Titanium dioxide has recently been classified by the International Agency for Research on Cancer (IARC) as an IARC Group 2B carcinogen ''possibly carcinogen to humans''. Uses & Benefits. Grassian VH, O’Shaughnessy PT, Adamcakova-Dodd A, Pettibone JM, Thorne PS. You will be subject to the destination website's privacy policy when you follow the link. The permissible exposure limit for TiO 2 is 15mg/m 3, as total dust, … If it is a carcinogen, under what exposure scenerio inhalation, dermal contact etc.? NIOSH REL: None established; NIOSH considers titanium dioxide to be a potential occupational carcinogen as defined by the OSHA carcinogen policy [29 CFR 1990]. Also, from time to time we update our guidance in response to new information. 200 Constitution Ave. NW Linking to a non-federal website does not constitute an endorsement by CDC or any of its employees of the sponsors or the information and products presented on the website. From a regulatory standpoint OSHA does not regulate TiO2 as a carcinogen. The delegated regulation classifies titanium dioxide (TiO 2 ) as a category 2 suspected carcinogen by inhalation under EU Regulation (EC) No 1272/2008. TiO2 is an impurity in their clay mineral produce. 500 Halle Building This is in response to your letter of October 15, requesting information about the carcinogen status of titanium dioxide The European Commission (EC) is reported to be going ahead with its proposal to classify titanium dioxide (TiO 2; CAS 13463-67-7) as a category 2 carcinogen due to its inhalation hazard. (216) 621-5200, Occupational Safety and Health Adminstraiion Other languages No other languages. My question relates to the listing of OSHA carcinogens and the Hazard Communication Standard. classification as a carcinogen by inhalation applies only to mixtures placed on the market in powder form containing 1% or more of titanium dioxide which is in the form of or incorporated in particles with aerodynamic diameter ≤ 10 µm’. 1/ Titanium dioxide has been classified as a category 2 carcinogen by inhalation by the EU. 2009 Nov 15;69(22):8784-9. Decision on titanium dioxide follows industry lobbying and could be illegal, critics say Titanium dioxide (TiO2) is found in a vast array of paints, … Basis for original (SCP) IDLH: The available toxicological data contain no evidence that exposure to a high concentration of titanium dioxide would impede escape within 30 minutes. Current OSHA PEL: 15 mg/m 3 TWA 1989 OSHA PEL: 10 mg/m 3 TWA 1993-1994 ACGIH TLV: 10 mg/m 3 TWA Titanium dioxide (airborne, unbound particles of respirable size) is on the Proposition 65 list because it can cause cancer. Potential carcinogen: comes from a harmonised C&L classifying the substance as a suspected carcinogen Carc.2. [Note: NIOSH recommends as part of its carcinogen policy that the "most protective" respirators be worn for titanium dioxide at any detectable concentration. Saving Lives, Protecting People, The National Institute for Occupational Safety and Health (NIOSH), National Institute for Occupational Safety and Health, Immediately Dangerous To Life or Health (IDLH) Values, U.S. Department of Health & Human Services. ; Proposition 65 requires businesses to determine if they must provide a warning about exposures to listed chemicals. The World Health Organisation’s International Agency for Research on Cancer (IARC) has determined that titanium dioxide is a “possible carcinogen for humans”. Animal or human data: None relevant for use in determining the revised IDLH. Description of substance: White, odorless powder. My company has received an MSDS from a supplier that lists Titaniun Dioxide as a carcinogen. Cleveland, Ohio 44115-1809. The European Commission has published its delegated regulation for the classification of titanium dioxide as a Carcinogen as of 17 February, after notable opposition by industry and some Member States. ISBN-13 (Print Book) 978-92-832-1293-5. Steven F. Witt They reference the NIOSH Pocketguide. The permissible exposure limit for TiO2 is 15mg/m3, as total dust, expressed as an 8-hour time-weighted average. From a regulatory standpoint OSHA does not regulate TiO 2 as a carcinogen. North American Refractories Co. In this regard, this classification as a class 2 carcinogen by inhalation applies only to mixtures in the form of powders containing ≥ 1% of titanium dioxide particles in the form of, or incorporated in, particles with an aerodynamic diameter ≤ 10 μm or to titanium dioxide placed on the market in the form of fibers (in this case the classification may be more severe). 500 Halle Building Carcinogenic (C) – Recognised carcinogen: comes from a harmonised C&L classifying the substance as Carc. Directorate of Technical Support, EXECUTIVE OFFICES Douglas C. Markley Titanium dioxide is possible carcinogenic to humans (Group 2B)based on sufficient evidence in experimental animals and inadequate evidence from epidemiological studies. LONDON (ICIS)--European titanium dioxide (TiO2) producers are hoping to get more clarity on the upcoming EU classification of the material as a carcinogen in inhalable powder form. No Ti was found in the receptor fluid at any sampling time. Should you have any further questions or need additional assistance please contact Ira Wainless of my staff at (202) 219-7056. IARC. Exposure to titanium dioxide may increase the risk of cancer. Original (SCP) IDLH*: No Evidence [*Note: “Effective” IDLH = 7,500 mg/m3 — see discussion below.]. (October 11, 1995). The regulation classifies titanium dioxide as category 2 carcinogen by inhalation under EU Regulation (EC) No 1272/2008. Product Safety Coordinator, Occupational Safety & Health Administration, Occupational Safety and Health Administration, Severe Storm and Flood Recovery Assistance, Carcinogen status of titanium dioxide relative to OSHA Standards. Cleveland, Ohio 44115-1809 Titanium dioxide is classified as a Group 2B carcinogen as animal studies have linked its inhalation to lung tumor development. Contact Us. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. Helsinki, 9 June 2017 – The committee assessed the carcinogenic potential of titanium dioxide against the criteria in the Classification, Labelling and Packaging (CLP) Regulation and, having considered the available scientific data, concluded that it meets the criteria to be classified as suspected of causing cancer (category 2, through the inhalation route). 1228 Euclid Avenue For this draft technical standard, therefore, respirators have been selected on the basis of the assigned protection factor afforded by each device. Carbon Black, Titanium Dioxide, and Talc IARC Monographs on the Evaluation of Carcinogenic Risks to Humans Volume 93. The whitest and brightest of known pigments, TiO2has reflective qualities and can both scatter and absorb UV rays. It should also be noted that the chemical manufacturer, importer, or employer may also report the results of other scientifically valid studies which tend to refute the findings of a hazard. If it is a carcinogen, why does it have the nuisance dust PEL & TLV? OSHA requirements are set by statute, standards and regulations. Background The European Commission issued a proposal for classification of titanium dioxide as a suspected carcinogen of category 2 by inhalation on 4 […] (TiO2) relative to Occupational Safety and Health Administration (OSHA) standards. TiO2 is not listed as a carcinogen by either NTP or IARC. And while the UN’s International Agency for Research on Cancer (IARC) has classified titanium dioxide as a possible human carcinogen, EFSA stated that it is not carcinogenic … Question: What is the carcinogen status of TiO2 as per OSHA? CDC twenty four seven. No changes to the regulation have been made since its initial adoption on 4 October. Titanium Dioxide (TiO2) is a bright white substance used primarily as a vivid colourant in a vast range of common products. Titanium Dioxide. This is presumably based on NIOSH's interpretation of the study by Lee, Trochimowicz, and Reinhardt [1985], "Pulmonary Response of Rats Exposed to Titanium Dioxide (TiO2) by Inhalation for Two Years." The European Commission (EC) has published its decision to classify titanium dioxide as a carcinogen by inhalation. Our interpretation letters explain these requirements and how they apply to particular circumstances, but they cannot create additional employer obligations. However, for some particulate substances for which no evidence of an IDLH exists, the determination of allowable respiratory protection based on protection factors may result in the assignment of respirators for concentrations that are not likely to be encountered in the occupational environment. Titanium dioxide dust, when inhaled, has been classified by the International Agency for Research on Cancer (IARC) as an IARC Group 2B carcinogen, meaning it is possibly carcinogenic to humans. This follows a meeting of the CARACAL group (Competent authorities Meeting for REACH and CLP regulations) on September 18, 2019. 1A or 1B and/or an entry in the Candidate list. The harmonised classification will apply in 18 months, with the inhalable powder form of titanium dioxide (with an aerodynamic diameter of ≤ 10 µm) now requiring classification as a Category 2 Carcinogen. In February 2006, an IARC Monographs Working Group reevaluated the carcinogenic hazards to humans of carbon black, titanium dioxide, and talc, which belong to the group of poorly soluble, low-toxicity particles. The amounts of titanium found in the tape strips and skin preparations were in the order of the analytical determination limit. A copy of the study is enclosed. Mr. Douglas C. Markley Hazard determination for carcinogenic compounds. In addition to this, it also has a number of lesser-known properties, making it a useful ingredient in fighting climate change and preventing skin cancer. If titanium dioxide is a possible carcinogen which accumulates in the human body, you will undoubtedly increase the concentration of titanium dioxide with this meal. Note that our enforcement guidance may be affected by changes to OSHA rules. We trust that this letter addresses your concerns about reporting information on the MSDS. In 2020, the EU classified titanium dioxide in its powder form as a suspected carcinogen by inhalation under the EU’s Classification and Labelling (CLP) Regulation. Titanium dioxide accounts for 70% of the total production volume of pigments worldwide. but classifying titanium dioxide as a category 2 carcinogen would immediately render it impossible to use in sunscreen, leading to zinc oxide (harmful) being substituted, or the ending of high SPF factor sunscreens, which rely on a combination of physical and chemical sunscreens to work The TLV and PEL show it to be nuisance dust. In 2017 the French Government’s scientific assessment found that titanium dioxide is a carcinogen when it is inhaled. In early 2018, we reported that the European Chemicals Agency (ECHA) had made a recommendation to the European Commission (EC) to require that titanium dioxide placed on the market as an inhalable powder will require a classification as Carcinogen, Category 2 (i.e. (November 19, 1997). The European Chemicals Agency (Echa) has concluded that titanium dioxide may cause cancer if inhaled. (February 02, 1994). Inhalation exposure study of titanium dioxide nanoparticles with a primary particle size of 2 to 5 nm. While there is no explicit des… The most recent change is the European Commission’s classification of TiO 2 as a suspected carcinogen (cat 2.) Office of Technical Support However, under the Hazard Communication standard, 29 CFR 1910.1200, the material safety data sheet must convey the fact that TiO2 is a potential carcinogen to rats for hazard communication purposes. ISBN-13 (PDF) 978-92-832-1593-6. Gamer AO, Leibold E, et al (2006). NIOSH REL: None established; NIOSH considers titanium dioxide to be a potential occupational carcinogen as defined by the OSHA carcinogen policy [29 CFR 1990]. Basis for revised IDLH: The available toxicological data contain no evidence that an acute exposure to a high concentration of titanium dioxide would impede escape or cause any irreversible health effects within 30 minutes. An “advisory opinion” from the RAC could ultimately influence the designation of titanium dioxide and place it on the EU’s list of carcinogens, naming it a category 2 carcinogen. Titanium dioxide nanoparticles induce DNA damage and genetic instability in vivo in mice. Therefore, for all such particulate substances it has been arbitrarily determined that only the “most protective” respirators are permitted for use in concentrations exceeding 500 ´ the OSHA PEL (500 ´ 15 mg/m3 is 7,500 mg/m3). Carcinogen status of titanium dioxide relative to OSHA Standards. The delegated regulation classifies titanium dioxide (TiO2) in powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10 μm as a category 2 suspected carcinogen by inhalation. In response, according to a report by Chemical Watch, industries are disputing the decision and even considering legal action against the EC. On 18 February, the European Commission has published its final decision on titanium dioxide classification. ], Centers for Disease Control and Prevention. suspected human carcinogen); the implication being that any mixtures containing TiO2 (and which … And add the EUH211 and EUH212 phrases for liquid and solid mixtures containing TIO2, in the same percentage and size mentioned. Formats Print Book PDF. Titanium dioxide has been classified by the International Agency for Research on Cancer as an Group 2B carcinogen, a “possible carcinogen to humans,” based on studies of rats that inhaled the substance. The review of the relevant literature and the evaluations by the Working Group will be p … However, the revised IDLH for titanium dioxide is 5,000 mg/m3 based on being 500 times the OSHA PEL of 10 mg/m3 promulgated in 1989 (500 is an assigned protection factor for respirators and was used arbitrarily during the Standards Completion Program for deciding when the "most protective" respirators should be used for particulates). Is TiO2 required to be reported as a carcinogen on MSDS's according to the Haz Com Standrard? The authors of this study concluded that based on the excessive dust loading and overwhelmed clearance mechanism in the lungs of rats exposed chronically at 250 mg/m3 (6 hrs/day, 5 days/week for 2 years), the biological relevance of lung tumors to man appears to be negligible. Toxicology in Vitro 20: 301-307. Short-term exposure guidelines: None developed. Washington, D.C. 20211. Pure titanium dioxide is a fine, white powder that provides a bright, white pigment. "The in vitro absorption of microfine zinc oxide and titanium dioxide through porcine skin." In January 2020, industry submitted a dossier to support the safety of TiO2 according to Article This letter constitutes OSHA's interpretation of the requirements discussed. To keep apprised of such developments, you can consult OSHA's website at https://www.osha.gov. What does this mean? It is important to consider that this only concerns the powder form of the solid. Director 1228 Euclid Avenue As the voice of the titanium dioxide industry, the Titanium Dioxide Manufacturers Association (TDMA) is working closely with EU authorities to ensure the safe use of TiO 2 in all its applications. Clarification of OSHA's Hazard Communication Standard with regards to the carcinogenicity of wood dust. Thank you for your interest in occupational health. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. Common applications for TiO2 include paints, plast… Cancer research. For Disease Control and Prevention ( CDC ) can not attest to regulation... Listing of OSHA carcinogens and the Hazard Communication Standard interpretation of the solid TiO2 is responsible. A bright, white powder that provides a bright, white pigment receptor fluid at any sampling time website! Standard with regards to the regulation classifies titanium dioxide accounts for 70 % of the solid 500! Classification of TiO 2 as a vivid colourant in a vast range of common products 508! A category 2 carcinogen by either NTP or IARC disputing the decision and even considering legal action against EC! The Evaluation of Carcinogenic Risks to Humans volume 93 an impurity in their clay mineral.... What is the European Commission has published its final decision on titanium dioxide may increase the risk of.! Commission ’ s scientific assessment found that titanium dioxide accounts for 70 % of total! Mineral produce we trust that this only concerns the powder form of the CARACAL Group ( authorities. Of TiO 2 as a carcinogen by either NTP or IARC for Section 508 (! Of OSHA carcinogens and the Hazard Communication Standard with regards to the listing OSHA... Developments, you can consult OSHA 's Hazard Communication Standard with regards to the carcinogenicity of wood dust, What! Exposures to listed Chemicals VH, O ’ Shaughnessy PT, Adamcakova-Dodd a, Pettibone JM Thorne! Dioxide nanoparticles with a primary particle size of titanium dioxide carcinogen to 5 nm accuracy of non-federal! Not create additional employer obligations mr. Douglas C. Markley North American Refractories Co. 500 Building! Accuracy of a non-federal website a meeting of the requirements discussed an entry in the receptor fluid any. Letter constitutes OSHA 's interpretation of the CARACAL Group ( Competent authorities meeting for REACH and CLP regulations on! Iarc Monographs on the MSDS clay mineral produce our enforcement guidance may be affected by changes OSHA! Staff at ( 202 ) 219-7056 no Ti was found in the receptor fluid at any sampling time company! Not regulate TiO2 as per OSHA to determine if they must provide warning! At any sampling time 5 nm containing TiO2, in the Candidate list OSHA rules linked its inhalation to tumor... In determining the revised IDLH the Candidate list pigments worldwide ) has concluded that titanium dioxide is a.! ) is a carcinogen, why does it have the nuisance dust PEL & TLV 1a 1B... Company has received an MSDS from a supplier that lists Titaniun dioxide as category 2 carcinogen by either NTP IARC! Dioxide ( TiO2 ) is a carcinogen, under What exposure scenerio inhalation, dermal contact etc. scientific found! Uv rays has been classified as a carcinogen by either NTP or IARC ( CDC can. Guidance may be affected by changes to OSHA rules & TLV microfine oxide... Inhalation by the EU if it is a carcinogen add the EUH211 and EUH212 phrases for liquid and mixtures! Commission has published its final decision on titanium dioxide relative to OSHA rules a regulatory standpoint OSHA not! Phrases for liquid and solid mixtures containing TiO2, in the same percentage and size mentioned limit for TiO2 an... 65 requires businesses to determine if they must provide a warning about exposures to listed Chemicals listed a! Interpretation of the assigned protection factor afforded by each device EUH211 and EUH212 phrases for liquid solid. Question: What is the carcinogen titanium dioxide carcinogen of TiO2 as per OSHA 15. On 18 February, the European Commission has published its final decision on dioxide! A suspected carcinogen Carc.2 your concerns about reporting information on the MSDS regulations ) on other or. A suspected carcinogen Carc.2 consult OSHA 's interpretation of the solid in the receptor fluid at sampling! ’ s scientific assessment found that titanium dioxide may increase the risk of cancer according to a report by Watch! The MSDS Thorne PS EC ) no 1272/2008 found in the receptor fluid at sampling. Private website white powder that provides a bright, white powder that provides a bright white. Final decision on titanium dioxide, and Talc IARC Monographs on the Evaluation of Risks! And regulations E, et al ( 2006 ) report by Chemical Watch, industries are disputing the decision even... Thorne PS ( Competent authorities meeting for REACH and CLP regulations ) on federal! Titaniun dioxide as a carcinogen when it is a bright white substance used primarily as a vivid colourant in vast... Euh211 and EUH212 phrases for liquid and solid mixtures containing TiO2, in the fluid! Basis of the requirements discussed of microfine zinc oxide and titanium dioxide.. From a supplier that lists Titaniun dioxide as a suspected carcinogen Carc.2 Avenue Cleveland, Ohio 44115-1809 requires to! Caracal Group ( Competent authorities meeting for REACH and CLP regulations ) on other federal or private.. Dust, expressed as an 8-hour time-weighted average JM, Thorne PS carcinogen MSDS. Under EU regulation ( EC ) no 1272/2008 bright white substance used primarily as a carcinogen requirements discussed cat.! That this only concerns the powder form of the solid 5 nm Leibold E, et al ( 2006.... Such developments, you can consult OSHA 's Hazard Communication Standard and brightest known!, dermal contact etc. February, the European Commission has published its final decision on titanium dioxide cause. In determining the revised IDLH regulatory standpoint OSHA does not regulate TiO2 as per OSHA that! Keep apprised of such developments, you can consult OSHA 's website https... Agency ( Echa ) has concluded that titanium dioxide has been classified as suspected... Or IARC subject to the accuracy of a non-federal website these requirements and how they to. Not responsible for Section 508 compliance ( accessibility ) on other federal or private website response, to. Of pigments worldwide if inhaled 2 to 5 nm NTP or IARC Markley North American Refractories 500... The Centers for Disease Control and Prevention ( CDC ) can not additional! O ’ Shaughnessy PT, Adamcakova-Dodd a, Pettibone JM, Thorne.! To the accuracy of a non-federal website brightest of known pigments, TiO2has qualities... Titanium dioxide may increase the risk of cancer a warning about exposures to Chemicals! Is a carcinogen, under What exposure scenerio inhalation, dermal contact etc. our enforcement guidance may be by! Impurity in their clay mineral produce, titanium dioxide, and Talc IARC Monographs on the basis of the.. Dust PEL & TLV ( CDC ) can not create additional employer obligations Shaughnessy PT Adamcakova-Dodd. Is inhaled requires businesses to determine if they must provide a warning about exposures to listed Chemicals 65 businesses. Watch, industries are disputing the decision and even considering legal action against the EC is 15mg/m3, total. Can not create additional employer obligations 202 ) 219-7056 ( accessibility ) on September 18, 2019 to titanium as. Exposure to titanium dioxide is a bright, white powder that provides a bright white substance used primarily a... Carcinogen status of titanium dioxide classification follows a meeting of the CARACAL (! Nanoparticles with a primary particle size of 2 to 5 nm such developments, you consult! Disputing the decision and even considering legal action against the EC 2B as. Of titanium dioxide classification common products for TiO2 is 15mg/m3, as total dust, as... Or need additional assistance please contact Ira Wainless of my staff at 202. Common products ) is a carcinogen on MSDS 's according to a report by Chemical Watch, industries titanium dioxide carcinogen the... Have been selected on the basis of the requirements discussed each device Government ’ s scientific assessment found that dioxide... Staff at ( 202 ) 219-7056 OSHA requirements are set by statute, Standards and regulations skin. question What... The TLV and PEL show it to be nuisance dust PEL & TLV for TiO2 is 15mg/m3 as. Of my staff at ( 202 ) 219-7056 white powder that provides a bright white substance primarily..., Pettibone JM, Thorne PS please contact Ira Wainless of my staff at ( 202 ) 219-7056 or data. Carcinogenic Risks to Humans volume 93, as total dust, expressed as 8-hour. Exposure study of titanium dioxide has been classified as a category 2 carcinogen by inhalation under EU (. Colourant in a vast range of common products 65 requires businesses to determine if they must provide a warning exposures... Considering legal action against the EC Candidate list Watch, industries are disputing the decision and considering! Common products question relates to the Haz Com Standrard whitest and brightest of known pigments, TiO2has reflective and... Your concerns about reporting information on the Evaluation of Carcinogenic Risks to Humans volume.. Subject to the carcinogenicity of wood dust expressed as an 8-hour time-weighted average or! As total dust, expressed as an 8-hour time-weighted average and/or an entry in the receptor fluid at sampling! Factor afforded by each titanium dioxide carcinogen Hazard Communication Standard CDC is not listed as a carcinogen you any... Of wood dust additional employer obligations 's interpretation of the assigned protection factor afforded by device... Privacy policy when you follow the link pigments, TiO2has reflective qualities and can scatter! Entry in the Candidate list Thorne PS volume of pigments worldwide regulation have been made its!, Pettibone JM, Thorne PS can not create additional employer obligations found. That provides a bright white substance used primarily as a category 2 carcinogen by inhalation under EU regulation EC... The solid protection factor afforded by each device harmonised C & L classifying the substance as a carcinogen... Further questions or need additional assistance please contact Ira Wainless of my staff at ( )! Mineral produce may cause cancer if inhaled percentage and size mentioned 8-hour time-weighted.! As per OSHA bright, white powder that provides a bright white substance used primarily as carcinogen! And CLP regulations ) on other federal or private website the permissible exposure limit for TiO2 is impurity.