Sodium perchlorate

Endpoint summary

Additional information

Bacterial reverse mutation test with recommended Salmonella typhimurium tester strains.

The evaluation of the toxicity was performed on the basis of the observation of any decrease in the number of revertant colonies and any thinning of the bacterial lawn using five strains of the bacteria. No noteworthy increase in the number of revertants, which could be considered to be biologically significant, was noted in any tester strains, in any experiments, with and without a metabolic activation system (S9 mix). Under the experimental conditions, Anhydrous Sodium Perchlorate did not show any mutagenic activity in the bacterial reverse mutation test with recommended Salmonella typhimurium tester strains.

Mammalian cell gene mutation test using L5178Y mouse lymphoma cells

After a preliminary toxicity test, Anhydrous Sodium Perchlorate was tested in two independent experiments, in the absence and presence of a rat liver metabolising system (S9 mix). Cytotoxicity was measured by assessment of adjusted relative total growth (Adj. RTG) and relative suspension growth (Adj. RSG) as well as cloning efficiency following the expression time (CE2). The number of mutant clones (differentiating small and large colonies) were checked after the expression of the mutant phenotype. Using a treatment volume of 100 μL/20 mL, the selected dose-levels were 156.3, 312.5, 625, 1250, 2500 and 5000 μg/mL for both mutagenicity experiments with and without the S9 mix. Following the 3-hour treatment and the 24-hour treatment without S9 mix, no noteworthy cytotoxicity was found. Similarly there was no evidence of mutagenicity, either following either the

3-hour or the 24-hour treatment. Experiments with the S9 mix revealed no noteworthy cytotoxicity in the first experiment but the second experiment showed evidence of slight toxicity at the highest dose level (5000 µg/mL), shown by a 39% decrease in Adj. RTG. However, there was no significant mutation frequency noted following the 3-hour treatment in either experiment. Under the experimental conditions, the test item did not show any mutagenic activity in the mouse lymphoma assay.

Chromosome aberrations in cultured human lymphocytes.

The test item was tested in two independent experiments, both with and without a liver metabolizing system (S9 mix), obtained from rats previously treated with Aroclor 1254. Under the experimental conditions, anhydrous sodium perchlorate did not induce chromosome aberrations in cultured human lymphocytes.

Short description of key information:
Sodium Perchlorate was investigated in a reverse mutation test on Salmonella typhimurium in accordance with OECD guideline No. 471 and EU
Method B.13/.14; in a chromosome aberration test according to OECD guideline no. 473 and EU method B.10 and in an in vitro mammalian cell
gene mutation test according to OECD no. 476 and EU method B.17.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

According to EU regulation (EC) No 1272/2008 (CLP) andEU Directive 67/584/EEC, anhydrous sodium perchlorate is not classified for mutagenicity.

Justification : Under the experimental conditions, Anhydrous Sodium Perchlorate did not show any mutagenic activity in the bacterial reverse mutation test with recommendedSalmonella typhimuriumtester strains. The test substance also failed to show any mutagenic activity in a mammalian cell gene mutation test using L5178Y mouse lymphoma cells and did not induce chromosome aberrations in cultured human lymphocytes. For all three tests the test item was tested in two independent experiments, both with and without a liver metabolizing system (S9 mix).