China NIFDC Consults on Six Guidelines for In Vitro Testing, Sunscreen Performance Testing, and Animal Testing

1

Technical Guidelines for In Vitro Mammalian Cells Chromosome Aberration Test

• When applying for anti-hair loss or hair dyeing products registration, it is required to submit in vitro mammalian cells chromosome aberration test data;

• When applying for new cosmetic ingredients (NCIs) registration or notification, it is required to submit mutagenicity test data. The test can be used to assess the mutagenicity of NCIs;

• When conducting safety assessment, the data of in vitro mammalian cells chromosome aberration test is commonly adopted as evidence for assessing the mutagenicity of cosmetic ingredients.

During the review of the test report or data, it was frequently found that there were errors in the setting of the highest concentration of the test substance or the number of metaphases used for   chromosome analysis, or the result judgement was unreasonable.

This Guidelines is to standardize the application of this test in assessing the mutagenicity of cosmetic products and NCIs.

The main contents of the Guidelines include the formulation background, legal basis, application scope, basic principles, principles of test substance preparation and dosage design, control substance setting principles, selection principles of cells and exogenous metabolic activation systems, experimental design, result analysis and evaluation, etc.

2

Technical Guidelines for In Vitro Mammalian Cell Gene Mutation Test

• When applying for anti-hair loss or oxidative hair dyeing products   registration, it is required to submit mutagenicity and genotoxicity test   data. The in vitro mammalian cell gene mutation test can be used as one of the detection methods of gene mutation endpoint;

• When applying for NCIs registration or notification, it is required to submit mutagenicity test data. The test can be used to assess the mutagenicity of NCIs;

• The safety assessment of the mutagenic genotoxicity endpoint of cosmetic ingredients is usually based on the data from in vitro mammalian cell gene mutation test.

This Guidelines is to standardize the application of this test in assessing the mutagenicity of cosmetic products and NCIs.

The main contents of the Guidelines include the formulation background, legal basis, application scope, basic principles, principles of test substance preparation and dosage design, control substance setting principles, selection principles of cells and exogenous metabolic activation systems, result analysis and evaluation, etc.

3

Technical Guidelines for Determination of the Sun Protection Factor (SPF) of Sunscreen Products

The sun protection performance of sunscreen products is represented by the SPF value. It is required to test the SPF value before applying for sunscreen product registration.

This Guidelines is to give scientific suggestions for SPF testing of sunscreen products, as well as result analysis and evaluation.

The main contents of the Guidelines include the overview, basic principles, basic content (such as light source, subjects, SPF value standard substance, MED measurement, and exclusion criteria), result analysis and evaluation, as well as terminology explanation.

4

Technical Guidelines for Determination of the Waterproof Performance of Sunscreen Products

Before applying for the registration of sunscreen products claiming “waterproof”, “sweatproof”, “suitable for outdoor activities such as swimming”, etc., it is required to test the waterproof performance based on the claimed waterproof degree or time.

This Guidelines is to give scientific suggestions for waterproof performance testing of sunscreen products, as well as result analysis and evaluation.

The main contents of the Guidelines include the overview, basic principles, basic content (such as equipment requirements, general waterproof performance test, and strong waterproof performance test), result analysis and evaluation, as well as terminology explanation.

5

Technical Guidelines for Acute Inhalation Toxicity Test of Cosmetics

Due to the product dosage forms, application methods, and/or ingredient characteristics, cosmetic products or some of their ingredients may have inhalation exposure risks. In case of possible inhalation exposure, the health hazard effects caused by inhalation exposure shall be taken into account in the safety assessment, during which the acute inhalation toxicity shall be considered first.

The method in this Guidelines is applicable to the acute inhalation toxicity test research of cosmetic ingredients that may have inhalation exposure risks. It does not apply to certain special ingredients, such as insoluble equiaxed or fibrous materials, and nanomaterials.

The test results can serve as the basis for acute inhalation toxicity assessment, and the determination of the dosage of subchronic toxicity tests and other toxicological tests.

The main contents of the Guidelines include the overview, basic principles, basic content (such as test substances, experimental animals, exposure methods, test methods and doses, observation time and indicators), result analysis and evaluation, references, terminology explanations, as well as an appendix. The appendix introduces a specific test method that can be referred to.

6

Acute Inhalation Toxicity - Technical Guidelines for Acute Toxic Class (ATC) Method

• Cosmetics used by spraying, such as aerosols and sprays, may enter the human body through inhalation. Therefore, it is required to assess the potential safety risks of inhalation toxicity;

• When applying for NCI registration or notification, the required toxicological test data include an inhalation toxicity test (this test shall be done for the ingredient that may have inhalation exposure risks).

Notes: ATC Method is to use a small number of animals to participate a step-by-step acute inhalation toxicity test on a series of test substances with fixed concentration, so as to provide information on the inhalation toxicity   characteristics of the test substance, and determine the acute inhalation toxicity of the substances and their classification.

The method in this Guidelines is applicable to the toxicity classification, research and safety assessment of cosmetic ingredients (ingredients with a single component and a clear structure) that may have inhalation exposure risks. It does not apply to poorly soluble isomers, fibers, nanomaterials, etc.

The main contents of the Guidelines include the formulation background, legal basis, applicable scope, basic principles, preparation and quality control of the test substance, experimental animals selection, exposure conditions control, test groups setting, observation and detection indicators, principles for judging results, references, terminology explanations and an appendix. The appendix introduces a specific test method that can be referred to.