Comparative analysis of skin sensitization potency of acrylates (methyl acrylate, ethyl acrylate, butyl acrylate, and ethylhexyl acrylate) using the local lymph node assay

Dearman, Rebecca J.; Betts, Catherine J.; Farr, Craig H.; McLaughlin, James E.; Berdasco, Nancy Anne M.; Wiench, Karin; Kimber, Ian

doi:10.1111/j.1600-0536.2007.01215.x

Cited by 35 publications

(19 citation statements)

References 25 publications

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“…4,9,10 The glue used in adhesives usually consists of an acrylate polymer which is a mixture of mostly 3 different acrylate monomers. While polymerized acrylates are usually called nonirritant and hypoallergenic, monomers are considered as strong skin sensibilizer, 12,13 acrylates were also named the "Contact Allergen of the Year" by the American Contact Dermatitis Society in 2012. 14 Of course, other substances in adhesives such as benzoyl peroxide may potentially be immune sensitizers.…”

mentioning

confidence: 99%

Adhesives Used for Diabetes Medical Devices

Heinemann

Kamann

2016

J Diabetes Sci Technol

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mentioning

confidence: 99%

Adhesives Used for Diabetes Medical Devices

Heinemann

Kamann

2016

J Diabetes Sci Technol

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“…A local lymph node assay in CBA/Ca mice yielded an EC3 value of 11.2% for n-butyl acrylate tested in acetone/olive oil (4:1) (Dearman et al 2007). n-Butyl acrylate was therefore found to have a moderate to weak sensitizing potential in this test system.…”

Section: Allergenic Effects Sensitizing Effects On the Skinmentioning

confidence: 98%

“…Documentation was published in 1985 (documentation "n-Butyl acrylate" 1993), followed by supplements in 1996 (supplement "n-Butyl acrylate" 1999 (MAK value)), 1999 (supplement "n-Butyl acrylate" 2001 (allergenic effects)), 2000 (supplement "n-Butylacrylat" 2000 (peak limitation), available in German only) and 2007(supplement "n-Butylacrylat" 2007, available in German only). The purpose of this supplement was to re-evaluate local irritation based on the proposals made by Brüning et al (2014) and to review the benchmark concentrations calculated in the 1996 supplement (supplement "n-Butyl acrylate" 1999).…”

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confidence: 99%

n ‐Butyl acrylate [MAK Value Documentation, 2017]

Hartwig

Arand²

2018

The MAK‐Collection for Occupational Health and Safety

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The German Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area has re‐evaluated the maximum concentration at the workplace (MAK value) of 2 ml/m 3 for n‐butyl acrylate. The critical effect in a two‐year inhalation study with rats was reserve cell hyperplasia with loss of ciliated or olfactory cells at the lowest concentration of 15 ml/m 3 . The lower confidence limit of the benchmark dose for an extra risk of 5% increase of the critical effect incidence (BMDL 05 ) of about 3 ml/m 3 , which had been calculated in the previous evaluations, was confirmed. Since 2014, the Commission uses an empirical approach to set MAK values for substances with critical effects on the upper respiratory tract or the eyes. Based on this approach, the equivalent concentration at the workplace is 1.5 ml/m 3 . However, studies in humans to investigate the sensory irritation of n‐butyl acrylate are lacking. As the structurally related ethyl acrylate possesses a RD 50 value as well as subchronic and chronic NOAECs similar to those of n‐butyl acrylate, the NOAEC of 2.5 ml ethyl acrylate/m 3 for sensory irritation in volunteers was used as a read‐across. As the MAK value for ethyl acrylate has been set at 2 ml/m 3 , the MAK value of 2 ml/m 3 for n‐butyl acrylate could be confirmed. In analogy to ethyl acrylate, the assignment of n‐butyl acrylate to Peak Limitation Category I and the excursion factor of 2 were confirmed. The NOAECs for developmental toxicity in rats and mice are sufficiently high so that damage to the embryo or foetus is unlikely when the MAK value is observed. Thus, n‐butyl acrylate continues to be classified in Pregnancy Risk Group C. The substance is marginally clastogenic in vitro but not in vivo and was not carcinogenic in a 2‐year inhalation study in rats. There are only a few cases of contact sensitization in humans but there are positive results in local lymph node assays. Data on airway sensitization are still not available. n‐Butyl acrylate continues to be designated with “Sh”. Skin absorption was calculated to contribute significantly to the systemic toxicity and n‐butyl acrylate is designated with an “H”.

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“…studies, mainly in the dental medical field, have been conducted on the toxicity of (meth)acrylic monomers including cytotoxicity (Dickson et al, 1993;Yoshii, 1997), systemic toxicity with oral or percutaneous administration (Autian, 1975;Tanii and Hashimoto, 1982) and dermal sensitivity (Walle et al, 1982;Rustemeyer and Frosch, 1996;Kiec-Swierczynska, 1996;Kanerva et al, 1997;Geukens and Goossens, 2001;Dearman et al, 2007). In terms of the toxicity of these substances in skin, there have been studies on dermal sensitivity in both experimental animals (Walle et al, 1982;Dearman et al, 2007) and in humans (Rustemeyer and Frosch, 1996;Kiec-Swierczynska, 1996;Kanerva et al, 1997;Geukens andGoossens, 2001).…”

mentioning

confidence: 96%

The potential dermal irritating effect of residual (meth)acrylic monomers in pressure sensitive adhesive tapes

Tokumura¹,

Matsui²,

Suzuki³

et al. 2009

Drug and Chemical Toxicology

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It is generally thought that residual unpolymerized (meth)acrylic monomers commonly found in pressure sensitive adhesive tapes for medical use may cause dermal irritation, but a systematic study has never been carried out. Therefore, we assessed the potential dermal irritating effect of residual (meth)acrylic monomers. We studied seven acrylic monomers, acrylic acid (AA), methyl acrylate (MA), ethyl acrylate (EA), n-butyl acrylate (n-BA), n-hexyl acrylate (n-HA), 2-ethylhexyl acrylate (2-EHA) and 2-hydroxyethyl acrylate (HEA), as well as three methacrylic monomers, methacrylic acid (MAA), methyl methacrylate (MMA) and 2-hydroxyethyl methacrylate (2-HEMA). We first examined their cytotoxic effect on a cultured dermis model using the MTT method to determine their EC(50) and then performed a primary irritation test in rabbits using the monomers at three different concentrations (i.e., EC(50) , one-tenth EC(50) and 10 times EC(50)). Marked variations were found in cytotoxic and dermal irritating activities among the (meth)acrylic monomers tested. HEA exhibited the most potent dermal irritation having the lowest erythema dose (the concentration which gives a primary dermal irritation index of 1.00) of 460 ppm. But the other monomers exhibited less potent dermal irritation (lowest erythema doses > or =1000 ppm). For the monomers, significant correlation was found between cytotoxic activity and in vivo dermal irritating activity. Our results show that residual unpolymerized (meth)acrylic monomers in adhesive tapes are unlikely to induce skin irritation except for HEA. This study also suggests that cultured skin models are extremely useful as a screening method for chemical substances that could potentially cause dermal irritating activity.

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Comparative analysis of skin sensitization potency of acrylates (methyl acrylate, ethyl acrylate, butyl acrylate, and ethylhexyl acrylate) using the local lymph node assay

Cited by 35 publications

References 25 publications

Adhesives Used for Diabetes Medical Devices

Adhesives Used for Diabetes Medical Devices

n ‐Butyl acrylate [MAK Value Documentation, 2017]

The potential dermal irritating effect of residual (meth)acrylic monomers in pressure sensitive adhesive tapes

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