Skin sensitization

Skin sensitization

_H-CLAT® (Human Cell Line Activation Test) _

The h-CLAT® is an in vitro method recognized as a NAM (New Approach Methodology) for assessing the skin sensitization potential of chemicals and cosmetic ingredients. Performed using the human THP-1 cell line, this test measures the expression of the CD86 and CD54 markers associated with dendritic cell activation.

Compliant with OECD Test Guideline 442E, the h-CLAT® addresses Key Event 3 of the Adverse Outcome Pathway (AOP) for skin sensitization and is one of the reference methods integrated into Defined Approaches (OECD 497).

At Eurosafe, the h-CLAT® has been conducted under GLP for more than 10 years, combining scientific expertise, regulatory know-how, and the generation of robust data to support your safety assessments.

KeratinoSens™

The KeratinoSens™ assay is a validated in vitro method recognized by the OECD (Test Guideline 442D) for assessing the skin sensitization potential of chemicals and cosmetic ingredients.

This method addresses Key Event 2 (KE2) of the Adverse Outcome Pathway (AOP) for skin sensitization, namely the activation of keratinocytes through the Nrf2/ARE signaling pathway.

The assay is based on the use of a genetically modified human keratinocyte cell line containing a reporter gene under the control of an Antioxidant Response Element (ARE).

DPRA (Direct Peptide Reactivity Assay)

The DPRA (Direct Peptide Reactivity Assay) is a validated in chemico method recognized by the OECD (Test Guideline 442C) for assessing the skin sensitization potential of chemicals and ingredients.

This method addresses Key Event 1 (KE1) of the Adverse Outcome Pathway (AOP) for skin sensitization, namely the covalent binding of an electrophilic substance to skin proteins. This molecular interaction represents the initiating event in the skin sensitization process.

The DPRA is integrated into the Defined Approaches described in OECD Test Guideline 497 and is considered a reference method for characterizing the molecular initiating event of skin sensitization within the framework of New Approach Methodologies (NAMs).

SENS-IS

The Sens-IS assay, developped by Immunosearch, measures quantitatively the over expression of 62 specific biomarkers of skin sensitization, irritation and Redox system by RT-PCR after application of chemicals, mixture, natural extracts on 3D reconstructed human epidermis.

  • Qualitative and quantitative response
  • Distinguishes irritation and sensitization
  • 3D reconstitued epidermis = closer to the skin therefore a complete biological system accounting for multiple cellular responses
  • Larger domain of applications than the other sensitization assays, with capacity to test lipophilic compounds
  • Good compliance with LLNA
  • Suitable for finished products

OECD validation is in progress.

Cover Key event 2 (Activation of keratinocytes)

Retrieve information about Sens-IS.

Flyer Sens-is-1

Flyer Sens-is-2

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Last posters

  • Safety assessment of cosmetic ingredients for skin sensitization using QSAR in silico tool

    3/15/2019

    Skin sensitization methods are developed to protect workers and consumers from chemical exposures. In 2012, OECD Test Guideline 168 (TG) addressed the 5 Key Events (KE) of the skin sensitization Adverse Outcome Pathway (AOP)[1]. To respond to cellular and tissue events(KE2, KE3) in vitro alternative methods were well described such as OECD TG 442C (Direct Peptide Reactivity Assay, DPRA); OECD TG 442D (KeratinoSens™) and OECD TG 442E (human Cell Line Activation Test, h-CLAT). The two biomarkers based test SENS-IS and the Genomic Allergic Detection Test (GARD) are under consideration by the OECD for the development of the respective TGs.

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  • Cosmetics exposure data - Particular case of children from birth

    3/15/2019

    It is commonly accepted that the Skin Surface Area over Body weight ratio (SA/BW) of infants and children is higher as compared with that in adults. Regarding the safety assessment process of cosmetic ingredients, Toxicological Reference Values (TRV) are expressed as mg/kg bw and the change in the ratio of surface area/body weight compared with an adult would give, according to A.G. Renwick (1998), a discrepancy of 2.3-fold for children at birth (except premature infants). Such inter individual variation is already covered by the generally accepted default value of 100 calculated for individual ingredients which is composed of 10 for interspecies variations (4.0 for toxicokinetics) and 10 for human variability, covering toxicokinetic (3.2) and toxicodynamic (3.2) differences between children and adults (A.G. Renwick (1998) and SCCS (2018)). Scheuplein et al. (2002) estimate that an uncertainty factor of 10 applied to this intra-species variability is a sufficiently powerful parameter to take into account child/adult variability, for children over 6 months old. This estimate may not be relevant for children under 6 months of age, in the absence of developmental or systemic toxicity studies. Given the ambiguity of these data, the question was raised whether the use of an increased uncertainty/safety factor would be relevant to cover children at birth exposure to cosmetic ingredients and ensure their safety under normal and reasonably foreseeable conditions of use.

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  • In-silico modelization of compounds interaction with Bile salt Export Pump (BSEP): an alternative approach to predict hepatotoxicity

    3/15/2019

    BSEP is an efflux transporter protein present in the hepatocytes membrane that plays important role in bile acid flow from hepatocyte cell into the bile canaliculi (1,2). Impaired BSEP activity due to drug interaction leads to accumulation of bile acid within the hepatocyte cells and results in cholestasis liver injury (DILI)(3). However, due to the lack of a X-ray structure of BSEP, there is no detail information about interaction of compounds with BSEP.

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  • In silico prediction of Structure and compound affinity of Multidrug Resistance-associated Protein 2 (MRP2) for predicting hepatotoxicity.

    3/15/2019

    MRP2 is an unidirectional efflux transporter mainly present in liver, that primarily transports organic anions, including drug conjugates and conjugated bilirubin. MRP2 supports a function in the terminal excretion and detoxification of endogenous and xenobiotic organic anions. Due to the lack of a X-ray structure of MRP2, there is no detail information about interaction of compounds with MRP2.

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  • Essential oils mixtures safety-in-use evaluation in personal care products

    2/11/2019

    Essentials oil are defined as complex natural substances. Their composition varies according to the geographical origin of the plant, the part of the plant used, the conditions of production or the method of production. The number of components present in these volatile oils can be very high, despite a structural variation rather limited (3 major atoms: carbon, hydrogen and oxygen). All these characteristics justify the difficulty of carrying out a reliable and relevant toxicological assessment of these ingredients, which are very popular in cosmetic industry. Thanks to chromatographic methods, it is now possible to know the nature and concentration of all the compounds present in an essential oils mixture. Thus, trhough analysis reports obtained by chromatography, the maximum acceptable concentration of a mixture for a given finished cosmetic product can be determined on the basis of the compound identified as limiting. The toxicological approach here applied is mainly based on the QRA methodology (*Qualitative Risk Assessment*) used for the calculation of IFRA certificates. Each compound identified by chromatography has a toxicity reference value (TRV) and a theoretical skin absorption rate. In the absence of TRV, the Threshold of Toxicological Concern approach (TTC - Cramer) will be applied.

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