CLH REPORT FOR BORIC ACID AND BORATES CLH report Proposal for Harmonised Classification and Labelling Based on Regulation (EC) No 1272/2008 (CLP Regulation), Annex VI, Part 2 International Chemical Identification: Boric acid [1]; Diboron trioxide [2]; Tetraboron disodium heptaoxide, hydrate [3]; Disodium tetraborate, anhydrous [4]; Orthoboric acid sodium salt [5]; Disodium tetraborate decahydrate [6]; Disodium tetraborate pentahydrate [7] EC Numbers: 233-139-2 [1]; 234-343-4 [1]; 215-125-8 [2]; 235-541-3 [3]; 215- 540-4 [4;6;7]; 237-560-2 [5] CAS Numbers: 10043-35-3 [1]; 11113-50-1 [1]; 1303-86-2 [2]; 12267-73-1 [3]; 1330-43-4 [4]; 13840-56-7 [5]; 1303-96-4 [6]; 12179-04-3 [7] Index Numbers: 005-007-00-2 [1]; 005-008-00-8 [2]; 005-011-00-4 [3;4;5]; 005- 011-01-1 [6]; 005-011-02-9 [7] Contact details for dossier submitter: Swedish Chemicals Agency Esplanaden 3a, P.O Box 2 SE-172 13 Sundbyberg, Sweden [email protected] +46 8 519 41 100 Version number: 2 Date: 2018-11-02 [04.01-MF-003.01] CLH REPORT FOR BORIC ACID AND BORATES CONTENTS 0. BACKGROUND INFORMATION ....................................................................................................................... 1 1. IDENTITY OF THE SUBSTANCES .................................................................................................................... 3 1.1 NAMES AND OTHER IDENTIFIERS OF THE SUBSTANCES .......................................................................................... 3 1.1.1 Annex VI Index No. 005-007-00-2 .............................................................................................................. 3 1.1.2 Annex VI Index No. 005-008-00-8 .............................................................................................................. 4 1.1.3 Annex VI Index No. 005-011-00-4 .............................................................................................................. 5 1.1.4 Annex VI Index No. 005-011-01-1 .............................................................................................................. 8 1.1.5 Annex VI Index No. 005-011-02-9 .............................................................................................................. 9 1.2 COMPOSITION OF THE SUBSTANCES ..................................................................................................................... 10 1.2.1 Annex VI Index No. 005-007-00-2 ............................................................................................................ 10 1.2.2 Annex VI Index No. 005-008-00-8 ............................................................................................................ 10 1.2.3 Annex VI Index No. 005-011-00-4 ............................................................................................................ 10 1.2.4 Annex VI Index No. 005-011-01-1 ............................................................................................................ 11 1.2.5 Annex VI Index No. 005-011-02-9 ............................................................................................................ 11 2 PROPOSED HARMONISED CLASSIFICATION AND LABELLING ......................................................... 12 2.1 PROPOSED HARMONISED CLASSIFICATION AND LABELLING ACCORDING TO THE CLP CRITERIA ......................... 12 2.1.1 Annex VI Index No. 005-007-00-2 ............................................................................................................ 12 2.1.2 Annex VI Index No. 005-008-00-8 ............................................................................................................ 13 2.1.3 Annex VI Index No. 005-011-00-4 ............................................................................................................ 14 2.1.4 Annex VI Index No. 005-011-01-1 ............................................................................................................ 15 2.1.5 Annex VI Index No. 005-011-02-9 ............................................................................................................ 16 3 HISTORY OF THE PREVIOUS CLASSIFICATION AND LABELLING ................................................... 18 4 JUSTIFICATION THAT ACTION IS NEEDED AT COMMUNITY LEVEL .............................................. 18 5 IDENTIFIED USES .............................................................................................................................................. 19 6 DATA SOURCES.................................................................................................................................................. 19 7 PHYSICOCHEMICAL PROPERTIES .............................................................................................................. 19 7.1.1 Annex VI Index No. 005-007-00-2 ............................................................................................................ 20 7.1.2 Annex VI Index No. 005-008-00-8 ............................................................................................................ 20 7.1.3 Annex VI Index No. 005-011-00-4 ............................................................................................................ 21 7.1.4 Annex VI Index No. 005-011-01-1 ............................................................................................................ 22 7.1.5 Annex VI Index No. 005-011-02-9 ............................................................................................................ 23 8 EVALUATION OF PHYSICAL HAZARDS ..................................................................................................... 23 9 TOXICOKINETICS (ABSORPTION, METABOLISM, DISTRIBUTION AND ELIMINATION) ........... 23 9.1 SHORT SUMMARY AND OVERALL RELEVANCE OF THE PROVIDED TOXICOKINETIC INFORMATION ON THE PROPOSED CLASSIFICATION(S) ...................................................................................................................................... 24 10 EVALUATION OF HEALTH HAZARDS ......................................................................................................... 25 10.1 ACUTE TOXICITY ............................................................................................................................................ 25 10.2 SKIN CORROSION/IRRITATION ......................................................................................................................... 25 10.3 SERIOUS EYE DAMAGE/EYE IRRITATION ......................................................................................................... 25 10.4 RESPIRATORY SENSITISATION......................................................................................................................... 25 10.5 SKIN SENSITISATION ....................................................................................................................................... 25 10.6 GERM CELL MUTAGENICITY ........................................................................................................................... 25 10.7 CARCINOGENICITY ......................................................................................................................................... 25 10.8 REPRODUCTIVE TOXICITY............................................................................................................................... 25 10.8.1 Adverse effects on sexual function and fertility .................................................................................... 26 [04.01-MF-003.01] CLH REPORT FOR BORIC ACID AND BORATES 10.8.2 Short summary and overall relevance of the provided information on adverse effects on sexual function and fertility ................................................................................................................................................ 27 10.8.2.1 Animal information .......................................................................................................................................... 27 10.8.2.2 Human information ........................................................................................................................................... 27 10.8.3 Comparison with the CLP criteria ....................................................................................................... 28 10.8.4 Adverse effects on development ............................................................................................................ 28 10.8.5 Short summary and overall relevance of the provided information on adverse effects on development 30 10.8.5.1 Animal information .......................................................................................................................................... 30 10.8.5.2 Human information ........................................................................................................................................... 30 10.8.6 Comparison with the CLP criteria ....................................................................................................... 31 10.8.7 Adverse effects on or via lactation ....................................................................................................... 34 10.8.8 Conclusion on classification and labelling for reproductive toxicity ................................................... 34 10.9 SPECIFIC TARGET ORGAN TOXICITY-SINGLE EXPOSURE .................................................................................. 34 10.10 SPECIFIC TARGET ORGAN TOXICITY-REPEATED