Testing of Cosmetic Ingredients and Cosmetic Products
Testing of Cosmetic Ingredients
For the safety evaluation of cosmetic ingredients, the Scientific Committee on Consumer Safety shares recommendations for testing approaches in “THE SCCS NOTES OF GUIDANCE FOR THE TESTING OF COSMETIC INGREDIENTS AND THEIR SAFETY EVALUATION 10TH REVISION”, SCCS/1602/18 Final version. The use of NAMs (New Approach Methodology / non-animal alternative methods) is requested wherever ECVAM (European Centre for the Validation of Alternative Methods) validated methods are available.
LAUS could provide the following studies under GLP for you.
NAMs: in vitro non-animal alternative methods
- For skin corrosion testing
- OECD 431, EC B.40bis, Reconstructed Human Epidermis (RhE) Test Method using the validated human skin model EpiDerm™
- OECD 435, In vitro Membrane Barrier Test Method, Corrositex® test method
- For skin irritation testing
- OECD 439, Reconstructed Human Epidermis (RhE) Test Method, EpiDerm
- For eye corrosion testing
- OECD 437, EC B.47, The Bovine Cornea Opacity Permeability (BCOP) test method
- For eye irritation testing
- OECD 492, Reconstructed human tissue (RhT)-based test method
NAMs for the assessment of skin sensitization according to the Adverse Outcome Pathway (APO)
- OECD 442C, EC B.59, In chemico skin sensitisation Direct Peptide Reactivity Assay (DPRA)
- OECD 442D, EC B.60, In vitro Skin Sensitisation Assays addressing the KE on keratinocyte activation, ARE KeratinoSens test method
- OECD 442E, EC B.72, Human Cell Line Activation test (h-CLAT)
NAM for acute oral toxicity
- 3T3 NRU (Neutral Red Uptake) test*
Two tests for the base level genotoxicity testing of cosmetic substances:
- OECD 471, Bacterial Reverse Mutation Test, covering gene mutations
- OECD 487, In vitro Micronucleus Test for structural (clastogenicity) and numerical (aneugenicity) chromosome aberrations
- Physical state, color, odor
- EC A.6 Solubility in water and relevant solvents
- EC A.8, n-octanol/water partition coefficient along with pH and temperature conditions (Log Pow)
- EC A.9, Flash point
- EC A.2, Boiling point
- EC A.1, Melting temperature
- EC A.3, Relative density
- EC A.4, Vapor pressure
- UV light absorption spectrum of compounds or UV filters
- For Nanomaterials and Nanoparticles special requirements apply. Contact us for more information.
In addition, LAUS is specialized in biodegradability studies for ingredients and cosmetic products. E.g., the following studies are recommended to determine if the COSMOS standards for chemically processed agro-ingredients in organic and/or natural cosmetics are met:
- OECD 301A, percentage of degradation > 70%
- OECD 301B, OECD 301D, OECD 301F or OECD 310 meet a percentage degradation > 60%
Based on the Cosmetics Regulation, all studies will be carried out in accordance with the principles of Good Laboratory Practice (Council Directive 87/18/EEC).
Testing of Cosmetic Products
Before placing cosmetic products on the market, they need to undergo a safety assessment and the competent authorities should be notified of certain information as specified in the REGULATION (EC) No 1223/2009, Annex I.
LAUS can support you with the following studies to fulfill your requirements.
The physical and chemical characteristics of the substances or mixtures, as well as the cosmetic product:
A local toxicity evaluation:
- In vitro skin irritation
- In vitro eye irritation
- In vitro skin sensitization
There is a rising public awareness regarding sustainability. LAUS also offers biodegradability studies for cosmetic products:
- Ready Biodegradability, OECD 301 A, B, D, F
And we can support you with studies to assess
- Endocrine Properties
Cosmetic products containing Nanomaterials shall be notified to the Commission including a full characterization and toxicological profile of the material. Please ask for a tailor-made testing approach.
Cosmetic and personal care products are ranging from creams, lotions, soaps, bath and shower preparations, to deodorants, shaving products, make-up, hair colorants, toothpaste and sunscreen.
They are categorized in rinse-off and leave-on product as well as by intended area of application, e. g. skin, lip, face, nail, hair products.
If you need to rise experimental data for your ingredient or cosmetic product, don’t hesitate to contact the experts from LAUS.
* will be subcontracted
Evaluation of the Potential for Mutagenicity of Cosmetic Substances within the EU
In April 2014 the 8th Revision of the Addendum to the SCC`s Notes of Guidance (NoG) for the Testing of Cosmetic Ingredients was adopted, which includes a general recommendation for the evaluation of the potential for mutagenicity of cosmetic substances within the EU:
Addendum to the SCCS`s Notes of Guidance (NoG) for the Testing of Cosmetic Ingredients and their Safety Evaluation, 8th Revision, SCCS/1501/12, 9. April 2014.
According to the document two different genotoxic endpoints should be tested:
- Mutagenicity (Gene mutation)
Bacterial Reverse Mutation Test - Ames Test [OECD 471]
- Structural and numerical chromosome aberrations (clastogenicity and aneuploidy)
in vitro Micronucleus Test [OECD 487]
If the results of both studies should differ the performance of an in vitro Comet Assay is recommended.
In case of biocidal compounds, antibiotics or nanomaterials instead of a bacterial reverse mutation test a gene mutation test in mammalian cells should be performed like the HPRT Test or the Mouse Lymphoma Assay.
The following figure shows four different possible scenarios for testing the mutagenicity: