Final Report of the Safety Assessment of Methylisothiazolinone

Burnett, Christina L.; Bergfeld, Wilma F.; Belsito, D.; Klaassen, Curtis D.; Marks, James G.; Shank, Ronald C.; Slaga, Thomas J.; Snyder, Paul W.; Andersen, F. Alan

doi:10.1177/1091581810374651

Cited by 91 publications

(117 citation statements)

References 20 publications

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“…In animal studies, the inhalation of a mixture of CMIT/MIT has been shown to cause decreased weight gain and pulmonary hemorrhages in rats [4]. Another study also reported cellular toxicity to rat alveolar macrophages from inhalation [20].…”

Section: Discussionmentioning

confidence: 99%

“…A mixture of CMIT/MIT is well known to cause allergic dermatitis responses via contact with the air although rare in the respiratory disease [4–8]. However, the Korea Centers for Disease Control and Prevention (KCDC) under the Ministry of Health and Welfare declared HD as a cause of lung injury and recalled HD products in November 2011.…”

Section: Introductionmentioning

confidence: 99%

“…Moreover, previous animal studies also investigated the effect of inhalation of a mixture of CMIT/MIT, which has been shown to cause pulmonary toxicity in rats [4, 20]. Therefore, it is important to determine the potential functional loss that can be caused by inhalation exposure to a mixture of CMIT/MIT.…”

Section: Introductionmentioning

confidence: 99%

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Effects of a mixture of chloromethylisothiazolinone and methylisothiazolinone on peripheral airway dysfunction in children

et al. 2017

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BackgroundChildren who were only exposed to a mixture of chloromethylisothiazolinone (CMIT) and methylisothiazolinone (MIT) as humidifier disinfectant (HD) components were evaluated for humidifier disinfectant-associated lung injury (HDLI) from 2012. This study was to evaluate the pulmonary function using, impulse oscillometry (IOS) for children exposed to a mixture of CMIT/MIT from HD.MethodsTwenty-four children who were only exposed to a mixture of CMIT/MIT, with no previous underlying disease, were assessed by IOS. Diagnostic criteria for HDLI were categorized as definite, probable, possible, or unlikely. Home visits and administration of a standardized questionnaire were arranged to assess exposure characteristics.ResultsDefinite and probable cases showed higher airborne disinfectant exposure intensity during sleep (32.4 ± 8.7 μg/m3) and younger age at initial exposure (3.5 ± 3.3 months) compared with unlikely cases (17.3 ± 11.0 μg/m3, p = 0.026; 22.5 ± 26.2 months, p = 0.039, respectively). Reactance at 5 Hz was significantly more negative in those with high-density exposure during sleep (mean, -0.463 kPa/L/s vs. low density, -0.296, p = 0.001). The reactance area was also higher with high-density exposure during sleep (mean, 3.240 kPa/L vs. low density, 1.922, p = 0.039). The mean bronchodilator response with high-density exposure was within the normal range for reactance.ConclusionsSignificant peripheral airway dysfunction were found in children with high levels of inhalation exposure to a mixture of CMIT/MIT during sleep. Strict regulation of a mixture of CMIT/MIT exposure were associated with positive effects on lung function of children.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Effects of a mixture of chloromethylisothiazolinone and methylisothiazolinone on peripheral airway dysfunction in children

et al. 2017

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“…day cream) and rinse-off cosmetics (e.g. shampoo) in 2005 [3]. However, the first cosmetic cases of contact allergy appeared in 2010 [4] and since then, European alert systems (such as REVIDAL [Réseau de Vigilance en Dermato-Allergologie] in France) have highlighted an increasing number of sensitized patients.…”

mentioning

confidence: 99%

Contact allergy caused by methylisothiazolinone: the Belgian-French experience

Aerts

Goossens

Giordano‐Labadie

2015

European Journal of Dermatology

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Contact allergy caused by methylisothiazolinone: the Belgian-French experienceThe chemical Kathon CG ® , a mixture of the preservatives methylchloroisothiazolinone (MCI) and methylisothiazolinone (MI), was the leading cause of a worldwide epidemic of contact-allergic reactions in the eighties. From 2000 on, MI alone became allowed in industrial products and in 2005 authorities gave a green light for its use in leave-on and rinse-off cosmetics up to a maximum concentration of 100 ppm (0.01%). Following initial occupational cases, a continuously increasing number of consumers sensitized to MI have been reported and both Belgian and French allergy groups decided to routinely test MI in their baseline series from 2010 onwards. Two multicenter studies, comprising 8,680 and 7,874 patients in Belgium and France respectively, both clearly show the rise in contact allergy caused by MI, with a spectacular sensitization rate of ∼ 6.0% in 2012, even increasing to 7.0% in 2013. Mostly middle-aged women, presenting with facial-and/or hand dermatitis, were affected, although very young children were reported as well. Furthermore, the data confirmed that sensitization is primarily caused by cosmetics (mostly leave-on, but also rinse-off), household detergents and water-based paint. This unprecedented outbreak of contact sensitization to a preservative agent in Europe, and beyond, should have alerted the authorities much sooner and meanwhile the need for safer use concentrations of MI in cosmetics, detergents and industrial products is becoming more urgent every day.

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“…Według innych badań u zwierząt i ludzi (z udziałem zdrowych ochotników), u których MI wielokrotnie aplikowano pod okluzją (human repeated insult patch test -HRIPT), związek wykazywał właściwości uczulające tylko w bardzo wysokim stężeniu (> 600-1000 ppm) (3,21). Na tej podstawie uznano, że wywołanie uczulenia przez MI w dopuszczalnej ilości poniżej 100 ppm jest mało prawdopodobne (3,9,18,21). Okazało się jednak, że wyniki oceny metodą LLNA sugerują raczej zaliczenie MI do związków o umiarkowanych, a nawet silnych właściwościach uczulających (19,22).…”

Section: Właściwości Uczulające MCI I Miunclassified

ISOTHIAZOLINONES AS CAUSAL FACTORS OF CONTACT ALLERGY EPIDEMICS IN THE 20th AND 21st CENTURIES

Chomiczewska-Skóra¹,

Krêcisz²,

Kieć-Swierczyńska³

2014

Med Pr

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StreszczenieChlorometyloizotiazolinon (chloromethylisothiazolinone -MCI) i metyloizotiazolinon (methylisothiazolinone -MI) od końca lat 70. XX w. do 2014 r. stanowiły konserwanty powszechnie stosowane w kosmetykach, artykułach chemii gospodarczej i produktach przemysłowych. Pierwsze przypadki alergii kontaktowej na mieszaninę MCI/MI odnotowano w latach 1980-1982 w Szwecji, a następnie w wielu ośrodkach europejskich obserwowano istotny wzrost częstości uczuleń na te związki. Został on zahamowany dzięki wprowadzeniu w Europie i niektórych krajach pozaeuropejskich regulacji prawnych dotyczących dopuszczalnego stęże-nia MCI i MI w produktach konsumenckich i przemysłowych. Zezwolenie od 2000 r. na stosowanie bez limitu samego MI w produktach przemysłowych i od 2005 w kosmetykach w stężeniu do 100 ppm spowodowało w ostatnich latach znaczący wzrost liczby uczulonych na ten związek. Alergiczne kontaktowe zapalenie skóry związane z MI występuje zarówno u dorosłych, jak i dzieci, charakteryzuje się często ciężkim przebiegiem, a do wywołania objawów nierzadko dochodzi na drodze powietrznopochodnej. Do najistotniejszych źródeł uczulenia na MI należą kosmetyki i farby. W odpowiedzi na narastający problem epidemii alergii kontaktowej na izotiazolinony opracowano rekomendacje sugerujące zakaz stosowania MI w kosmetykach typu "leave-on" oraz uznanie za dopuszczalne stężenia 15 ppm w produktach kosmetycznych "rinse-off". Zalecenia te prawdopodobnie zostaną wprowadzone w życie w 2014 r. Med. Pr. 2014;65(4):543-554 Słowa kluczowe: izotiazolinony, chlorometyloizotiazolinon, metyloizotiazolinon, alergia kontaktowa, epidemia Abstract Chloromethylisothiazolinone (MCI) and methylisothiazolinone (MI) have been widely used as preservatives in cosmetics, household products and industrial products since the late 1970s. First cases of contact allergy to the MCI/MI combination were noted in 1980-1982 in Sweden. Then, a significant increase in the frequency of sensitization to these compounds was observed in many European centers. The increase has been stopped by the introduction of legislation on their maximum concentrations in consumer and industrial products in Europe and in some non-European countries. But approval of the use of MI alone without limits in industrial products (from 2000) and at a maximum concentration of 100 ppm in cosmetics (from 2005) resulted in an unprecedented increase in the number of individuals sensitized to this compound. Allergic contact dermatitis due to MI occurs in both adults and children. It is often manifested by severe symptoms, which may be also induced by airborne exposure. The most important sources of sensitization include cosmetic products and paints. To counteract the increasing problem of contact allergy epidemic to MI, the recommendations have been developed, suggesting the ban on the use of MI in "leave-on" cosmetics and maximum concentration of 15 ppm in "rinse-off" products. These recommendations are likely to be implemented in 2014. Med Pr 2014;65 (4) WSTĘPZwiązki o właściwościach konserwujący...

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Final Report of the Safety Assessment of Methylisothiazolinone

Cited by 91 publications

References 20 publications

Effects of a mixture of chloromethylisothiazolinone and methylisothiazolinone on peripheral airway dysfunction in children

Effects of a mixture of chloromethylisothiazolinone and methylisothiazolinone on peripheral airway dysfunction in children

Contact allergy caused by methylisothiazolinone: the Belgian-French experience

ISOTHIAZOLINONES AS CAUSAL FACTORS OF CONTACT ALLERGY EPIDEMICS IN THE 20th AND 21st CENTURIES

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