Medical Equipment & Supplies
HYDROCYN aqua® Biocompatibility Test
HYDROCYN aqua® has gone through biocompatibility study in various labs to show it is safe and biocompatible on human cells.
The table below shows the biocompatibility test results for HYDROCYN aqua® which demonstrates compliance with ISO 10993-1(Reference number ISO 10993-1:2009(E)) & OECD
The table below shows the biocompatibility test results for HYDROCYN aqua® which demonstrates compliance with ISO 10993-1(Reference number ISO 10993-1:2009(E)) & OECD
| No | Report Title | Assessment / Result |
|---|---|---|
| 1 | ISO Acute Dermal Toxicity Study (ISO 10993- 11:2010(E)) |
No lethal or adverse toxic effects demonstrated |
| 2 | ISO In Vivo Studies: Intracutaneous Reactivity Test (ISO 10993- 10:2010(E)) |
No evidence of erythema or oedema was observed |
| 3 | ISO In Vivo Studies: Primary Skin Irritation Test (ISO 10993- 10:2010(E)) |
No irritation responses noted or considered negligible |
| 4 | ISO Genotoxicity Studies: In vitro Micronucleus Assay (ISO 10993- 3:2010(E)) |
Did not induce any significant micronucleus formation and is non-clastogenic |
| 5 | ISO Cytotoxicity Studies: MTT Assay (ISO 10993- 5:2009(E)) |
No Cytotoxic effect shown on mammalian cell line |
| 6 | ISO Skin Sensitization Study-Guinea-Pig Maximization Test Extract – Freunds Complete Adjuvant and distilled water (DIN EN ISO 10993- 10:2007(E)) |
No delayed dermal contact on test species shown |
| 7 | ISO Ocular Irritation Study in Rabbits (DIN EN ISO 10993- 10:2007(E)) |
No irritation shown in the treated eyes. Test article is non-irritant |
| 8 | ISO Vaginal Irritation Study in Rabbits (DIN EN ISO 10993- 10:2007(E)) |
No vaginal irritation was observed on test species |
| 9 | ISO Acute Oral Toxicity Study in Rodents (ISO 10993- 11:2010(E)) |
Did not cause any lethal effects in rats when administered orally |
| 10 | ISO Acute Inhalation Toxicity Study (OECD guideline No.403 (Tradition Protocol); adopted on September 07, 2009) | Did not cause any lethal effects/abnormalities in Wistar rats when administered by nose only inhalation route |
HYDROCYN aqua® Antimicrobial Effectiveness Study
HYDROCYN aqua® showed to have reduced microbial growth population of Bacillus subtilis, Candida albicans, Clostridium difficile, Enterococcus faecalis VRE, Mycobacterium bovis, Staphylococcus aureus MRSA, Trichophyton mentagrophytes, Gardnerella vaginalis and Sprothrix schenckii more than 95% following 10 minutes exposure.
This shows that HYDROCYN aqua® solution exhibits an effective antimicrobial activity by inhibiting growth of microorganisms.
This shows that HYDROCYN aqua® solution exhibits an effective antimicrobial activity by inhibiting growth of microorganisms.
| Microorganism Species | Percent Reduction |
|---|---|
| Bacillus subtilis | 99.9996% |
| Candida albicans | 99.9999% |
| Clostridium difficile | 99.9976% |
| Clostridium sporogenes | 98.4471% |
| Enterococcus faecalis VRE | 99.9999% |
| Mycobacterium bovis | 99.9998% |
| Staphylococcus aureus MRSA | 99.9999% |
| Trichophyton mentagrophytes | 99.9999% |
| Gardnerella vaginalis | 99.9999% |
| Sporothrix schenkii | 99.9999% |