Directa Plus is the first company in the world in its field to have conducted, since 2015, and published the results of a series of toxicology screening tests to independently certify the non-toxicity and non-cytotoxicity of its products. For the categories listed below, we have received certifications for both our Basic G+®/Grafysorber® and Pure G+® (pristine graphene nanoplatelets) products.
◦ EYE IRRITATION
◦ SKIN CORROSION
◦ SKIN IRRITATION
◦ REPRODUCTIVE TOXICITY
◦ SENSITIZING POTENTIAL
◦ Mucosal tolerability on alveolar epithelium
The results of cell viability test in tissues treated with Pure G+® for 6 and 24 hours classify Pure G+® as NON-IRRITANT product. The assay of the pro-inflammatory cytokine TNFalpha shows that tissues treated with PURE G + did not show statistically significant changes in the release of TNFalpha compared to CTR- (p> 0.05 vs CTR-) and therefore no inflammatory reactivity was highlighted.
◦ Skin Absorption
Pure G+® was applied on tissue surface for 6 and 24 hours. At the end of the experimental time, the calculation of the quantity of graphene penetrated through the epidermis was presented.
Collected experimental data does not show any absorption risk potential for G+®: no statistical differences were recorded among the control conditions and treated ones.
◦ Analysisi of the ecotoxic potential of Grafysorber
The aim of the test is to determine the ecotoxic effects of products in biological systems. In particular, a growth inhibition test on the alga Pseudokirchneriella subcapitata was conducted according to OECD 201 and the ISO8692 guidelines. Grafysorber G+® showed to have no ecotoxic potential.
Safety measures & procedures
We have adopted the following safety measures and procedures for our entire G+® production process in order to minimise risk:
◦ The G+® production units are contained within chambers equipped with air conditioning, aspiration and filtering systems. The chambers also guarantee a thermal and acoustic barrier
◦ The air filtration system ensures the expulsion of process gases and guarantees a high air renewal rate
◦ All staff members attend safety courses. They are equipped with the best individual protection devices available on the market and follow procedures that are continually updated to guarantee maximum safety
◦ The Expansion unit of our production plant is CE certified, and we are working towards receiving CE certification of the entire production plant and for our production processes
We also continually monitor the following safety aspects of our G+® production process:
◦ The characteristics of the nanomaterial
◦ Possible localised emissions or the spread of acid derived from intercalated graphite
◦ Possible localised emissions or the spread of crystalline silica
◦ Identification of the presence of other potentially, directly or indirectly, dangerous substances.
Our textile products containing Graphene Plus are certified Dermatologically Tested and Hypoallergenic,
to assure their complete safety for contact with human skin.
We have conducted two new tests related to G+® print on fabrics at IOM Safenano, an independent British institute of scientific excellence in the areas of health, safety at work and the environment.
The new analyzes (abrasion and bioelution tests) confirm the absence of release of graphene nanoplatelets related to wear of the garment and sweat.