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Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Three in vitro genotoxicity/mutagenicity studies were conducted on the test article. The results of the studies are:

OECD 471: Negative with and without metabolic activation.

OECD 487: Negative with and without metabolic activation.

OECD 490: Negative with and without metabolic activation.

The mutagenicity potential of MTDID 44430 was evaluated in the bacterial reverse mutation assay (Ames assay).  The study was conducted according to OECD 471 (1997) in compliance with OECD GLP. S. typhimurium strains TA98, TA100, TA1535, and TA1537 and E.coli strain WP2 uvrA were utilized in the presence and absence of metabolic activation (Aroclor 1254 -induced rat liver S9 mix). A stock solution of MTDID 44430 was prepared in 200 proof ethanol and administered at concentrations up to 5000 ug/plate. The vehicle control for all assays was 200 proof ethanol. Precipitation was observed at concentrations of 2500 ug/plate and greater.  No increase in revertant colonies was observed in any strain in the presence or absence of metabolic activation. MTDID 44430 was not mutagenic under the conditions of this assay.

The potential for MTDID 44430 to induce micronuclei in TK6 cells was evaluated.  The study was conducted according to OECD 487 in compliance with OECD GLP. TK6 cultures were treated with 200 Proof Ethanol dilutions of MTDID 44430 at concentrations of 0.7, 40.5, and 56.3 ug/mL for 4-hours with metabolic activation; 20.7, 40.5, and 50.6 ug/mL for 4-hours without metabolic activation; and 7.5, 15.0, and 18.7 ug/mL for 27-hours without metabolic activation. No statistically significant increase in the percent of micronucleated cells was noticed under any test conditions. MTDID 44430 did not induce micronuclei in this assay.

The mutagenic potential of MTDID 44430 was evaluated in the Mouse lymphoma Assay with L5178Y mouse lymphoma cells.  The study was conducted according to OECD 490 in compliance with OECD GLP. Using ethanol as a vehicle, MTDID 44430 was tested for a 3-hour treatment period up to concentrations of 25 and 80 ug/mL in the absence and presence of S9-mix, respectively. MTDID 44430 was also tested for a 24-hour treatment period up to concentrations of 40 ug/mL in the absence of S9-mix. No biologically relevant mutagenic responses were noted in the presence or absence of metabolic activation. MTDID 44430 was not mutagenic in this assay.

Additional information

Justification for classification or non-classification

Based on the results of the studies, the test substance is not classified for genotoxicity/mutagenicity according to GHS.