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MEA was evaluated in CoRAP regarding its respiratory sensitiation potential. The initial concern for sensitisation was clarified. Based on the available animal and human data, the eMSCA concluded that MEA did not meet the criteria for classification for skin or respiratory sensitisation (CoRAP Substance Evaluation Report, September 2018).

Additional information

Mäkelä et al (2011) examined 20 cases of occupational asthma (OA) diagnosed at the Finnish Institute of Occupational Health (FIOH) during the period 1994–2004 in workers employed in professional cleaning work were described. OA was diagnosed according to patient history, lung function examinations and specific challenge tests with measurements of the forced expiratory volume in 1 second and peak expiratory flow values. Of the 20 patients diagnosed with OA, 5 were attributed to wax-removing detergents containing ethanolamines. One case of OA was confirmed to be caused by triethanolamine (TEA), in the single patient who was challenged with pure TEA. Exposure to pure test substance was not conducted. The author concluded that ethanolamines in the tested products were the likely cause of the reaction in all cases. However, there is a significant lack of clarity regarding the formulation of the wax-removing detergents tested (defined solely as containing either test substance or TEA). Only 1 patient was challenged with pure TEA. No patients were challenged with pure test substance. Therefore the study is not suitable to assess the repiratory senistisation potential of the test substance.

 

Kamyo et al (2004) report on a 65-y-old man who ingested about 600 mL of an alkaline detergent (pH 11.7) containing 3.3% test substance. After vomiting with choking several times, he presented to the emergency center with asthma-like symptoms 95 min after ingestion. Despite treatment with bronchodilators, steroids and epinephrine, respiratory dysfunction progressed to acute respiratory distress syndrome resulting in death on the 4th hospital day. An autopsy was performed 2 h post-mortem. Tracheal and bronchial lumina were empty. Respiratory mucous membranes were partially necrotic and had a deep blue or reddish purple discoloration. The lungs had severe hemocongestion and increased weight (right=1440 g, left=1200 g. The sectioned lung surface was mottled, particularly dorsally. On histology studies the trachea and bronchi had partial desquamation and there are coagulation necrosis of the mucous membrane. The lungs had areas with normal-appearing alveoli which other areas had severely damaged alveoli. In the latter areas, invasion of varying intensity by inflammatory cells was seen. Squamous epithelium or hyaline membranes had replaced necrotic respiratory epithelium in some areas. In this case, no clear evidence of respiratory sensitisation was presented after an acute response in the patient following oral ingestion (subsequent choking and vomiting) of an alkaline detergent (pH 11.7) containing 3.3% test substance.

Finally , Savonius et al (1994) report on two cases of occupational asthma (OA) caused by tri-ethanolamine. In addition they report on one case of occupational asthma caused by an ethanolamine-containing detergent. The detergent contained 8% MEA and 9% sodium metasilicate. , OA diagnosis was based on a provocation test in an inhalation challenge chamber with the suspected agent. Measurements of respiratory function (PEF/FEV1). The spirometric values were normal and she had no bronchial hyperreactivity. PEF surveillance for 2 weeks showed a pattern typical of occupational asthma. Because of the fever her diffusion capacity was also followed up in the challenge tests. The placebo test with polyol was negative. The test with a detergent containing ethanolamine in hot water induced an immediate but long lasting asthmatic reaction, and 7 h after the test a fever of 38 °C. but no changes in diffusion capacity. The decrease in FEV1 was 27 %. However, the effects of the test substance alone were not investigated. The author concluded that a reaction, other than an allergic one, or a reaction to something other than the test substance could not be discounted. (ie. reaction to alkaline irritant (sodium metasilicate) in the product).