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. Short-term exposure guidelines: None developed. This letter constitutes OSHA's interpretation of the requirements discussed. 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. We trust that this letter addresses your concerns about reporting information on the MSDS. Also, from time to time we update our guidance in response to new information. (November 19, 1997). 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. 2009 Nov 15;69(22):8784-9. From a regulatory standpoint OSHA does not regulate TiO 2 as a carcinogen. Common applications for TiO2 include paints, plast… [Note: NIOSH recommends as part of its carcinogen policy that the "most protective" respirators be worn for titanium dioxide at any detectable concentration. 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). Titanium Dioxide (TiO2) is a bright white substance used primarily as a vivid colourant in a vast range of common products. 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. Titanium dioxide accounts for 70% of the total production volume of pigments worldwide. Note that our enforcement guidance may be affected by changes to OSHA rules. Original (SCP) IDLH*: No Evidence [*Note: “Effective” IDLH = 7,500 mg/m3 — see discussion below.]. No changes to the regulation have been made since its initial adoption on 4 October. 1A or 1B and/or an entry in the Candidate list. ; Proposition 65 requires businesses to determine if they must provide a warning about exposures to listed chemicals. Grassian VH, O’Shaughnessy PT, Adamcakova-Dodd A, Pettibone JM, Thorne PS. The amounts of titanium found in the tape strips and skin preparations were in the order of the analytical determination limit. What does this mean? The permissible exposure limit for TiO2 is 15mg/m3, as total dust, expressed as an 8-hour time-weighted average. Is TiO2 required to be reported as a carcinogen on MSDS's according to the Haz Com Standrard? 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. 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. If it is a carcinogen, under what exposure scenerio inhalation, dermal contact etc.? 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. From a regulatory standpoint OSHA does not regulate TiO2 as a carcinogen. 1228 Euclid Avenue 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. 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. Director (TiO2) relative to Occupational Safety and Health Administration (OSHA) standards. The regulation classifies titanium dioxide as category 2 carcinogen by inhalation under EU Regulation (EC) No 1272/2008. 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. 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’. The most recent change is the European Commission’s classification of TiO 2 as a suspected carcinogen (cat 2.) No Ti was found in the receptor fluid at any sampling time. 500 Halle Building Background The European Commission issued a proposal for classification of titanium dioxide as a suspected carcinogen of category 2 by inhalation on 4 […] They reference the NIOSH Pocketguide. Thank you for your interest in occupational health. 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 … The World Health Organisation’s International Agency for Research on Cancer (IARC) has determined that titanium dioxide is a “possible carcinogen for humans”. Carcinogen status of titanium dioxide relative to OSHA Standards. The TLV and PEL show it to be nuisance dust. Should you have any further questions or need additional assistance please contact Ira Wainless of my staff at (202) 219-7056. 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. Potential carcinogen: comes from a harmonised C&L classifying the substance as a suspected carcinogen Carc.2. Question: What is the carcinogen status of TiO2 as per OSHA? 1/ Titanium dioxide has been classified as a category 2 carcinogen by inhalation by the EU. Washington, D.C. 20211. For this draft technical standard, therefore, respirators have been selected on the basis of the assigned protection factor afforded by each device. In January 2020, industry submitted a dossier to support the safety of TiO2 according to Article Titanium dioxide nanoparticles induce DNA damage and genetic instability in vivo in mice. Formats Print Book PDF. 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." 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. Gamer AO, Leibold E, et al (2006). The permissible exposure limit for TiO 2 is 15mg/m 3, as total dust, … Uses & Benefits. ISBN-13 (PDF) 978-92-832-1593-6. NIOSH REL: None established; NIOSH considers titanium dioxide to be a potential occupational carcinogen as defined by the OSHA carcinogen policy [29 CFR 1990]. Clarification of OSHA's Hazard Communication Standard with regards to the carcinogenicity of wood dust. Cleveland, Ohio 44115-1809 (February 02, 1994). While there is no explicit des… You will be subject to the destination website's privacy policy when you follow the link. 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. Description of substance: White, odorless powder. Other languages No other languages. This is in response to your letter of October 15, requesting information about the carcinogen status of titanium dioxide On 18 February, the European Commission has published its final decision on titanium dioxide classification. Contact Us. The review of the relevant literature and the evaluations by the Working Group will be p … Hazard determination for carcinogenic compounds. 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. OSHA requirements are set by statute, standards and regulations. 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. The European Chemicals Agency (Echa) has concluded that titanium dioxide may cause cancer if inhaled. Titanium dioxide (airborne, unbound particles of respirable size) is on the Proposition 65 list because it can cause cancer. In response, according to a report by Chemical Watch, industries are disputing the decision and even considering legal action against the EC. 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. If it is a carcinogen, why does it have the nuisance dust PEL & TLV? Douglas C. Markley And add the EUH211 and EUH212 phrases for liquid and solid mixtures containing TIO2, in the same percentage and size mentioned. Titanium dioxide is classified as a Group 2B carcinogen as animal studies have linked its inhalation to lung tumor development. 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. 500 Halle Building Titanium Dioxide. 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. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. Directorate of Technical Support, EXECUTIVE OFFICES 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). Mr. Douglas C. Markley TiO2 is an impurity in their clay mineral produce. Exposure to titanium dioxide may increase the risk of cancer. Pure titanium dioxide is a fine, white powder that provides a bright, white pigment. 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''. ISBN-13 (Print Book) 978-92-832-1293-5. This follows a meeting of the CARACAL group (Competent authorities Meeting for REACH and CLP regulations) on September 18, 2019. 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. 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 European Commission (EC) has published its decision to classify titanium dioxide as a carcinogen by inhalation. Cancer research. ], Centers for Disease Control and Prevention. My company has received an MSDS from a supplier that lists Titaniun Dioxide as a carcinogen. My question relates to the listing of OSHA carcinogens and the Hazard Communication Standard. Decision on titanium dioxide follows industry lobbying and could be illegal, critics say Titanium dioxide (TiO2) is found in a vast array of paints, … Inhalation exposure study of titanium dioxide nanoparticles with a primary particle size of 2 to 5 nm. 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. TiO2 is not listed as a carcinogen by either NTP or IARC. Our interpretation letters explain these requirements and how they apply to particular circumstances, but they cannot create additional employer obligations. (October 11, 1995). A copy of the study is enclosed. To keep apprised of such developments, you can consult OSHA's website at https://www.osha.gov. Office of Technical Support 1228 Euclid Avenue Toxicology in Vitro 20: 301-307. In 2017 the French Government’s scientific assessment found that titanium dioxide is a carcinogen when it is inhaled. Titanium dioxide is possible carcinogenic to humans (Group 2B)based on sufficient evidence in experimental animals and inadequate evidence from epidemiological studies. 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. NIOSH REL: None established; NIOSH considers titanium dioxide to be a potential occupational carcinogen as defined by the OSHA carcinogen policy [29 CFR 1990]. IARC. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. Carbon Black, Titanium Dioxide, and Talc IARC Monographs on the Evaluation of Carcinogenic Risks to Humans Volume 93. Cleveland, Ohio 44115-1809. 200 Constitution Ave. NW 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). Steven F. Witt 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. The whitest and brightest of known pigments, TiO2has reflective qualities and can both scatter and absorb UV rays. 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 The delegated regulation classifies titanium dioxide (TiO 2 ​) as a category 2 suspected carcinogen by inhalation under EU Regulation (EC) No 1272/2008. CDC twenty four seven. It is important to consider that this only concerns the powder form of the solid. "The in vitro absorption of microfine zinc oxide and titanium dioxide through porcine skin." (216) 621-5200, Occupational Safety and Health Adminstraiion 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. 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