Product Safety

Synthetic amorphous silica manufactured by flame hydrolysis or by precipitation in an aqueous solution is characterized by its amorphous structure. The determination method used on typical samples is enrichment of the crystalline fraction followed by X-ray Diffraction. The detection limit of this method is less than 0.05 percent by weight. Under consideration of this detection limit Evonik Degussa GmbH silica are considered to be amorphous.

Toxicology

Ecotoxicology

Synthetic amorphous silica is an inorganic water insoluble substance. For this reason its bioavailability is very low for aquatic organisms. In acute tests according to OECD test guidelines with fish and daphnia nominal concentrations of 1000 and 10 000 mg / l respectively showed no effects. Based on the physicalchemical and acute toxicological data no chronic effects and no bioaccumulation are expected in aquatic organisms. The general guidelines for the examination of the biodegradability of substances (OECD-, EEC-guidelines) can be used only for organic substances. Synthetic amorphous silica is an inert inorganic substance and will not biodegraded by microorganisms. The German commission for the evaluation of water polluting substances has classified synthetic amorphous silica as a not water endangering substance (KBwS-No: 849). Silica is also included in the OSPAR List of Substances / Preparations. Used and Discharged Offshore which Are Considered to Pose Little or No Risk to the Environment (PLONOR).

Information on Handling

Air removal pumps are recommended for facilities that process Evonik Specialty Silica in powder form. In conditions where Evonik Specialty Silica concentrations exceed the MAK (maximum work place exposure) value of 4 mg / m3 (inhalable fraction), a dust mask (P2 Particle Filter Class) must be worn. Electrostatic charges may form when handling Evonik Specialty Silica, so that the facilities used must be adequately grounded. To avoid the feeling of dryness that results from contact with bare skin, Evonik Specialty Silica should be washed off using water and exposed skin should be treated with moisturizing cream. Spilt product should be collected with a minimum of dust build-up and collected in adequately sealable containers. Evonik Specialty Silica can be disposed of as per recommendations in the European Waste Type Catalog, which is set up by industry. 

Statutory Status

Based on currently applicable standards of Chemical Substance Legislation, the Hazardous Substance Advisory and Transportation Regulations, hydrophilic Evonik Degussa GmbH Specialty Silica products are not classified as dangerous substances or goods.

You can obtain further information on Product Safety or our Safety Data Sheets from.

Evonik Degussa GmbH, IM-PT-PS
+49 6181 59-4787
+49 6181 59-4205

Further Information

• Hydrophilic synthetic amorphous silicon dioxide (CAS-No.
112926-00-8 resp. 7631-86-9 (ex)) is in line with the quality requirements of EU-Directive 2008 / 84 / EC for direct food additive E 551, as we know from typical data.
• Europe: 2000 / 72 / EC
“Silicon dioxide” is listed with Ref.-No. 86240 and CAS-No.
7631-86-9 as an additive without any restrictions and / or specification in EU directive 2000 / 72 / EC:
• USA: 21 CFR
“Silicon dioxide” is listed in 21 CFR (Code of Federal Regulations,
USA) in § 172.480 as “anticaking agent” in food which “may be safely used” with a limitation of <2 %.
• USA: FCC
Evonik Degussa GmbH Specialty Silica of type SIPERNAT^® with CAS-No. 112926-00-8 (ex 7631-86-9) meet or exceed the Food Chemicals Codex (Vth Edition) monograph for Silicon Dioxide.
• Safe Drinking Water and Toxic Enforcement Act of 1986
Evonik Degussa GmbH Specialty Silica do not contain any of the chemicals on the most recent California list of chemicals, published 2008.
• CONEG
Evonik Degussa GmbH Specialty Silica are in compliance with
CONEG (Coalition of North East Governors) Model Toxic Legislation requiring that combined total levels of lead, cadmium, mercury and hexavalent chromium are less than 100 ppm.
• TSCA
Silicon dioxide, chemically prepared” is listed generically as silica and is registered as CAS-No. 7631-86-9 in the Toxic Substances Control Act (TSCA) Inventory.
• OZONE DEPLETING CHEMICALS
Evonik Degussa GmbH do not use Class I or Class II Ozone Depleting Chemicals in its manufacture. Evonik Specialty Silica fully comply with Section 611 of the US Environmental Protection Agency’s Clean Air Act of 1990.
• EPA
Hydrophilic Evonik Degussa GmbH Specialty Silica with CAS-No. 112926-00-8 (ex. 7631-86-9) are listed on the “Inert Ingredient List” of EPA on list 4 A.**
• USP / NF Current Edition
Evonik Degussa GmbH Specialty Silica SIDENT^® meet the requirements of the American National Formulary monograph for Dental-Type silica and that of the European Pharmacopolia for silica, Dental-Type.
• Kosher
Evonik Degussa GmbH Specialty Silica of type SIPERNAT^® and SIDENT^® are certified Kosher under the supervision of the Chief Rabbinate of Jerusalem. Certification is renewed annually.
• Halal
Evonik Degussa GmbH Specialty Silica of type SIPERNAT^® and SIDENT^® are certified Halal under the supervision of Ahmadiyya Muslim Jamaat, Frankfurt am Main.
• INCI
All SIDENT^®-Types (SIDENT^® 8, SIDENT^® 9, SIDENT^® 10 and SIDENT^® 22 S) and all hydrophilic synthetic amorphous silica of type SIPERNAT^® (e. g. SIPERNAT^® 22 or SIPERNAT^® 50) are listed under the INCI name: “Hydrated Silica”. SIPERNAT^® D 10, SIPERNAT^® D 11 and SIPERNAT^® D 13 are listed under the INCI name: “Silica (and) Dimethicone”.
SIPERNAT^® D 17 is listed under the INCI name: “Silica Silylate”.


** For Feed and Food applications in EU, only products ex Wesseling plant, produced according to HACCP and FAMI-QS principles, may be used.