Division 3.8.3 Consideration of all the significant routes of absorption
United Kingdom
Dermal, oral and inhalation routes of exposure are potentially relevant for human exposure to cosmetic products. It is essential to calculate the systemic exposure in order to compare it with the relevant NOAEL. The ratio between these two is defined as the margin of safety, which is an indicator of whether the product can be considered safe or not (see also section 3.8.4 and following).
Absorption is linked to the bioavailability of a substance, and is essential for calculating the margin of safety. Systemic exposure can be calculated as:
Absorption can occur through several external routes: dermal, oral and inhalation.
If the intended exposure for the cosmetic product is not in line with the route of exposure in the safety data, route-to-route extrapolation should be considered.
In addition, there may also be a possibility of secondary inhalation exposure where cosmetic products contain volatile substances which can be inhaled unintentionally in the case of direct use, e.g. toluene in nail polish, various substances contained in nail modelling gels, etc.
- (a)Absorption after dermal exposure
- (b)Absorption after oral exposure
- (c)Absorption after inhalation
Annotations
Footnotes
- f1
-
I.e.‘the systemically available dose that passes the relevant physical barriers (gastro-intestinal, skin or lung structures) and becomes available in the blood stream for subsequent distribution to tissues and organs’, ref. M. Pauwels, V. Rogiers, p. 262.
Notes on Division 3
Footnotes
- f1
-
The SCCS’s Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation, 8th Revision, SCCS/1501/12, and its subsequent updates.
Notes on Division 3.8
Footnotes
- f1
-
M. Pauwels, V. Rogiers, Human Health Safety Evaluation of Cosmetics in the EU: A Legally Imposed Challenge to Science, Toxicology and Applied Pharmacology, 243 (2010), p. 261.
- f2
-
Communication from the Commission to the European Parliament and the Council on the animal testing and marketing ban and on the state of play in relation to alternative methods in the field of cosmetics, COM(2013) 135 final.