Titanium Dioxide

Please note, this OEL/ADE monograph also applies to the alternate CAS RN 1317-80-2. TiO2, also known as titanium (IV) oxide or titania, is the naturally occurring oxide of titanium. It is used as a pigment under the names titanium white, Pigment White 6 (PW6), or CI 77891. Four naturally occurring TiO2 polymorphs exist. They are rutile, anatase, brookite and TiO2 (B). Anatase and rutile are tetragonal, brookite is orthorhombic and TiO2 (B) is monoclinic. In all four polymorphs, titanium is coordinated octahedrally by oxygen, but the position of the octahedra differs between polymorphs. TiO2 is widely used in confectionery, cosmetics, foods, in the plastics industry, and in topical and oral pharmaceutical formulations as a white pigment. In pharmaceutical formulations, TiO2 is used as a white pigment in film-coating suspensions, sugar-coated tablets, and gelatin capsules. TiO2 may also be admixed with other pigments. TiO2 is also used in dermatological preparations and cosmetics, such as sunscreens.

Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API). This monograph also contains the acceptable daily exposure (ADE) value.

Titanium Dioxide

CAS Registry Number:
13463-67-7
Cost:
$639 USD

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Why do you need this OEL Fastrac monograph?

OEL Fastrac monographs are a cost-effective and convenient way to meet the requirements for PDEs (ADEs) contained in the EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012), as well as PIC/S and ANVISA requirements, and to obtain the following information:

  • The numerical OEL and control band assignment needed to determine the level of required engineering controls and personal protective equipment
  • A listing of all cited references utilized in the derivation of the OEL and ADE
  • An expert review and discussion with respect to the critical endpoints of concern, the rationale for the choice of endpoints, and dose that is to be used in the derivation of the ADE (PDE), as required by the EMA's Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

Benefits of OEL Fastrac monographs

  • Fully documented. 10-12 pages in length, with calculations and cited references.
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  • Save money. Similar documents cost 5-12 times as much.
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To order an OEL/ADE monograph for Titanium Dioxide, just click the ADD TO CART button.

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Affygility Solutions’ OEL Fastrac service is an user-friendly system that enables us to make confident decisions and focus on moving the compound safely through our facility. We can quickly access the database to determine if a new drug is within the OEL Fastrac library, and if so, immediately download a detailed OEL banding report. The OEL Fastrac system has been a helpful tool in our overall EH&S program.
  • K. Rosenthal
  • Director of Manufacturing