Palkhade Rajendra, Sammal Deepali, Parmar Jitendra, Chavhan Snehal
Biological Sciences Division, ICMR-NIOH, Ahmedabad, Gujarat, India.
NFSU, Gandhinagar, Gujarat, India.
Ann Med. 2025 Dec;57(1):2491664. doi: 10.1080/07853890.2025.2491664. Epub 2025 Apr 17.
In view of overzealous use of Alcohol based hand sanitizer (ABHS) during COVID-19 pandemic and associated alarming rise in the cases of hand eczema and dermatitis around the world. We conducted an dermal toxicity with objective of exploring the acute and subacute effects of ethanol based hand sanitizer (EBHS) on Sprague Dawley rats.
To evaluate acute and subacute dermal toxicity due to ethanol based hand sanitizer (EBHS) on Sprague Dawley rats.
In first phase, following Organisation for Economic Co-operation and Development (OECD) Technical Guidelines (TG) 402, we conducted acute dermal toxicity study with two rats and EBHS containing 72.34% ethanol. In second phase, sub-acute dermal toxicity study was conducted, following OECD TG 410 with five groups of rats (10 animals of either sexes in each group) at various doses.
In both the studies, no erythema, oedema, and eschar was observed. Although no clinical signs of toxicity were observed in both the studies, one death was encountered in subacute study. Macroscopically skin was normal; however, microscopic changes such as hyperkeratosis, parakeratosis, erosion, and extracellular oedema in epidermis and diffuse inflammatory cell infiltration in dermis was observed, suggestive of spongiotic dermatitis and 'clinic-pathological discordance'. However, attributing this changes to ethanol is difficult due to methodological limitations and confounders.
In both the studies, ethanol based hand sanitizer (EBHS) was found to be non-irritant with LD of > 2000 mg/kg and classified as Class 5/Unclassified according to GHS classification. Although, spongiotic changes were observed, methodological limitation of absence of control group in TG 402 and confounding effect of water and occlusion in all the animals/groups in both studies prevented us to attribute it to ethanol.
鉴于在新冠疫情期间酒精基洗手液（ABHS）的过度使用以及全球手部湿疹和皮炎病例的惊人增加。我们进行了一项皮肤毒性研究，目的是探讨乙醇基洗手液（EBHS）对斯普拉格-道利大鼠的急性和亚急性影响。
评估乙醇基洗手液（EBHS）对斯普拉格-道利大鼠的急性和亚急性皮肤毒性。
在第一阶段，按照经济合作与发展组织（OECD）技术指南（TG）402，我们对两只大鼠进行了急性皮肤毒性研究，使用的EBHS含有72.34%的乙醇。在第二阶段，按照OECD TG 410对五组大鼠（每组10只雌雄大鼠）进行了不同剂量的亚急性皮肤毒性研究。
在两项研究中，均未观察到红斑、水肿和焦痂。虽然两项研究中均未观察到毒性的临床体征，但在亚急性研究中出现了一例死亡。宏观上皮肤正常；然而，观察到微观变化，如表皮角化过度、角化不全、糜烂和细胞外水肿，以及真皮中的弥漫性炎性细胞浸润，提示海绵状皮炎和“临床病理不一致”。然而，由于方法学限制和混杂因素，很难将这些变化归因于乙醇。
在两项研究中，乙醇基洗手液（EBHS）被发现无刺激性，LD>2000mg/kg，根据全球化学品统一分类和标签制度（GHS）分类为第5类/未分类。虽然观察到了海绵状变化，但TG 402中缺乏对照组的方法学限制以及两项研究中所有动物/组中的水和闭塞的混杂效应使我们无法将其归因于乙醇。
