定义
美国FDA 物质登记 · UNII 806AV2E065 · 登记名称 SODIUM HEXAFLUOROSILICATE · 单一化学物质
化妆品中的作用
防止牙菌斑ANTIPLAQUE护理口腔ORAL CARE
安全与法规参考
- 限用
- 英国
来源: 东盟化妆品指令 · 欧盟化妆品法规 · 韩国食药处 化妆品法规信息 · 台湾FDA 化妆品成分 · 台湾FDA 化妆品法规 · 英国化妆品法规
阿根廷 · 巴西
- Field of application and/or use : (a) Toothpastes (b) Mouthwashes
- Maximum concentration permitted at final product : 0.15% expressed as fluorine. When it is mixed with other fluorine compounds permitted, the maximum concentration fluoride total must not exceed 0.15%
- Use conditions and warnings that must appear on the label : a) - Contains sodium fluorsilicate. For toothpaste containing 0.1% -0.15% fluoride, except if is already included that is contraindicated for children (e.g. “for adult use only”) it must contain the following warning: “Children under 6 years: Use an amount like a pea size, with adult supervision during brushing to minimize swallowing. If you ingest fluoride from other sources, consult your doctor or dentist" b) - Contains sodium fluorsilicate. - Keep out of children reach. - Do not use in children under 6 years old
东盟
- Field of application and/or use : Oral hygiene products
- Maximum authorised concentration in the finished cosmetic product : 0.15% calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0.15%.
- Other limitations and requirements : Thailand only 0.11% calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0.11%.
- Conditions of use and warning which must be printed on the labels : • Contains sodium fluorosilicate • Children of 6 years and under: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor(12)
台湾
- ※ 染髮產品之限量標準:係指該成分依產品使用說明書混合後之最高允許使用量。
- ※ 化粧品之外包裝或容器,應明顯標示本表所列成分之注意事項。因外包裝或容器表面積過小或其他特殊情形致不能標示者,應於標籤、仿單或以其他方式刊載之。
- ※ 本表所稱之口腔製劑,包含非藥用牙膏、漱口水類及美白牙齒類等化粧品。
- ※ 化粧品宣稱效能者,須符合化粧品標示宣傳廣告涉及虛偽誇大或醫療效能認定準則規定。
- 用途 : 使用限制
- 最大配合量 : 口腔製劑 : 0.15%(以 F 計)
- 倘混合使用其他我國準用之氟化合物,其氟總量不得超過0.15%。
- 2. 非藥用牙膏含氟化合物者, 應刊載其氟含量。
欧盟
- Product Type, body parts : Oral products
- Maximum concentration in ready for use preparation : 0,15 % calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
- Wording of conditions of use and warnings : Contains sodium fluorosilicate For any toothpaste with compounds containing fluorine in a concentration of 0.1 to 0.1'5.0% calculated as F unless it is already labelled as contra-indicated for children (e.g. "for adult use only") the following labelling is obligatory: "Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor."
来源: 韩国食药处 化妆品法规信息
韩国有毒物质 GHS 分类: 危险 · H301 (第3类) · H332 (第4类) · H318 (第1类)
欧盟化妆品法规 附录III(限用物质) 第40项 · 最高浓度 0,15 % calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % · 适用 Oral products
来源: 欧盟限用成分(附录III)
Restriction III/40 · Other restriction: ban substances that deplete the ozone layer
来源: 欧盟 CosIng 成分清单
详细资料——标示名称、识别编号、物性、试验记录、文献
别名和识别信息
SODIUM FLUOROSILICATEINCI소듐플루오로실리케이트韩国标示名称(食药处标准名)Silicate(2-), hexafluoro-, disodium同义名
- CAS No.化学物质登记号
- 16893-85-9
- EC No.欧盟化学品目录编号
- 240-934-8
- DTXSID美国EPA化学品编号
- DTXSID9036933
- DTXCID美国EPA化合物编号
- DTXCID7016933
- IUPAC
- Disodium hexafluoridosilicate(2-)
- 分子式
- F6Na2Si
- 分子量
- 188.055 g/mol
产品实际使用的用途
这是向美国 EPA 申报含该成分的 10 款产品的用途。其中包括化妆品以外的产品,排在前几行的即为该成分的主要用途。
- Degradant/impurity (EPA)4
- Anti-scaling agent2
- Abrasive2
- Cleaning agent1
- Pharmaceutical (EPA)1
来源: 美国EPA CompTox
刺激与致敏试验记录
记录有皮肤试验 2 项、眼部试验 4 项。
归类为低1 项
试验结论基本一致(100%)。 这是对原料本身的试验记录,与成品中所含浓度下的刺激性不同。
查看全部 6 项试验
- Classification not possible
Skin Sensitization · Screening - Category 3
Skin Irritation · Screening - Serious eye damage/eye irritation - Category 2A
Eye Irritation · Screening - Category 6.4A (Category 2A)
Eye Irritation · Read Across - Category 2A
Eye Irritation · Screening - Eye irritation - category 2A
Eye Irritation · Screening
来源: 美国EPA CompTox