定義
米国FDA 物質登録 · UNII 1X545W620G · 登録名 AMMONIUM HEXAFLUOROSILICATE · 単一の化学物質
化粧品での役割
安全性・規制情報
- 制限
- イギリス
出典: ASEAN 化粧品指令 · EU 化粧品規則 · 韓国食薬処 化粧品規制情報 · 台湾FDA 化粧品成分 · 台湾FDA 化粧品規制 · 英国 化粧品規則
アルゼンチン · ブラジル
- 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 ammonium 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 ammonium fluorsilicate. - Keep out of children reach. - Do not use in children under 6 years old
ASEAN
- 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 ammonium 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。
欧州連合
- 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 ammonium 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."
出典: 韓国食薬処 化粧品規制情報
韓国の有害物質GHS分類: 危険 · H301 (区分3) · H331 (区分3) · H311 (区分3)
EU化粧品規則 附属書III(制限物質) 第42項 · 最大濃度 0.15% calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0.15% · 適用 Oral products
出典: EU 制限成分(附属書III)
Restriction III/42 · Other restriction: ban substances that deplete the ozone layer
出典: EU CosIng 成分リスト
詳しい資料 — 表示名・識別番号・物性・試験記録・文献
別名・識別情報
- CAS No.化学物質登録番号
- 16919-19-0
- EC No.EU化学物質目録番号
- 240-968-3
- DTXSID米国EPA化学物質番号
- DTXSID6047076
- DTXCID米国EPA化合物番号
- DTXCID601860091
- IUPAC
- Bisammonium hexafluoridosilicate(2-)
- 分子式
- F6H8N2Si
- 分子量
- 178.15 g/mol
測定された物性
- 性状
- Ammonium fluorosilicate appears as a white crystalline solid. Noncombustible. Corrodes aluminum. Used as a disinfectant, in etching glass, metal casting, and electroplating. · White solid, [Hawley] Colorless crystals, soluble in water, [MSDSonline]
- 臭い
- ODORLESS
- 融点
- TWO MODIFICATIONS @ ROOM TEMP: STABLE, CUBIC PHASE, METASTABLE, TRIGONAL PHASE · 230 °C
- 溶解性
- SLIGHTLY SOL IN ALCOHOL, INSOL IN ACETONE · 18.16 G/100 CC WATER @ 17 °C
- 密度
- 2 at 68 °F (USCG, 1999) - Denser than water, will sink · 2.011 g/cu cm
物質そのものを測定した値で、原料商品の規格ではありません。
出典: PubChem
製品が実際に使っている用途
米国EPAにこの成分を届け出た製品5件の用途です。化粧品以外の製品も含まれるため、上の数行がこの成分の主な使い道といえます。
- Soil amendments2
- Stabilizing agent1
- Etching agent1
- Pharmaceutical (EPA)1
出典: 米国EPA CompTox
刺激・感作試験の記録
皮膚試験3件・眼試験4件の記録があります。
試験の結論はおおむね一致しています(100%)。 原料そのものを試験した記録で、完成品に含まれる濃度での刺激性とは異なります。
試験7件をすべて見る
- Classification not possible
Skin Sensitization · Screening - Category 2
Skin Irritation · Screening - Category 6.3A (Category 2)
Skin Irritation · Read Across - Eye irritation - category 2A
Eye Irritation · Screening - Category 6.4A (Category 2A)
Eye Irritation · Read Across - Category 2A
Eye Irritation · Screening - Serious eye damage/eye irritation - Category 2
Eye Irritation · Screening
出典: 米国EPA CompTox