Seven selected parabens (4 allowed, 3 banned in cosmetics) were tested in order to confirm and expand historical data on their toxicological properties and safety. The aim was to apply novel in vitro methods, which have been sufficiently technically and scientifically validated for the purposes of toxicological testing of chemicals. The study included several toxicological endpoints such as skin/eye irritation, skin sensitization, endocrine disruption and genotoxicity. The battery of selected methods comprised regulatory accepted EpiDermTM skin model (OECD TG 439); EpiOcularTM corneal model (OECD TG 492) and scientifically valid test method HET-CAM (DB-ALM Protocol No. 47); in chemico test DPRA (OECD TG 442C); in vitro test LuSens (OECD TG 442D) and in vitro test h-CLAT (OECD TG 442E); Ames MPFTM (Xenometrix) and XenoScreen YES/YAS (Xenometrix). Overall, none of the 4 allowed parabens exhibited skin/eye irritation or genotoxicity. However, all allowed parabens in cosmetics were predicted as samples with potentially sensitizing properties in the LuSens and h-CLAT test methods, but not confirmed by DPRA. Endocrine disruption was recorded only at high concentrations, whereas methyl paraben and ethyl paraben exhibited the lowest activity. This study confirmed the safety of use of the allowed parabens in the highest recommended concentrations in cosmetics or pharmaceuticals.
- MeSH
- alternativy testů na zvířatech * metody MeSH
- kosmetické přípravky * toxicita MeSH
- kůže MeSH
- parabeny toxicita MeSH
- techniky in vitro MeSH
- zvířata MeSH
- Check Tag
- zvířata MeSH
- Publikační typ
- časopisecké články MeSH
As resistance of bacterial strains to antibiotics is a major problem, there is a need to look for alternative treatments. One option is antimicrobial photodynamic inactivation (aPDI). The pathogenic cells are targeted by a nontoxic photosensitizer while the surrounding healthy tissue is relatively unaffected. The photosensitizer is activated by light of t appropriate wavelength resulting in the generation of reactive oxygen species that are cytotoxic for the pathogens. In this work, the photosensitizer TMPyP and silver nanoparticles (AgNPs) were investigated for their synergistic antibacterial effect. We tested these two substances on two bacterial strains, methicillin-resistant Staphylococcus aureus 4591 (MRSA) and extended-spectrum beta-lactamases-producing Klebsiella pneumoniae 2486 (ESBL-KP), to compare their effectiveness. The bacteria were first incubated with TMPyP for 45 min or 5 h, then irradiated with a LED source with the total fluence of 10 or 20 J/cm2 and then placed in a microbiological growth medium supplemented with AgNPs. To accomplish the synergistic effect, the optimal combination of TMPyP and AgNPs was estimated as 1.56-25 μM for TMPyP and 3.38 mg/l for AgNPs in case of MRSA and 1.56-50 μM for TMPyP and 3.38 mg/l for AgNPs in case of ESBL-KP at 45 min incubation with TMPyP and fluence of 10 J/cm2. Longer incubation and/or longer irradiation led to a decrease in the maximum values of the photosensitizer concentration to produce the synergistic effect. From this work it can be concluded that the combination of antimicrobial photodynamic inactivation with a treatment including silver nanoparticles could be a promising approach to treat bacterial infection.
- MeSH
- antibakteriální látky farmakologie MeSH
- antiinfekční látky * farmakologie MeSH
- fotochemoterapie * metody MeSH
- fotosenzibilizující látky farmakologie MeSH
- Klebsiella pneumoniae MeSH
- kovové nanočástice * MeSH
- methicilin rezistentní Staphylococcus aureus * MeSH
- porfyriny * farmakologie MeSH
- rezistence na methicilin MeSH
- stříbro farmakologie MeSH
- Publikační typ
- časopisecké články MeSH
Medical devices must be tested before marketing in accordance with ISO EN 10993-10 in order to avoid skin sensitization. This standard predominantly refers to the in vivo test but does not exclude the use of in vitro methods that have been sufficiently technically and scientifically validated for medical device testing. It is foreseen that, due to the complexity of the sensitization endpoint, a combination of several methods will be needed to address all key events occurring in the sensitization process. The objective of this pilot study was to evaluate the sensitization potential of selected medical devices using a combination of in chemico (DPRA, OECD TG 442C) and in vitro (LuSens, OECD TG 442D) methods in comparison with the in vivo (LLNA DA, OECD TG 442A) method and to suggest a possible testing strategy for the safety assessment of medical device extracts. Overall, one of the 42 tested samples exhibited positive results in all employed test methods, while 33 samples were predicted as non-sensitizing in all three performed methods. This study demonstrated good agreement between in vitro and in vivo results regarding non-sensitizing samples; however, some discrepancies in positive classification were recorded. A testing strategy is suggested in which negative results are accepted and any positive results in the in chemico or in vitro tests are followed up with a third in vitro test and evaluated in accordance with the “2 out of 3 approach”. This strategy may reduce and replace animal use for testing the sensitization potential of medical devices.
- MeSH
- alergická kontaktní dermatitida * MeSH
- alternativy testů na zvířatech * MeSH
- biotest MeSH
- kůže MeSH
- pilotní projekty MeSH
- techniky in vitro MeSH
- zvířata MeSH
- Check Tag
- zvířata MeSH
- Publikační typ
- časopisecké články MeSH
