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