JACC Report 51 – Synthetic Amorphous Silica

JACC 051 : Synthetic Amorphous Silica | September 2006

This report has been produced as part of the ECETOC Joint Assessment of Commodity Chemicals (JACC) programme. It presents a critical evaluation of the physico-chemical properties, toxicology, ecotoxicology and environmental fate and impact of (non-crystalline) synthetic amorphous silica (SAS, plural: SASs). SASs are white, fluffy powders or milky-white dispersions of these powders (usually in water). SASs are hydrophilic, but can be made hydrophobic by surface treatment. SASs are produced by the wet route (precipitated silica, silica gel) or the thermal route (pyrogenic silica). SASs are used in various industrial applications (e.g. thickening of elastomers) and in consumer products (e.g. cosmetics and pharmaceuticals). Crystalline and/or amorphous silicas are ubiquitous on the earth in soils and sediments, and in living organisms (e.g. diatoms), but only the dissolved form is bioavailable. On a global scale, the level of man-made SAS represents up to 2.4% of the dissolved silica naturally present in the aquatic environment. The rate of SAS released into the environment during the product life cycle is negligible in comparison with the natural flux of silica in the environment. Based on available data, SAS is not toxic to environmental organisms (apart from physical desiccation). In conclusion, SAS presents a low risk for adverse effects to the environment. When experimental animals inhale SAS dust, it dissolves in the lung fluid and is rapidly eliminated. If swallowed, the vast majority of SAS is excreted in the faeces and there is little accumulation in the body. Following absorption across the gut, SAS is eliminated via urine without modification in animals and humans. SAS is not expected to be broken down (metabolised) in mammals. Both the mammalian and environmental toxicology of SASs are significantly influenced by the physical and chemical properties, particularly those of solubility and particle size. SAS has no acute intrinsic toxicity by inhalation. Adverse effects, including suffocation, that have been reported were caused by the presence of high numbers of respirable particles generated to meet the required test atmosphere. These results are not representative of exposure to commercial SASs and should not be used for human risk assessment. Though repeated exposure of the skin may cause dryness and cracking, SAS is not a skin or eye irritant, and it is not a sensitiser. Repeated-dose and chronic toxicity studies confirm the absence of toxicity when SAS is swallowed or upon skin contact. Long-term inhalation of SAS caused some adverse effects in animals (increases in lung inflammation, cell injury and lung collagen content), all of which subsided after exposure. Neither inhalation nor oral administration caused neoplasms (tumours). SAS is not mutagenic in vitro. No genotoxicity was detected in in vivo assays. SAS does not impair development of the foetus. Fertility was not specifically studied, but the reproductive organs in long-term studies were not affected. In humans, SAS is essentially non-toxic by mouth, skin or eyes, and by inhalation. Epidemiology studies show little evidence of adverse health effects due to SAS. Repeated exposure (without personal protection) may cause mechanical irritation of the eye and drying/cracking of the skin.