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Technical Report: Barium Diboron Tetraoxide

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Technical Report: Barium Diboron Tetraoxide Technical report: barium diboron tetraoxide Agency technical report on the classification and labelling of Barium diboron tetraoxide EC Number: 237-222-4 CAS Number: 13701-59-2 Health and Safety Executive Chemicals Regulation Division Redgrave Court Merton Road Bootle L20 7HS [email protected] Date: MAY 2021 1 Technical report: barium diboron tetraoxide Contents Brief summary ........................................................................................................................... 3 Introduction ............................................................................................................................... 4 Overview of current and proposed classification and labelling ................................................ 4 General substance information: ................................................................................................ 6 Background ................................................................................................................................ 6 Scientific assessment of the physical, human health and environmental hazard classes ........ 7 Physical Hazards ........................................................................................................................ 7 Health Hazards .......................................................................................................................... 7 Acute toxicity ......................................................................................................................... 7 Specific target organ toxicity – single exposure (STOT SE).................................................. 10 Skin corrosion/irritation ...................................................................................................... 10 Serious eye damage/irritation ............................................................................................. 10 Respiratory sensitisation ..................................................................................................... 10 Skin sensitisation ................................................................................................................. 10 Specific target organ toxicity – repeated exposure (STOT RE) ............................................ 10 Germ cell mutagenicity ....................................................................................................... 10 Carcinogenicity .................................................................................................................... 10 Reproductive toxicity ........................................................................................................... 10 Aspiration toxicity ................................................................................................................ 14 Environmental hazards ............................................................................................................ 14 Hazardous to the aquatic environment .............................................................................. 14 Other hazards .......................................................................................................................... 14 Hazardous to the ozone layer ............................................................................................. 14 Overall conclusion ................................................................................................................... 15 References ............................................................................................................................... 16 Glossary of terms used in Agency technical reports ............................................................... 17 2 Technical report: barium diboron tetraoxide Brief summary The conclusion of the Agency technical report is that barium diboron tetraoxide meets the classification criteria for: Acute tox. 3; H301 (Toxic if swallowed with an ATE value of 100 mg/kg bw) Repr. 1B; H360FD (May damage fertility. May damage the unborn child.) Is this in agreement with the RAC opinion? NO RAC concluded that barium diboron tetraoxide should also be classified as Acute Tox. 4; H332 (Harmful if inhaled) with an ATE value of 1.5 mg/L. The conclusion of the Agency technical report is that this classification is not supported by the available data. No classification is warranted for acute toxicity via the inhalation route. At the time of publication, this mandatory classification and labelling has not been agreed and/or adopted in Great Britain. 3 Technical report: barium diboron tetraoxide Introduction Under Article 37 of the GB CLP Regulation1, the Agency2 is required to produce a technical report for each substance on which the Committee for Risk Assessment (RAC) of the European Chemicals Agency produces an opinion3. This technical report documents an independent scientific assessment, conducted by HSE technical specialists, of the classification and labelling of barium diboron tetraoxide. Table 1. Information considered in the scientific assessment Document Included in assessment EU CLH report Yes Annexes to the EU CLH report Yes RAC opinion Yes Background document Yes Information submitted during the EU public Yes consultation process (RCOM table, including attachments) RAC minority opinion(s) Not applicable Other information: No This information has been evaluated against the classification and labelling criteria set out in the GB CLP Regulation. 1The retained CLP Regulation (EU) No. 1272/2008 as amended for Great Britain 2 HSE acting in its capacity as the GB CLP Agency 3 Under Article 37(4) of Regulation (EU) No 1272/2008 on classification, labelling and packaging of substances and mixtures 4 Technical report: barium diboron tetraoxide Overview of current and proposed classification and labelling Table 2. Current and proposed classification and labelling Classification Labelling Index International EC No. CAS Hazard Class Hazard Pictogram, Hazard Suppl. Hazard Specific Notes No. Chemical No. and Category Statement Signal Word Statement Statement Concentration Identification Code(s) Code(s) Code(s) Code(s) Code(s) Limits, M- factors GB MCL List 056- barium salts, Acute Tox. 4* H332 GHS07 * A1 entry 002-0 with the Acute Tox. 4* H302 Wng 0-7 exception of barium sulphate, salts of 1-azo-2- hydroxynapht halenyl aryl sulphonic acid, and of salts specified elsewhere in Annex VI of 1272/2008 EU dossier TBD barium 237- 13701- Add Add Add Add Add submitter’s diboron 222-4 59-2 Repr. 1B H360FD GHS08 H360FD oral: proposal tetraoxide ATE = Modify Retain Retain Retain 530mg/kg bw Acute Tox. 4 H302 GHS07 H302 Remove Remove Modify Remove 4 Technical report: barium diboron tetraoxide Classification Labelling Index International EC No. CAS Hazard Class Hazard Pictogram, Hazard Suppl. Hazard Specific Notes No. Chemical No. and Category Statement Signal Word Statement Statement Concentration Identification Code(s) Code(s) Code(s) Code(s) Code(s) Limits, M- factors Acute Tox. 4* H332 Dgr H332 EU RAC TBD barium 237- 13701- Add Add Add Add Add opinion diboron 222-4 59-2 Repr. 1B H360FD GHS08 H360FD inhalation: tetraoxide ATE = 1.5mg/L Modify Modify Modify Modify (dusts or mists) Acute Tox. 4 H301 GHS06 H301 oral: Acute Tox. 3 Dgr ATE = Retain Retain 100mg/kg bw H332 H332 Agency TBD barium 237- 13701- Add Add Add Add Add technical diboron 222-4 59-2 Repr. 1B H360FD GHS08 H360FD oral: report tetraoxide ATE = conclusion Modify Modify Modify Modify 100mg/kg bw Acute Tox. 3 H301 GHS06 H301 Dgr Remove Remove Remove Acute Tox. 4* H332 H332 Resulting TBD barium 237- 13701- Repr. 1B H360FD GHS08 H360FD Add MCL entry diboron 222-4 59-2 Acute Tox. 3 H301 GHS06 H301 oral: on GB MCL tetraoxide Dgr ATE = list 100mg/kg bw TBD: To be determined 5 Technical report: barium diboron tetraoxide General substance information: Active substance in Plant Protection Products: ☐ Active substance in Biocidal Products: ☐ Chemical registered under REACH: ☒ Background Barium diboron tetraoxide is a chemical substance within the scope of Regulation (EC) No 1907/2006. Barium diboron tetraoxide is included in a group entry (Index No. 056-002-00-7) of Annex VI of CLP (and the GB mandatory classification and labelling (MCL) list) for barium salts. The group entry has a harmonised/mandatory classification for acute toxicity (via oral and inhalation exposure). Barium diboron tetraoxide is a metal borate that is used in industry for the manufacture of coating and paints, thinners and paint removers. It is also used by professional workers and consumers. The dossier submitter (DS; Sweden) submitted a targeted CLH report to ECHA in August 2019, proposing the inclusion of harmonised classification for reproductive toxicity, modification of the existing classification for acute oral toxicity and removal of acute inhalation toxicity. This was based on data from the substance itself (obtained using a commercial form, Busan 11-M1), supported with read-across data from boric acid and borax (disodium tetraborate decahydrate). RAC considered the use of these substances for read- across acceptable against ECHA’s ‘Read-Across Assessment Framework’: • Formation of compounds: metal borates dissolve in water to form boric acid, which is the predominant species at acidic and neutral pH, and tetrahydroxyborate anion. Therefore, barium diboron tetraoxide is expected to convert to boric acid and barium cations, which can form metal-ion complexes with tetrahydroxyborate, in the stomach. Borax converts to boric acid and sodium cations in the
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