D-gluconic acid: genetic toxicity: in vitro: 006 key | experimental result
HERO ID
4940238
Reference Type
Technical Report
Year
2015
Language
English
| HERO ID | 4940238 |
|---|---|
| Year | 2015 |
| Title | D-gluconic acid: genetic toxicity: in vitro: 006 key | experimental result |
| Authoring Organization | European Chemicals Agency |
| Publisher Text | ECHA |
| City | Helsinki, Finland |
| Abstract | Aim: The investigation of a genotoxic activity of the test item Gluconic acid technical 50/50 (batch SX4G6)provided by Members of the Gluconic Acid and its Derivatives REACH Consortium has been carried out in compliance with the OECD Guideline 473 (2014), using test for chromosome aberration by in vitro human lymphocyte metaphase analysis. Methods: In the experimental conditions with metabolic activation (5% of S9-mix) or without metabolic activation (4-hour treatment), no cytotoxicity was noted at the highest concentration tested of 10 mM, with 103.6 and 88.4% of mitotic index compared to the control, respectively. The concentration of 10 mM was retained as the maximum concentration to be tested in the assay with 5% of S9-mix and without metabolic activation following the 4-hour treatment. In return, when using a 20-hour treatment, a strong cytotoxicity was noted at the highest concentration tested of 10 mM, with 21% of mitotic index compared to the control. The immediately lower concentration of 5 mM induced a moderate cytotoxicity, with 63.8% of mitotic index compared to the control. Under these conditions, the concentration of 10 mM was retained as the maximum concentration to be tested in the assay without metabolic activation following the 20-hour treatment, but a narrowed range of concentrations was performed in order to reach a concentrations inducing 55±5% of cytotoxicity. Results: The test item Gluconic acid technical 50/50 did not induce any statistically significant increases in the frequency of aberrant cells excluding or including gaps or in the number of breaks per cell in the 4- hour treatment and in the 20-hour treatment without metabolic activation and in the 4-hour treatments with 5 % of S9-mix in human lymphocytes. Otherwise, no statistically significant increases in the number of cells with numerical aberrations were noted both with and without metabolic activation using a long or a short-term treatment. |
| Url | https://echa.europa.eu/registration-dossier/-/registered-dossier/1957/7/7/2/?documentUUID=1be65162-91b3-466f-9c09-72709930f84c |
| Is Certified Translation | No |
| Dupe Override | No |
| Number Of Pages | 8 |
| Is Public | Yes |
| Language Text | English |