毒理性
识别和使用:当酸值约为20时,卵磷脂形成蜡状团块;当酸值约为30时,为可倾倒的浓稠流体。它是一种可食用且可消化的天然来源的表面活性剂和乳化剂。用于人造黄油、巧克力和一般食品工业。此外,还用于药品和化妆品。它还有许多其他工业用途,包括处理皮革和纺织品。它还用作实验性药物。人类暴露和毒性:在临床刺激研究中,含有0.3%或3%卵磷脂65%(65%卵磷脂溶液)的化妆品配方、含有0.83%卵磷脂粉末的肥皂(在0.5%下测试)以及卵磷脂脂质体通常不具有刺激性。最严重的反应是几乎察觉不到的红斑。氢化卵磷脂也不具有刺激性,且氢化卵磷脂(含有15%的凡士林)不是致敏剂。此外,含有3%卵磷脂65%的晒黑油、含有0.1%卵磷脂65%的睫毛膏和含有0.3%卵磷脂65%的粉底均不具有致敏性。以每天22至83克的剂量给人类受试者服用卵磷脂,持续两到四个月以改善工作能力,并未伴随任何不良反应。然而,被大豆蛋白污染的卵磷脂作为药物辅料可能会引起大豆过敏患者的反应。含有0.3%卵磷脂65%(65%卵磷脂溶液)的粉底在人类受试者中不是光致敏剂。动物研究:在单次封闭贴片试验(兔子)中,卵磷脂65%(65%卵磷脂溶液)具有轻微刺激性,含有3%卵磷脂65%的产品几乎无至轻度刺激性,含有2.25%卵磷脂65%的产品对兔子的皮肤无刺激性。在一项豚鼠浸泡研究中,含有0.83%卵磷脂粉末的肥皂0.5%几乎无刺激性。卵磷脂65%(65%卵磷脂溶液)和含有2.25%或3.0%卵磷脂65%的产品对未冲洗的兔眼无至轻微刺激性。含有0.83%卵磷脂粉末的肥皂(在25%下测试)具有中等刺激性,而含有卵磷脂的脂质体在Draize试验中几乎无刺激性。将小鼠暴露于卵磷脂气溶胶4小时/天,持续2天后,肺部出现局部内皮细胞肿胀和间质性水肿。小鼠被喂食含有5至10毫克卵磷脂和糖的混合物(以提高适口性),第二组被喂食卵磷脂(5至10毫克)和胆固醇(4至5毫克)。小鼠被繁殖,其后代按照相同的程序给药;继续给药直到所有小鼠垂死或死亡。对照组随意给予实验室饲料。总共喂食卵磷脂、卵磷脂和胆固醇或对照饲料的小鼠数量分别为166、212和360。动物被杀死并进行了脑部解剖。在大脑神经细胞肿瘤的检查中,在喂食卵磷脂的73只动物中发现了18只,在喂食卵磷脂和胆固醇的88只动物中发现了27只,而在188只对照组动物中没有发现大脑神经细胞肿瘤。
IDENTIFICATION AND USE: Lecithins forms a waxy mass when the acid value is about 20; pourable, thick fluid when the acid value is around 30. It is an edible and digestible surfactant and emulsifier of natural origin. Used in margarine, chocolate and in the food industry in general. In addition, it is used in pharmaceuticals and cosmetics. It has many other industrial uses, including treating leather and textiles. It is also used as experimental medication. HUMAN EXPOSURE AND TOXICITY: In clinical irritation studies, cosmetic formulations containing 0.3% or 3% lecithin 65% (solution of 65% lecithin), a soap containing 0.83% lecithin powder (tested at 0.5%), and lecithin liposomes were generally non-irritating. Barely perceptible erythema was the most severe reaction observed. Hydrogenated lecithin also was not an irritant, and hydrogenated lecithin (15% in petrolatum) was not a sensitizer. Additionally, a tanning oil containing 3% lecithin 65%, a mascara containing 0.1% lecithin 65%, and a foundation containing 0.3% lecithin 65% were non-sensitizing. Administration to human subjects of lecithin in daily doses varying from 22 to 83 g for two to four months to improve working capacity was not accompanied by any untoward reactions. However, lecithin contaminated by soy proteins and used as an excipient in drugs can cause reactions in patients with soy allergy. A foundation containing 0.3% lecithin 65% (solution of 65% lecithin) was not a photosensitizer in human subjects. ANIMAL STUDIES: In single-insult occlusive patch tests (rabbits), lecithin 65% (solution of 65% lecithin) was minimally irritating, products containing 3% lecithin 65% were practically non- to mildly irritating, and a product containing 2.25% lecithin 65% was non-irritating to the skin of rabbits. In a guinea pig immersion study, 0.5% of a soap containing 0.83% lecithin powder was practically non-irritating. Lecithin 65% (solution of 65% lecithin) and products containing 2.25% or 3.0% Lecithin 65% were non- to minimally irritating to unrinsed rabbit eyes. A soap containing 0.83% lecithin powder (tested at 25%) was moderately irritating, and lecithin-containing liposomes were practically nonirritating in a Draize test. After exposing mice to aerosolized lecithin 4 hr/day for 2 days, lungs showed focal endothelial cell swelling and interstitial edema. Mice were fed 5 to 10 mg lecithin mixed with sugar (for palatability), and a second group was fed lecithin (5 to 10 mg) and cholesterol (4 to 5 mg). The mice were bred and their offspring dosed following the same procedures; dosing continued until all mice became moribund or had died. A control group was given laboratory feed ad libitum. The total number of mice fed lecithin, lecithin and cholesterol, or control feed was 166, 212, and 360, respectively. Animals were killed and brain necropsies performed. Brain nerve cell tumors were found in 18 of 73 examined animals fed lecithin and in 27 of 88 examined animals fed lecithin and cholesterol, whereas, no brain nerve cell tumors were found in 188 control animals.
来源:Hazardous Substances Data Bank (HSDB)