Transcript tolérance produits finis-11-2013 - Laboratoire Bio-HC

TOLERANCE OF FINISHED
COSMETIC PRODUCTS
Study
Test procedure
Delay
Study code
2 weeks
HICV
5 weeks
IC-EP
TOLERANCE FINISHED PRODUCTS
LOCAL TOLERANCE
SKIN IRRITATION
IN VIVO
24 hrs Patch-test under medical or dermatological control
Positive control, negative control
2 readings on 24 and 48 hours
IRRITATION CUTANÉE
SUR ÉPITHÉLIUM
Assessment of irritating potential of
reconstructed epidermis (Episkin Model)
Topic application on the surface of tissues
Contact period : 18-24 hours
OCULAR IRRITATION
2 METHODS
2 alternative methods : Het-CAM+CFIO
▪ on the chorionallantoic membrane of the hen’s egg + SIRC cytotoxicity
3 weeks
IOP
OCULAR IRRITATION
HET-CAM test
Assessment of irritating potential after application on the chorionallantpïc membrane of
the hen’s egg.
OJFR dated December 28 1996 – Decree dated November 29 1996- Annex IV
2 weeks
MCAJO
According to Official Journal of French Republic dated December 30, 1999 – Decree of
December 27, 1999- Annex V
▪ Performed on mouse lung fibroblasts (cell line L929)
2 weeks
AGA
OCULAR IRRITATION
DIFFUSION IN AGAROSE GEL
OCULAR IRRITATION
NEUTRAL RED UPTAKE TEST
OCULAR IRRITATION ON
EPITHELIA
OCULAR CORROSIVITY
finished
product
by
application
on
human
According to Official Journal of French Republic dated December 30, 1999 – Decree of
December 27, 1999- Annex VI
▪ Performed on rabbit cornea fibroblasts (SIRC line)
Assessment of ocular irritating potential of a cosmetic formulation on reconstructed
human corneal epithelia in vitro (HCE Skinethic model).
2 weeks
RNN
5 weeks
IO-HCE
5 weeks
IO-COR
▪ Performed on L929 cell line
Comparison of IC50 with and without UVA irradiations
3 weeks
PTC
▪ Performed on reconstructed epidermis in vitro (liposoluble products)
Comparison of UVA cytotoxicity in control epidermis and treated epidermis
5 weeks
PTCE
J. et al, Proc 6th World Congress on alternatives & animal USE in the life Sciences (August 21-25,2007)
Assessment of corrosive and severe irritant potential for eye –Fluorescein linkage assay
on MDCK cells
According to OECD n° 460
PHOTOTOXIC POTENTIAL - IN VITRO STUDY
PHOTOTOXICITY
BIO-HC – S.A.R.L au capital de 40 000 euros – RCS BX B 408057610 – TVA Intracommunautaire : FR 56 408057610
PA de Magellan – 14 rue Claude Chappe – 33600 PESSAC – Tél : (33)05-57-26-14-30 – Fax : (33)05-57-26-14-31 – E-mail : [email protected]
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TOLERANCE OF FINISHED
COSMETIC PRODUCTS
Study
Delay
Study code
7 weeks
1 series per month
PSHM
7 weeks
1 series per month
PTPA
Test procedure
TOLERANCE FINISHED PRODUCTS
SENSITIZATION POTENTIAL
SENSITIZATION
Methodology proposed by MARZULLI & MAIBACH – Study performed in USA
Prerequisite : Patch-test
▪ Performed in 50 or 100 volunteers
Induction : 3 weeks – rest period : 2 weeks – challenge application : 1 week
PHOTOTOXIC AND PHOTOALLERGIC POTENTIALS
PHOTOSENSITIZATION
Assessment of phototoxicity and photoallergy - Study performed in USA
Studies performed in parallel
Prerequisite : Patch-test
Induction : 3 weeks with UV exposition – rest period : 2 weeks – challenge application : 1 week
TOLERANCE TO REPEATED APPLICATIONS
Body care products
Prerequisite : Patch-test
▪ Applications performed in volunteers under normal conditions of use, study under medical or
dermatological control
4 weeks
(at least)
Option :
Cosmetic qualities +
subjective efficacy (USE)
Face care products
Prerequisite : Patch-test/ acute ocular irritation
▪ Applications performed in volunteers under normal conditions of use, study under medical /
dermatological / ophthalmological control
▪ Application of product on the cubital fossa during 1 week + application on the target zone during a
definite period
4 weeks
(at least)
CUBITAL FOSSA TEST
▪ Performed in volunteers. Applications on cubital fossa
NORMAL CONDITIONS OF
USE
USE-T
HIT-USE
4 weeks
(at least)
HIT
7 weeks
PC
COMEDOGENIC POTENTIAL
COMEDOGENICITY
Prerequisite : Patch-test/ acute ocular irritation
▪ Performed in volunteers, under medical or dermatological control
Application 1 week on the cubital fossa
Application 4 weeks on the face
Counting of inflammatory and retentional elements
BIO-HC – S.A.R.L au capital de 40 000 euros – RCS BX B 408057610 – TVA Intracommunautaire : FR 56 408057610
PA de Magellan – 14 rue Claude Chappe – 33600 PESSAC – Tél : (33)05-57-26-14-30 – Fax : (33)05-57-26-14-31 – E-mail : [email protected]
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TOLERANCE FINISHED PRODUCTS
TOLERANCE OF FINISHED
COSMETIC PRODUCTS
Delay
Study Code
TOLERANCE OF PRODUCTS
FOR BUCCAL HYGIENE
▪ Performed on in vitro reconstituted human oral epithelium (Epi Oral Tissue Model, MatTek)
1 control group/1 treated group/1 group treated with a market benchmark
Application of product onto the epithelia
3 contact times
Determination of ET50
5 weeks
MJE
TOLERANCE OF PRODUCTS
FOR NASAL HYGIENE
▪ Performed on in vitro human nasal epithelium (EpiAirway epithelium Model, MatTek) reconstituted
from bronchial and tracheal epithelial cells
1 control group/1 treated group/1 group treated with a market benchmark
Application of product onto the epithelia
3 contact times
Determination of ET50
5 weeks
MNE
TOLERANCE OF PRODUCTS
FOR INTIMATE HYGIENE
▪ Performed on human vaginal-ectocervical tissue model (modèle EVTM=EpiVaginal Tissue Model)
1 control group/1 treated group/1 group treated with a market benchmark
Application of product onto the epithelia
3 contact times
Determination of ET50
5 weeks
MVE
Study
Test procedure
*Notes :
Concerning Volunteers assays :
• Tolerance assays involving repeated applications (USE-T or HIT-USE) may be associated to a subjective or an objective assessment of efficacy
BIO-HC – S.A.R.L au capital de 40 000 euros – RCS BX B 408057610 – TVA Intracommunautaire : FR 56 408057610
PA de Magellan – 14 rue Claude Chappe – 33600 PESSAC – Tél : (33)05-57-26-14-30 – Fax : (33)05-57-26-14-31 – E-mail : [email protected]
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