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Annex XV dossier
PROPOSAL FOR IDENTIFICATION OF A SUBSTANCE AS A CATEGORY 1A OR 1B CMR , PBT, vPvB OR A SUBSTANCE OF AN EQUIVALENT LEVEL OF CONCERN
Substance Name(s): Diboron trioxide EC Number(s): CAS Number(s): 215-125-8 1303-86-2
Federal Institute for Occupational Safety and Health (BAuA) Federal Office for Chemicals Friedrich-Henkel-Weg 1 25 44149 Dortmund Germany
PUBLIC VERSION: This report does not include the confidential annexe referred to in the document.
ANNEX XV IDENTIFICATION OF SVHC
PROPOSAL FOR IDENTIFICATION OF A SUBSTANCE AS A CATEGORY 1A OR 1B CMR, PBT, VPVB OR A SUBSTANCE OF AN EQUIVALENT LEVEL OF CONCERN ................................................................................3 PART I..........................................................................................................................................................................4 JUSTIFICATION .........................................................................................................................................................4 1 IDENTITY OF THE SUBSTANCE AND PHYSICAL AND CHEMICAL PROPERTIES .................................4 1.1 Name and other identifiers of the substance ...................................................................................................4 1.2 Composition of the substance .........................................................................................................................5 1.3 Physico-chemical properties ...........................................................................................................................5 2 HARMONISED CLASSIFICATION AND LABELLING ....................................................................................9 3 ENVIRONMENTAL FATE PROPERTIES...........................................................................................................10 4 HUMAN HEALTH HAZARD ASSESSMENT.....................................................................................................10 5 ENVIRONMENTAL HAZARD ASSESSMENT ..................................................................................................10 6 CONCLUSIONS ON THE SVHC PROPERTIES .................................................................................................10 6.1 PBT, vPvB assessment ...................................................................................................................................10 6.2 CMR assessment.............................................................................................................................................10 6.3 Substances of equivalent level of concern assessment. ..................................................................................10 PART II ........................................................................................................................................................................11 INFORMATION ON USE, EXPOSURE, ALTERNATIVES AND RISKS ...............................................................11 1 INFORMATION ON MANUFACTURE, IMPORT/EXPORT AND USES CONCLUSIONS ON EXPOSURE 11 1.1 Information on Manufacture, Import/Export and Uses...................................................................................11 1.2 Information on Occupational Exposure ..........................................................................................................13 1.3 Information on Consumer Exposure...............................................................................................................14 2 CURRENT KNOWLEDGE ON ALTERNATIVES ..............................................................................................14 3 RISK-RELATED INFORMATION .......................................................................................................................14 REFERENCES .............................................................................................................................................................16
Table 1: Table 2: Table 3: Table 4: Table 5: Table 6: Substance identity ........................................................................................................................................4 Constituents..................................................................................................................................................5 Impurities .....................................................................................................................................................5 Additives ......................................................................................................................................................5 Overview of physicochemical properties.....................................................................................................6 Classification according to Annex VI, Part 3, Table 3.1 (list of harmonised classification and labelling of hazardous substances) of Regulation (EC) No 1272/2008...........................................................................9 Table 7: Classification according to Annex VI, Part 3, Table 3.2 (list of harmonised classification and labelling of hazardous substances from Annex I to Directive 67/548/EEC) of Regulation (EC) No 1272/2008............9
PROPOSAL FOR IDENTIFICATION OF A SUBSTANCE AS A CATEGORY 1A OR 1B CMR, PBT, VPVB OR A SUBSTANCE OF AN EQUIVALENT LEVEL OF CONCERN
The substance is proposed to be identified as substance meeting the criteria of Article 57 (c) of Regulation (EC) 1907/2006 (REACH) owing to its classification as toxic for reproduction category 1B1 which corresponds to classification as toxic for reproduction category 22.
Summary of how the substance meets the CMR (Cat 1A or 1B) criteria Diboron trioxide is listed by Index number 005-008-00-8 of Regulation (EC) No 1272/2008 as amended and adapted to technical and scientific progress by Regulation (EC) No 790/2009, as of 1 December 2010, and classified in Annex VI, Part 3, Table 3.1 (list of harmonised classification and labelling of hazardous substances) as toxic for reproduction, Repr. 1B (H360FD: May damage fertility. May damage the unborn child.). The corresponding classification in Annex VI, part 3, Table 3.2 (the list of harmonised classification and labelling of hazardous substances from Annex I to Directive 67/548/EEC) of Regulation (EC) No 1272/2008 is toxic for reproduction, Repr. Cat. 2 (R60: May impair fertility. R61: May cause harm to the unborn child). Therefore, this classification of the substance in Regulation (EC) No 1272/2008 as amended and adapted to technical and scientific progress by Regulation (EC) No 790/2009 shows that it meets the criteria for classification as toxic for reproduction in accordance with Article 57 (c) of REACH.
Registration dossiers submitted for the substance? Yes
Classification in accordance with Regulation (EC) No 1272/2008 Annex VI, part 3, Table 3.1 List of harmonised classification and labelling of hazardous substances. Classification in accordance with Regulation (EC) No 1272/2008, Annex VI, part 3, Table 3.2 List of harmonised classification and labelling of hazardous substances (from Annex I to Council Directive 67/548/EEC).
PART I JUSTIFICATION
Name and other identifiers of the substance
Table 1: Substance identity
EC number: EC name: CAS number (in the EC inventory): CAS number: CAS name: IUPAC name: Index number in Annex VI of the CLP Regulation Molecular formula: Molecular weight range: Synonyms: 215-125-8 diboron trioxide 1303-86-2 1303-86-2 Boron oxide (B2O3) diboron trioxide 005-008-00-8 B2O3 69.62 g/mol Boric oxide
ANNEX XV IDENTIFICATION OF SVHC 1.2 Composition of the substance
Name: Diboron trioxide Description: mono-constituent substance Degree of purity: > 97 % w/w3 Further details on the composition of the substance are confidential and can be found in the technical dossier or the confidential annex. Table 2: Constituents
Constituents Diboron trioxide Typical concentration > 97 % w/w
Table 3: Impurities
Impurities confidential Typical concentration Concentration range Remarks
Table 4: Additives
Additives confidential Typical concentration Concentration range Remarks
The physico-chemical properties were taken from the lead registration dossier for boric oxide and are considered acceptable by DE-CA.
Based on the minimum typical content indicated in the registration dossiers (downloaded on 13/10/2011) 5
ANNEX XV IDENTIFICATION OF SVHC Table 5: Overview of physicochemical properties4
Property Physical state at 20C and 101.3 kPa Melting/freezing point Boiling point Value white odourless crystalline solid > 633 K Not determined since melting point is above 300 C Not determined since melting point is above 300 C Technically not feasible Boric oxide reacts quickly with water to form boric acid. B2O3(s) + 3H2O(l) 2H3BO3(aq) The EU Annex V definition of solubility is the saturation mass concentration of the substance in water at a given temperature. Given that boric oxide reacts with water it would be technically impossible to determine the saturation mass concentration of boric oxide. Any attempt to determine the solubility would in effect be measuring the solubility of boric acid. In saturated aqueous boric acid, boric oxide will immediately react with water and crystallise out as solid boric acid. In conclusion, it is therefore technically impossible to determine the solubility of boric oxide as a discrete species. Partition coefficient noctanol/water (log value) Not determined since a partition coefficient is not required if the substance is inorganic The dissociation constant for boric oxide as such cannot be determined because boric oxide is Decomposition occurred Remarks
The references of the values reported in Table 5 will be available in the technical dossier. In case references need to be included an additional column could be added manually to Table 5. 6
converted into boric acid/borate upon dissolution in water Flash point According to Annex VII, section 7.9, column 2 of Regulation No. 1907/2006, flashpoint is not required if the substance is inorganic. Diboron trioxide is an inorganic substance, therefore the test is not required. A study performed according to EU Method A.10 (Flammability (Solids)), the United Nations Document, Recommendations of the Transport of Dangerous Goods, Manual of Tests and Criteria (Test N.1.) and HSE Code of PhysioChemical Properties 1982, it was determined that the test substance should be classified as "not a highly flammable solid". Testing can be waived in accordance with REACH Column 2 of Annex VII, section 7.10: The study does not need to be conducted because Boron oxide reacts quickly with water to form boric acid. It has been determined that the test substance was not classified as a pyrophoric solid according to UN Recommendations on the Transport of Dangerous Goods, Manual of Tests and
Flammability Flammability upon ignition (solids,gases):
Criteria for substances of Class 4, Division 4.2. According to Annex VII, section 7.11, column 2 of Regulation No. 1907/2006, explosive properties of the substance is not required if there are no chemical groups associated with explosive properties present in the molecule. Potential explosive properties are indicated by the presence of certain reactive groups in the molecule. The molecular structure of diboron trioxide indicates that such groups are not present. No reactive or unstable groups are present. The molecular structure does not indicate that these substances will explode under the conditions of the test as described in Test Guideline A.14 of EC Directive 92/69/EEC. It was determined that diboron trioxide should be classified as not a self-heating substance of Class 4, Division 4.2. The material meets all criteria for exemption from testing and has a structure not al all conducive with that required to exhibit oxidising tendencies. United Nations Recommendations on the Transportation of Dangerous Goods, Manual of Tests and Criteria (Test N4).
Diboron trioxide is listed by Index number 005-008-00-8 of Regulation (EC) No 1272/2008 (as amended and adapted to technical and scientific progress by Regulation (EC) No 790/2009 as of 1 December 2010) in Annex VI, Part 3, Table 3.1 (list of harmonised classification and labelling of hazardous substances) as follows: Table 6: Classification according to Annex VI, Part 3, Table 3.1 (list of harmonised classification and labelling of hazardous substances) of Regulation (EC) No 1272/2008
Index No International Chemical Identification Classification Hazard Class and Category Code Repr. 1B Hazard statement Code Pictogram, Signal Word Code GHS08 Dgr Labelling Hazard statement Code Suppl. Hazard statement Code(s) Specific Conc. Limits, Mfactors
00500800-8
Repr. 1B; H360FD: C 3,1 %
Hazard statement code: H360FD: May damage fertility. May damage the unborn child.
Diboron trioxide is covered by Index number 005-008-00-8 of Regulation (EC) No 1272/2008 (as amended and adapted to technical and scientific progress by Regulation (EC) No 790/2009 as of 1 December 2010) in Annex VI, Part 3, Table 3.2 (list of harmonised classification and labelling of hazardous substances from Annex I to Directive 67/548/EEC) as follows: Table 7: Classification according to Annex VI, Part 3, Table 3.2 (list of harmonised classification and labelling of hazardous substances from Annex I to Directive 67/548/EEC) of Regulation (EC) No 1272/2008
Index No 005-008-00-8 Chemical name diboron trioxide; boric oxide Classification Repr.Cat. 2; R60-61 Labelling T R: 60-61 S: 53-45 Concentration Limits Repr. Cat. 2; R60-61: C 3,1 %
Risk phrases: R60-61:
May impair fertility. May cause harm to the unborn child
See section 2 on Harmonised Classification and Labelling.
CONCLUSIONS ON THE SVHC PROPERTIES
PBT, vPvB assessment
Diboron trioxide is listed by Index number 005-008-00-8 of Regulation (EC) No 1272/2008 as amended and adapted to technical and scientific progress by Regulation (EC) No 790/2009, as of 1 December 2010, and classified in Annex VI, Part 3, Table 3.1 (list of harmonised classification and labelling of hazardous substances) as toxic for reproduction, Repr. 1B (H360FD: May damage fertility. May damage the unborn child.). The corresponding classification in Annex VI, part 3, Table 3.2 (the list of harmonised classification and labelling of hazardous substances from Annex I to Directive 67/548/EEC of Regulation (EC) No 1272/2008 is toxic for reproduction, Repr. Cat. 2 (R60: May impair fertility. R61: May cause harm to the unborn child). Therefore, this classification of the substance in Regulation (EC) No 1272/2008 as amended and adapted to technical and scientific progress by Regulation (EC) No 790/2009 shows that it meets the criterion for classification as toxic for reproduction in accordance with Article 57 (c) of REACH. 6.3 Substances of equivalent level of concern assessment.
PART II INFORMATION ON USE, EXPOSURE, ALTERNATIVES AND RISKS
INFORMATION ON MANUFACTURE, IMPORT/EXPORT AND USES CONCLUSIONS ON EXPOSURE
Information on Manufacture, Import/Export and Uses
Several companies have registered diboron trioxide in 2010. Registration data indicate import and/or production volumes for diboron trioxide with a total volume more of 1000 tonnes per year. No information was identified on current annual EU export volumes. Based on the information from the ECHA dissemination website (ECHA 2012). different identified uses by workers in industrial settings, professional workers and consumers are described (Tables 8 and 9). Table 8: Identified uses in industrial and professional settings as reported in the REACH registration dossiers for diboron trioxide
Identified use Glass Production (Borosilicate and crystal glass) Glass fibre production Frits production Refractories Use of Borates in Metallurgy Flame retardents Nuclear applications catalysts Use of Borates polymer production intermediate use in the production of non oxide ceramic powders Use of Borates in detergents and cleaners Use of Borates in Industrial Fluids INKS/PAINTS Production of monocrystalline gallium arsenide wafers Reagent chemicals Agriculture Construction materials Adhesives Crystal growth Use of substance for production
ANNEX XV IDENTIFICATION OF SVHC Table 9: Diboron trioxide in consumer applications (based on the information from the ECHA dissemination website ECHA 2012)
Identified use Uses of Borates in detergents and cleaners Product category PC 1: Adhesives, sealants PC 3: Air care products PC 31: Polishes and wax blends PC 34: Textile dyes, finishing and impregnating products; including bleaches and other processing aids PC 35: Washing and cleaning products (including solvent based products) PC 4: Anti-freeze and de-icing products PC 16: Heat transfer fluids PC 24: Lubricants, greases, release products PC 25: Metal working fluids PC 37: Water treatment chemicals PC 1: Adhesives, sealants PC 34: Textile dyes, finishing and impregnating products; including bleaches and other processing aids PC 12: Fertilisers PC 9b: Fillers, putties, plasters, modelling clay PC 21: Laboratory chemicals PC 19: Intermediate PC 20: Products such as phregulators, flocculants, precipitants, neutralisation agents PC 21: Laboratory chemicals PC 30: Photo-chemicals PC 37: Water treatment chemicals PC 18: Ink and toners PC 26: Paper and board dye, finishing and impregnation products: including bleaches and other processing aids Subsequent Article category service life Yes
Agriculture Construction materials Reagent chemicals
Yes Yes AC 4: Stone, plaster, cement, glass and ceramic articles AC 11: Wood articles
AC 1: Vehicles AC 2: Machinery, mechanical appliances, electrical/electronic articles AC 3: Electrical batteries and accumulators AC 5: Fabrics, textiles and apparel AC 6: Leather articles AC 8: Paper articles AC 10: Rubber articles
ANNEX XV IDENTIFICATION OF SVHC The substance has also been registered in a number of preparations listed in the SPIN (Substances in Preparations in Nordic Countries; 2011) - online database. Assigned use categories include: paints, lacquers and varnishes, glazing materials, welding and soldering agents, construction materials, fireproof cement, protective chemicals, photo-chemicals, others. Diboron trioxide is a fire resistant additive for paints and electronics (HSDB 2010). Preparations for soldering can contain 30-50 % of diboron trioxide. (MSDS Finoflux Ltpaste, 2008). Contents of 25-50 % diboron trioxide are reported for a flux agent suitable for alloys and/or ceramic glazings. (MSDS Alpha Flux, 2007)
Information on Occupational Exposure
Diboron trioxide is a solid at room temperature and has a negligible vapour pressure. In industry it is used as bulk material or in solutions. The main routes of occupational exposure are expected to be inhalation of dust or particles and dermal contact. Due to personal hygienic measures ingestion is not considered to be relevant. Diboron trioxide is the anhydride form of boric acid. Because of its hygroscopic properties diboron trioxide reacts easily with water to form boric acid and hydrates (Smith 1999). In summary, the quantification of exposure to diboron trioxide is difficult. In general, occupational exposure may occur during production of diboron trioxide, when diboron trioxide is used as reactant for the synthesis of borates or other boric compounds and in a wide variety of industrial uses including the production and use of detergents and cleaners, processing aid, metal working fluids, glass and glass fibres, ceramics, catalysts, flame retardants, biocides and insecticides (cf. Table 8). Workers in industrial and professional settings may be also exposed when using diboron trioxide containing products like soldering paste or developer and fixer solution in photographic application. An Occupational Exposure Limit (8hr TWA) for diboron trioxide of 10 mg/m3 was adopted in some European countries, i. e. in Belgium, Denmark, Iceland, Ireland, Norway, France, Portugal, Italy, Switzerland and Spain. The OEL (8 hr TWA) in Greece and Austria is 15 mg/m3. To our knowledge measurements of exposure to diboron trioxide solely are not available. Garabrant et al. (1984) reported measurements on occupational exposure to dust containing boric acid and diboron trioxide at a borate/boric acid manufacturing plant. The observed concentration of total particulate matter measured during full shift in eight samples ranged from 1.2 to 8.5 mg/m3 with a mean of 4.1 mg/m3. No further information was provided on the fraction of diboron trioxide in the dust which leaves some uncertainties about the exposure of workers.
Information on Consumer Exposure
Diboron trioxide is used in the production of different glass types, glass fibres, ceramics and enamels. Exposure calculations for do-it-yourself installation or removal of glass wool insulation and release of glazed ceramic ware and food contact materials as well as migration studies from glass ware are cited in the Annex XV dossier for boric acid (ECHA 2010). It is thereby chemically/physically bound into the different types of glass, ceramic products and enamels, thus the liberation of diboron trioxide from these products is extremely unlikely to result in any significant exposure to consumers using such products. However, the registration dossiers for diboron trioxide point out further uses with potential relevance for consumer exposure (cf. Table 9). Some of these are also listed in the SPIN-online database (2011). Publicly available exposure data explicitly referring to diboron trioxide are rare. The included SPIN-exposure toolbox provides a qualitative evaluation of consumer exposure based on the data available in the register resulting in rankings of no, potential, probable and very probable indications. Its characterisation of consumer exposure to diboron trioxide is potentially for Norwegian and Swedish data of 2008 and Swedish data of 2009, the most recent data judged. The Risk Assessment Committee mentions the substance in its assessment of consumer risks arising from the presence of boron compounds in preparations for photographic applications. It concluded that if exposure via food and drinking water is considered as additional boron source, photographic applications pose a risk to consumers, for the specific scenarios based on reasonable worst case assumptions if film developer solutions are prepared from powder formulations and used for tank or tray processing on the same day (RAC 2010).
CURRENT KNOWLEDGE ON ALTERNATIVES
Diboron trioxide might be used as an alternative to other boron compounds and vice versa. Diboron trioxide could for example be used to replace other boron compounds especially boric acid as additive to TiO2 pigments in polymers (E.I. du Pont de Nemours and Co., 1999), in catalyst production (BASF Aktiengesellschaft, 1981), and in ceramics (Matsushita Electric Industrial Co., 1999). In certain applications diboron oxide can be replaced by boron nitride (Osram Sylvania Inc., 1999). Other boron compounds are not considered to be adequate substitutes for diboron trioxide due their similar toxicity to reproduction.
In the Chemical Safety Reports the risk for the different consumer uses of products containing boron is considered adequately controlled besides single uses for which use is advised against or concentration limits have been set as risk management measure. Therefore a restriction proposal appears not to be an adequate measure. The most important sources of exposure are food and drinking water. It has to be considered that all sources of boron exposure (like boron compounds in preparations for photographic applications or occupational exposure) contribute to the total boron exposure, and thus to the risk for consumers.
ANNEX XV IDENTIFICATION OF SVHC Due to the toxicological similarities of boron compounds classified as toxic to reproduction category 1B the following boron compounds have already been included in the Candidate List following their identification as substances of very high concern: Boric acid (CAS: 10043-35-3); covering also boric acid, crude natural (CAS: 11113-50-1) Disodium tetraborate, anhydrous (CAS: 1330-43-4); covering also disodium tetraborate pentahydrate (CAS: 12179-04-3), disodium tetraborate decahydrate (CAS: 1303-96-4) and tetraboron disodium heptaoxide, hydrate (CAS: 12267-73-1) Tetraboron disodium heptaoxide, hydrate (CAS: 12267-73-1); covering also disodium tetraborate, anhydrous (CAS: 1330-43-4), disodium tetraborate pentahydrate (CAS: 12179-04-3), disodium tetraborate decahydrate (CAS: 1303-96-4) With respect to the endpoint of concern (reproductive toxicity) diboron trioxide was not considered a priority substance for substance evaluation. As an argument of high importance, it is emphasized that diboron trioxide could be used to replace other boron compounds and contributes to the overall addition of toxicologically relevant boron. In order to ensure consistency for all classified boron compounds, diboron trioxide should be treated equally.
References to Part I REACH. Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC.
EU, 2008. Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006.
References to Part II BASF Aktiengesellschaft (1981): EP0038479A1. Katalysatoren fr die Oligomerisierung von Olefinen. 28.10.1981
https://data.epo.org/publication-server/rest/v1.0/publication-dates/19811028/patents/EP0038479NWA1/document.html
ECHA 2010: Annex XV dossier for boric acid, CAS 10043-35-3/11113-50-1
http://echa.europa.eu/web/guest/information-on-chemicals/transitional-measures/annex-xv-transitional-reports
ECHA 2012: public information on registered substances:
E.I. du Pont de Nemours and Co (1999): WO9523195. Gegen Verfrbung bestndige silanisierte Titandioxydpigmente wenn in Polymere eingearbeitet. 19.08.1999
http://www.patent-de.com/19990819/DE69505955T2.html
Garabrant 1984: Respiratory and eye irritation from boron oxide and boric acid dusts; Garabrant DH, Bernstein L, Peters JM, Smith TJ. , J Occup Med. 1984 Aug; 26(8):584-6 HSDB,2010: Hazardous Substances Data Bank
http://toxnet.nlm.nih.gov/cgi-bin/sis/search/f?./temp/~dolEtm:1
Matsushita Electric Industrial Co., Ltd. (1999): DE69603390T2. Zinkoxidkeramiken und Verfahren zu ihrer Herstellung. 30.12.1999
http://www.patent-de.com/19991230/DE69603390T2.html
MSDS Finoflux Ltpaste, 2008;
http://www.laboshop.com/fileadmin/media/sdb/42059_sdb_deu.pdf (last
access 19.10.11) access 19.10.11)
MSDS Alpha Flux, 2007;
http://www.schuetz-dental.de/uploads/media/Alpha_Flux__D__01.pdf (last
ANNEX XV IDENTIFICATION OF SVHC Osram Sylvania Inc. (1999): DE19838136A1. Borat-Leuchtstoff-Synthese unter Verwendung von Bornitrid. 25.02.1999
http://www.patent-de.com/19990225/DE19838136A1.html
RAC 2010: Opinion on new scientific evidence on the use of boric acid and borates in photographic applications by consumers ECHA/RAC/A77-O-0000001273-82-05/F
http://echa.europa.eu/documents/10162/17233/rac_opinion_borates_20100429_en.pdf
Smith 1999: Issues concerning the measurement of borate in occupational environments Robert A. Smith und Frederick M. Ascherl, Am Ind Hyg Assoc J. 1999 Sep-Oct; 60(5):651-8 SPIN 2011. SPIN Database.
http://195.215.251.229/DotNetNuke/default.aspx
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