Safety of toys — Part 7: Requirements and test methods for finger paints

ISO 8124-7:2015 specifies requirements for the substances and materials used in finger paints. It is applicable to finger paints only. It is not applicable to paints intended to be applied to the face or body e.g. face paints. Additional requirements are specified for markings, labelling and containers.

Sécurité des jouets — Partie 7: Exigences et méthodes d'essai pour les peintures digitales

General Information

Status
Published
Publication Date
30-Sep-2015
Technical Committee
Drafting Committee
Current Stage
9093 - International Standard confirmed
Start Date
08-Mar-2021
Completion Date
08-Mar-2021
Ref Project

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INTERNATIONAL ISO
STANDARD 8124-7
First edition
2015-10-01
Safety of toys —
Part 7:
Requirements and test methods for
finger paints
Sécurité des jouets —
Partie 7: Exigences et méthodes d’essai pour les peintures digitales
Reference number
ISO 8124-7:2015(E)
ISO 2015
---------------------- Page: 1 ----------------------
ISO 8124-7:2015(E)
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© ISO 2015, Published in Switzerland

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ii © ISO 2015 – All rights reserved
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ISO 8124-7:2015(E)
Contents Page

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

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

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

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Requirements .......................................................................................................................................................................................................... 2

4.1 General ........................................................................................................................................................................................................... 2

4.2 Colourants ................................................................................................................................................................................................... 2

4.3 Preservatives ............................................................................................................................................................................................ 3

4.4 Migration of certain elements .................................................................................................................................................... 3

4.5 Limits for impurities .......................................................................................................................................................................... 3

4.5.1 Limits for primary aromatic amines ............................................................................................................... 3

4.5.2 Limits for other impurities...................................................................................................................................... 4

4.6 Taste and smell ....................................................................................................................................................................................... 5

4.7 pH value ........................................................................................................................................................................................................ 5

4.8 Binding agents, extenders, humectants and surfactants .................................................................................... 5

4.9 N-Nitrosamines....................................................................................................................................................................................... 5

4.10 Container ...................................................................................................................................................................................................... 5

Annex A (informative) Rationale .............................................................................................................................................................................. 6

Annex B (informative) Non exhaustive list of colourants that are commonly used in

finger paints and need to be in compliance with both the general and specific

purity requirements ......................................................................................................................................................................................... 9

Annex C (normative) Method for the detection of certain azo colourants and determination

of free primary aromatic amines ......................................................................................................................................................13

Annex D (normative) List of preservatives allowed for use in finger paints and maximum

allowed concentrations ..............................................................................................................................................................................28

Annex E (normative) Method for the determination of hexachlorobenzene, polychlorinated

biphenyls and benzo[α]pyrene ...........................................................................................................................................................32

Annex F (informative) Ingredients used in the manufacture of finger paints ........................................................49

Annex G (informative) Labelling guidelines and manufacturer’s markings ............................................................51

Bibliography .............................................................................................................................................................................................................................53

© ISO 2015 – All rights reserved iii
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ISO 8124-7:2015(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.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).

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. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www.iso.org/patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation on the meaning of ISO specific terms and expressions related to conformity

assessment, as well as information about ISO’s adherence to the WTO principles in the Technical

Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information

The committee responsible for this document is ISO/TC 181, Safety of toys.

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

— Part 5: Determination of total concentration of certain elements of toys
— Part 6: Certain phthalate esters in toys and children’s products
— Part 7: Requirements and test methods for finger paints
— Part 8: Age determination guidelines
iv © ISO 2015 – All rights reserved
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ISO 8124-7:2015(E)
Introduction

This part of ISO 8124 contains requirements which are intended to reduce the risks to children when

finger paints are used as intended or in a foreseeable way, bearing in mind the behaviour of children.

In particular it is recognized that finger paints present different risks when compared to other toys

because of their intended use which requires application to the hands and fingers of young children.

It cannot be ruled out that some of the paint material will be ingested or flicked into the eye or that

prolonged contact with the skin will occur. Therefore, in order to address the particular risks associated

with finger paints, this part of ISO 8124 contains requirements relating to the ingredients that may be

used in the manufacture of finger paints and limitations on certain impurities that may be found in

these ingredients. It also sets out certain requirements on the packaging and labelling of finger paints.

Chemical Abstract Service Registry Numbers (CAS) or Colour Index Numbers given in the Tables are

provided for information purposes only.
Annex A provides rationale for the requirements.
© ISO 2015 – All rights reserved v
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INTERNATIONAL STANDARD ISO 8124-7:2015(E)
Safety of toys —
Part 7:
Requirements and test methods for finger paints
1 Scope

This part of ISO 8124 specifies requirements for the substances and materials used in finger paints. It is

applicable to finger paints only.

It is not applicable to paints intended to be applied to the face or body e.g. face paints.

Additional requirements are specified for markings, labelling and containers.
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 787-9, General methods of test for pigments and extenders — Part 9: Determination of pH value of an

aqueous suspension
ISO 8124-3:2010, Safety of toys — Part 3: Migration of certain elements
3 Terms and definitions
For the purposes of this document the following definitions apply.
3.1
finger paint

aqueous semi-solid or liquid, coloured mixture specially designed for children to apply directly to

suitable surfaces with the fingers and hands

Note 1 to entry: Finger paint supplied in powder form is mixed with water according to the manufacturer’s

instructions before being considered in relation to this part of ISO 8124.
3.2
colourant
pigment or dyestuff
Note 1 to entry: For definitions of pigment and dyestuff see A.2.
3.3
extender

material in granular or powder form, insoluble in the medium and used to modify or influence certain

physical properties

Note 1 to entry: [SOURCE: ISO 4618:2014, definition 2.102, modified — Note 1 to entry deleted]

3.4
humectant
substance that delays the drying process
© ISO 2015 – All rights reserved 1
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ISO 8124-7:2015(E)
3.5
binding agent

water-soluble or miscible, non-volatile component that binds the paint to the surface to which it has

been applied
3.6
preservative
substance that prevents the growth of undesirable micro-organisms
3.7
surfactant
surface active substance that reduces the surface tension of the solution
Note 1 to entry: It can be used to make components miscible.
3.8
embittering agent
substance that gives the product a bitter taste
4 Requirements
4.1 General

Finger paints supplied in powder form shall be assessed against this part of ISO 8124 when mixed with

water in accordance with the manufacturer’s instructions.

When assessed according to the rules set out in the United Nations Globally Harmonized System of

Classification and Labelling of Chemicals (GHS), a finger paint shall not be classified with any of the

following health hazards:
— acute toxicity (hazard class 3.1);
— skin corrosion/irritation (hazard class 3.2);
— serious eye damage/eye irritation (hazard class 3.3);
— respiratory or skin sensitization (hazard class 3.4);
— germ cell mutagenicity (hazard class 3.5);
— carcinogenicity (hazard class 3.6);

— reproductive toxicity – adverse effects on sexual function and fertility or on development

(hazard class 3.7);

— specific target organ toxicity — single exposure effects other than narcotic effects (hazard class 3.8);

— specific target organ toxicity — repeated exposure (hazard class 3.9);
— aspiration hazard (hazard class 3.10).
4.2 Colourants
See A.2.

4.2.1 Colourants used in finger paint shall not have any of the health hazard classifications set out in

4.1 (hazard class 3.1 to 3.10).
2 © ISO 2015 – All rights reserved
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ISO 8124-7:2015(E)

NOTE Annex B provides a list of commonly used colorants that have been found to meet the requirements

of 4.2, providing they meet the purity requirements specified. These fall into one or more of the following

categories: Colourants permitted for use in food and/or cosmetics and other pigments which meet the general

requirements of 4.1.

4.2.2 Finger paints shall not contain azo colourants that by cleavage of one or more azo groups can

produce the primary aromatic amines listed in Tables 1 and 2 when tested in accordance with the test

method specified in Annex C.
4.3 Preservatives
See A.3.

Finger paints shall be preserved using only the preservatives listed in Annex D. The maximum

concentrations of preservatives shall not exceed the limits in column 4 of Table D.1 in Annex D.

Methods for the determination of certain preservatives are set out in the EU Cosmetics Legislation,

(see Bibliography) and should be used when evaluating the maximum concentrations specified in the

column “maximum allowed concentration” of Table D.1. Alternative methods that provide an equivalent

detection limit may also be used.
4.4 Migration of certain elements
See A.4.

The concentration of elements shall not exceed the maximum limit values for finger paint specified in

ISO 8124-3:2010, Table 1.
4.5 Limits for impurities
See A.5.
4.5.1 Limits for primary aromatic amines

4.5.1.1 The primary aromatic amines listed in Table 1 shall not be detectable when tested in accordance

with the test method in Annex C.
Table 1 — Primary aromatic amines
Primary aromatic amines CAS Number
Benzidine 92–87–5
2-Naphthylamine 91–59–8
4-Chloro-2-methylaniline (4-Chloro-o-toluidine) 95–69–2
4-Aminobiphenyl 92–67–1

4.5.1.2 Finger paint shall not contain carcinogenic primary aromatic amines (see Table 2 for a non-

exhaustive list of relevant substances) in a total amount exceeding 20 mg/kg, with no individual primary

aromatic amine exceeding 10 mg/kg, when tested in accordance with Annex C. The limitation does not

apply to aromatic aminocarboxylic acids or aminosulfonic acids.
Table 2 — Other primary aromatic amines (non-exhaustive list)
Primary aromatic amine CAS Number
o-Aminoazotoluene (4-o-Tolyazo-o-toluidine) 97–56–3

For certain pigments limit values for 3,3’-Dichlorobenzidine are given Annex B, Table B.1.

© ISO 2015 – All rights reserved 3
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ISO 8124-7:2015(E)
Table 2 (continued)
Primary aromatic amine CAS Number
2-Amino-4-nitrotoluene (5-Nitro-o-toluidine) 99–55–8
4-Chloroaniline 106–47–8
2,4-Diaminoanisole 615–05–4
4,4’-Diaminodiphenylmethane (4,4’-Methylenedianiline) 101–77–9
3,3’-Dichlorobenzidine 91–94–1
3,3’-Dimethoxybenzidine 119–90–4
3,3’-Dimethylbenzidine 119–93–7

3,3’-Dimethyl-4,4’-diaminodiphenylmethane (4,4’-Methylenedi-o-toluidine) 838–88–0

p-Cresidine (6-Methoxy-m-toluidine) 120–71–8
2 , 2 ’ - D ic h l o r o - 4 , 4 ’ - me t hy l e ne d i a n i l i ne 101–14–4
(4,4’-Methylene-bis-2-chloroaniline)
4,4’-Oxydianiline 101–80–4
4,4’-Thiodianiline 139–65–1
o-Toluidine 95–53–4
2,4-Xylidine 95–68–1
2,6-Xylidine 87–62–7
4-Amino-3-fluorophenol 399–95–1
6-Amino-2-ethoxynaphthalene not available
2-Methoxyaniline (o-Anisidine) 90–04–0
4-Aminoazobenzene 60–09–3
4-Methyl-m-phenylenediamine (Toluene-2,4-diamine) 95–80–7
2,4,5-Trimethylaniline 137–17–7
Aniline 62–53–3

For certain pigments limit values for 3,3’-Dichlorobenzidine are given Annex B, Table B.1.

4.5.2 Limits for other impurities
See A.5.

Finger paints shall not contain the impurities specified in Table 3, column 1 above the limits specified

in column 2 when colourants specified in column 3 are used, when tested in accordance with Annex E.

Table 3 — Impurities in finger paints
Values in milligrams per kilogram of finger paint
Impurity Limit Finger paints of concern
Polychlorinated biphenyls < 2 Finger paints containing chlorinated
colourants or colourants manufac-
tured in chlorinated solvents
Hexachlorobenzene < 5 Finger paints containing chlorinated
colourants or colourants manufac-
(CAS No. 118–74–1)
tured in chlorinated solvents
Benzo (α) pyrene < 0,05 Only for finger paints containing
carbon black
(CAS No. 50–32–8)
4 © ISO 2015 – All rights reserved
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ISO 8124-7:2015(E)
4.6 Taste and smell
See A.7.
Finger paints shall not be sweetened, flavoured or fragranced.

An embittering agent in accordance with Table 4 shall be added in order to discourage and minimize

the ingestion of paint.
Table 4 — Embittering agents
Embittering agent CAS Number
Naringin CAS 10236–47–2
Denatonium benzoate CAS 3734–33–6

The bitterness should be detectable by taste when the finger paint is diluted with water in a ratio of 1:100.

The following levels have been found suitable: naringin 1 %; denatonium benzoate 0,0004 % (4 mg/kg).

The relative bitterness of these substances is approximately 1:3 000 (naringin : denatonium benzoate).

The embittering agent and its concentration should be such that it provides a bitter taste during the

expected lifetime of the finger paint.
4.7 pH value
See A.8.

The pH value of the finger paint shall be between 4,0 and 10,0 when tested in accordance with ISO 787-9.

4.8 Binding agents, extenders, humectants and surfactants

Finger paints shall only use binding agents, extenders, humectants and surfactants which are not

classified with any of the health hazards set out in in 4.1 (hazards class 3.1 to 3.10).

NOTE See Annex F for a list of compounds known to be commonly used in finger paints.

4.9 N-Nitrosamines
See A.9.

Finger paints shall not contain more than 0,02 mg/kg of N-nitrosodiethanolamine (NDELA), CAS

No.:1116-54-7.

NOTE One suitable and validated test method is detailed in EN 71–12:2013, 7.2.1 and Clause 8. Other test

methods may be used provided they are validated for finger paints.
4.10 Container
See A.10.

Containers used for finger paints shall not have a design that is likely to be mistaken by children with

containers of foodstuffs or drinks.

Manufacturers should take into consideration the material(s), shape, volume, colours, labelling, other

packaging and the means of access to the contents, when assessing similarity with containers of

foodstuff or drinks.
© ISO 2015 – All rights reserved 5
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ISO 8124-7:2015(E)
Annex A
(informative)
Rationale
A.1 Finger paints

In addition to water, finger paints essentially consist of colourants, binders, preservatives and

embittering agents and may additionally contain extenders, humectants and surfactants. Finger paints

may be coloured by using colouring substances or mixtures containing colouring and other ingredients

which are incorporated into a finger paint to impart colour to the finger paint.
A.2 Colourants
See 4.2.

Annex B contains a list of colourants which are suitable for finger paints subject to them meeting

certain purity requirements. It includes colourants specific to finger paints, food colourants and

cosmetic colourants.

More detailed requirements on aromatic amines are included in order to exclude risks which may

derive from impurities in colourants.

Dyes are intensely coloured or fluorescent organic substances only, which impart colour to a substrate

by selective absorption of light. They are soluble and/or go through an application process which, at

least temporarily, destroys any crystal structure by absorption, solution, and mechanical retention, or

by ionic or covalent chemical bonds.

Pigments are coloured, black, white or fluorescent particulate organic or inorganic solids which usually

are insoluble in, and essentially physically and chemically unaffected by, the vehicle or substrate in

which they are incorporated. They alter appearance by selective absorption and/or by scattering of

light. Pigments are usually dispersed in vehicles or substrates for application, as for instance in the

manufacture or inks, paints, plastics or other polymeric materials. Pigments retain a crystal or

particulate structure throughout the coloration process.
A.3 Preservatives
See 4.3.

The use of appropriate preservatives in water-based systems like finger paints is necessary in order to

provide protection against the growth of bacteria, fungi and yeasts and maintain a hygienic compound.

Preservatives allowed for use in finger paints are listed in Annex D. The following properties were taken

into consideration when drafting this list: high efficacy with respect to micro-organisms accompanied

by suitable toxicological performance (e.g. low human toxicity, low volatility, low odour), suitable

technical performance (e.g. solubility in water-based systems, stability against other ingredients,

stability against chemical or physical influences) and suitable environmental performance [e.g. low

adsorbable organic halogens (AOX), low persistence]. The list includes, for example, preservatives that

are allowed for cosmetic use or for food use.
A.4 Elements
See 4.4.
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ISO 8124-7:2015(E)

The limit values and test methods for the migration of certain elements in finger paints are specified in

ISO 8124-3, Table 1, row 3.
A.5 Limits for primary aromatic amines
See 4.5.1.1 and 4.5.1.2.

Table 1 lists the four primary aromatic amines which shall not be determinable in finger paints at the

limit of quantification (LOQ) using the method described in Annex C using GC-MS as the detection

technique. Table 2 lists 24 primary aromatic amines which were taken from Table 2 of EN 71-7:2014

entitled “Other carcinogenic primary aromatic amines (non-exhaustive list)”. Therefore, the listing of

primary aromatic amines in Table 2 of this part of ISO 8124 has been described as a non-exhaustive list

and does not preclude other primary aromatic amines from being analysed. The information provided in

Chromatography (C.6.5) and Precision (C.8) includes the four primary aromatic amines listed in Table 1,

and 18 primary aromatic amines from Table 2. The inclusion of 18 rather than all 23 primary aromatic

amines in Table 2 reflects the difficulty in obtaining the suitable commercial standards at the time of

writing this part of ISO 8124. The information in C.5 and C.8 should provide the competent analyst with

indicative information in the determination of other primary aromatic amines where/when calibration

standards are available. The limitation for primary aromatic amines does not apply to aromatic

aminocarboxylic acids or aminosulfonic acids because they are considered to be harmless.

A.6 Limit for benzo(α)pyrene
See 4.5.2.

Benzo(α)pyrene in finger paints is limited to the currently technically achievable analytical limit of

quantitation (LOQ) of 0,02 mg/kg.
A.7 Taste and smell
See 4.6.

The addition of sweeteners, flavourings and fragrances to a finger paint may be determined by an

assessment of the individual ingredients in the formulation of the finger paint.

The requirement to add an embittering agent to finger paints is intended to minimize potential oral

ingestion by young children who may deliberately or accidentally put some of the finger paint in their

mouth.

It should be noted that products with added embittering agents show remarkable bitterness, which

may remain for a while after putting it into the mouth.

Experience has shown that the bitterness in finger paint will last for the product’s lifetime, if one of the

two embittering agents in Table 4 is used in diluted finger paint as given in the Note in 4.6.

A.8 pH value
See 4.7.

The use of calcium carbonate may raise the pH value as a result of more dissociation by dilution with

water in accordance with ISO 787-9 up to pH 10.

Some types of formulations containing calcium carbonate show pH values higher than 10 because the

dilution of the finger paint is made with distilled water. This may also be found for small amounts of

calcium carbonate in finger paint. Such a high increase as an analytical artefact does not happen when

tap water is used to dilute the finger paint.
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ISO 8124-7:2015(E)
A.9 N-Nitrosamines
See 4.9.

To avoid the possible formation of N-nitrosamines avoid using formulations that combine

diethanolamine andtriethanolamine (which is known to be often contaminated with diethanolamine

or which can be decomposedto diethanolamine) with possible sources of nitrite that may be present in

certain preservatives (e.g. bronopol) and other raw materials.

Work undertaken during the development of EN 71-12:2013, showed that the only N-nitrosamine of

relevance for finger paints is N-nitrosodiethanolamine (NDELA), CAS No.:1116-54-7. Consequently

this part of ISO 8124 sets a limitation on NDELA only. EN 71-12:2013 mentions other N-nitrosamines

because this aligns with the EU toy safety directive but other N-nitrosamines are not known to occur in

finger paints.

EN 71-12:2013 contains a validated test method for the determinations of NDELA in finger paints but

other test methods may be used provided they are validated for determination of NDELA in a typical

finger paint matrix.
A.10 Containers
See 4.10.

This requirement is intended to minimize the potential for a child to mistake finger paint for a foodstuff

or a drink. The requirement is one of a series of precautionary measures (e.g. embittering agents, no

flavour, no sweetening, no fragrance, warning to parents to supervise) intended to discourage the

ingestion of finger paints by typical users (e.g. two years and above).
A.11 Labelling guidelines
See Annex G.

Young children have a propensity for exploring objects orally. The warning phrase recognizes the

fact that children under three years of age may be tempted to taste or eat the finger paint and this is

something that the supervisor would be expected to discourage or prevent. Even though finger paints

that are in conformity with this part of ISO 8124 may be considered to present a minimal risk, ingestion

of repeated amounts of finger paint is not recommended.
8 © ISO 2015 – All rights reserved
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ISO 8124-7:2015(E)
Annex B
(informative)
Non exhaustive list of colourants that are commonly used in finger
paints and need to be in compliance with both the general and
specific purity requirements
Table B.1 lists organic colourants commonly used in finger paints.
Table B.1 — Organic colourants which are commonly used in finger paints

No. Colour CI Generic Name CI Constitution CAS Number Limitations, requirements and information

Number
1 Yellow Pigment Yellow 1 11680 2512–29–0 See .
Check purity criteria for amine limits and
that excess coupling component is less than
1 000 ppm (parts per million).
2 Pigment Yellow 3 11710 6486–23–3 See .
Check purity criteria for amine limits and
that excess coupling component is less than
1 000 ppm.
3 Pigment Yellow 12 21090 6358–85–6 3,3’-Dichlorobenzidine ≤ 5 mg/kg: see C.1
detection limit of the method.
4 Pigment Yellow 13 21100 5102–83–0 3,3’-Dichlorobenzidine ≤ 5 mg/kg: see C.1
detection limit of the method.
5 Pigment Yellow 14 21095 5468–75–7 3,3’-Dichlorobenzidine ≤ 5 mg/kg: see C.1
detection limit of the method.
6 Pigment Yellow 17 21105 4531–49–1 3,3’-Dichlorobenzidine ≤ 5 mg/kg: see C.1
detection limit of the method.
7 Pigment Yellow 74 11741 6358–31–2 Check purity criteria for amine limits and
that excess coupling component is less than
1 000 ppm.
8 Pigment Yellow 138 56300 30125–47–4
9 Pigment Yellow 139 56298 36888–99–0
10 Pigment Yellow 151 13980 31837–42–0
11 Yellow Pigment Yellow 154 11781 68134
...

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