Safety of toys — Part 3: Migration of certain elements

ISO 8124-3:2010 specifies maximum acceptable levels and methods of sampling and extraction prior to analysis for the migration of the elements antimony, arsenic, barium, cadmium, chromium, lead, mercury and selenium from toy materials and from parts of toys. Maximum acceptable levels are specified for the migration of the elements listed above from the following toy materials: coatings of paints, varnishes, lacquers, printing inks, polymers and similar coatings; polymeric and similar materials, including laminates, whether textile-reinforced or not, but excluding other textiles and non-woven textiles; paper and paperboard, up to a maximum mass per unit area of 400 g/m2; natural, artificial or synthetic textiles; glass/ceramic/metallic materials, excepting lead solder when used for electrical connections; other materials, whether mass-coloured or not (e.g. wood, fibreboard, hardboard, bone and leather); materials intended to leave a trace (e.g. the graphite materials in pencils and liquid ink in pens); pliable modelling materials, including modelling clays and gels; paints to be used as such in the toy, including finger paints, varnishes, lacquers, glazing powders and similar materials in solid or liquid form. The requirements in ISO 8124-3:2010 apply to the following toys and toy components of toys and toy materials: all intended food and oral contact toys, cosmetic toys and writing instruments categorized as toys, irrespective of any age grading or recommended age labelling; all toys intended for or suitable for children up to 72 months of age; accessible coatings, irrespective of any age grading or recommended age labelling; accessible liquids, pastes, gels (e.g. liquid paints, modelling compounds) irrespective of any age grading or recommended age labelling.

Sécurité des jouets — Partie 3: Migration de certains éléments

General Information

Status
Withdrawn
Publication Date
17-Mar-2010
Withdrawal Date
17-Mar-2010
Technical Committee
Drafting Committee
Current Stage
9599 - Withdrawal of International Standard
Start Date
16-Mar-2020
Completion Date
16-Mar-2020
Ref Project

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INTERNATIONAL ISO
STANDARD 8124-3
Second edition
2010-04-01
Safety of toys —
Part 3:
Migration of certain elements
Sécurité des jouets —
Partie 3: Migration de certains éléments
Reference number
ISO 8124-3:2010(E)
ISO 2010
---------------------- Page: 1 ----------------------
ISO 8124-3:2010(E)
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ii © ISO 2010 – All rights reserved
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ISO 8124-3:2010(E)
Contents Page

Foreword ............................................................................................................................................................iv

Introduction.........................................................................................................................................................v

1 Scope......................................................................................................................................................1

2 Normative references............................................................................................................................2

3 Terms and definitions ...........................................................................................................................2

4 Maximum acceptable levels .................................................................................................................3

4.1 Specific requirements...........................................................................................................................3

4.2 Interpretation of results ........................................................................................................................3

5 Principle..................................................................................................................................................4

6 Reagents and apparatus.......................................................................................................................4

6.1 Reagents.................................................................................................................................................4

6.2 Apparatus...............................................................................................................................................4

7 Selection of test portions .....................................................................................................................5

8 Preparation and extraction of test portions........................................................................................5

8.1 Coatings of paint, varnish, lacquer, printing ink, polymer and similar coatings............................5

8.2 Polymeric and similar materials, including laminates, whether textile-reinforced or not,

but excluding other textiles..................................................................................................................6

8.3 Paper and paperboard ..........................................................................................................................6

8.4 Natural, artificial or synthetic textiles .................................................................................................7

8.5 Glass/ceramic/metallic materials.........................................................................................................7

8.6 Other materials, whether mass-coloured or not, e.g. wood, fibreboard, bone and leather...........8

8.7 Materials intended to leave a trace......................................................................................................8

8.8 Pliable modelling materials, including modelling clays and gels ..................................................10

8.9 Paints, including finger paints, varnishes, lacquers, glazing powders and similar

materials in solid or liquid form.........................................................................................................11

9 Detection limits of quantitative elemental analysis .........................................................................12

10 Test report............................................................................................................................................12

Annex A (normative) Sieve requirements ......................................................................................................13

Annex B (informative) Selection of procedure...............................................................................................14

Annex C (informative) Background and rationale .........................................................................................15

Bibliography......................................................................................................................................................21

© ISO 2010 – All rights reserved iii
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ISO 8124-3:2010(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies

(ISO member bodies). The work of preparing International Standards is normally carried out through ISO

technical committees. Each member body interested in a subject for which a technical committee has been

established has the right to be represented on that committee. International organizations, governmental and

non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the

International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

The main task of technical committees is to prepare International Standards. Draft International Standards

adopted by the technical committees are circulated to the member bodies for voting. Publication as an

International Standard requires approval by at least 75 % of the member bodies casting a vote.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent

rights. ISO shall not be held responsible for identifying any or all such patent rights.

ISO 8124-3 was prepared by Technical Committee ISO/TC 181, Safety of toys.

This second edition cancels and replaces the first edition (ISO 8124-3:1997) which has been technically

revised.

ISO 8124 consists of the following parts, under the general title Safety of toys.

⎯ Part 1: Safety aspects related to mechanical and physical properties
⎯ Part 2: Flammability
⎯ Part 3: Migration of certain elements

⎯ Part 4: Swings, slides and similar activity toys for indoor and outdoor family domestic use

iv © ISO 2010 – All rights reserved
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ISO 8124-3:2010(E)
Introduction

The requirements of this part of ISO 8124 are based on the bioavailability of certain elements resulting from

the use of toys and should not, as an objective, exceed the following levels per day:

⎯ 0,2 µg for antimony;
⎯ 0,1 µg for arsenic;
⎯ 25,0 µg for barium;
⎯ 0,6 µg for cadmium;
⎯ 0,3 µg for chromium;
⎯ 0,7 µg for lead;
⎯ 0,5 µg for mercury;
⎯ 5,0 µg for selenium.

For the interpretation of these values, it has been necessary to identify an upper limit for the ingestion of toy

material. Very limited data have been available for identifying this upper limit. As a working hypothesis, a

summed average daily intake of the various toy materials has been gauged at the currently accepted value of

8 mg/d, being aware that in certain individual cases these values might be exceeded.

By combining the daily intake with the bioavailability values listed above, limits are obtained for various toxic

elements in micrograms per gram of toy material (milligrams per kilogram) and are detailed in Table 1. The

values obtained have been adjusted to minimize children's exposure to toxic elements in toys and to ensure

analytical feasibility, taking into account limits achievable under current manufacturing conditions

(see Annex C).
© ISO 2010 – All rights reserved v
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INTERNATIONAL STANDARD ISO 8124-3:2010(E)
Safety of toys —
Part 3:
Migration of certain elements
1 Scope

1.1 This part of ISO 8124 specifies maximum acceptable levels and methods of sampling and extraction

prior to analysis for the migration of the elements antimony, arsenic, barium, cadmium, chromium, lead,

mercury and selenium from toy materials and from parts of toys.

1.2 Maximum acceptable levels are specified for the migration of the elements listed in 1.1 from the

following toy materials:

⎯ coatings of paints, varnishes, lacquers, printing inks, polymers and similar coatings (see 8.1);

⎯ polymeric and similar materials, including laminates, whether textile-reinforced or not, but excluding other

textiles and non-woven textiles (see 8.2);
⎯ paper and paperboard, up to a maximum mass per unit area of 400 g/m (see 8.3);
⎯ natural, artificial or synthetic textiles (see 8.4);

⎯ glass/ceramic/metallic materials, excepting lead solder when used for electrical connections (see 8.5);

⎯ other materials, whether mass-coloured or not (e.g. wood, fibreboard, hardboard, bone and leather)

(see 8.6);

⎯ materials intended to leave a trace (e.g. the graphite materials in pencils and liquid ink in pens) (see 8.7);

⎯ pliable modelling materials, including modelling clays and gels (see 8.8);

⎯ paints to be used as such in the toy, including finger paints, varnishes, lacquers, glazing powders and

similar materials in solid or liquid form (see 8.9).

1.3 The requirements in this part of ISO 8124 apply to the following toys and toy components of toys and

toy materials (see C.2.1):

⎯ all intended food and oral contact toys, cosmetic toys and writing instruments categorized as toys,

irrespective of any age grading or recommended age labelling;
⎯ all toys intended for or suitable for children up to 72 months of age;

⎯ accessible coatings, irrespective of any age grading or recommended age labelling;

⎯ accessible liquids, pastes, gels (e.g. liquid paints, modelling compounds), irrespective of any age grading

or recommended age labelling.
© ISO 2010 – All rights reserved 1
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ISO 8124-3:2010(E)

1.4 Packaging materials are not included, unless they are intended to be kept, e.g. boxes, containers, or

unless they form part of the toy or have intended play value (see C.2.2).

NOTE No requirements are given for toys and parts of toys which, due to their accessibility, function, mass, size or

other characteristics, are obviously unlikely to be sucked, licked or swallowed, bearing in mind the normal and foreseeable

behaviour of children (e.g. the coating on the crossbeam of a swing set, the tyres of a toy bicycle).

2 Normative references

The following referenced documents are indispensable for the application 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.

ISO 8124-1, Safety of toys — Part 1: Safety aspects related to mechanical and physical properties

ISO 3696, 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
base material
material upon which coatings may be formed or deposited
3.2
coating

all layers of material formed or deposited on the base material of a toy, including paints, varnishes, lacquers,

inks, polymers or other substances of a similar nature, whether they contain metallic particles or not, no matter

how they have been applied to the toy, and which can be removed by scraping with a sharp blade

3.3
detection limit of a method

three times the standard deviation of the result obtained in the blank test using that method by the laboratory

carrying out the analysis
3.4
mass-coloured materials

materials, such as wood, fibreboard, hardboard, leather, bone and other porous substances, which have

absorbed colouring matter without formation of a coating
3.5
paper and paperboard
that having a maximum mass per unit area of 400 g/m

NOTE Above this mass per unit area, the substance is treated as “other material”, and may be fibreboard or

hardboard, etc.
3.6
scraping
mechanical process for removal of coatings down to the base material
3.7
toy material
all accessible materials present in a toy
2 © ISO 2010 – All rights reserved
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ISO 8124-3:2010(E)
4 Maximum acceptable levels
4.1 Specific requirements
See C.3.

Toys and parts of toys, as specified in Clause 1, are deemed to meet the requirements of this part of

ISO 8124 when the adjusted value of migration of elements from them comply with the maximum limits given

in Table 1 when tested in accordance with Clauses 7, 8 and 9.
4.2 Interpretation of results
See C.4.

Due to the precision of the methods specified in this part of ISO 8124, an adjusted analytical result is required

to take into consideration the results of interlaboratory trials. The analytical results obtained in accordance

with Clauses 7, 8 and 9 shall be adjusted by subtracting the analytical correction in Table 2 to obtain an

adjusted analytical result.

Materials are deemed to comply with the requirements of this part of ISO 8124 if the adjusted analytical result

for the migrated element is less than or equal to the value given in Table 1.
Table 1 — Maximum acceptable element migration from toy materials
Values in milligrams per kilogram of toy material
Element
Toy material
Sb As Ba Cd Cr Pb Hg Se
Any toy material given in Clause 1, except modelling
60 25 1 000 75 60 90 60 500
clay and finger paint
Modelling clay and finger paint 60 25 250 50 25 90 25 500
Table 2 — Analytical correction
Element Sb As Ba Cd Cr Pb Hg Se
Analytical correction (%) 60 60 30 30 30 30 50 60
EXAMPLE

An analytical result for lead of 120 mg/kg was obtained. The necessary analytical correction taken from Table 2 is 30 %.

Therefore, the adjusted analytical result is
120 × 30
120−= 120− 36
100
= 84 mg/kg.

This is deemed as complying with the requirements of this part of ISO 8124 (maximum acceptable migration of lead as

given in Table 1 is 90 mg/kg).
© ISO 2010 – All rights reserved 3
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ISO 8124-3:2010(E)
5 Principle

Soluble elements are extracted from toy materials under conditions that simulate the material remaining in

contact with stomach acid for a period of time after swallowing. The concentrations of the soluble elements

are then determined quantitatively by specified analytical methods with specified detection limits.

6 Reagents and apparatus

NOTE No recommendation is made for the reagents, materials and apparatus necessary for carrying out elemental

analyses within the detection limits specified in Clause 9.
6.1 Reagents
During the analyses, use only reagents of recognised analytical grade.
6.1.1 Hydrochloric acid solution, c(HCl) = (0,07 ± 0,005) mol/l.
6.1.2 Hydrochloric acid solution, c(HCl) = (0,14 ± 0,010) mol/l.
6.1.3 Hydrochloric acid solution, c(HCl) = approximately 1 mol/l.
6.1.4 Hydrochloric acid solution, c(HCl) = approximately 2 mol/l.
6.1.5 Hydrochloric acid solution, c(HCl) = approximately 6 mol/l.
6.1.6 General purpose reagent n-heptane, (C H ); 99 %.
7 16
6.1.7 Water of at least grade 3 purity, in accordance with ISO 3696.
6.2 Apparatus
See C.5.
Normal laboratory apparatus and

6.2.1 Plain-weave wire-cloth stainless steel metal sieve, of nominal aperture 0,5 mm and tolerances as

indicated in Table A.1.

6.2.2 Means of measuring pH to an accuracy of ± 0,2 pH units. Cross-contamination shall be prevented.

See C.5.2.
6.2.3 Membrane filter, of pore size 0,45 µm.
6.2.4 Centrifuge, capable of centrifuging at (5 000 ± 500) g .
See C.5.3.
6.2.5 Means of agitating the mixture, at a temperature of (37 ± 2) °C.

6.2.6 Series of containers, of gross volume between 1,6 × and 5,0 × that of the volume of hydrochloric

acid extractant.
See C.5.4.
1) g = 9,806 65 m/s .
4 © ISO 2010 – All rights reserved
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ISO 8124-3:2010(E)
7 Selection of test portions
See C.6.

A laboratory sample for testing shall consist of a toy either in the form in which it is marketed, or in the form in

which it is intended to be marketed. Test portions shall be taken from the accessible parts (see ISO 8124-1) of

a single toy sample. Identical materials in the toy may be combined and treated as a single test portion, but

additional toy samples shall not be used. Test portions may be composed of more than one material or colour

only if physical separation, e.g. dot printing, patterned textiles or mass limitation reasons, precludes the

formation of discrete specimens.

NOTE The requirement does not preclude the taking of reference portions from toy materials in a different form,

provided that they are representative of the relevant material specified above and the substrate upon which they are

deposited.
Test portions of less than 10 mg of material shall not be tested.
8 Preparation and extraction of test portions

8.1 Coatings of paint, varnish, lacquer, printing ink, polymer and similar coatings

8.1.1 Test portion preparation

Remove the coating from the laboratory sample by scraping (see 3.6) at room temperature and comminute it

at a temperature not exceeding ambient. Collect enough coating to obtain a test portion of preferably not less

than 100 mg which will pass through a metal sieve of aperture 0,5 mm (6.2.1).

If only between 10 mg and 100 mg of comminuted uniform coating is available, extract this in accordance with

8.1.2 and calculate the quantity of the appropriate elements as if a test portion of 100 mg had been used.

Report the mass of the test portion in accordance with 10 e).

In the case of coatings that by their nature cannot be comminuted (e.g. elastic/plastic paint), remove a test

portion of coating from the laboratory sample without comminuting.
8.1.2 Extraction procedure

Using a container of appropriate size (6.2.6), mix the test portion prepared in 8.1.1 with 50 × its mass of an

aqueous HCl solution at (37 ± 2) °C of c(HCl) 0,07 mol/l (6.1.1). [Where the test portion has only a mass of

between 10 mg and 100 mg, mix the test portion with 5,0 ml of this solution (6.1.1) at (37 ± 2) °C.]

Shake for 1 min. Check the acidity of the mixture (6.2.2). If the pH is greater than 1,5, add dropwise, while

shaking the mixture, an aqueous solution of c(HCl) approximately 2 mol/l (6.1.4) until the pH of the mixture is

between 1,0 and 1,5.

Protect the mixture from light. Agitate the mixture continuously at (37 ± 2) °C (6.2.5) for 1 h and then allow to

stand for 1 h at (37 ± 2) °C.

Without delay, efficiently separate the solids from the solution, firstly by filtration using a membrane filter

(6.2.3) and, if necessary, by centrifuging at up to 5 000 g (6.2.4). Carry out the separation as rapidly as

possible after completion of the standing time. If centrifuging is used, it shall take no longer than 10 min and

shall be reported in accordance with 10 e).

If the resulting solutions are to be stored for more than one working day prior to elemental analysis, stabilize

them by adding hydrochloric acid so that the concentration of the stored solution is approximately

c(HCl) = 1 mol/l (6.1.3). Report such stabilization in accordance with 10 e).
© ISO 2010 – All rights reserved 5
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ISO 8124-3:2010(E)

8.2 Polymeric and similar materials, including laminates, whether textile-reinforced or not,

but excluding other textiles
8.2.1 Test portion preparation

Obtain a test portion of preferably not less than 100 mg of the polymeric or similar materials, while avoiding

heating of the materials, according to the following procedure.

Cut out test portions from those areas having the thinnest material cross-section in order to ensure a surface

area of the test pieces as large as possible in proportion to their mass. Each piece shall, in the uncompressed

condition, have no dimension greater than 6 mm.

If the laboratory sample is not of a uniform material, obtain a test portion from each different material present

in a mass of 10 mg or more. Where there is only between 10 mg and 100 mg of uniform material, report the

mass of the test portion in accordance with 10 e) and calculate the quantity of the appropriate elements as if a

test portion of 100 mg had been used.
8.2.2 Extraction procedure

Follow the extraction procedure in 8.1.2 using the test portions prepared in accordance with 8.2.1.

8.3 Paper and paperboard
8.3.1 Test portion preparation
See C.7.

Obtain a test portion of preferably not less than 100 mg of the paper or paperboard.

If the laboratory sample is not of a uniform material, where possible, obtain a test portion from each different

material present in a mass of not less than 100 mg. Where there is only between 10 mg and 100 mg of

uniform material, report the mass of the test portion in accordance with 10 e) and calculate the quantity of the

appropriate elements as if a test portion of 100 mg had been used.

If the paper or paperboard to be tested is coated with paint, varnish, lacquer, printing ink, adhesive or similar

coating, test portions of the coating shall not be taken separately. In such cases, take test portions from the

material so that they also include representative parts of the coated area and report this in accordance

with 10 e). Extract test portions obtained in accordance with 8.3.2.
8.3.2 Extraction procedure

Macerate the test portion prepared in 8.3.1 with 25 × its mass of water (6.1.7) at (37 ± 2) °C so that the

resulting mixture is homogeneous. Quantitatively transfer the mixture to the appropriate-sized container

(6.2.6). Add to the mixture a mass of aqueous solution of c(HCl) = 0,14 mol/l (6.1.2) at (37 ± 2) °C which has

25 × the mass of the test portion.

Shake for 1 min. Check the acidity of the mixture (6.2.2). If the pH is greater than 1,5, add dropwise, while

shaking the mixture, an aqueous solution of c(HCl) approximately 2 mol/l (6.1.4) until the pH of the mixture is

between 1,0 and 1,5.

Protect the mixture from light. Agitate the mixture continuously at (37 ± 2) °C (6.2.5) for 1 h and then allow to

stand for 1 h at (37 ± 2) °C.

Without delay, efficiently separate the solids from the solution, firstly by filtration using a membrane filter

(6.2.3) and, if necessary, by centrifuging at up to 5 000 g (6.2.4). Carry out the separation as rapidly as

possible after completion of the standing time. If centrifuging is used, it shall take no longer than 10 min and

shall be reported in accordance with 10 e).
6 © ISO 2010 – All rights reserved
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ISO 8124-3:2010(E)

If the resulting solutions are to be stored for more than one working day prior to elemental analysis, stabilize

them by adding hydrochloric acid so that the concentration of the stored solution is approximately

c(HCl) = 1 mol/l. Report such stabilization in accordance with 10 e).
8.4 Natural, artificial or synthetic textiles
8.4.1 Test portion preparation
See C.8.

Obtain a test portion of preferably not less than 100 mg by cutting the textile material into pieces that in the

uncompressed condition have no dimension greater than 6 mm.

If the sample is not of a uniform material or colour, where possible, obtain a test portion from each different

material or colour present in a mass greater than 100 mg. Materials or colours present in amounts between

10 mg and 100 mg shall form part of the test portion obtained from the main material.

Samples taken from patterned textiles shall be representative of the whole material.

8.4.2 Extraction procedure

Follow the extraction procedure in 8.1.2 using the test portions prepared in accordance with 8.4.1.

8.5 Glass/ceramic/metallic materials
8.5.1 Test portion preparation
See C.9.

Toys and toy components shall first be subjected to the small parts test in accordance with ISO 8124-1. If the

toy or component fits entirely within the small parts cylinder and contains accessible glass, ceramic or metallic

materials (excepting lead solder when used for electrical connections), then the toy or component shall be

extracted in accordance with 8.5.2 after removal of any coating in accordance with 8.1.1.

NOTE Toys and toy components that have no accessible glass, ceramic or metallic materials do not require

extraction in accordance with 8.5.2.
8.5.2 Extraction procedure

Place the weighed toy or toy component in a 50 ml glass cylinder with a nominal height of 60 mm and

diameter of 40 mm.

NOTE This type of container will take all components/toys that fit inside the small parts cylinder defined in

ISO 8124-1.

Add a sufficient measured volume of an aqueous solution of c(HCl) = 0,07 mol/l (6.1.1) at (37 ± 2) °C to just

cover the toy or component. Cover the container, protect the contents from light and allow the contents to

stand for 2 h at (37 ± 2) °C.

Without delay, efficiently separate the solids from the solution, firstly by decantation followed by filtration using

a membrane filter (6.2.3) and, if necessary, by centrifuging at up to 5 000 g (6.2.4). Carry out the separation

as rapidly as possible after completion of the standing time. If centrifuging is used, it shall take no longer than

10 min and shall be reported in accordance with 10 e).

If the resulting solutions are to be stored for more than one working day prior to elemental analysis, stabilize

them by adding hydrochloric acid so that the concentration of the stored solution is approximately

c(HCl) = 1 mol/l (6.1.3). Report such stabilization in accordance with 10 e).
© ISO 2010 – All rights reserved 7
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ISO 8124-3:2010(E)

8.6 Other materials, whether mass-coloured or not, e.g. wood, fibreboard, bone and leather

See C.10.
8.6.1 Test portion preparation

Obtain a test portion of preferably not less than 100 mg of the material in accordance with 8.2.1, 8.3.1, 8.4.1

or 8.5.1, as appropriate.

If the laboratory sample is not of uniform material, a test portion shall be obtained from each different material

present in a mass of 10 mg or more. Where there is only between 10 mg and 100 mg of uniform material,

report the mass of the test portion in accordance with 10 e) and calculate the quantity of the appropriate

elements as if a test portion of 100 mg had been used.

If the material to be tested is coated with paint, varnish, lacquer, printing ink or a similar coating, follow the

procedure in 8.1.1.
8.6.2 Extraction procedures

Extract the materials in accordance with 8.1.2, 8.3.2 or 8.5.2, as appropriate. Report the method used in

accordance with 10 e).
8.7 Materials intended to leave a trace
8.7.1 Test portion preparation for materials in solid form

Obtain a test portion of preferably not less than 100 mg by cutting the material into pieces which in the

uncompressed condition have no dimension greater than 6 mm.

A test portion shall be obtained from each different material intended to leave a trace present in the laboratory

sample in a mass of 10 mg or more. Where there is only between 10 mg and 100 mg of material, report the

mass of the test portion in accordance with 10 e) and calculate the quantity of the appropriate elements as if a

test portion of 100 mg had been used.

If the material contains any grease, oil, wax or similar material, enclose the test portion in hardened filter

paper and remove these ingredients with n-heptane (6.1.6) by extraction before treatment of the test portion

as described in 8.7.4. Take analytical measures to ensure that the removal of the ingredients referred to is

quantitative. Report the solvent used in accordance with 10 e).
8.7.2 Test portion preparation for materials in liquid form

Obtain a test portion of preferably not less than 100 mg of the material from the laboratory sample. The use of

an appropriate solvent to faci
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