Safety Assessment

The good tolerance of ICHTHYOL® PALE has been verified in numerous toxicological studies. ICHTHYOL® PALE showed itself to be well-tolerated both in short-term as well as long-term administration. There was no evidence of any teratogenic, mutagenic or cancerogenic properties.

The safety of a raw material such as ICHTHYOL® PALE is best illustrated by calculating the safety factor.

A safety factor of at least 100 is generally recognized for substances which are subject to the German Federal Food Law, meaning that there is an interval of a factor of 100 between the no-effect-level (NOEL), found in animal experiments, and the respective quantity of substance which, when applied as intended and applied correctly, under the most unfavourable conditions can have an effect on humans or will be absorbed by the body.

ICHTHYOL® PALE can be used in both rinse-off as well as in leave-on products. Since these two product groups are to be evaluated differently regarding availability and penetration of the active substance, two safety factors are determined for ICHTHYOL® PALE referring to the highest possible exposure. With hair shampoo (rinse-off) and body lotion (leave-on) as formulation examples, the following safety factors – clearly above the required minimum value of 100 – result for the active ingredient ICHTHYOL®.

Formulation Safety Factor (reference value: ≥ 100)
Shampoo (rinse-off) 230.769
Body Lotion (leave-on) 1.730

ICHTHYOL® PALE can, therefore, be classified as a safe active substance in accordance with the new EC-Directive for Cosmetics.