Aluminum Sulfate, Hydrated (ACS & FCC): ORAL (LD50):
Acute: >9000 mg/kg in the mouse MSDS. >9000 mg/kg in the rat MSDS.

Acute Toxicity

There is little indication that aluminum is acutely toxic by oral exposure despite it is widely found in foods, drinking water, and many antacid preparations ^L2149. In 1988, a population of about 20 000 citizens of Camelford, England, was exposed to increased levels of aluminum for 5 days. The aluminum was accidentally ingested by the population from a water supply facility using aluminum sulfate for water treatment ^L2149.

Some adverse effects observed were nausea, vomiting, diarrhea, mouth ulcers, skin ulcers, skin rashes, and arthritis-type pain were observed. It was concluded in one study that the adverse effects of aluminum sulfate were primarily mild and transient. No long-lasting effects on health could be attributed to the exposures from aluminum in the drinking water during this period ^L2149.

Chronic Toxicity

In humans, excess exposure to aluminum via dialysis water (aluminum sulfate) is a known etiological factor in several pathological conditions in patients treated with hemodialysis. Clinical symptoms and signs of aluminum toxicity include hypercalcemia, anemia, vitamin D refractory osteodystrophy, and a dialysis encephalopathy. Bone pain, pathological fractures, and proximal myopathy may occur. Aluminum has also been suggested as an etiology of several neurodegenerative diseases such as Alzheimer senile and pre-senile dementia, as well amyotrophic sclerosis. Despite this, the most recent investigations have failed to confirm this hypothesis. A study in man has verified a number of possible deleterious interactions of aluminum salts with phosphorous metabolism, especially in long-term ingestion of aluminum-containing antacids ^L2152.

It has been suggested that aluminum exposure is a risk factor for the development or acceleration of onset of Alzheimer disease (AD) in humans. The world health organization has completed a meta-analysis of 20 epidemiological studies done to test the hypothesis that aluminum in drinking-water is a risk factor for Alzheimer disease. Six studies on populations in Norway were considered of sufficiently high quality to meet the general criteria for exposure and outcome assessment and the adjustment for at least some confounding variables ^L2149.

Of six studies that examined the relationship between aluminum in drinking- water and dementia, three found a positive relationship, but three did not. However, each of the studies had significant deficiencies in the study design (e.g. ecological exposure assessment; failure to consider aluminum exposure from all sources and to control for important confounders, such as education, socioeconomic status, and family history; the use of surrogate outcome measures for AD; and selection bias) ^L2149.

In general, the relative risks determined were less than 2, with large confidence intervals, when the total aluminum concentration in drinking-water was 0.1 mg/L or higher. Due to the pathogenesis of AD and knowledge obtained from studies, it was concluded that the present epidemiological evidence does not support a causal association between AD and aluminum in drinking-water ^L2149.

In addition to the epidemiological studies that examined the relationship between AD and aluminum in drinking-water, two studies studied cognitive dysfunction in elderly populations in relation to the levels of aluminum in drinking water. The results proved conflicting. A study of 800 male subjects, age 80-89, drinking water containing aluminum concentrations up to 98 ?g/L found no relationship. The second study used “any evidence of mental impairment” as an outcome measure and found a relative risk of 1.72 at aluminum drinking-water concentrations above 85 ?g/L in 250 males. Such data are insufficient to show that aluminum is a cause of cognitive impairment in the elderly ^L2149.

Note on possible risk of breast cancer

Widespread concern has been raised regarding the exposure to aluminum in deodorant/antiperspirant products, with inconclusive results ^L2165, ^L2167, ^L2168, ^L2169. Results from a more recent case-control study suggest an association between underarm cosmetic use and aluminum concentration in breast tissue and breast cancer. The observed association of underarm cosmetic use with breast cancer was, however, limited to women who report using the products multiple times a day before age of 30 ^A32464.