Mastic gum is used for health products and in the food industry, and is being tested for several clinical indications. Nevertheless, information on its safety is scarce. Our aim was to test the local and systemic toxicity of RPh201, a botanical extract of gum mastic, and to assess the toxicokinetic profile of the mastic gum constituents masticadienonic acid (MDA) and isomasticadienonic acid (IMDA). 340 Sprague-Dawley rats were administered twice weekly subcutaneously with placebo or different doses of RPh201 for 6 months with an interim group at 3 months and a 4-week recovery group. No systemic toxicity was observed with RPh201. Local injection site reactions were observed in all animals, with comparable severity and frequency in the placebo and high dose groups. However, given the relative increase in tissue reaction in the high dose group, these changes were attributed to RPh201 administration. Nevertheless, considering the minor local irritation effects and clear trend for reversibility, the effects were not judged to be adverse. The toxicokinetic study revealed that the MDA and IMDA exposure increased with dose and the increase was supra-proportional on all days. This study supports a “no observed adverse effect level” (NOAEL) of 300 mg/kg body weight in Sprague-Dawley rats.

乳香胶用于保健产品和食品工业，并且正在测试几种临床适应症。然而，关于其安全性的信息很少。我们的目的是测试RPh201（一种乳香树胶的植物提取物）的局部和全身毒性，并评估乳香树胶成分乳香二十二烯酸（MDA）和异麦芽四烯酸（IMDA）的毒代动力学特征。340只Sprague-Dawley大鼠每周两次皮下注射安慰剂或不同剂量的RPh201，共6个月，过渡组为3个月，恢复期为4周。RPh201没有观察到全身毒性。在所有动物中均观察到局部注射部位反应，在安慰剂和高剂量组中，其严重程度和发生频率相当。但是，鉴于高剂量组的组织反应相对增加，这些更改归因于RPh201管理。但是，考虑到较小的局部刺激作用和明显的可逆性趋势，该作用并没有被认为是不利的。毒代动力学研究表明，MDA和IMDA的暴露量随剂量增加而增加，并且在整天中都是超比例的。这项研究支持Sprague-Dawley大鼠的“未观察到的不良反应水平”（NOAEL）为300 mg / kg体重。