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Human volunteer study with PGME: Eye irritation during vapour exposure

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Author: Emmen, H.H. · Muijser, H. · Arts, J.H.E. · Prinsen, M.K.
Type:article
Date:2003
Institution: TNO Voeding Centraal Instituut voor Voedingsonderzoek TNO
Source:Toxicology Letters, 140-141, 249-259
Identifier: 237043
doi: doi:10.1016/S0378-4274(03)00021-3
Keywords: Toxicology · Toxicology and Applied Pharmacology · Human volunteer study · Propylene glycol monomethyl ether · Subjective symptoms · Propanediol derivative · Propylene glycol methyl ether · Unclassified drug · Clinical article · Clinical feature · Clinical trial · Conference paper · Conjunctiva · Controlled clinical trial · Controlled study · Cornea · Double blind procedure · Exposure · Eye irritation · Eyelid reflex · Follow up · Intestine muscle · Muscle cramp · Myalgia · Odor · Perception · Priority journal · Shivering · Skin · Throat · Toxicity testing · Vapor · Adult · Double-Blind Method · Eye · Eye Diseases · Humans · Irritants · Male · Propylene Glycols · Volatilization

Abstract

The objective of this study was to establish the possible occurrence of eye irritation and subjective symptoms in human volunteers exposed to propylene glycol monomethyl ether (PGME) vapour at concentrations of 0, 100 and 150 ppm. Testing was conducted in 12 healthy male volunteers using a repeated measures design. Each subject was exposed for 2.5 h to each of the three exposure conditions that were spaced 7 days apart. The exposure sequences were counterbalanced and the exposure to the test substance and the effect measurements were conducted in a double-blind fashion. During all exposure sessions, 20 ppm diethyl ether was used as a 'masking agent' for vapour exposure. Measurements of pre- and post exposure eye redness, corneal thickness, tear film break-up time, conjunctival epithelial damage, blinking frequency, and subjective ratings on discomfort were used to evaluate the possible irritating effects of PGME. The results indicated no significant treatment effects for any of the objective parameters. Results of the subjective ratings indicated very slight effects on the eyes in the 150 ppm PGME condition only. No significant effects of treatment were found for the remaining questions concerning the perceived intensity of the smell in the room, the (un)pleasantness of the smell, the perceived effects on the skin, effects on the throat, shivering, muscle aching, and intestinal cramps. In conclusion, the results of the present study indicated minimal subjective eye effects at 150 ppm only, and no impact on the objective measures of eye irritation at either of the two exposure levels. It was concluded that the no adverse effect concentration for eye irritation due to PGME vapour was at least 150 ppm. © 2003 Elsevier Science Ireland Ltd. All rights reserved.