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EC number: 245-842-1 | CAS number: 23726-91-2
Table 7.6.1/2: Preliminary Toxicity Test
WP2 uvr A
*: Partial absence of bacterial background lawn
See the attached document for information on tables of results – mutagenicity test
In a reverse gene mutation assay performed according to the OECD test guideline No. 471 and in compliance with GLP, strains of Salmonella typhimurium (TA 1535, TA 1537, TA 98 and TA 100) and Escherichia coli WP2 uvr A were exposed to the test material diluted in DMSO using the plate incorporation method. The dose range for the range-finding test was determined in a preliminary toxicity assay and was 50 to 5000 and 5 to 5000 μg/plate for WP2uvrA-and the Salmonella strains respectively. The experiment was repeated on a separate day using an amended dose range (15 to 5000 µg/plate), fresh cultures of the bacterial strains and fresh test material formulations. Negative, vehicle (DMSO) and positive control groups were also included in mutagenicity tests.
The vehicle control plates gave counts of revertant colonies within the normal range. All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies, both with or without metabolic activation. Thus, the sensitivity of the assay and the efficacy of the S9-mix were validated. The test material caused a visible reduction in the growth of the bacterial background lawn to all of the Salmonella strains both with and without S9 from 1500 μg/plate, although less toxicity was observed to TA 98. However, no toxicity was noted to E.coli strain WP2uvrA- at any test material dose level. The test material was tested up to the maximum recommended dose level of 5000 μg/plate. No test material precipitate was observed on the plates at any of the doses tested in either the presence or absence of S9-mix.No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, at any dose level either with or without metabolic activation.
Under the test condition, the test material is not mutagenic with and without metabolic activation to S. typhimurium (TA 1535, TA 1537, TA 98 and TA 100) and E. coli WP2 uvr A according to the criteria of the Annex VI of the Regulation (EC) No. 1272/2008 (CLP).
This study is considered as acceptable and satisfies the requirement for reverse gene mutation endpoint.
Table 7.6/1: Summary of genotoxicity tests
Test / Guideline
K, rel. 1
E. coli WP2
Up to limit concentration
-S9 : non mutagenic
+S9 : non mutagenic
Gene mutation Assay (Test n° 1):
A Bacterial Reverse mutation Assay (Ames test) was performed according to OECD guideline No. 471 with the substance (See Table 7.6/1). No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains under the test condition, with any dose of the substance, either in the presence or absence of metabolic activation. The substance does not induce gene mutations in bacteria whereas all positive control chemicals (with and without metabolic activation) induced significant increase of colonies. The substance is therefore considered as non-mutagenic according to the Ames test.
The test material has no harmonized classification for human health according to the Regulation (EC) No. 1272/2008 including ATP6.
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