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GB/T 37647-2019: Toy and children product - General principles for migration test of certain elements
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GBT37647-2019
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 97.200.50
Y 57
Toy and children product - General principles for
migration test of certain elements
ISSUED ON: JUNE 04, 2019
IMPLEMENTED ON: JANUARY 01, 2020
Issued by: State Administration for Market Regulation;
Standardization Administration of the People’s Republic of
China.
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 4
4 Overview ... 7
5 Reagents and materials ... 7
6 Instruments ... 8
7 General principles for sweat migration test model ... 9
8 General principles for saliva migration test model ... 13
9 General principles for gastric juice migration test model ... 16
10 Test report ... 19
Appendix A (Informative) Selection guidance for migration test models ... 20
Appendix B (Informative) Selection guidance for test method (gravimetric
method and area method) ... 25
Appendix C (Informative) Technical information of migration test model ... 28
References ... 30
Toy and children product - General principles for
migration test of certain elements
1 Scope
This Standard specifies the sampling method, sample preparation and sample
extraction method for the migration test of certain elements in toy and children
product in the simulated human environment.
This Standard applies to the pretreatment of migration test of certain elements,
such as aluminum, antimony, arsenic, barium, boron, cadmium, chromium,
cobalt, copper, lead, manganese, mercury, nickel, selenium, strontium, tin, zinc,
in toy and children product in the simulated human environment (including
sweat, saliva, and gastric juice environments). Migration tests of other certain
elements can be performed with reference to this Standard after verification.
This Standard does not apply to the toy or children product which is clearly
excluded from the possibility of being sucked, licked, chewed, swallowed or
exposed to the skin for a long term, due to its accessibility, function, mass, size
or other characteristics, in consideration of children's normal use and
foreseeable behavior.
2 Normative references
The following documents are indispensable for the application of this document.
For dated references, only the dated version applies to this document. For
undated references, the latest edition (including all amendments) applies to this
document.
GB 6675.1-2014, Toys safety - Part 1: Basic code
GB 6675.2, Safety of toys - Part 2: Mechanical and physical properties
GB 6675.4-2014, Safety of toys - Part 4: Migration of certain elements
GB/T 6682, Water for analytical laboratory use - Specification and test
methods
3 Terms and definitions
Terms and definitions determined by GB 6675.1-2014, GB 6675.4-2014 and the
following ones are applicable to this document. For ease of use, some of the
3.8 Reasonably foreseeable abuse
The possible way of use, which uses toy and children product in ways that are
not recommended by the supplier, but may occur under normal circumstances,
including the normal free behavior of children by combining toys and children
products.
Examples: dismantle, drop, or use toy and children product in non-
recommended ways.
Note: Rewrite GB 6675.1-2014, definition 3.17.
3.9 Sample area
The area of the test sample, which is immersed in the test solution, that is in
contact with the solution and is not covered.
3.10 Base material
The material, on which coating can form or adhere to the surface.
[GB 6675.4-2014, definition 3.1]
3.11 Coating
All material layers that are formed or attached to the base material of the toy
and children product.
Examples: paint, varnish, lacquer, ink, polymer, metal particle or other similar
substances that are attached to the base material.
Note: Rewrite GB 6675.4-2014, definition 3.2.
3.12 Paper and paperboard
Paper and paperboard whose maximum mass per unit area is not more than
400 g/m2.
Note: paper and paperboard whose mass per unit area exceeds 400 g/m2 shall
be treated as "other materials", and may also be fiberboard or cardboard.
[GB 6675.4-2014, definition 3.5]
3.13 Scraping
The mechanical process of separating the coating from the base material,
which shall not scrap the base material.
[GB 6675.4-2014, definition 3.6]
5.5 Ammonia water: the mass fraction is 25%, ρ = 0.91 g/mL.
5.6 Dilute ammonia water: the mass fraction is 1%.
5.7 Sodium hydroxide (NaOH): c (NaOH) ≈ 0.1 mol/L.
5.8 Magnesium chloride hexahydrate (MgCl2·6H2O).
5.9 Calcium chloride dihydrate (CaCl2·2H2O).
5.10 Dipotassium hydrogen phosphate trihydrate (K2HPO4·3H2O).
5.11 Potassium carbonate (K2CO3).
5.12 Potassium chloride (KCl).
5.13 Hydrochloric acid: the mass fraction is 37%.
5.14 N-heptane: chemically pure; the mass fraction is not less than 99%.
5.15 Hydrochloric acid solution: c (HCl) = (0.07 ± 0.005) mol/L.
5.16 Hydrochloric acid solution: c (HCl) = (0.14 ± 0.010) mol/L.
5.17 Hydrochloric acid solution: c (HCl) ≈ 2 mol/L.
5.18 Hydrochloric acid solution: c (HCl) ≈ 6 mol/L.
5.19 Hydrochloric acid solution: the mass fraction is 1%.
5.20 Unless otherwise specified, use only analytical reagents or reagents above
the grade.
6 Instruments
6.1 Test sieve: plain stainless-steel wire mesh sieve; the rated aperture is 0.5
mm.
6.2 pH meter: the accuracy is not less than ± 0.1pH unit; it shall be prevented
from cross-contamination.
6.3 Membrane filter: the pore size is 0.22 μm and 0.45 μm.
6.4 Centrifuge: the centrifugal capacity is (5 000 ± 500) g (g = 9.806 65 m/s2).
6.5 Constant-temperature oscillator: the temperature is constant at (37 ± 2) °C
during oscillation; the oscillation frequency accuracy is not less than ±5
times/min.
physical separation methods (those caused by reasons such as dot dyeing,
printing textiles or quality restrictions).
Note: It does not exclude the acquisition of any form of reference sample, as
long as the reference sample can represent the relevant toy and children
product material and the basic materials that are attached to them as
specified above.
If the material mass is 10 mg ~ 100 mg, it shall be processed and calculated as
100 mg of test sample. The sample whose mass is less than 10 mg can be
exempted from testing or tested by area method.
7.3.2 Sample preparation
7.3.2.1 Coating
At room temperature, adopt the method of scraping to obtain coating from the
sample of toy and children product; pulverize the sample under the condition
that does not exceed the ambient temperature. Obtain not less than 100 mg of
coating test sample as much as possible from the materials that pass through
a test sieve whose pore size is 0.5 mm (see 6.1).
For coatings that cannot be pulverized due to their own characteristics (such as
elastic/ plastic paint), transfer the test sample directly from the sample without
pulverizing the coating.
7.3.2.2 Other materials
Try to remove not less than 100 mg of test sample as much as possible; avoid
material heating when removing. The test sample shall be cut from the smallest
thickness of the material section, so as to ensure that the ratio of the test sample
area to the test sample mass is as large as possible. The dimensions of each
test sample in any direction shall not be greater than 6 mm in the uncompressed
state.
If the material is spot-dyed or printed textile, the removed test sample shall be
a representative sample of the overall material.
If there is a coating on the to-be-tested material, firstly remove the coating on
the material according to the sampling procedure of 7.3.2.1; then, perform
sampling on the base material.
If the material is liquid, no processing such as shredding is required; take
samples directly.
7.3.3 Sample extraction
7.4.2.1 Coating
The base material and coating shall not be separated when preparing the test
sample. When calculating the sample area, only calculate the area that is
covered by the coating. If the sample is covered by the coating only on one side,
only count the area of one side. The sample area of the taken test sample shall
be larger than 1 cm2 as far as possible.
When taking a sample, cut the test sample from the minimum thickness of the
base material section as far as possible, to ensure that the area of the base
material is as small as possible, so as to reduce the impact on the coating test.
For the sample which is covered with only one side of the coating, during the
sample extraction process, certain elements in the extraction solution not only
originate from the to-be-tested coating sample, but also from the base material,
and the test results may be stricter than actual conditions.
When testing the coating sample, in order to avoid being affected by the base
material, the non-tested surfaces can be wax-sealed.
7.4.2.2 Other materials
Remove a test sample of not less than 1 cm2 as far as possible; avoid heat or
pressure on the material when removing. For the base material that is covered
with a coating on the surface, use mechanical methods to remove the coating
before preparing the sample.
Paints, coatings, and plating shall not be considered as barriers that render
components that contain certain elements in toy and children product
inaccessible.
Considering that the incision will affect the test results, a complete sample shall
be selected when preparing the sample. When cutting is required, choose the
smallest thickness, as far as possible, for cutting. When the sample thickness
is less than or equal to 0.5 mm, take the area of one side of the sample as the
sample area; when the sample thickness is greater than 0.5 mm and less than
or equal to 2 mm, take the sum of the areas of the front and back of the sample
as the sample area; when the sample thickness is greater than 2 mm, take the
sum of the areas of the front and back of the sample and the area of its side as
the sample area.
For the sample that has inconsistent front and back materials, during the
simultaneous test, only calculate the area of the accessible part of the to-be-
tested material. In this case, the migrated certain elements may be from non-
tested materials; therefore, the test results may be stricter than the actual
conditions.
centrifuge (see 6.4) to separate. The centrifugation time shall not exceed 10
minutes, which shall be stated in the report.
9 General principles for gastric juice migration test
model
9.1 Overview
Use a certain volume of simulated gastric juice (see 9.2) to process the sample
under specific migration conditions. See Appendix C for technical information
on the preparation of the gastric juice migration test model.
9.2 Simulated gastric juice preparation
Take 900 mL of water (see 5.1) into a 1 000 mL conical flask; add 5.81 mL of
hydrochloric acid (see 5.13); stir well; transfer the solution to a 1 000 mL
volumetric flask; add water (see 5.1) to fix-volume to 1 000 mL. Use standard
anhydrous sodium carbonate or other standard-calibrated solutions to titrate, to
obtain accurate hydrochloric acid solution concentration. The concentration
shall be (0.07 ± 0.005) mol/L. This solution is a simulated gastric juice.
If the mass fraction of the used concentrated hydrochloric acid is not 37%, the
volume of added hydrochloric acid shall be recalculated.
9.3 Sampling
The test sample shall be taken from accessible parts of individual toy and
children product. The same material on a single product can be combined as
the same test sample; but the material of other samples shall not be used at
the same time. The test sample shall not contain more than one material or
more than one color, unless the sample cannot be effectively separated by
physical separation methods.
Example: physical separation methods which cannot be used for effective
separation due to dot dyeing, printing textiles, or quality restrictions.
Note: it does not exclude the acquisition of any form of reference sample, as
long as the reference sample can represent the relevant toy and children
product material and the basic materials that are attached to them as
specified above.
If the material mass is 10 mg ~ 100 mg, it shall be processed and calculated as
100 mg of test sample. The sample whose material mass is less than 10 mg
can be exempted from testing.
9.4 Sample preparation
a coating on the to-be-tested material, firstly remove the coating on the material;
then, perform sampling on the base material. The test sample shall be cut from
the smallest thickness of the material section, so as to ensure that the ratio of
the test sample area to the test sample mass is as large as possible.
9.5 Sample extraction
9.5.1 Glass, ceramic, metal materials
Put toy and children product or their components into a 50 mL glass container;
the nominal size of the container is: height of 60 mm, diameter of 40 mm. Add
simulated gastric juice (see 9.2) at room temperature, so that the solution can
just immerse the test sample. Cover the container; protect it from light; place it
at a temperature of (37 ± 2) °C for 2 h. Then, immediately separate the solids
in the mixture effectively by filtration. If necessary, use a membrane filter (see
6.3) or a centrifuge (see 6.4) to separate. The centrifugation time shall not
exceed 10 minutes, which shall be stated in the report.
9.5.2 Other materials
Use a suitable extraction container (see 6.6); mix the simulated gastric juice 50
times the mass of the test sample AND the test sample at room temperature.
Shake for 1 min and check the acidity of the mixture. If the pH value is greater
than 1.5, then, add dropwise hydrochloric acid solution (see 5.17) whose
concentration is about 2 mol/L, until the pH value of the mixture reaches the
range of 1.0 ~ 1.5. In a constant-temperature oscillator (see 6.5) at (37 ± 2) °C,
avoid light; continue to oscillate for 1 h; then, leave it at (37 ± 2) °C for 1 h. Then,
immediately separate the solids in the mixture effectively by filtration. If
necessary, use a membrane filter (see 6.3) or a centrifuge (see 6.4) to separate.
The centrifugation time shall not exceed 10 minutes, which shall be stated in
the report. Immediately perform elemental analysis test of the filtrate.
For materials which contain grease, oils, waxes or similar materials, a dewaxing
process shall be performed. Wrap the test sample in hard filter paper; before
the extraction process, use n-heptane (see 5.14) or other suitable solvent
extraction to remove the above components. Use appropriate analytical
methods to ensure that the removal of these components is quantitative. The
solvent that is used shall be stated in the report as required. After the wax is
removed, leave the test sample on the hard filter paper; perform extraction of
the hard filter paper and the test sample together. Use the original test sample
mass to calculate the simulated gastric juice volume.
For paper, paperboard, and test samples that have been dewaxed, first add
water (see 5.1) 25 times the mass of the test sample to soak the test sample;
then, add hydrochloric acid solution (see 5.16), of which the mass is 25 times
of the test sample and the concentration is 0.14 mol/L.
Appendix A
(Informative)
Selection guidance for migration test models
A.1 Overview
In order to use this Standard reasonably, it is necessary to understand the
migration of certain elements in toy and children product in the body fluid
environment. The way and degree of migration of certain elements to the
human body are related to the way children use products and the characteristics
of certain elements. The migration test models in this Appendix include sweat
migration that is caused by contact of toy or children products with the skin,
saliva migration that is caused by contact with the mouth, and gastric juice
migration that is caused by swallowing. Related studies have confirmed that
gastric juice migration capacity is often greater than sweat migration and saliva
migration capacity.
A.2 Theoretical basis for sweat migration test model
Most toys and children products will have skin contact with users. For example,
pencils and toys will intermittently or continuously come into contact with hands
during use; children clothing will continue to come into contact with body skin
during the wearing stage; children metal jewelry has been in prolonged contact
with skin of specific parts of the body. Because human skin secretes sweat, the
product material will be infiltrated to a certain extent when in contact with the
skin, and certain elements in the material will be migrated out into the human
sweat, and there is a potential risk of being absorbed by the body. Therefore,
sweat migration is a common way that certain elements may enter the body.
A.3 Theoretical basis for saliva migration test model
Oral contact mainly includes actions such as sucking, licking, and chewing.
Some children products on the market are specially designed for oral use, such
as teething rings for children's bites, pacifiers for oral sucking. The products that
are involved in oral behavior include a wide range; in addition to products which
are specifically used for the mouth, it also includes other products that are easy
to be bitten by children due to abuse, such as pens; although their size is too
large to be completely put in the mouth, the raised part will still be bitten by
children. In children's oral behavior, the product material will be infiltrated by
saliva, and certain elements in the material will migrate out into the saliva of the
human body, and there is a potential risk of being absorbed by the human body.
Therefore, saliva migration is a common way that certain elements may enter
the body.
a) Whether the children play mat be directly ingested? No, the infant play
mat is large enough, and it is not a small part that can be ingested directly.
It’s unnecessary to consider branch 1.
b) Whether it can come into contact with the mouth? Yes, the corners of the
play mat can come into contact with the mouth. It’s necessary to consider
branch 2. Whether it is easy to fall off due to biting when it comes into
contact with the mouth? Yes, it is necessary to consider the gastric juice
migration and the saliva migration.
c) Whether it can come into contact with the hands? Yes, the baby may crawl
on the play mat and it is very likely to come into contact with the hands.
It’s necessary to consider branch 2. However, its materials are not easy to
remain on the hands; it’s necessary to consider sweat migration.
d) Whether it can come into contact with other parts of the body? Yes, infants
may crawl or lie down on the play mat, and face, arms (which may be bare)
and feet may be exposed; it’s necessary to consider branch 4.
According to the evaluation results, there may be sweat migration, saliva
migration, and gastric juice migration in the use of children floor mat.
Note that when using the migration test model evaluation figure, it is important
to reasonably evaluate all possible occurrences of normal use and reasonable
abuse of the product; do not miss any exposure patterns.
A.5.2 Examples of migration test model selection
A.5.2.1 Paperboard jigsaw puzzle for children under three
For the paperboard jigsaw toy product, it shall choose the gastric juice migration
test model. According to the analysis in Figure A.1, toy products have three
types of migration at the same time. Considering that the migration capacity of
certain elements in gastric juice is often much greater than sweat migration and
saliva migration, so, when a product has more than one exposure mode, and
each exposure mode contributes equally, the gastric juice migration test model
can be selected, that is, give priority to the most severe situation, so as to better
protect children's health.
A.5.2.2 Infant textile and clothing products
For infant textile and clothing products, select the sweat migration test model.
According to the analysis in Figure A.1, infant textile and clothing products have
three types of migration at the same time; however, this product is a product
that has been in contact with the skin for a long time, and the contribution of
sweat migration is far greater than the contribution of gastric juice migration and
saliva migration; so, select the sweat migration test model.
Appendix B
(Informative)
Selection guidance for test method (gravimetric method and area
method)
B.1 Overview
Both the sweat migration test model and saliva migration test model in this
Appendix provide two test methods, namely gravimetric method and area
method.
B.2 Sweat migration test model
B.2.1 Overview
The sweat migration test model is mainly applicable to toys and children
products mainly in contact with the skin, including but not limited to children
clothing, children shoes, children accessories, children stationery, and children
care products. Compared to gastric juice migration, children products which are
involved in sweat migration tests usually have the characteristic of long-term
contact with the skin.
B.2.2 Selection guidance for test method
The gravimetric method is generally suitable for toys and children products,
which are mainly made of materials that are easily infiltrated by sweat, such as
textile children products. In this case, it is difficult to calculate the effective
contact area between the product material and sweat.
The area method is generally suitable for toys and children products, which are
mainly made of materials that are not easily infiltrated by sweat, such as plastic
children straps and metal children stationery boxes; therefore, the risk of
migration of certain elements of surface materials to human sweat is greater; in
this case, the area method is more consistent with the actual situation.
However, it is worth noting that if the materials of certain toys and children
products are not easy to be infiltrated by sweat, but the materials are more likely
to be worn away, so that the internal materials are exposed, the gravimetric
method can also be considered. Because the same kind of toys and children
products usually contain multiple materials, in this case, comprehensive
consideration shall be given. In order to facilitate the operation of the test
method, for all materials of the same kind of toys and children products, a
relatively suitable migration test method can be used.
Appendix C
(Informative)
Technical information of migration test model
C.1 Overview
The determination of the technical conditions of the sweat, saliva, and gastric
juice migration test models is based on the actual physiological conditions of
children in China; it refers to the technical conditions of the existing standard
system; at the same time, it comprehensively consider the requirements of
migration conditions that are beneficial to most certain elements, and the
protection of children health and safety.
C.2 Sweat migration test model
Human sweat mainly contains components, such as amino acids, lactic acid,
ammonia, urea, inorganic salts; the skin surface pH is affected by various
components, such as sebum that is secreted by the skin, emitted CO2 and
sweat. There is a certain difference in the sweat pH between children in the
East and the West. For children in the East, the pH value of the skin surface of
different body parts, different genders, and different age groups will have certain
differences. The pH value of younger people is lower; the normal skin surface
pH value of children in the East ranges at 4.4 ~ 5.6. The temperature of the
human skin changes with the ambient temperature. When the human body
sweats, the skin temperature is about 34 °C; the skin temperature after
sweating no longer rises significantly.
C.3 Saliva migration test model
The main components of human saliva are water, electrolytes, sugars, lipids,
proteins. With age, the components of saliva will change to some extent. The
normal saliva pH of children in the East is about 7.0. The normal oral
temperature of the human body is 36.9 °C ~ 37.5 °C.
Oral behavior is common in young children; younger children have longer daily
oral behaviors and higher frequencies. Studies show that children's daily oral
behavior time is different in different age groups; the maximum average length
of each age group is about 2 h. The frequency of oral behavior of children under
24 months is about 81 times/h.
C.4 Gastric juice migration test model
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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