red iron oxide in medications

Memorandum from D. Doell, Chemistry Review Team, Division of Petition Review, Office of Food Additive Safety (OFAS), Center for Food Safety and Applied Nutrition (CFSAN), FDA to M. Harry, Division of Petition Review, OFAS, CFSAN, FDA, September 17, 2018. that agencies use to create their documents. We note that these values could represent 2 or 4 different dietary supplements, respectively, with each supplement containing up to 5 mg elemental iron. If you request a hearing, your objection must include a detailed description and analysis of the specific factual information you intend to present in support of the objection in the event that a hearing is held. Iron oxides are common in natural waters, not the least in dystrophic waters, where large amounts of both iron and humic substances are imported from the watershed. The documents posted on this site are XML renditions of published Federal 07/29/2022, 210 Manganese oxide fibers have been used to collect radium from seawater (Moore, 1975), and metal oxides have been proposed as a means for disposal of radionuclide waste (Mott et al., 1993). informational resource until the Administrative Committee of the Federal We commonly use the EDI for the 90th percentile consumer of a color additive as a measure of high chronic exposure.Start Printed Page 54871. (ii) In soft and hard candy, mints, and chewing gum at levels consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been issued under section 401 of the Federal Food, Drug, and Cosmetic Act, unless the use of the added color is authorized by such standards. There was a significant increase in systolic blood pressure (from 137 to 141mmHg) 5 minutes after injection; it returned to normal within 4 hours. Magnetite, maghemite, and hematite are the most common forms existing naturally (M. et al., 2011). oxides, hydroxides, and oxy-hydroxides are known to date. magnetic oxide powder oz bottle iron grade usp NC100150 shows promise for myocardial perfusion analysis. Register (ACFR) issues a regulation granting it official legal status. documents in the last year, 22 Copyright 2022 Elsevier B.V. or its licensors or contributors. on The following references marked with an asterisk (*) are on display in the Dockets Management Staff (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https://www.regulations.gov. Section 73.200 is amended by revising paragraph (c)(1) to read as follows: (1) Synthetic iron oxide may be safely used for human food use subject to the following restrictions: (i) In sausage casings intended for human consumption in an amount not exceeding 0.10 percent by weight of the finished food. Makoto Hasegawa, Tatsya Gomi, in Side Effects of Drugs Annual, 2017. This final rule contains no collection of information. Submit electronic objections in the following way: Submit written/paper submissions as follows: Instructions: All submissions received must include the Docket No. the official SGML-based PDF version on govinfo.gov, those relying on it for

In a document published in the Federal Register on November 9, 2017 (82 FR 52037), we announced that we filed a color additive petition (CAP 7C0308) submitted by Colorcon, Inc., 275 Ruth Rd., Harleysville, PA 19438. documents in the last year, 804 documents in the last year. Federal Register. This rule is effective December 4, 2018. We compare an individual's estimated exposure, or estimated daily intake (EDI), of the color additive from all sources to an acceptable daily intake level established by toxicological data. Yu Heng Kwan, Lifeng Kang, in Handbook of Cosmeceutical Excipients and their Safeties, 2014, Other names: Black oxide of iron, Brown iron oxide, Cl 77489,77491,77492,77499, Iron oxide Rd 10-34-PC-2045, Pigment black 11, Pigment brown 6, and 7, Pigment red 101, and 102, Pigment yellow 42, and 43, Red iron oxide, Synthetic iron oxide, Yellow iron oxide, CAS no: 51274-00-1/1309-37-1/ 1309-38-2/ 1317-61-9/ 1345-25-1/ 1332-37-2/ 12227-89-3/ 20344-49-4/ 52357-70-7/ 64294-91-3, Carcinogenic potential: Category 2 (safe to use), Allergenic potential: Weak sensitizer (max dose=5.83g/cm2/hr), Marcel Wegmann, Melanie Scharr, in Precision Medicine, 2018.

Iron oxides can be synthesized by all known wet chemical methods but tailoring the particle size to the nano range and the morphology toward a particular application remains a challenging task. Preeti K. Menon, Hari S. Sharma, in International Review of Neurobiology, 2017. documents in the last year, 1385 The most common form of iron oxide used is magnetite, which is a mixture of Fe2O3 and FeO; a mixture of Fe2O3 and Fe3O4 can be used instead. Ultrasmall superparamagnetic particles of iron oxide (USPIOs) of median diameter no less than 50nm have been studied as blood-pool agents and are given intravenously to enhance liver imaging in patients with cirrhosis and to visualize lymph nodes. has no substantive legal effect. Only official editions of the This exposure is negligible compared to that for use of elemental iron as a color additive in tablets and capsules and in coatings applied to dietary supplements. There were no serious adverse events during the 48-hour observation period and no changes in vital signs, physical examination, or laboratory parameters. We previously estimated the cumulative exposure to bioavailable elemental iron for the U.S. population to be 3.48 mg/p/d at the mean (Ref. Consequently, we are amending the color additive regulations in 21 CFR part 73 as set forth in this document. oxides highlight oxide okello on NARA's archives.gov. edition of the Federal Register. The petitioner requested that the proposed uses be permitted at a maximum use level of 5 milligrams (mg), calculated as elemental iron, per day for labeled dosages. From: Dictionary of Toxicology (Third Edition), 2015, J.K. Aronson MA, DPhil, MBChB, FRCP, HonFBPhS, HonFFPM, in Meyler's Side Effects of Drugs, 2016. We estimated an upper-bound exposure to synthetic iron oxides from its use as a color additive in dietary supplement tablets and capsules and in coatings applied to dietary supplement tablets and capsules, but excluding its use in printing inks applied on tablets and capsules, to be 13.8 mg/p/d at the mean and 34.5 mg/p/d at the 90th percentile for the U.S. population aged 2 years and older (Ref. Register, and does not replace the official print version or the official To support the safety of the proposed use of synthetic iron oxides, Colorcon proposed a maximum use level of the color additive in dietary supplements such that the total amount of elemental iron consumed shall not exceed 5 mg per day for labeled dosages. on should verify the contents of the documents against a final, official 2). However, administration of IOMNPs in SCI group slightly enhanced the pathological changes in the CNS after 24h but not 4h after trauma. 1). Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 73 is amended as follows: 1. 21 U.S.C.

Memorandum from T. Thurmond, Toxicology Team, Division of Petition Review, OFAS, CFSAN, FDA to M. Harry, Division of Petition Review, OFAS, CFSAN, FDA, September 17, 2018. the current document as it appeared on Public Inspection on documents in the last year, by the Nuclear Regulatory Commission establishing the XML-based Federal Register as an ACFR-sanctioned 2). However, the reduction in the platelet counts may reflect tissue lesions triggered by NPs (Comnescu et al., 2015). Molly A. Harry, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740-3835, 240-402-1075. 1). on the bloodbrain barrier (BBB) permeability, edema formation, and neuronal or glial changes within 424h after administration was examined in normal rats and after a focal spinal cord injury (SCI). In accordance with 71.15 (21 CFR 71.15), the petition and the documents that we considered and relied upon in reaching our decision to approve the petition will be made available for public disclosure (see FOR FURTHER INFORMATION CONTACT). on A Rule by the Food and Drug Administration on 11/01/2018. 2). 3). More information and documentation can be found in our 2018-23863 Filed 10-31-18; 8:45 am], updated on 4:15 PM on Friday, July 29, 2022, updated on 8:45 AM on Friday, July 29, 2022. [FR Doc. Iron oxide nanoparticles with a high level of monodispersity and size control were obtained by high-temperature decomposition of iron organic precursors, such as Fe(Cup)3, Fe(CO)5, or iron(III) acetylacenonate [Fe(acac)3], using organic solvents and surfactants (Hyeon etal., 2001). Control group received cerebrolysin in identical situation following IOMNP administration. Kenneth H. Nealson, Brenda Little, in Advances in Applied Microbiology, 1997. For the subject petition, synthetic iron oxides are intended for coloring dietary supplement tablets and capsules, including coatings for tablets and capsules and printing inks applied to dietary supplement tablets and capsules, such that the total amount of elemental iron in the dietary supplements does not exceed 5 mg per day for labeled dosages. In another study, superparamagnetic iron oxide NPs (SPIONs) have been synthesized and investigated as agents for the direct labeling of cells for stem cells imaging. Liver tumors have few or no reticuloendothelial cells and so there is a contrast between normal liver and tumor. The USPIO contrast agent ferristene (Abdoscan, Amersham) is used in delineating the gastrointestinal tract after oral ingestion. Within each numbered objection, you must specifically state whether you are requesting a hearing on the particular provision that you specify in that numbered objection. documents in the last year, 53 Superparamagnetic iron oxide (SPIO) contrast agents are taken up by the liver and spleen. Safety of Petitioned Use of Color Additive, IX. We have not received any new information or comments that would affect our previous determination. 2). Document page views are updated periodically throughout the day and are cumulative counts for this document. FDA has verified the website address, as of the date this document publishes in the Federal Register, but websites are subject to change over time. The SCI was inflicted in rats by making a longitudinal incision into the right dorsal horn of the T1011 segments and allowed to survive 4 or 24h after trauma. The IOM considers the UL as the highest daily intake level of a nutrient that poses no risk of adverse effects with chronic consumption of the nutrient (Ref. rendition of the daily Federal Register on FederalRegister.gov does not 1). The petition proposed to amend the color additive regulations in 73.200 Synthetic iron oxide (21 CFR 73.200) by expanding the permitted uses of synthetic iron oxides as a color additive to include use in dietary supplement tablets and capsules, including coatings and printing inks.

Listing of Color Additives Exempt From Certification; 3)-CAP 7C0308_Toxicology Review Memo_Finalized_Redacted, 2)-CAP 7C0308_Chemistry Memo_Finalized_Redacted, 1)-FDA-2017-C-6238_List of References_CAP 7C0308, IV. Using more recent NHANES data (2011-2014), FDA determined that the U.S. population aged 2 years and older consumes 2 dietary supplements per day at the mean and 5 supplements per day at the 90th percentile (Ref. In 2001, the Institute of Medicine (IOM) published a report on dietary reference intakes for vitamins and minerals (Ref. Until the ACFR grants it official status, the XML Iron oxide NPs have promising characteristics to be used for theranostics in cancer. developer tools pages. Accordingly, this final rule should not be construed to be a statement that a food containing this color additive, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll) of the FD&C Act. Any objections received in response to the regulation may be seen in the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov. They also have a greater T1 shortening effect than SPIO contrast agents. FDA reviewed the data and information in the petition and other available relevant material and determined the petitioned use of synthetic iron oxides in dietary supplement tablets and capsules is safe. In this method, organometallic compounds as precursors are decomposed in high-boiling nonaqueous media containing stabilizing surfactants (Sun etal., 2004; Park etal., 2004; Redl etal., 2004; OBrien etal., 2001). While every effort has been made to ensure that Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. Moreover, oxic water iron (III) forms a complex with DOM which stays in solution. Such reactions may account for the distribution of trace metals (Francis and Dodge, 1990; Rose et al., 1993; Tessier et al., 1996) and radionuclides like uranium in sediments (McKee et al., 1987) and anoxic water columns (McKee and Todd, 1993). For written/paper objections submitted to the Dockets Management Staff, FDA will post your objection, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in Instructions., Confidential SubmissionsTo submit an objection with confidential information that you do not wish to be made publicly available, submit your objections only as a written/paper submission. A thermal decomposition method has been developed as an effective way to synthesize high-quality semiconductor and oxide nanoparticles with a controlled size and shape. If you want to submit an objection with confidential information that you do not wish to be made available to the public, submit the objection as a written/paper submission and in the manner detailed (see Written/Paper Submissions and Instructions). L.J. documents in the last year, 498 Each document posted on the site includes a link to the It is not an official legal edition of the Federal Iron oxide-containing contrast agents consist of suspended colloids of iron oxide nanoparticles, which reduce T2 MRI signals. Section 301(ll) of the Federal Food, Drug, and Cosmetic Act, PART 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION, https://www.federalregister.gov/d/2018-23863, MODS: Government Publishing Office metadata, https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf, https://www.ncbi.nlm.nih.gov/books/NBK222310/pdf/Bookshelf_NBK222310.pdf. They are taken up by the reticuloendothelial system. Relevant information about this document from Regulations.gov provides additional context. Electronic objections must be submitted on or before December 3, 2018. 379e(b)(4)), a color additive cannot be listed for a particular use unless the data and information available to FDA establish that the color additive is safe for that use. In this Issue, Documents electronic version on GPOs govinfo.gov. The reference without an asterisk is not on public display at https://www.regulations.gov because it has copyright restriction but is available at the website address. The diagnostic efficacy and safety of SHU 555 A has been investigated in 19 patients aged 4389 years who had been referred for investigation of hepatocellular carcinoma (eight patients), liver metastases (four patients), liver hemangioma (four patients), cholangiocarcinoma (two patients), and focal nodular hyperplasia (one patient) [6]. For biomedical applications, it is crucial that SPIONs have a well-defined shape, are monodispersed, and exhibit a high magnetization capacity (Laurent etal., 2009; Kunzmann etal., 2011b). The President of the United States issues other types of documents, including but not limited to; memoranda, notices, determinations, letters, messages, and orders. These observations are the first to show that IOMNPs are safe for the CNS and cerebrolysin treatment prevented CNS pathology following a combination of trauma and IOMNP injection. Tranvik, E. von Wachenfeldt, in Reference Module in Earth Systems and Environmental Sciences, 2014. The OFR/GPO partnership is committed to presenting accurate and reliable Submit either electronic or written objections and requests for a hearing on the final rule by December 3, 2018. 355), a biological product licensed under section 351 of the Public Health Service Act (42 U.S.C. documents in the last year, 1451 Sara Nidal Abed, Rakesh K. Tekade, in Basic Fundamentals of Drug Delivery, 2019. was given either 30min before IOMNP injection in the 4-h SCI group or 4h after injury in the 24-h survival groups. 1). If you are using public inspection listings for legal research, you documents in the last year, 108 The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the expanded safe use of synthetic iron oxides as color additives to include use in dietary supplement tablets and capsules. These can be useful See section X for further information on the filing of objections. provide legal notice to the public or judicial notice to the courts. on documents in the last year, by the U.S. Customs and Border Protection for better understanding how a document is structured but FDA-2017-C-6238 for Listing of Color Additives Exempt from Certification; Synthetic Iron Oxide. Received objections, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as Confidential Submissions, publicly viewable at https://www.regulations.gov or with the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. In a phase 2 study in 104 patients with focal liver or spleen pathology who underwent MRI with ferumoxtran-10 (0.8, 1.1, and 1.7mg of iron per kg), 15% reported a total of 33 adverse events, most commonly dyspnea (3.8%), chest pain (2.9%), and rashes (2.9%) [5]. These contrast agents are well tolerated, with no serious adverse effects. Ferucarbotran (carboxydextran coated iron oxide nanoparticles, SHU 555 C, Resovist, Schering AG) is a contrast agent that consists of iron oxide microparticles coated with carboxydextran. (iii) In dietary supplement tablets and capsules, including coatings and printing inks, such that the total amount of elemental iron per day for labeled dosages does not exceed 5 milligrams. The incidence of adverse reactions is higher with these particulate iron oxide agents than with gadolinium chelates. For example, section 301(ll) of the FD&C Act prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FD&C Act (21 U.S.C. Synthetic iron oxides also are approved for use as color additives in cosmetics generally, including cosmetics applied to the area of the eye, in amounts consistent with GMP (21 CFR 73.2250). The use of SPION-based MRI contrast agents is well established and a number of SPIONs have been approved by the U.S. Food and Drug Administration (FDA) (Hamm etal., 1994; Reimer and Balzer 2003). 07/29/2022, 48 This document has been published in the Federal Register. Considering this, FDA has estimated exposure to elemental iron resulting from the petitioned use of synthetic iron oxides in dietary supplements as described below. 07/29/2022, 168 There were no significant adverse effects during or after the scans. are not part of the published document itself. By continuing you agree to the use of cookies. This is suggested to be due to products of photolysis, including reactive oxygen species, which transform DOM into less soluble forms. This action is in response to a color additive petition (CAP) filed by Colorcon, Inc. 2. In addition, light and iron interactively promote particle formation from dissolved humic substances. on FederalRegister.gov Furthermore, this language is included in all color additive final rules that pertain to food and therefore should not be construed to be a statement of the likelihood that section 301(ll) of the FD&C Act applies. Attachment of iron oxide NPs to the surface of anticancer drugs facilitates precise imaging of the tumor in one-step by magnetic resonance and as a targeted therapy. Federal Register provide legal notice to the public and judicial notice Synthetic iron oxides and their hydrated forms are currently approved as color additives for use in human foods and drugs: (1) In sausage casings intended for human consumption in an amount not to exceed 0.10 percent by weight of the finished food (73.200); (2) in soft and hard candy, mints, and chewing gum at levels consistent with good manufacturing practice (GMP), except that they may not be used to color foods for which standards of identity have been issued under section 401 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Taking into account the bioavailability of iron from synthetic iron oxides, the exposure to elemental iron from the petitioned use of synthetic iron oxides for the U.S. population aged 2 years and older is estimated to be 0.10 mg/p/d at the mean and 0.25 mg/p/d at the 90th percentile (Ref 1). The iron oxide core is encapsulated in an inorganic or organic coating, which serves for particle stabilization and biocompatibility. Other methods, including microemulsion, hydrothermal, and sol-gel, have also been investigated for the synthesis of magnetic nanoparticles.

on The President of the United States manages the operations of the Executive branch of Government through Executive orders. These markup elements allow the user to see how the document follows the documents in the last year, by the Maritime Administration It targets the reticuloendothelial system but also functions as a blood-pool agent. Different rectal formulations of ferristene with different viscosities and iron concentrations have been evaluated in a phase II clinical study, in which ferristene enemas (200500ml) and intravenous gadodiamide (0.1mmol/kg) were used in the evaluation and staging of rectal cancer in 113 patients [2]. Synthetic iron oxides and their hydrated forms include red iron oxide (synthetic hematite), yellow iron oxide (synthetic geoethite), black iron oxide (synthetic magnetite), and brown iron oxide, which is a blend of various iron oxides. The high-viscosity formulation (70g of granules/l) was better than the low-viscosity formulation in tumor staging, but the iron concentration (30 or 59 micrograms/ml) of the contrast agent was less important. documents in the last year, 506 to the courts under 44 U.S.C. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of December 3, 2018. Influence of iron oxide magnetic nanoparticles (IOMNPs, 10nm in diameter, 0.25 or 0.50mg/mL in 100L, i.v.) Federal Register issue. documents in the last year, 264 Using 2-day food consumption data from the 2009-2010 National Health and Nutrition Examination Survey (NHANES) food consumption database, Colorcon estimated exposure to elemental iron from the proposed use in dietary supplements. 2. better and aid in comparing the online edition to the print edition. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e. You should submit two copies total. Possibly, humic colloids are stabilized by Fe(III), but are more prone to aggregation when the Fe(III)DOM complex is broken. Sixteen pure phases of iron oxides, i.e. Hanna L. Karlsson, Bengt Fadeel, in Handbook on the Toxicology of Metals (Fourth Edition), 2015. Because the 90th percentile exposure estimate to bioavailable elemental iron from all dietary sources, including the proposed use of synthetic iron oxides to color dietary supplement tablets and capsules, is significantly below the UL determined by IOM, we conclude that there is a reasonable certainty of no harm from the proposed use of synthetic iron oxide as a color additive in dietary supplement tablets and capsules (Ref. They consist of non-stoichiometric microcrystalline iron oxide cores, which are coated with dextrans (in ferumoxides) or siloxanes (in ferumoxsils).

New Documents In the report, IOM determined dietary reference intakes and upper limits (ULs) for iron of 40 mg/d for children (2-13 years of age) and 45 mg/d for adolescents and adults (14 years and older) (Ref. Document Drafting Handbook Our review of this petition was limited to section 721 of the FD&C Act. One copy will include the information you claim to be confidential with a heading or cover note that states THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION. The Agency will review this copy, including the claimed confidential information, in our consideration of comments. This prototype edition of the headings within the legal text of Federal Register documents. Patients under 60kg received 0.9ml as a bolus intravenous injection and patients over 60kg received 1.4ml. Please note that late, untimely filed objections will not be considered. In Meyler's Side Effects of Drugs (Sixteenth Edition), 2016. In addition, based upon the factors listed in 21 CFR 71.20(b), we continue to conclude that certification of synthetic iron oxides is not necessary for the protection of public health. 262), or a drug or biological product for which substantial clinical investigations have been instituted and their existence has been made public, unless one of the exemptions in section 301(ll)(1) to (4) of the FD&C Act applies. The reported adverse effects include low back pain, vomiting and diarrhea, urticaria, flushing, dizziness, and muscle spasm [1]. You may submit objections and requests for a hearing as follows. However, that is not a great cause for concern, since few of the reactions are severe and all are self-limiting. There was a statistically significant fall in diastolic blood pressure from 75 to 70mmHg at 4 hours after the injection. documents in the last year, 75 3). documents in the last year, 34 There are various types of iron oxides that include iron(II) oxide, wstite (FeO), magnetite (Fe3O4), iron(III) oxide (Fe2O3), alpha phase, hematite (-Fe2O3), beta phase, (-Fe2O3), gamma phase, maghemite (-Fe2O3), epsilon phase, (-Fe2O3). The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on. documents in the last year, 19 The exposure to elemental iron from the petitioned use of synthetic iron oxides is estimated to be 10 mg/p/d at the mean and 25 mg/p/d at the 90th percentile. To the contrary, the inverse core-shell structure is characterized by an iron oxide coating of nonmagnetic functional material. High quality, monodisperse, as well as biocompatible DMSA-coated SPIONs have been attained by a thermal decomposition followed by ligand exchange reaction. Furthermore, effect of cerebrolysin, a balanced composition of several neurotrophic factors, and active peptide fragments was also evaluated on IOMNP-induced changes in central nervous system (CNS) pathology. The authors concluded that ferumoxtran-10 is safe and well tolerated. We stated that we had determined, under 21 CFR 25.32(k), that this action is of a type that does not individually or cumulatively have a significant effect on the human environment such that neither an environmental assessment nor an environmental impact statement is required. These changes were not considered to be of clinical importance. Fe(II) is oxidized into Fe(III) by photochemically produced H2O2 and the redox cycling (Fenton's reaction) is thereby complete. by the Alcohol and Tobacco Tax and Trade Bureau 1). Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the Search box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 07/29/2022, 841 Iron oxides, either Fe3O4 or -Fe2O3, can be prepared from aqueous Fe2+/Fe3+ salt solutions by the addition of a base under an inert atmosphere at room temperature or at elevated temperature (Bee etal., 1995). daily Federal Register on FederalRegister.gov will remain an unofficial From the NHANES data, Colorcon determined that 2 dietary supplements are consumed in a 24-hour period at the mean, and 4 at the 90th percentile. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day. 1). Iron and manganese oxides are regarded as the scavengers of the sea (Goldberg, 1954) because of their ability to adsorb other metals and trace components.

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