dog model, sodium ligninsulphonate was an effective inhibitor of pepsin proteolysis.

Rats exposed to sodium ligninsulphonate in the drinking water in doses at about 10000 mg/kg b.w. per day for 16 weeks had histological changes of the liver and kidneys, and an increased weight of the same organs as well as the spleen. In addition, these rats had skin lesions at the base of the tail, anaemia and raised leucocyte levels. Sodium ligninsulphonate caused no adverse effects at a dose level up to about 2500 mg/kg b.w. per day.

Ligninsulphonates may modify digestive physiology and gastrointestinal tract characteristics of rats.

In a United States patent, ligninsulphonates applied topically was shown to be effective against Herpes simplex virus in infected human cell lines in culture as well as in vaginal infections in female mice and guinea pigs.

53.4.3     Toxicity to reproduction

No data have been found regarding reproductive and developmental effects following exposure by inhalation, oral administration, or dermal contact.

Sodium ligninsulphonate did not possess estrogenic activity in a recombinant yeast screen.

53.4.4     Mutagenic and genotoxic effects

No data have been found.

53.4.5     Carcinogenic effects

No data have been found.

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