The rising movement of “Clean Beauty” products has been growing as consumers demand honesty, transparency, sustainability and safety from their skin care and hygiene products. Not to be confused with natural or organic, the term “clean” refers to products formulated without harmful ingredients.
MB Research Labs has long been a partner in the safety testing of cosmetic ingredient and finish products. We test both natural and synthetic materials, so as you may adjust your sourcing and need to validate ingredients, MB Research will be there for you.
MB Research offers industry leading in vitro toxicology testing protocols where we are able to screen your ingredients and finished products for ocular irritation, skin irritation, skin sensitization, corrosivity and more.
With a wide range of in vivo and in vitro test protocols available, MB Research Labs offers comprehensive capabilities to address your unique needs and goals. With expertise in many areas of in vivo and in vitro testing, research, and safety evaluations, MB Research serves the testing needs of both government and industry.
Complete support services including consultation, protocol development, quality assurance, analytical chemistry and archive facilities are integral components of studies performed at MB. Our technical and support procedures are in full compliance with OECD, FDA, and EPA.
SOT 2019 in Baltimore! Don’t miss our special posters on Thursday Morning!
Alternative Vehicles Allow the LuSens Test Method to Predict Dermal Sensitization of Mixtures 8:30 AM – 11:30 AM. Session: Late-Breaking 9: Toxicokinetics; Mixtures, Abstract 3488, Poster Board P284
Classification of EPA Ocular Irritants and Non-Irritants by the OptiSafe™ Test Method of Mixtures 8:30 AM – 11:30 AM. Session: Late-Breaking 3: Model Systems; Nanotoxicology, Abstract 3383, Poster Board P173
Ethanol as an alternative vehicle for determining skin sensitization potential using the Human Cell Line Activation Test (h-CLAT) 8:30 AM – 11:30 AM. Session: Late-Breaking 3: Model Systems; Nanotoxicology, Abstract 3385, Poster Board P175
SenzaGen and MB Research Labs have signed a license agreement that gives MB Research the right to market and sell SenzaGen’s animal-free GARD™ test platform worldwide.
The collaboration between these two labs is hoped to offer US clients better access to the novel sensitization testing platform offered by SenzaGen and also falls into line with MB Research’s acute and subchronic toxicology testing portfolio.
GARD™ consists of a group of tests for analyzing chemicals’ ability to start an allergic reaction in humans. By analyzing hundreds of markers, GARD™ generates large amounts of data and delivers results with over 90 percent accuracy. This can be compared to today’s standard method – tests on mice – which only achieves 70-75 percent precision. SenzaGen’s test can also quantify the allergenic potential of a chemical substance.
About MB Research Labs Since 1972, MB Research Labs has offered toxicology testing services to the cosmetic, consumer product, agri-chemical, biotechnology and pharmaceutical industries. A leading CRO with over 30 years’ experience in the in vitro/alternative and mechanistic toxicity testing field, we maintain a prominent position in non-animal testing in the US, EU and many other countries, MBRL is always ready to adopt, as well as invent new non-animal-based predictive toxicity testing technologies. Our laboratories offer GLP assays in full compliance with OECD, FDA and EPA test guidelines, as well as custom-designed toxicity evaluations.
About SenzaGen AB
SenzaGen makes it possible to replace animal experiments with in vitro genetic testing to determine the allergenicity of the chemicals we come into contact with in our daily lives, such as for example in cosmetics, pharmaceuticals, food products and dyes. The company’s patented tests are the most reliable on the market and provide more information than traditional evaluation methods. The tests are sold via license laboratories (CRO) and distributors, and via the headquarters in Lund and the sales office in the US. Over the next few years the company will expand geographically, make alliances with more distribution partners and launch further unique tests. SenzaGen has its headquarters in Lund in Sweden and a subsidiary in the USA.
Thought I would share a good article I happened upon featuring toxic tales that appeared in National Geographic. I found the article to be a fun and an insightful article with historical references that were amazing.
The Draize Rabbit Eye Test (DRET) is the regulatory ‘Gold Standard’ for assessing and categorizing ocular irritation/corrosivity. The DRET focuses attention on damage to a number of different ocular structures, which are scored and weighted based on toxicological importance. The structures are as follows: Cornea (CO) – 80 points, Conjunctiva (Conj) – 20 points, and Iris (IR) – 10 points.
The heaviest weighting is on corneal damage, which is 80 points out of the total 110-point scale devised by Draize. Corneal irritation scoring is based on assessment of opacities on the cornea, Conj irritation is assessed by increased vascularization, and iridial damage is assessed by function of the iris (ability to constrict or dilate pupil)and deepening of the rugae.
PorCORA – Corneal Irritation Focus
Since the CO scores have the heaviest weight, and most often are the drivers of eye irritation, we developed the Porcine Cornea Opacity Reversibility Assay (PorCORA), an ex vivo corneal model. The PorCORA can distinguish between a material’s potential to cause severe (reversible) versus corrosive (irreversible) damage. Excised cultured porcine corneas are topically dosed with a test material and kept in culture for 21 Days. Corneal damage is visually assessed and scored. If CO reverse and are not visible by Day 21, the test material is categorized as a non-corrosive material and deemed to not cause permanent ocular damage.
In internal validation studies, we tested 56 chemicals and dilutions of chemicals ranging from corrosive (GHS category 1) to non-irritating (GHS not categorized). Using Cooper Statistics, we arrived at an accuracy of 89% with a positive and negative predictivity of 85% (cat. 1) and 93% (not cat.1), respectively.
To determine if these Cooper Statistics could be improved, we used the drivers of classification concept based on Barroso et al., 2016*. Upon re-examination of our data based on this published database and methodology, we found that four chemicals (1,2,4-Triazole, N-Butanol, 2,5-Dimethyl-2,5-Hexanediol, and Potassium Cyanate) had invalid tests (animals euthanized prior to day 21) or produced irritation not driven by corneal opacities. These chemicals were removed from our dataset. Without these four chemicals the accuracy improved to 92%. Moreover, the major change was in our positive predictivity, which increased to 91%. The negative predictivity for this subset of chemicals remained the same.
Lastly, PorCORA’s predictivity was assessed based on CO persistence; i.e., materials that produced low CO scores (from Draize Rabbit Eye Tests). Of the 56 chemicals tested, 40 had low severity (i.e., CO mean scores < 3). The accuracy for persistence of low CO scores was 88% with positive and negative predictivity of 79%, and 92%, respectively.
* Barroso, J., Pfannenbecker, U., Adriaens, E., Alépée, N., Cluzel, M., De Smedt, A., Hibatallah, J., Klaric, M., Mewes, K., Millet, M., Templier, M., McNamee, P. 2016. Cosmetics Europe compilation of historical serious eye damage/irritation in vivo data analysed by drivers of classification to support selection of chemicals for development and evaluation of alternative methods/strategies: the Draize eye test Reference Database (DRD). Arch. Toxicol. 91:521-547.
Based on these data, the PorCORA was proven to be a valid test to assess a material’s potential to distinguish reversible versus irreversible eye damage.
Appropriate choices of validation chemicals, based on the drivers of classification, have proven valuable and should be applied to replacement ocular assays that previously failed to meet acceptance criteria.
PorCORA testing results are encouraging and future studies are planned that will pursue mixtures and chemical substances of unknown or variable composition, complex reaction products and biological materials. PorCORA
If you would like to find out more about PorCORA and other in vitro/alternative toxicology testing methods, please click here.
Corrositex® is an in vitro method used to determine the dermal corrosive potential of chemicals and chemical mixtures.
Corrositex® has been designed as a replacement for the dermal corrosivity rabbit test based upon proprietary biomembrane and chemical detection technology. Corrositex® is also OECD approved – OECD Test Guideline 435: Non-Animal Dermal Corrosivity Test for Packing Group Classification.
* For two (2) or more samples sent together; Single (1) sample price: $995