Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

A reliable Bacterial Reverse Mutation Assay was performed with J-37 according to OECD Guideline 471 in Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and Escherichia coli WP2 uvr A (Mi-Young, 2010). The following test concentrations were used:

0, 1.60, 3.20, 6.40, 12.8, 25.8 and 51.2 µg/plate = +S9

0, 62.5, 125, 250, 500, 1000 and 2000 µg/plate = -S9

The vehicle used was DMSO. The mean number of revertant colonies was less than twice compared to the negative control values at all dose levels of the test substance in the absence and presence of metabolic activation, without dose-related increase.

The growth inhibition was evident at 51.2 µg/plate in TA98 and TA100 strains, more than 64.0 µg/plate in TA1535 stains and 128 µg/plate in the TA1537 strain without metabolic activation. The background lawn could not be observed at 800 and 400 µg/plate of WP2uvrA (pKM101) strains without metabolic activation and any strains with metabolic activation at which deposition was not evident.

The deposition of the test substance was evident greater than 400 and 1000 µg/plate in WP2uvrA (Pkm101) strain without metabolic activation and all strains with metabolic activation, respectively. However, the deposition did not interfere with the colony counting.

Based on the results of this study, the test substance did not exhibit any indications of mutagenic potential under the conditions of this study. 


Short description of key information:
A key mutagenicity study (Ames test) with J-37 showed no mutagenicity effect in bacteria.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

According to DSD and CLP classification criteria for mutagenicity, no classification is required for J-37.