CLH REPORT FOR AMMONIUM BROMIDE Annex I to the CLH report Proposal for Harmonised Classification and Labelling Based on Regulation (EC) No 1272/2008 (CLP Regulation), Annex VI, Part 2 International Chemical Identification: Ammonium bromide EC Number: 235-183-8 CAS Number: 12124-97-9 Index Number: - 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: 2019-02-22 CLH REPORT FOR AMMONIUM BROMIDE CONTENTS 1 PHYSICAL HAZARDS .......................................................................................................................................... 6 2 TOXICOKINETICS (ABSORPTION, METABOLISM, DISTRIBUTION AND ELIMINATION) ............. 6 2.1.1 [Study 1] Biological half-life of bromide ions in humans (no guideline study) .......................................... 6 2.1.2 [Study 2] Distribution of ammonium bromide in mouse (no guideline study) ............................................ 6 2.1.3 [Study 3] Pharmacokinetics of oral and intravenous bromide in human volunteers (no guideline) .......... 6 2.1.4 [Study 4] Kinetics and distribution of sodium bromide in rat (no guideline study) .................................... 6 2.1.5 [Study 5] Distribution of sodium bromide in rat (no guideline study) ........................................................ 6 2.1.6 [Study 6] Intravenous and oral administration of sodium bromide to healthy Beagle dogs (no guideline study) 6 2.1.7 [Study 7] Bromide pharmacokinetics in vivo in dog (no guideline) ........................................................... 7 2.1.8 [Study 8] Dermal penetration (in vivo and in vitro) of bromide in human, pig and rabbit (no guideline study) 7 2.1.9 [Study 9] Distribution study of bromide in guinea pig (no guideline study) ............................................... 7 2.1.10 [Study 10] Dermal penetration of bromide in human and Guinea pig (males/females) ........................ 7 3 HEALTH HAZARDS ............................................................................................................................................. 8 3.1 ACUTE TOXICITY - ORAL ROUTE ............................................................................................................................ 8 3.1.1 Animal data ................................................................................................................................................. 8 3.1.1.1 [Study 1] Acute oral toxicity study of ammonium bromide .....................................................................................8 3.1.1.2 [Study 2] Acute oral toxicity study of sodium bromide ......................................................................................... 10 3.1.2 Human data............................................................................................................................................... 10 3.1.3 Other data ................................................................................................................................................. 10 3.2 ACUTE TOXICITY - DERMAL ROUTE ..................................................................................................................... 10 3.2.1 Animal data ............................................................................................................................................... 10 3.2.1.1 [Study 1] Acute dermal toxicity study of ammonium bromide .............................................................................. 10 3.2.1.2 [Study 2] Acute dermal toxicity study of sodium bromide .................................................................................... 11 3.2.2 Human data............................................................................................................................................... 11 3.2.3 Other data ................................................................................................................................................. 11 3.3 ACUTE TOXICITY - INHALATION ROUTE ............................................................................................................... 11 3.3.1 Animal data ............................................................................................................................................... 11 3.3.1.1 [Study 1] Acute inhalation toxicity study of ammonium bromide ......................................................................... 11 3.3.2 Human data............................................................................................................................................... 11 3.3.3 Other data ................................................................................................................................................. 11 3.4 SKIN CORROSION/IRRITATION.............................................................................................................................. 11 3.4.1 Animal data ............................................................................................................................................... 11 3.4.1.1 [Study 1] Acute Dermal Irritation/Corrosion study of ammonium bromide .......................................................... 11 3.4.1.2 [Study 2] Acute Dermal Irritation/Corrosion of sodium bromide .......................... Error! Bookmark not defined. 3.4.2 Human data............................................................................................................................................... 11 3.4.3 Other data ................................................................................................................................................. 11 3.5 SERIOUS EYE DAMAGE/EYE IRRITATION .............................................................................................................. 12 3.5.1 Animal data ............................................................................................................................................... 12 3.5.1.1 [Study 1] Acute Eye Irritation / Corrosion study of ammonium bromide .............................................................. 12 3.5.1.2 [Study 2] Acute Eye Irritation / Corrosion study of sodium bromide .................... Error! Bookmark not defined. 3.5.2 Human data............................................................................................................................................... 14 3.5.3 Other data ................................................................................................................................................. 14 3.6 RESPIRATORY SENSITISATION ............................................................................................................................. 14 3.7 SKIN SENSITISATION ............................................................................................................................................ 14 3.7.1 Animal data ............................................................................................................................................... 14 3.7.1.1 [Study 1] Guinea pig maximisation test of ammonium bromide............................................................................ 14 3.7.1.2 [Study 2] Guinea pig maximisation test of sodium bromide .................................. Error! Bookmark not defined. 3.7.2 Human data............................................................................................................................................... 17 3.7.3 Other data ................................................................................................................................................. 17 3.8 GERM CELL MUTAGENICITY ................................................................................................................................ 17 CLH REPORT FOR AMMONIUM BROMIDE 3.8.1 In vitro data .............................................................................................................................................. 17 3.8.1.1 [Study 1] Bacterial Reverse Mutation Test (Ames test; OECD TG 471) of ammonium bromide ......................... 17 3.8.1.2 [Study 2] Mammalian Cell Gene Mutation Test (OECD TG 476) of ammonium bromide in mouse lymphoma cells L5278Y.......................................................................................................................................................................... 17 3.8.1.3 [Study 3] Bacterial Reverse Mutation Test (Ames test; OECD TG 471) of sodium bromide ................................ 17 3.8.1.4 [Study 4] Mammalian Chromosome Aberration Test (OECD TG 473) of sodium bromide in cultured human lymphocytes ........................................................................................................................................................................... 18 3.8.1.5 [Study 5] Unscheduled DNA Repair Synthesis study of sodium bromide in HeLa S3 epitheloid cells, human cervical lymphoma................................................................................................................................................................. 18 3.8.2 Animal data ............................................................................................................................................... 18 3.8.2.1 [Study 1] In vivo micronucleus study (OECD TG 474) of ammonium bromide in mice ....................................... 18 3.8.3 Human data..............................................................................................................................................