Division (a) Absorption after dermal exposure

United Kingdom

The dermal absorption^f1 of a substance in a product is dependent on both intrinsic factors (e.g. LogPow, molecular weight) and its behaviour in the vehicle. Dermal in vivo human absorption of a substance can be estimated using the data from existing in vivo animal studies and in vitro studies on animal and human skin. When no measurement data are available and no absorption rate can be determined using a scientifically valid in silico method or default absorption rates, a worst case value of 100 % should be used for calculation of the systemic exposure^f2. In case MW > 500 Da and log Pow is smaller than – 1 or higher than 4, a value of 10 % dermal absorption can be considered.

Annotations

Footnotes

f1: Basic criteria for the in vitro assessment of dermal absorption of cosmetic ingredients (SCCS/1358/10).
f2: SCCS Notes of Guidance, para 3-7.2, p. 49.

Notes on Division 3

Footnotes

f1: The SCCS’s Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation, 8^th 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.

Notes on Division 3.8.3

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.