Name: Rapan Mud
The following Safety Assessment is carried out according
to the Council Directive 76/768/EEC, on the Safety of Cosmetic
Products and as amended by Commission Directives 2003/15/EC
(7th Amendment), 2003/83/EC (30th Amendment), and 2003/80/EC
The Assessment is conducted in accordance with the principles of Good Laboratory Practice referred to in Article 1 of Council Directive 2004/ 10/EC on the applications of the principles of good laboratory practice and the verification of their application for tests on chemical substances.
This assessment takes account of:
a) the general toxicological profile of each ingredient used:
b) the chemical structure of each ingredient:
c) the level of exposure of each ingredient;
d) the specific exposure characteristics of the areas on which the cosmetic product will be applied;
e) the specific exposure characteristics of the class of individuals for whom the cosmetic product is intended.
Review of Ingredients.
All of the ingredients have a history of use in cosmetic and toiletry products. Ingredients that are:
o Prohibited under the Cosmetics Directive
o Restricted when used beyond the allowed authorised conditions
o With toxicological data incompatible with the intended concentration and use
o Which have insufficient toxicological data nor safety in use experience
o Which are not properly characterised with regard to purity and analytical composition.
Assessment is based on ingredient safety review and information on the final formulation.
Ingredient Safety Review
Ingredients are listed below. Detailed information on the safety and toxicology of ingredients is held on file by Innovant Research Ltd.
Maris sal (sodium chloride, natural lake salt)
The above ingredients have been reviewed for potential to be skin irritants, sensitisers or photo-sensitisers
In addition in some instances data is available for systemic and sub-chronic toxicity
A review of the literature and of the structural chemistry has been made for each ingredient to estimate the likely potential for genotoxicity, reproductive effects and carcinogenicity. Taking the above into account and taking the safety data on file, it is considered that this formulation is safe for marketing.