A strategy consisting of a preliminary in vitro in vitro test with the Dermal irritection® method and a subsequent skin testwith the use of Patch tests at 48 hours of exposure on 12 volunteers.
- Get more comprehensive results for the product safety evaluator.
- Reduce the time needed to obtain information: the preliminary result provides important information within a few days.
- Reduce the number of volunteers in the analysis laboratory to a minimum. They will be better protected, reducing the possibility of infection by Covid-19.
The testing strategy
Normally, in the EU Commission’s guidelines for good laboratory practices, a preliminary in vitro test is required before performing Patch Tests on volunteers.
Our preliminary in vitro test is not a simple cytotoxicological test, but a real in vitro skin irritation test, based on a solid scientific basis, and with sustainable time and cost savings.
The subsequent dermatological test will then serve to provide additional information and can be conducted on a small number of volunteers, given that they will be kept under exam for 48 hours, with the same reliability as if the test had been executed with a bigger volunteer pool.
The strategy says that:
– If the result of the preliminary is “non-irritant”the test on volunteers can be executed for confirmation purposes.
– If the result is clearly “irritant” it will not be necessary to continue the testing on volunteers.
– if the result is “borderline” , in case of products that can be placed on the market even if they have a moderate to medium degree of irritation, the volunteer test will be used to investigate the degree of irritation.