Registration Dossier

Administrative data

Description of key information

Amongst other exposure related observations in human data, four publications are detailed discussing respiratory irritation potential of monopropylene glycol (Varughese at al 2005, Moline et al 2000, Wieslander 2001 and Wieslander and Norback 2010).

Additional information

The Moline et al. (2000) study evaluated exposure to mixed glycols, including butylene, diethylene, triethylene and monopropylene glycol. No significant acute change in voice quality, pulmonary function, or vocal cord appearance was found. Although actors with exposures to elevated or peak levels of glycols reported more symptoms than actors with less exposure, the mixed nature of the exposures makes it impossible to identify any symptoms as being due to monopropylene glycol exposure. 

 

The Varughese et al. (2005) study also looked at the possible acute and chronic exposure of subjects to glycol theatrical fogs which led to associations between glycol fog uses and decreased pulmonary function with symptoms of coughing and dry throat reported. The mixed nature of the exposures makes it impossible to identify any symptoms as being due to monopropylene glycol exposure. 

 

The Wieslander (2001) study evaluated acute exposure to monopropylene glycol during a 1 minute aviation emergency training exercise. The publication concluded that short exposure to monopropylene glycol mist from artificial smoke generators may cause acute ocular and upper respiratory irritation in non-asthmatic subjects. However, review of these data support different conclusions that no respiratory effects occurred in this study.

 

The Wieslander and Norback (2010) study evaluated the effects of exposure to monopropylene glycol in professional painters exposed to volatile organic compounds and microbial volatile organic compounds in water based paints. The publication concluded that house painters may have a risk of physiological reactions in the ocular and nasal mucosa. However, the mixed nature of the exposures makes it impossible to identify any symptoms as being due to monopropylene glycol exposure. 

 

The human exposure data available showing possible respiratory effects of monopropylene glycol, are detailed and critiqued in full in the endpoint study summary for irritation / corrosion (IUCLID section 7.3).