Safety Evaluation of Cosmetics

Safety Evaluation of Cosmetics

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Safety evaluation of cosmetic ingredients is based upon the testing principles of the risk assessment process most typically applied to chemical substances.  The regulatory drive of Cosmetic safety is driven by the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the EU Regulation 1223/2009.

The FD&C Act prohibits the marketing of adulterated or misbranded cosmetics in interstate commerce and EU Regulation 1223/2009 aims to protect human health, reduce and regulate animal testing as well as make information more available to consumers, leading to the introduction of the product ingredient file concept.

In 2013, the European Union (EU) enacted the Directive 76/768/EC, the primary law that outlines cosmetics safety requirements.  This Directive includes the 7th amendment which mandates prohibition of animal testing for cosmetic products and ingredients.

In accordance with European regulations, a Product Information File (PIF) must be authored for each cosmetic product and submitted to the competent authorities on demand.

A key part of the PIF is a safety assessment or Cosmetic Product Safety Report, which is a safety assessment that provides:

  • Toxicological profile of each substance in the finished product (including Hazard Identification)
  • Chemical and physical specifications of the substances
  • Exposure level for each substance
  • A risk characterization for each substance

Expert Cosmetic Safety Testing Partner

MB Research Labs has been the premier choice in conducting product safety assessments for the cosmetics, personal care, chemical and pharmaceutical industries for over 45 years.  Our expertise is sought out to ensure the safety our partners’ cosmetic ingredients.  MB Research is a leader in the use and development of In Vitro and Alternative Toxicology Tests and continue to introduce new testing methods regularly.

For more information about MB Research and our In Vitro Toxicology Testing Capabilities…

California SB-1249 – Testing Solutions – In Vitro & Alternatives

Cali SB-1249
Cali SB-1249

California Cruelty-Free Cosmetics Act (California SB-1249)

On Sep. 28,2018, California Governor Jerry Brown signed the California Cruelty-Free Cosmetics Act (California SB-1249), a bill banning the sale of cosmetics that undergo animal testing, making California the first state to approve such a ban.

The California Cruelty-Free Cosmetics Act makes it unlawful for cosmetic manufacturers to sell any cosmetic in California if the final product or any component of the product was tested on animals and goes into effect Jan. 1, 2020.

Products that have undergone testing on animals before that date can still be sold in California.  Earlier in the month, the bill passed the state legislature after it was narrowed in scope.

Are You Ready With In Vitro Testing?

I Love In Vitro Toxicology
I Love In Vitro Toxicology

MB Research Labs is positioned to help manufacturers with a suite of in vitro and alternative (non-animal) tests for cosmetic safety testing.  MB has over 45 years of toxicology testing experience and over 25 years of testing using non-animal test methods.

www.mbresearch.com/cosmetics.htm

 

GHS Categories for Eye Irritation

OECD 405 – GHS Toxicity Categorization for Eye Irritation & CorrosionRolling the Die with Eye Categories?Rolling the Die with Eye Categories?

MB Research Labs has developed a Dual Assay System for Eye Irritation Categorization

The Organization for Economic Co-Operation and Development (OECD) has prescribed the use of a weight-of-evidence (WoE) analysis, integrated with a sequential testing strategy, for the classification of acute eye hazards.  The October 2017 revision to the Health Effects Test Guideline No. 405 outlines a stepwise strategy that includes Step 6, “Perform validated and accepted in vitro or ex vivo ocular test(s),” specifying only four possible tests:  three designed to identify severe eye irritation/ corrosion (GHS Category 1) and one to identify non-irritants (GHS No Category), the top-down and bottom-up approaches, respectively.  The GHS Category 2 (eye irritant) classification is impossible by any one bottom-up or top-down test.

Dual Assays

The EpiOcular™ Eye Irritation Test; EIT (OECD 492), as a bottom-up test, either determines a material to be No Category, or that it causes eye effects, but cannot discriminate between eye irritation, serious eye damage, and corrosion.

Conversely, the top-down Bovine Corneal Opacity and Permeability; BCOP Test (OECD 437), is used for ruling in or ruling out Category 1 effects (serious eye damage/corrosion).  By using a dual-assay/approach system – the combination of the EIT and BCOP test – we have determined, with a high degree of accuracy, GHS Acute Eye Hazard Category 2 chemicals that cause reversible irritation to the eye.

Double Elimination

A Double Elimination occurs when a BCOP test rules out GHS Category 1 (severe irritation/corrosion) and the EIT rules out GHS No Category (non-irritant), analysis of the combined results concludes the only other possible designation – Category 2 (irritant). The classification defaults to Category 2A for labeling and handling purposes because at present differentiation between category 2A and 2B cannot be made.  Using this approach, we correctly identified 87% of the Category 2A/B chemicals as Category 2 after testing 42 chemicals (nine, 15, and 18 in Category 1, 2A/B, and No Category, respectively).

As a result of this analysis, we are encouraged by the potential of the BCOP-EIT dual-assay system, coupled with WoE evaluation, to correctly assign unknowns into GHS Category 1, Category 2A, and No Category Acute Eye Hazards without the use of less predictive and more expensive in vitro tests.  Moreover, in keeping with the OECD’s recommendations, we predict that such a system would greatly reduce reliance on the Draize Rabbit Eye Tests.

For more info about MB Research.

#mbresearch #invitrotox

57th Annual Meeting of the Society of Toxicology – MB Research Labs

Join Us on the Riverwalk SOT 57th Annual Meeting MB Research
Join Us on the Riverwalk SOT 57th Annual Meeting
MB Research

Visit MB Research Labs in San Antonio, Texas Mar 11th-15th, 2018 for the SOT 57th Annual Meeting and ToxExpo.

Come on by Booth #550 to get the latest on In Vitro/Alternative Toxicology Testing and Research performed at MB Research Labs.

http://www.mbresearch.com  #mbresearch #invitrotox

10th World Congress on Alternatives and Animal Use in the Life Sciences, Seattle, Washington

In Vitro Toxicology, Not SciFi Anymore
10th World Congress on Alternatives and Animal Use in the Life Sciences

MB Research Labs is honored to be attending the 10th World Congress on Alternatives and Animal Use in the Life Sciences. We will be presenting several posters focusing on the use and development of in vitro and alternative toxicology methods that are used in our laboratories.

Scientific Posters presented by MB Research Labs on the Use and Development of In Vitro and Alternative Toxicology Test Methods

More Information on In Vitro and Alternative Testing….

In Vitro Eye Irritation Testing

In Vitro Eye Irritation Testing-MB Research Labs
In Vitro Eye Irritation Testing- MB Research Labs

In Vitro Eye Irritation Testing

Currently, it is generally accepted that no single in vitro eye irritation test will be able to replace the in vivo Draize eye test
to predict across the entire range of irritation for different chemical classes. Several labs (including MB Research) have been working on strategic combinations of several in vitro and alternative test methods within a (tiered) testing strategy that could replace the Draize Rabbit Eye Test.

Available In Vitro & Alternative Eye Irritation Test Methods

  • OptiSafe™In Vitro Eye Irritation Test
  • 3D Human Ocular Tissue Equivalent Systems – MatTek, EpiSkin
  • HET-CAM – Hen’s Egg Test – Chorioallantoic Membrane (HET-CAM)
  • Bovine Corneal Opacity and Permeability Assay (BCOP)
  • Porcine Cornea Reversibility Assay (PorCORA)
  • Chorioallantoic Membrane Vascular Assay (CAMVA)
  • Replacement Ocular Battery (ROBatt)
  • Keratinocyte/Fibroblast Viability Assay (Neutral Red or MTT)
  • Keratinocyte Proliferation (turnover) Assay

For more info on in vitro and alternative toxicology methods, please see: www.mbresearch.com.

OptiSafe – Non-animal Ocular Irritation Test

OptiSafe™ – Non-animal Ocular Irritation Test 

OptiSafe Eye Irritation TestingOptiSafe™ Ocular Irritation Test

MB Research Labs is now offering the new OptiSafe™ – an in vitro test method in which a test substance is applied to a semi-permeable membrane. Damage to macromolecules in the membrane is measured to assess the test substance’s potential to cause eye irritation.

OptiSafe™ Background Information

OptiSafe™ is an acute in vitro irritation test method used to determine the ocular irritation potential based of a test substances utilizing a set of biochemical tests (mostly performed in parallel; “multiplexed”) which evaluate the potential of the test substance ability to disrupt, denature and degrade biological molecules. These measured values are relevant to GHS and EPA standard ocular safety classification systems.

Evaluated Mechanisms of Ocular Injury and Prediction Models

Different ocular irritants including, acids/bases, alcohols/aldehydes/ketones, strong oxidants and reactive chemicals/mixtures, damage the cornea and other tissues through additive and/or synergistic chemical reactions and biophysical effects.

Evaluated mechanisms of injury include:

  • Denaturation of specific water insoluble polymers that model the phospholipid bilayer of cells (which can occur at the corneal epithelium and conjunctiva).
  • Direct denaturation of macromolecules that model ordered collagen (which can occur at the corneal stroma).
  • Indirect denaturation of molecules across a membrane via osmotic effects (osmotic effects across the corneal epithelium and stroma can damage the cornea).
  • Potential to damage tissue via excessive oxidation and reactivity (which can occur at the epithelium, stroma, conjunctiva and iris).
  • Potential to damage tissues via extreme buffering (which can occur at the epithelium, stroma, conjunctiva and iris).

NICEATM reviewed a validation study conducted by the OptiSafe™ test method developer, Lebrun Labs, and concluded that the study data indicated that the OptiSafe™ method compared favorably to other in vitroocular toxicity testing methods. NICEATM is currently coordinating a validation study of the OptiSafe™ test method to demonstrate the reproducibility of the method among Lebrun Labs and two naïve laboratories. The study received support from an NIEHS Small Business Innovation Research grant. The study is ongoing and is expected to be completed in mid-2018.

MB Research Labs is a primary testing source using OptiSafe™ and has been deeply involved in the validation of OptiSafe™.

Utility of OptiSafe™

OptiSafe™ can be used to determine the irritation potential of cosmetics, creams, and a wide variety of consumer products. Results are presented as GHS, EPA classifications, an ocular irritation score and class.

OptiSafe™ can be used for:

  • Screening Finished Products for Ocular Irritation.
  • Ocular safety testing during product development for knowledge based formulation. (Products that irritate do not last long in the marketplace).

The Advantages of OptiSafe™ include:

  • Accurate Ocular Irritancy Test
  • High Sensitivity for Mild and Moderate Irritants
  • Fast Results
  • 1 year shelf life
  • Neither uses nor harms animals

MB Research Labs performs many other in vitro eye and dermal irritation tests for screening of cosmetics, consumer products, pharmaceuticals and chemicals.

www.mbresearch.com

OptiSafe™ is a trademark of Lebrun Labs, LLC and used here with permission.

Alternative Toxicology Testing – Local Lymph Node Assay (BrdU ELISA)

Local Lymph Node Assay BrdU ELISA (LLNA-BrdU ELISA)

The LLNA-BrdU ELISA is conducted at MB Research Labs and is based upon the OECD 442B Testing Guideline.  The LLNA is an alternative toxicology assay for dermal sensitization using CBA/J mice.  The LLNA is an alternative to guinea pig studies that require more animals and long test durations.

LLNA-BrdU ELISA
LLNA-BrdU ELISA

Assay Principle:

To determine the sensitizing potential of topically applied test material utilizing the LLNA, and measurement of lymphocyte proliferation by BrdU incorporation detected by ELISA.

Irritation Screen Test:

An initial Irritation Screen is performed using 3-5 highest achievable  concentrations. The screen consists of 2 animals per concentration that will be dosed in an identical manner to that of the main test. Ear measurements will be taken prior to dosing on Study Days 1 and 3, and prior to euthanasia on Study Day 6.  Measurements taken on Study Days 3 and 6 will be compared to pre- dosing measurements. If there is no effect, or an increase of <25% in ear thickness, the same concentrations will be assayed in definitive test.

However, if significant ear swelling (ES) is present (>25% over control), then an extended screen (Quantitative Irritation Test; QIT) is recommended. The QIT is similar to the Irritation Screen except 4-6 concentrations will be assayed to determine the highest non-irritating concentration.

Definitive Sensitization Test:

The main test will be conducted by topically applying test material to the dorsum of the ears at the 3-5 highest achievable concentrations (100 [liquid only], 50, 25, 10, 5, 2.5, 1, 0.5, etc.), which do not cause severe irritation or overt systemic effects.  Ear measurements will be taken on Study Days 1 (prior to first dosing), 3 (approximately 48 hours after initial dosing) and 6 (prior to euthanasia). Animals will be injected with BrdU on Study Day 5, approximately 24 hours prior to euthanasia. Auricular lymph nodes will be collected on Study Day 6, a single-cell suspension will be created and lymph node cells (LNC) will be assayed for BrdU incorporation via ELISA.

Assay Interpretation:

  • A Positive Response is when a Stimulation Index (SI) is greater than or equal to 1.6 (relative to that of control lymph nodes).
  • A “Borderline Positive Response” is defined as an SI from 1.6 to 1.9; additional information and testing may be needed.
  • A Negative Response is when the SI is <1.6.

For more information about this and other studies, please see:  www.mbresearch.com

56th Society of Toxicology Annual Meeting 2017 – Baltimore, MD – MB Research Labs

MB Research Goes to Baltimore 2017 SOT
56th Annual Meeting – Society of Toxicology

SOT 2017 MB Research Informational Page

MB Research Goes to Baltimore – Society of Toxicology 2017

 

Join Us at the 56th Annual Meeting of the Society of Toxicology and ToxExpo , Baltimore, Maryland, March 12-16, 2017

Stop by Booth#: 2469 and meet some of our Study Directors and Client Services.

Scientific Posters:

The h-CLAT for Assessment of Dermal Sensitization Potency of the OECD Proficiency Chemicals and of Commercially Available Mixtures

Wed 1:15pm-4:30pm. Session: Alternatives to Mammalian Models I, Abstract 2748, Poster Board P116

Further Evaluation of Chemicals and Mixtures for Skin Sensitization Potential and Potency Using a Reconstructed Human Epithelium (RhE) Tissue Model and the IVSA.

Wed 1:15pm to 4:30pm. Session: Autoimmunity/Hypersensitivity, Abstract 2957, Poster Board P508

Historical Performance of Weak Sensitizers in Different Animal Models.

Tues 9:30am-12:45am. Session: Non-Phamaceutical Safety Assessment, Abstract 1873, Poster Board P449

Resolving Corrosive/Severe Irritant Ocular Classifications using an Alternative Dual Ex Vivo Assay System.

Wed 1:15pm-4:30pm. Session: Alternatives to Mammalian Models I, Abstract 2761, Poster Board P129

 

Video Link: Replacing Animal Testing with Cultured Human Cells

Great video on advancement of in vitro alternative testing methods in Europe.

EuroNews Knowledge – Replacing Animal Testing with Cultured Human Cells

MB Research Labs is a leader in the US for development and validation of in vitro alternative test methods that reduce/replace the need for using live animals in product safety testing of consumer products, chemicals, pharmaceuticals and cosmetics.

More information about MB Research Labs and our Toxicology Testing Services….