Dermal penetration according to OECD TG 428

Similar documents
PIROCTONE OLAMINE AND ITS MONOETHANOLAMINE SALT

Further development of an in vitro model for studying the penetration of chemicals through compromised skin

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS

AcquaSeal Coconut Anti-Aging, Nourishing, Moisturization, Improves Slip. Tomorrow s Vision Today!

Safety aspects of skin penetration of nanoparticles in topically applied cosmetics / pharmaceuticals

PIF Introduction Including Safety Assessment

ADDENDUM. to the scientific Opinions on Climbazole (P64) ref. SCCS/1506/13 and SCCS/1590/17

European Cosmetic Regulation 1223/2009

Mr Elian LATI. BIO-EC Laboratory Longjumeau, France

STAIN-PROOF TEST RESULTS

LUPIN LIMITED SAFETY DATA SHEET

Summary and future perspectives

Dermal And Ocular Toxicology: Fundamentals And Methods READ ONLINE

Safety Data Sheet Macadamia Professional TM Nourishing Moisture Oil Treatment SECTION 1- IDENTIFICATION

Rosacea is a common facial skin disorder estimated

MATERIAL SAFETY DATA SHEET

spring back to life Phytofuse Renew functional active ingredient with elegant feel antioxidant, soothing, wound healing

Introduction. In vivo study Skin Adhesion of the Active. Dermoprotectyl cellular active. Dermoprotectyl cellular active

WHY IS THE SKIN BARRIER SO ESSENTIAL?

Our MISSION. To support any Brand wanting to. extend its offer to the cosmetic market

MATERIAL SAFETY DATA SHEET 1. PRODUCT AND COMPANY IDENTIFICATION:

MicroVue CICP Safety Data Sheet Revision Date: November 15, Section 1 Product and Company Identification

Cosmetic Products New EU Regulation Published

AC Kerazyme. Temporary Straightening, Curling, Conditioning & Protecting. Tomorrow s Vision Today!

ASIAN SKIN: ROLE OF UVA IN HYPERPIGMENTATION AND PREVENTION

ElfaMoist AC Humectant

Kewpie s 3 brothers of functional HA

The EU Cosmetics Regulation

Linearity FD BNP Siemens Stratus. Preparation For In Vitro Diagnostic use only.

SAFETY DATA SHEET 1. PRODUCT AND COMPANY IDENTIFICATION. Dissolve Glass and Multi-Surface Cleaner Concentrate

Linearity FD Cardiac, Siemens Stratus. Preparation For In Vitro Diagnostic use only.

A natural and broad spectrum antimicrobial skin active consisting of highly porous and micro-sized particles of pure silver

1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING 2. HAZARDS IDENTIFICATION

Research & Management Consultancy Partners: M. C. Perry B.Sc.(Hons), C.Biol., MSB., M.T.O.P.R.A. R. G. Perry

SIGMA-ALDRICH. Material Safety Data Sheet Version 5.6 Revision Date 05/30/2012 Print Date 07/08/2014

NATURAL WAVE THE NEW THIO-FREE WAVING SYSTEM WITH CREATINE. Via Canova, 8/ Corsico ITALY Tel Fax

ITSIPREP Material Safety Data Sheet. Name CAS # % Sodium Phosphate, monobasic <0.01 Sodium Phosphate, dibasic <0.

Safety Assurance of Cosmetic in Japan: Current Situation and Future Prospects

MATERIAL SAFETY DATA SHEET

M A T E R I A L S A F E T Y D A T A

Research & Management Consultancy Partners: M. C. Perry B.Sc.(Hons), C.Biol., MSB., M.T.O.P.R.A. R. G. Perry

Supplier Organisation Location Contact Information Chemform Pty Ltd ABN:

TO Whom It May Concern. RE: Directors of M/s Actual/Legal Manufacturer & complete address

Safety Data Sheet Globally Harmonized System

: SHOUT WIPES INSTANT STAIN REMOVER

Eye contour serum SEMBLANCE is a regenerating serum, used to correct and repair. 1) SQUALENE: Natural water balance

Material Safety Data Sheet acc. REACH

Material Safety Data Sheet Part # MSDS #:

Optiblot SDS-PAGE Gel

Cosmetics: life under the EU Regulation

MATERIAL SAFETY DATA SHEET

Over-the-Counter Sunscreens: Safety and Effectiveness Data

R&D, TESTING AND REGULATORY SERVICES TO THE PHARMACEUTICAL AND PERSONAL CARE INDUSTRIES

MATERIAL SAFETY DATA SHEET Effective Date: 04/08/2013

Product Information File (PIF) Summary

The Danish EPA Survey and Health Risk Assessment of Lead in Jewellery

MATERIAL SAFETY DATA SHEET RPM Wood Finishes Group 3194 Hickory Boulevard Hudson, North Carolina

MicroVue DPD Safety Data Sheet Revision Date: November 15, Section 1 Product and Company Identification. Section 2 Hazards Identification

MATERIAL SAFETY DATA SHEET

Reconnect, Respect, Rebalance skin s physiology

PO Box 9932 West Palm Beach, FL 33419

AC MOISTURE-PLEX ADVANCED PF. Hyaluronic Acid Alternative + Potent Moisturizer + Improves Barrier Integrity

ACB Kale Protein Blend Moisturizing + Film-Forming + Nourishing + Conditioning. Tomorrow s Vision Today!

Hyalurosmooth. by Beauty Creations. Natural fine line and wrinkle filler

Workplace Hazardous Materials Information System (WHMIS) Self Learning Package

MicroVue BAP Safety Data Sheet Revision Date: June 8, Section 1 Product and Company Identification. Section 2 Hazards Identification

To assess second-degree burn wound treatment with Water-Jel. Research Associate Professor. Stephen C. Davis Sr. Research Associate

MATERIAL SAFETY DATA SHEET

SAFETY DATA SHEET. SSS Bella Pearlescent Lotion Hand Soap

MATERIAL SAFETY DATA SHEET Kordon Termite Barrier

Coopex Residual Insecticide Other names: None

GELATIN SOLUTION, 5% ph 3.2

Date Printed: 04/16/2008 Date Updated: 01/30/2006 Version 1.6

Percutaneous Absorption: Drugs, Cosmetics, Mechanisms, Methods Download Percutaneous Absorption Drugs Cosmetics...

Consumer Habits and Practices for Formulated Cleaning Products and Personal Care Products

RHA (Resilient Hyaluronic Acid) 10 YEARS OF RESEARCH INTERNATIONAL PATENT SWISS ANTI-AGING EXPERTISE

Experimental Heated, Breathing and Sweating Manikins. Integrating radiant. Fatigue Lab constructs the. losses. military use. of human body heat

EpiCeram Topical therapeutic Skin Barrier Emulsion

BIOGOMM AGE. FM-097B Version 01 / /11

Interaction effects of radiation and convection measured by a thermal manikin wearing protective clothing with different radiant properties

THYME GUARD PAG 1 of 5

Material Safety Data Sheet Attached

MSDS MATERIAL SAFETY DATA SHEET Cu TEST TAIKONG CORP.

COSMETIC INGREDIENTS & PRODUCT SAFETY

CAS-No. EC-No. Index-No. Concentration Benzoin May be harmful if inhaled. May cause respiratory tract irritation.

MATERIAL SAFETY DATA SHEET

MATERIAL SAFETY DATA SHEET

MATERIAL SAFETY DATA SHEET

Safety Data Sheet Cola Fax CPE-K

SAFETY DATA SHEET SECTION 1: IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING. Fight s On Si

EVERYDAY HEROES DESERVE TO COME HOME SAFE

Neither lavender oil nor tea tree oil can be linked to breast growth in young boys

DMPA Dimethylolpropionic Acid in Air Dry Water Soluble Alkyd Resins

SKIN CARE FORMULATION INCORPORATING SODIUM LACTATES, SODIUM PCA AND LAURYL PCA: COMPARATIVE MOISTURISING EFFICACY ON ASIAN SKIN

Optiblot SDS-PAGE Gel

Research & Management Consultancy

(1 rwa. Personal CareNProducts Council. Kristen Hardin. Center for Drug Evaluation and Research, Food and Drug Administration

February 22, Dear Ms. Hardin,

Overview over ongoing ingredient issues

MATERIAL SAFETY DATA SHEET MSDS. Sun Pool Hardness Treatment

Transcription:

Bisphenol A Dermal penetration ti according to OECD TG 428 Dermal penetration of bisphenol A 1

Dermal absorption of BPA Exposure Mainly via ingestion Skin contact is generally considered as marginal Skin contact of cashiers via thermal paper? Precedent results Few studies focused on dermal absorption of BPA Diverging results Dermal penetration of bisphenol A 2

Previous studies Study Year Time Buffer Kaddar Mørck Zalko Marquet 2008 Applied dose n % in perfusate % in skin 2h 0% 3% 5h Physiological serum 0.7 µg 6 0.1% 6.9% 10h 0.7% 11.4% 2009 48h Ethanol 423 µg 11 13% 24.6% 2011 72h Ethanol/ Phosphate buffer Ethanol/ Phosphate buffer 2011 1-30h Acetone 2000 µg 5-11 11.4 µg 3 45.6% 41.5% Skin type pig skin human skin human skin 11.4-3 up to 20.8% 182.4 µg 65.3% pig skin up to 38.6% up to 12.7% in vivo rat skin Method Similar to OECD TG Adapted OECD TG 428 Organ culture in static diffusion cells - Dermal penetration of bisphenol A 3

Aim of the study Determine the dermal penetration rate of BPA according strictly to the OECD guidelines, in conditions as close as possible to reality: Use water as solution, to mimic sweat (composed of ~99% water, 0.5% mineral salts and 0.5% organic compounds) Dose applied in the plausible range: Biedermann (2010): 1.13 µg/finger Dose chosen for the study: 1.82 µg/cm 2 Dermal penetration of bisphenol A 4

Method Method: OECD Guideline 428 for the Testing of Chemicals, Skin Absorption: in vitro method. Performed: by Harlan Laboratories Ltd. at Itingen (CH), under GLP conditions. Skin: Human skin from cadavers. The integrity of the skin has been tested previously. Number of assays: 7 tests Exposure time : 24h Chemical: [ 14 C] Bisphenol A Quantification: By measuring the radioactivity (liquid scintillation) Dermal penetration of bisphenol A 5

Experimental design Federal Department of Home Affairs FDHA Membrane Rinse Application Tape Stripping Full Thickness Skin Tape Strip 1 Tape Strip 2 Tape Strip 3 Tape Strip 4 Tape Strip 5 etc Stratum corneum Skin Membrane 200 µm Skin Membrane Perfusate Interval 0-1 h Interval 1-2 h Interval 2-3 h Interval 3-4 h Interval 4-5h etc. Define the dermal penetration Dermal penetration of bisphenol A 6

Results (1) Dermal penetration of bisphenol A 7

Results (2): Perfusate absorption Dermal penetration of bisphenol A 8

Results (3): in skin Dermal penetration of bisphenol A 9

Comparison with previous studies Study Year Time Buffer Kaddar Applied n % in % in dose perfusate skin Skin type Method Kaddar N et al, 2008 : pig skin, 3%, 6.9% and 11.4% of the 5h Physiological applied dose serum 0.7 µg 6 0.1% 6.9% after 2, 5 and 10h respectively; applied pig skin dose TG: 10h 0.7% 11.4% Morck 2008 FOPH 2012 Mørck Zalko Marquet 2h 8h 0% 3% 5.1% - Marquet F Water et al, 2011 1.16 µg: in vivo 7 (rat) and (rat and 24h 8.6% 35.5% human skin human) 2009 48h Ethanol 423 µg 11 13% 24.6% 2011 72h Ethanol/ Phosphate buffer Ethanol/ Phosphate buffer 11.4 µg 3 45.4% 41.5% 11.4-182.4 µg 2011 1-30h Acetone 2000 µg 5-11 3 up to 65.3% up to 38.6% 20.8% up to 12.7% human skin human skin pig skin in vivo rat skin Similar to OECD OECD TG 428 Adapted OECD TG 428 Organ culture in static ti diffusion cells - Dermal penetration of bisphenol A 10

Negligible exposure by contact? In the EU risk assessment of 2008, 10% skin penetration was taken as no data were available. In this RA, dermal exposure is considered as negligible. Combined with worst-case concentration estimated by Biedermann et al (2010), assuming that up to 1.13 µg/day transferred to each finger, i.e. ~100 µg/day in total, considering the 10 fingers and that larger parts of the hand enter in contact with receipts. 8.6% * 100 µg = 8.6 µg/day passes through the skin TDI : 50 µg/kg bw/day, i.e. 3000 µg/day for a 60 kg person Confirmation that dermal exposure can be considered as marginal in relation to total exposure Dermal penetration of bisphenol A 11

Thanks for your attention! Reference: Demierre A.-L., Peter R., Oberli A., Bourqui-Pittet M. (2012). Dermal penetration of bisphenol A in human skin contributes marginally to total exposure. Toxicology Letters 213:305-308. Dermal penetration of bisphenol A 12