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CLH Report Annex I Annex I to the CLH report - non confidential - Proposal for Harmonised Classification and Labelling Based on Regulation (EC) No 1272/2008 (CLP Regulation), Annex VI, Part 2 International Chemical Identification: 1,3-bis(isocyanatomethyl)benzene; m-XDI EC Number: 222-852-4 CAS Number: 3634-83-1 Index Number: n.a. Contact details for dossier submitter: BAuA Federal Institute for Occupational Safety and Health Federal Office for Chemicals Friedrich-Henkel-Weg 1-25 44149 Dortmund, Germany Version number: 1.0 Date: August 2019 CLH REPORT FOR M-XDI CONTENTS 1 HEALTH HAZARDS ............................................................................................................................................. 3 1.1 RESPIRATORY SENSITISATION ............................................................................................................................... 3 1.1.1 Human data for the category source substances HDI, MDI, TDI............................................................... 3 1.1.1.1 Case reports .............................................................................................................................................................3 1.1.1.2 Longitudinal studies ............................................................................................................................................... 11 1.1.1.3 Case-control studies ............................................................................................................................................... 32 1.1.1.4 Cross-sectional studies ........................................................................................................................................... 34 1.1.2 Animal data for the category source substances HDI, MDI, and TDI ...................................................... 49 1.1.2.1 Pauluhn and Mohr, 1998 ........................................................................................................................................ 54 1.1.2.2 Respiratory sensitisation in mice (Matheson et al., 2005a; Matheson et al., 2005b) .............................................. 55 1.1.2.3 Hoymann et al., 1995 ............................................................................................................................................. 67 1.2 SKIN SENSITISATION ............................................................................................................................................ 72 1.2.1 Animal data for m-XDI ............................................................................................................................. 72 1.2.1.1 Skin sensitisation test in guinea pigs (Huntingdon, 1980) ..................................................................................... 72 1.2.1.2 GPMT (Safepharm, 1992)...................................................................................................................................... 73 1.2.1.3 GPMT (Huntingdon, 1997) .................................................................................................................................... 74 1.2.1.4 GPMT (Safepharm, 1998b) .................................................................................................................................... 75 2 REFERENCES ...................................................................................................................................................... 78 Note to the reader: For an explanation of the abbreviations used in this Annex, please refer to the list of abbreviations provided in the main dossier. 2 CLH REPORT FOR M-XDI 1 HEALTH HAZARDS 1.1 Respiratory sensitisation 1.1.1 Human data for the category source substances HDI, MDI, TDI 1.1.1.1 Case reports Table 1: Cases related to HDI, MDI, and/or TDI as documented in the published literature (non-comprehensive) Subject of the study Occupation/task Agent(s) Diagnosed disease/effects Reference Case report of three painters with #1: Spray-painting with polyisocyanate lacquer TDI #1: Asthmatic bronchitis (Swensson et al., 1955) respiratory tract symptoms #2: Painting with polyisocyanate plastic lacquer #2: Asthmatic symptoms/attacks #3: Spray-painting, brush-painting with plastic lacquer #3: Not specified (severe cough, pressure on the chest) Case report of six subjects with Developmental and experimental work on urethane TDI TDI respiratory sensitisation as (Williamson, 1965) respiratory symptoms suggestive foams and surface coatings; demonstrated by respiratory symptoms of diisocyanate sensitisation #1: Engineer, known to be sensitised to TDI. Re- exposure occurred unintentionally due to an accident. #2/3/4: Laboratory assistants using TDI to produce plastic foams. #5: Fitter dismantling equipment which was used in the making of foam. #6: Not accepted as a case of sensitisation as symptoms were attributed to anxiety. Examination by bronchial Not specified HDI. MDI, TDI Asthma (O'Brien et al., 1979) provocation test for sensitivity to TDI of 24 workers with respiratory disease handling diisocyanates Study to determine the TDI production TDI Asthmatic reactions; five workers were (Butcher et al., 1979) mechanisms of bronchial identified as non-reactors hyperreactivity ("sensitivity") to TDI in 28 workers with a history of sensitivity to TDI Case report of two workers with Not specified MDI #1: Occupational asthma (Zeiss et al., 1980) respiratory symptoms #1: Production supervisor #2.: Hypersensitivity pneumonitis #2: Welder, exposed continuously to polyurethane foam fumes 3 CLH REPORT FOR M-XDI Subject of the study Occupation/task Agent(s) Diagnosed disease/effects Reference Radioallergosorbent testing of 26 Not specified TDI Asthma (Butcher et al., 1980) TDI-reactive individuals shown to react to provocative inhalation challenge with TDI Case report of four subjects Welding of polyurethane belts MDI Asthma (Lob and Boillat, 1981) diagnosed with MDI-related asthma Case report of subject with Manufacturing engineer MDI Hypersensitivity pneumonitis and pleuritis (Friedman, 1982) repeated prolonged exposure to progressing to fibrosing alveolitis MDI Inhalation challenge tests in MDI: Not specified; TDI: Printers and laminators of TDI, MDI Occupational asthma in 24/40 workers with (Burge, 1982) exposed workers with respiratory flexible packaging MDI- and 30/51 workers with TDI-related symptoms related to TDI or MDI respiratory symptoms Case report of subject with Foreman in a garage where painting was done using a HDI Combined alveolitis and asthma (Malo et al., 1983) history of shortness of breath, polyisocyanate activator wheezing, malaise and chills Retrospective analysis of 109 MDI production MDI 8/109 workers were diagnosed with chronic (Diller and Herbert, MDI production workers obstructive bronchial disease and 3/109 with 1983) contact dermatitis. Case report of one subject Manufacture of shoe soles MDI Occupational asthma (Innocenti and Paggiaro, 1983) Case report of one patient with Packing and shipping of automobile equipment, MDI Hypersensitivity pneumonitis (Baur et al., 1984) symptoms of hypersensitivity occasionally engaged in spraying a mixture of MDI and pneumonitis polyol to produce polyurethane foam Case report of one patient Grain elevator operator/repairman cutting polyurethane MDI Occupational asthma (Chang and Karol, showing symptoms of severe plate made of MDI 1984) asthma Case report of two patients with Painting, insulating HDI, MDI Asthma, alveolitis (Laitinen et al., 1984) developed asthma and/or alveolitis Mechanistic challenge study in Not specified TDI Asthma (Mapp et al., 1985) four subjects exhibiting a late asthmatic response after TDI exposure Case-control study Iron and steel foundry; workers handling PepSet, a MDI Asthma (12/78) (Johnson et al., 1985) in 78 workers with respiratory chemical binding system containing MDI symptoms,.372 railway yard repair workers, representing 95% of the work force, served as negative controls. Case report of two workers who Gym-shoe factory, injecting MDI into shoe soles MDI #1: Asthma, hypersensitivity pneumonitis (Mapp et al., 1985) developed asthmatic symptoms #2: Asthma 4 CLH REPORT FOR M-XDI Subject of the study Occupation/task Agent(s) Diagnosed disease/effects Reference Case report of one patient with a Chemical industry technical representative, exposed MDI Occupational asthma (Banks et al., 1986) history of respiratory illness while unloading a railroad tank car containing MDI and having further work-related intermittent exposure Case report of one patient with Not specified TDI Asthma (Moller et al., 1986) asthma persisting for twelve years after single massive exposure to TDI Case report of four workers with Iron foundry; core making, sand mixing, and fettling MDI Asthma bronchiale due to contact with (Erban, 1987; Erban, respiratory symptoms associated with the Cold-Box process isocyanates 1988). Study on the inhibitive effect of Not specified TDI Asthmatic reactions (Boschetto et al., 1987) prednisone on late asthmatic reactions and airway inflammation induced by TDI in eight sensitised subjects with previously documented late asthmatic reactions Case report of one patient having Accidental peak exposure during maintenance work in TDI Isocyanate induced Asthma. Positive in (Banks and Rando, TDI-induced asthma a chemical plant (this peak exposure lead to onset of 1974 (after accident), no 1988) symptoms of asthma) hyperresponsiveness to challenge testing in 1985 (after 11 years without exposure to TDI), but positive in 1987 (after
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