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

10   Human toxicity

10.1   Single dose toxicity

10.1.1   Inhalation

Groups of 9-15 healthy non-smoking male volunteers between the ages of 18 and 40 were exposed to diammonium sulphate aerosols (or to other gaseous or aerosol pollutants alone or to mixtures of these) at a concentration of 0 or 0.133 mg/m³ (MMAD = 0.55 mm) for 4 hours. During the exposure each person had two 15 minutes exercise sessions on a treadmill. Environmental conditions were mildly stressful with a temperature of 30°C and a relative humidity of 60%. A battery of 19 measurements of pulmonary function was performed just prior to exposure; 2 hours into the exposure, following the first exercise session; 4 hours into the exposure, following the second exercise session; and 24 hours after exposure. Diammonium sulphate under the conditions of the experiment had no effect on the pulmonary function. Ozone in a concentration of 0.4 ppm affected the pulmonary function. The effect of exposure to a combination of ozone and diammonium sulphate seemed slightly greater (although not statistically significant) than exposure to ozone alone. (Stacy et al. 1983).

Twenty healthy non-smoking male and female volunteers aged 21-34 years were exposed by inhalation to clean air, diammonium sulphate aerosols at a concentration of 0.5 mg/m³ (MMAD = 1.0 mm), 1 ppm sulphur dioxide and combined diammonium sulphate/sulphur dioxide. Exposures lasted for 4 hours which included two light to moderate exercise stints for 15 minutes each. The study ran for 3 days/week for 3 consecutive weeks where each volunteer served as his or her own control. Clean air was breathed on day 1 and 3 of each week. Diammonium sulphate (week 1), sulphur dioxide (week 2) or the combination (week 3) was breathed on day 2. No significant changes were measured in pulmonary function or bronchial reactivity following exposure to diammonium sulphate, sulphur dioxide or the combination. The most common symptoms were upper respiratory and eye irritation. Three volunteers reported upper respiratory irritation during the exposure to diammonium sulphate alone and nine during the combined exposure. Two volunteers reported eye irritation during diammonium sulphate exposure alone and three during the combined exposure. (Kulle et al. 1984).

Eight healthy and nine asthmatic non-smoking volunteers aged 60-76 years were exposed by inhalation to clean air, diammonium sulphate at a concentration of 0.070 mg/m³ and sulphuric acid. Exposures to each of the test atmospheres (clean air, diammonium sulphate, or sulphuric acid) were separated by at least 1 week and lasted for 40 minutes composed of 30 minutes at rest and 10 minutes of light exercise on a treadmill. Diammonium sulphate exposure had no effect on pulmonary function parameters (forced expiratory volume in one second, forced vital capacity, and total respiratory resistance) in either group. (Koenig et al. 1993).

Sixteen healthy and seventeen asthmatic non-smoking volunteers with a mean age of 27 were exposed by inhalation to sodium chloride aerosols (control),diammonium sulphate aerosols at a concentration of about 0.1 or 1.0 mg/m³ (MMAD = 0.5-1 mm) and other sulphates (sodium bisulphate, ammonium bisulphate, sulphuric acid) by double blind randomisation. Exposures to each of the test atmospheres (control, diammonium sulphate, sodium bisulphate, ammonium bisulphate, or sulphuric acid) were separated by at least 3 hours and lasted for 16 minutes. To determine if sulphate inhalation caused increased reactivity to a known bronchoconstrictor, all volunteers inhaled carbachol following each 16 minutes exposure. Diammonium sulphate (and the other sulphates) produced a small but significant decrease in flow rates on maximum and partial expiratory flow-volume curves and potentiated the bronchoconstrictor action of carbachol at 1 mg/m³ both in asthmatic and healthy volunteers. The most significant changes were seen with the most acidic sulphates (sulphuric acid and ammonium bisulphate), which also produced a significant decrease at 1 mg/m³ in the mean specific airway conductance and in the forced vital capacity in one second in asthmatic volunteers. No significant changes on the pulmonary function occurred following exposure to 0.1 mg/m³ of sulphates. (Utell et al. 1982).

10.1.2   Oral intake

An 85-year old woman was found dead lying on the ground outside her house. The autopsy could not determine the definite cause of her death since routine poison analysis revealed no toxicological substances in her blood and the pathological examination showed nothing unusual. However, examination at the police laboratory of the solution in the beer can found next to her showed that it was very likely diammonium sulphate. Measurements showed a significant increase of ammonium and sulphate ions in serum and gastric contents. Therefore it was concluded that the cause of death was acute intoxication due to ingestion of diammonium sulphate. (Sato et al. 1999). 

10.1.3   Dermal contact

No data have been found.

10.1.4   Other routes

No relevant data have been found.

10.2   Repeated dose toxicity

Ten healthy and six asthmatic non-smoking volunteer men with a mean age of 42.3 were exposed by inhalation to purified air, diammonium sulphate aerosols at a concentration of 0.1 mg/m³ (MMAD = 0.3 mm) and other sulphates (ammonium bisulphate, sulphuric acid) in a blind experimental fashion with 1-2 days of exposure to air followed by 2-3 consecutive days of sulphate aerosol exposure. Exposures lasted for 2 hours with light exercise on bicycle ergometers for the first 15 minutes of each half hour. No consistent changes in pulmonary function or in symptoms occurred in the healthy or asthmatic men when exposed to diammonium sulphate aerosols. (Avol et al. 1979).

10.3   Toxicity to reproduction

No data have been found.

10.4   Mutagenic and genotoxic effects

No data have been found.

10.5   Carcinogenic effects

No data have been found.

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