Registration Dossier

Administrative data

Description of key information

Brief discussion of human data obtained from literature searches.

Additional information

Bitumen human data statement for 1Q 2017 dossier updates

A number of studies evaluating acute and chronic lung irritation and function in correlation with occupational exposure to bitumen fumes are available. Effects on acute and (sub)chronic respiratory inflammation and lung function in bitumen workers are reported(Hansen, 1991; Norseth 1991; Bergdahl 2004; Randem 2004; Tepper 2006; Ulvestad 2007; Ulvestad 2017)but because of co-exposure to a variety of other chemicals (e.g. benzene, coal tar, tobacco) the symptoms could not be attributed directly to fumes from bitumen. In addition, no consistent association was observed between acute and chronic clinical effects on lung function or respiratory irritation following exposure to bitumen fumes in additional human studies (Gamble 1999;Watkins 2002;Burstyn 2003; Randem 2003;Breuer 2011; Marczynski 2011; Pesch 2011; Raulf-Heimsoth 20011a, 2011b, 2011c; Rihs 2011; Spickenheuer 2011; Welge 2011). The qualitative evaluation of these epidemiology studies support the current hazard assessment including classification and labelling according to EU CLP of this compound.

 

 

References

Bergdahl IA, Toren K, Eriksson K, Hedlund U, Nilsson T, Flodin R, Jarvholm B (2004) Increased mortality in COPD among construction workers exposed to inorganic dust. The European Respiratory Journal 23(3), 402-6.

 

Breuer D, Hahn J-U, Höber D, Emmel C, Musanke U, Rühl R, Spickenheuer A, Raulf-Heimsoth M, Bramer R, Seidel A, Schilling B, Heinze E, Kendzia B, Marczynski B, Welge P, Angerer J, Brüning T, Pesch B (2011) Air sampling and determination of vapours and aerosols of bitumen and polycyclic aromatic hydrocarbons in the Human Bitumen Study. Archives of Toxicology 85 (Suppl 1), S11–S20.

 

Burstyn I, Boffetta P, et al. (2003) Estimating exposures in the asphalt industry for an international epidemiological cohort study of cancer risk. American Journal of Industrial Medicine 43(1), 3-17

 

Gamble JF, Nicolich MJ, Barone NJ, Vincent WJ (1999) Exposure-response of asphalt fumes with changes in pulmonary function and symptoms. Scandinavian Journal of Work, Environment & Health 25(3), 186-206.

 

Hansen ES (1991) Mortality of mastic asphalt workers. Scandinavian Journal of Work, Environment & Health 17(1), 20-24.

 

Marczynski B, Raulf-Heimsoth M, Spickenheuer A, Pesch B, Kendzia B, Mensing T, Engelhardt B, Lee E-H, Schindler BK, Heinze E, Welge P, Bramer R, Angerer J, Breuer D, Käfferlein HU, Brüning T (2011) DNA adducts and strand breaks in workers exposed to vapours and aerosols of bitumen: associations between exposure and effect. Archives of Toxicology 85 (Suppl 1), S53–S64.

 

Norseth T, Waage J, Dale I (1991) Acute effects and exposure to organic compounds in road maintenance workers exposed to asphalt. American Journal of Industrial Medicine 20(6), 737-744.

 

Pesch B, Spickenheuer A, Kendzia B, Schindler BK, Welge P, Marczynski B, Rihs H-P, Raulf-Heimsoth M, Angerer J, Brüning T. (2011) Urinary metabolites of polycyclic aromatic hydrocarbons in workers exposed to vapours and aerosols of bitumen. Archives of Toxicology 85 (Suppl 1), S29–S39.

 

Randem BG, Langard S, Kongerud J, Dale I, Burstyn I, Martinsen JI, Andersen A (2003) Mortality from non-malignant diseases among male Norwegian asphalt workers. American Journal of Industrial Medicine 43(1), 96-103.

 

Randem BG, Ulvestad B, Burstyn I, Kongerud J (2004) Respiratory symptoms and airflow limitation in asphalt workers. Occupational and Environmental Medicine 61(4), 367-369.

 

Raulf-Heimsoth M, Pesch B, Rühl R, Brüning T (2011a)The Human Bitumen Study: executive summary. Archives of Toxicology 85 (Suppl 1), S3–S9.

 

Raulf-Heimsoth M, Pesch, B, Kendzia B, Spickenheuer A, Bramer R, Marczynski B, Merget R, Brüning T (2011b)Irritative effects of vapours and aerosols of bitumen on the airways assessed by non-invasive methods. Archives of Toxicology 85 (Suppl 1), S41–S52.

 

Raulf-Heimsoth M, Marczynski B, Spickenheuer A, Pesch B, Welge P, Rühl R, Bramer R, Kendzia B, Heinze E, Angerer J, Brüning T (2011c) Bitumen workers handling mastic versus rolled asphalt in a tunnel: assessment of exposure and biomarkers of irritation and genotoxicity. Archives of Toxicology 85 (Suppl 1), S81–S87.

 

Rihs H-P, Spickenheuer A, Heinze E, Pesch B, Raulf-Heimsoth M, Angerer J, Brüning T (2011) Modulation of urinary polycyclic aromatic hydrocarbon metabolites by enzyme polymorphisms in workers of the German Human Bitumen Study. Archives of Toxicology 85 (Suppl 1), S73–S79.

 

Spickenheuer A, Rühl R, Höber D, Raulf-Heimsoth M, Marczynski B, Welge P, Breuer D, Gabriel S, Musanke U, Rode P, Heinze E, Kendzia B, Bramer R, Knecht U, Hahn J-U, Brüning T, Pesch B (2011) Levels and determinants of exposure to vapours and aerosols of bitumen. Archives of Toxicology 85 (Suppl 1), S21–S28.

 

Tepper AL, Burr GA, Feng HA, Singal M, Miller AK, Hanley KW, Olsen LD (2006) Acute symptoms associated with asphalt fume exposure among road pavers. American Journal of Industrial Medicine 49(9), 728-739.

 

Ulvestad B, Randem BG, Hetland S, Sigurdardottir G, Johannessen E, Lyberg T (2007) Exposure, lung function decline and systemic inflammatory response in asphalt workers. Scandinavian Journal of Work, Environment & Health 33(2), 114-121.

 

Ulvestad B, Randem BG, Skare Ø, Aaløkken TM, Myranek GK, Elihn K, Lund MB (2017) Lung function in asphalt pavers: a longitudinal study. International Archives of Occupational and Environmental Health, 90(1), 63-71.

 

Watkins DK, Chiazze L, Fryar CD, Fayerweather W (2002) A case control study of lung cancer and non-malignant respiratory diseases among employees in asphalt roofing manufacturing and asphalt production. Journal of Occupational and Environmental Medicine, 44, 551-8.

 

Welge P, Marczynski B, Raulf-Heimsoth M, Spickenheuer A, Kendzia B, Heinze E, Angerer J, Käfferlein HU, Pesch B, Brüning T (2011) Assessment of micronuclei in lymphocytes from workers exposed to vapours and aerosols of bitumen. Archives of Toxicology 85 (Suppl 1), S65–S71.