M Cellulon was not cytotoxic in either mutation assay (with or without the need of S9 metabolic activation) within the array of tested concentrations. The mutant frequencies of treated cultures varied randomly with Cellulon dose, within the variety acceptable for background mutant frequencies which is much less than 15 10-6. In the 14 cultures treated with Cellulon, only a single culture, within the activation mutation assay, had a mutant frequency that was B7-H3/ICOSLG Protein HEK 293 statistically elevated more than the mutant frequencies on the concurrent automobile handle cultures. This observation is constant with normal variation in background mutant frequency in independent cultures. As a result, BC was regarded adverse for inducing forward mutations in the HGPRT locus in CHO cells beneath both nonactivation and S9 metabolic activation circumstances. five.six. Limulus amebocyte iysate (LAL) assay Schmitt et al. [28] assayed the pyrogenicity of BC in Cellulon by utilizing the Limulus amebocyte Iysate (LAL) assay (Table three). As negativeTable 3 Summary from the genotoxicity reproductive toxicology studies with bacterial cellulose. Dosages Major final FGF-8f Protein Human results Ref.F. Dourado et al.Sort of studyCell line/animal modelIn vitro Comet assay Assay: 0.1, 0.five or 1 mg BC/ml Optimistic control: hydrogen peroxide (100 mM) DNA damages within the presence of BC fibres are related towards the unfavorable handle for each and every BC concentration; About 95 of cells showed none or insignificant DNA damage (comet class 0 and 1) BC didn’t result in an increase in the quantity of histidine revertants (mutations) per plate in any bacterial strain, either within the presence or absence of S9 microsomal enzymesChinese hamster ovary (CHO) cellsMoreira et al. [31]Ames testSalmonella typhimurium (TA 89, TA one hundred, TA 1535, TA 1537, TA 1538) with and with no metabolic activationNegative manage: water Assay: 0, 66.7, one hundred, 333, 667, 1000, and 2500 g/plateSchmitt et al. [28]Salmonella tryphimurium (TA97a, TA98, TA100 and TA102) Adverse manage: distilled waterPositive controls utilised without having metabolic activation: 2-nitrofluorene (TA 98, TA 1538) sodium azide (TA 100, TA 1535) ICR-191 with TA 1537 Constructive controls with metabolic activation: 2- aminoanthracene was used with all strains Assay, with and with out S9 mixture: 0.1, 0.five or 1.0 mg BC/mlThe results obtained, inside the presence of BC with out S9 mixture, correspond to spontaneous reversion for each and every strain and are related to these obtained to damaging manage; Inside the presence of S9 mixture, a rise of revertant colonies per plate, for the TA98 and TA100 strains, was detected as compared with control; having said that, the increases were in each case 2-fold and did not appear to become dose-relatedMoreira et al. [31]Positive controls devoid of S9: 9-fluorenone, sodium azide, mitomycin C; Positive controls with S9: 1,8-dihydroxy anthraquinone, 2-amino fluorine Assay: 0.333 g/ml to 10,000 g/ml Cellulon in McCoy’s Sa culture medium Good controls: mitomycin C, nonactivation series; cyclophosphamide, metabolic activation series Assay: replacement with the culture media with 2,five mL WMEI with 10 Ci/ml 3H-thymidine (50 Ci/ mmol), BC (501, 1000, 2000, 3010, 4010, and 5010 g/ml) Constructive controls: (2- acetylaminofluorene) Negative manage: WMEI with ten pCi/ml 3H-TdR, WMEI with sucrose Assay with and with out S9 metabolic activation: BC at 0.098-5.0 mg/ml, in F12 culture medium Adverse handle: Sucrose Constructive handle: (nonactivation assay, 5-bromo-2 deoxyuridine (BrdU) Metabolic activation: 3-methylcholanthreneS. typhimurium (TA97, TA98, TA10.