Standard No.:	GB/T 41413-2022
English Name:	Determination of migration of N-nitrosamines and N-nitrosatable substances in toys—High performance liquid chromatography-tandem mass spectrometry
Chinese Name:	玩具中N-亚硝胺及其前体物迁移量的测定 高效液相色谱-串联质谱法
Professional Classification:	GB    National Standard
Source Content Issued by:	SAMR; SAC
Issued on:	2022-4-15
Implemented on:	2022-4-15
Status:	valid
Target Language:	English
File Format:	PDF
Word Count:	10500 words
Translation Price(USD):	315.0
Delivery:	via email in 1 business day

GB/T 41413-2022 Determination of migration of N-nitrosamines and N-nitrosatable substances in toys - High performance liquid chromatography-tandem mass spectrometry WARNING - Persons using this document shall be familiar with normal laboratory practice. This document does not purport to address all of the safety problems, if any, associated with its use. It is the responsibility of the user to establish appropriate safety and health practices and to ensure compliance with any national regulatory conditions. 1 Scope This document describes the high performance liquid chromatography-tandem mass spectrometry for the determination of migration amount of N-nitrosamines and N-nitrosatable substances in toys and toy materials. ——Elastomer toys and elastomer components of toys. ——Finger paints. Example: Elastomer toys such as balloons and teethers. Note: For elastomer materials, N-nitrosamines and N-nitrosatable substances have currently been detected mainly in vulcanized materials. This document is applicable to the determination of migration amount of 13 types of N-nitrosamines and N-nitrosatable substances in the toys and toy elastomer materials listed above. The detection of other N-nitrosamines and N-nitrosatable substances may refer to this document after validation. 2 Normative references The following documents contain provisions which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. GB/T 6682 Water for analytical laboratory use - Specification and test methods 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 finger paint clay‑like or gel‑like coloring material that children apply directly to the surface of an object with their fingers or hands [Source: GB 6675.14-2014, 3.1] 3.2 elastomer flexible cross-linked macromolecular material that undergoes significant deformation under force at room temperature and can quickly return to a state and dimension close to its original one after release of the force Note: Not all elastomers contain N‑nitrosamines and N-nitrosatable substances. Possible sources of N‑nitrosamines and N-nitrosatable substances in elastomers and other relevant information are given in Annex A. [Source: EN ISO 472: 2013, 2.327, modified] 3.3 N-nitrosamine substance containing the characteristic functional group–N–N=O, generally formed by the reaction of amines with nitrosating agents under acidic conditions Note 1: The amines involved are mainly secondary amines. Note 2: Nitrite, for example, is a nitrifying agent. 3.4 N-nitrosatable substance substance that, under specific conditions, may migrate into a test solution and be converted into an N‑nitrosamine through nitrosation 4 Principle Migrate the N-nitrosamines and N-nitrosatable substances in the sample into the test solution which is used as the migration matrix, convert the N-nitrosatable substances into N‑nitrosamines through nitrosation, and determine the migration amount of N‑nitrosamines in the final test solution using high performance liquid chromatography‑tandem mass spectrometry. The test solution for N‑nitrosamines in finger paints is water. The test solution for N-nitrosatable substances in finger paints, as well as for N-nitrosamines and N-nitrosatable substances in elastomers, is simulated saliva. 5 Reagents and materials 5.1 Reagents Unless otherwise specified, all reagents used shall be analytically-pure reagents and water used shall be Class-I water recommended in GB/T 6682. 5.1.1 Sodium bicarbonate (NaHCO3) (CAS No. 144-55-8). 5.1.2 Sodium chloride (NaCl) (CAS No. 7647-14-5). 5.1.3 Potassium carbonate (K2CO3) (CAS No. 584-08-7). 5.1.4 Sodium nitrite (NaNO2) (CAS No. 7632-00-0). 5.1.5 Concentrated hydrochloric acid (CAS No. 7647-01-0): with a mass fraction of 36.0% to 38.0%. 5.1.6 Sodium hydroxide (CAS No. 1310-73-2). 5.1.7 Hydrochloric acid solution with a concentration of 1mol/L: Transfer about 85mL of concentrated hydrochloric acid (5.1.5) into a 1L volumetric flask, and dilute to the scale with water. The solution is valid for 6 months. 5.1.8 Sodium hydroxide solution with a concentration of 1mol/L: Weigh 40g of sodium hydroxide (5.1.6) into a 1L volumetric flask, and dilute to the scale with water. The solution is valid for 6 months. 5.1.9 Hydrochloric acid solution with a concentration of 0.1mol/L: Transfer 10mL of hydrochloric acid solution (5.1.7) into a 100mL volumetric flask, and dilute to the scale with water. The solution is valid for 6 months. 5.1.10 Sodium hydroxide solution with a concentration of 0.1mol/L: Transfer 10mL of sodium hydroxide solution (5.1.8) into a 100mL volumetric flask, and dilute to the scale with water. The solution is valid for 6 months.

Contents Foreword i 1 Scope 2 Normative references 3 Terms and definitions 4 Principle 5 Reagents and materials 6 Apparatus 7 Sample preparation 8 Determination 9 Calculation of results 10 Limit of quantification 11 Precision 12 Test report Annex A (Informative) Background and basic principle of this document Annex B (Normative) 13 types of N-nitrosamines detected in this document Annex C (Informative) Total ion chromatogram of 13 types of N-nitrosamines Annex D (Informative) Precision test results Bibliography