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EC number: 205-483-3 | CAS number: 141-43-5
Animal data demonstrate that MEA does not have a sensitising potential.
After challenge with 4.1 %, 2.05 % and 0.41 % of the test substance, 3/15, 2/15 and 3/15 animals reacted positively after 72 hours. Two out of 15 animals showed a reaction to the vehicle. Of the 12 control animals, none reacted to the test substance or the vehicle. Possible cross reactions to 5 % of triethanolamine and 7 % of diethanolamine occurred in 3 and 2 animals, respectively. In a 2nd test, only 1 or 2 animals showed a reaction to 4.1 % and 2.05 % of the test substance, but none of the animals reacted to 0.41 % of the test substance or the physiological saline solution used as a vehicle in this study. Moreover, reactions to 10 % of triethanolamine and 7 % of diethanolamine were only observed in 1 and 2 animals, respectively. Of the 12 control animals none reacted to one of the ethanolamines, and 1/12 animals reacted to the vehicle after 24 hours.
The sensitising potential of MEA, as well as di- and triethanolamine, was studied using the guinea pig maximisation test (Wahlberg and Boman, 1996). Groups of 15 animals were induced with either MEA, DEA or TEA and then challenged after three weeks with the inducing amine and the two others. Prior to the topical induction, pretreatment with 10% sodium dodecyl sulphate was carried out. The challenge reactions were read blindly 48 and 72 h after application of the patches. Control groups of twelve animals were given the same treatment (FCA, vehicle, occlusion, etc.) except for the inducing amine. No statistically significant difference between actively induced animals and control animals was observed and there was no indication of cross reactivity.
Additionally an local lymph node assay with hydrochloride salt of the substance, which is a close analogue of the substance, is available. In this study, according to OECD Guideline 429, female CBA/Ca mice were exposed to concentrations up to 70% of the hydrochloride salt. No signs of systemic toxicity were noticed. The statistically significant increases in cellularity, caused by the 70% concentration and in 3H-thymidine incorporation into the lymph node cells, caused by the 70% and 30% preparations, failed to reach the stimulation index criterion of 1.5 or 3, respectively, and thus lie below the threshold of immunologic relevance. Lymph node weights were not statistically significantly increased.
Kamije et al (2009) evaluated the respiratory sensitisation in the guinea pig in vivo using measurementsof bronchoconstriction (Pao) and analysis of Histamine in Bronchoalveolar Lavage Fluid (BALF) following exposure to the test substance. In addition, measurements were made of contraction of the guinea pig trachea ex vivo, following exposure to the test substance and the test substance in combination with other agents known to affect respiratory function. Exposure to the test substance caused a significant increase in bronchoconstriction over control, which was decreased by co administration of atropine and diphenhydramine hydrochloride. The test substance did not cause an increase in histamine in BALF. The observed effects are likely of mechanistic origin. A possible mechanism of action is via direct agonistic effects at histamine H1 and muscarinic receptors. Therefore, this study provides no evidence for respiratory sensitization or occupational asthma.
Three case studies were published related to either occupational asthma or accidental exposure to products containing ethanolamines. The first case study of 20 patients diagnosed with occupational asthma confirmed one case to be caused by triethanolamine via a skin prick test with pure triethanolamine. Skin prick tests with products containing ethanolamines did not result in positive reactions (Mäkelä, 2011). A second case study describes a patient that ingested an alkaline detergent containing 3.3% of the test substance. The patient was found to have acute respiratory stress syndrome and there were areas in his lungs with severely damaged alveoli. The patient died on the 4th hospital day (Kamijo, 2004). The third case study describes three workers with occupational asthma that all reacted positively to respiratory challenges with products containing triethanolamine. One of the workers also reacted positive on a standard skin prick test. None of them was able to continue their work, due to their asthma (Savonius, 1994). These studies suggest that ethanolamines (more specifically: triethanolamine) can lead to respiratory sensitisation. However, they do not provide conclusive information on the possible respiratory sensitisation to the test substance.
Classification, Labeling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No 1272/2008. Based on these information the test item is not considered to be classified for skin or respiratory sensitisation under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.
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