LAB - Expt. 2

Article 8 of the ASEAN Cosmetics Directive

requires an “assessment of the safety for human health of the finished product, its ingredients, its chemical structure and its level of exposure”

Safety Assessor

The safety assessment is to be performed by a qualified

professional defined as the ______

Article 3 of the ASEAN Cosmetic Directive

As per this provision, the cosmetic product put on the market must not cause damage to the human health when applied under normal or reasonably foreseeable condition of use taking into account…

• skin irritation

• skin sensitization

As far as skin is concerned, the two main untoward reactions to be avoided are _____ and _____

environmental factors

Cosmetic products are often applied on areas exposed to ______

• photo irritation

• photosensitization

photo-induced reactions (2)

eye tolerance

has to be addressed with optimal attention as a major component of the safety assessment for a cosmetic product

Systemic toxicity

may result from percutaneous absorption or from accidental (children) or reasonably foreseeable (e.g. oral hygiene products, lipsticks) oral intake should also be considered

Cosmetic ingredients

mostly chemicals and often mixtures of chemicals of synthetic origin or natural extracts.

careful selection of ingredients

key issue for ensuring the safety of the finished product

structure

The ______ of the chemical determines its chemical and biological reactivity

• cosmetic interest

• safety

In terms of chemical structure, it has to be considered from two points of view (2)

in vitro

Skin penetration can be assessed using ____ methods

toxicological profile of a raw material

obtained by analyzing available data, published or not, concerning the raw material

suppliers

main sources of toxicological data on ingredients

International Fragrance Association

IFRA stands for?

manner of use

This factor is most important since it determines the amount of substance which may be absorbed through the skin or mucous membranes, or ingested or inhaled.

Local tolerance

largely depends on the whole formulation

Bovine Cornea Opacity and Permeability Test;

BCOP stands for?

Fluorescein Leakage Test

FLT stands for?

Trans Epithelial Permeability

TEP stands for?

Hen’s Egg Test - Chorioallantoic Membrane

HET-CAM stands for?

RBC - Red Blood Cell Test

RBC test stands for?

Tissue Equivalent Assay

TEA stands for?

• analysis

• exposure

modern approach to safety assessment is based on a thorough ____ of available data and conditions of _____

Safety Assessor

should possess qualification in relevant fields for example a diploma in the field of pharmacy, toxicology, dermatology, medicine or a similar discipline and be suitably trained in the safety assessment of cosmetics