Registration Dossier

Toxicological information

Endpoint summary

Currently viewing:

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information
The test compound 3-methoxyacetophenone is negative for gene mutation in vitro.
Link to relevant study records
Reference
Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data is from peer reviewed publication
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Ames assay was performed to evaluated the mutagenic nature of the test compound m-Methoxyacetophenone
GLP compliance:
not specified
Type of assay:
bacterial gene mutation assay
Species / strain / cell type:
S. typhimurium TA 100
Details on mammalian cell type (if applicable):
No data available
Additional strain / cell type characteristics:
not specified
Metabolic activation:
not specified
Metabolic activation system:
No data
Test concentrations with justification for top dose:
103, 102, 101, 100 and 10-1 µg per plate.
Vehicle / solvent:
No data available
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
not specified
Positive control substance:
not specified
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Preincubation period: No data available
- Exposure duration: No data available
- Expression time (cells in growth medium): No data available
- Selection time (if incubation with a selection agent): No data available
- Fixation time (start of exposure up to fixation or harvest of cells): No data available

SELECTION AGENT (mutation assays): No data available
SPINDLE INHIBITOR (cytogenetic assays): No data available
STAIN (for cytogenetic assays): No data available

NUMBER OF REPLICATIONS: No replications were performed

NUMBER OF CELLS EVALUATED: No data available

DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data available

OTHER EXAMINATIONS:
- Determination of polyploidy: No data available
- Determination of endoreplication: No data available
- Other: No data available

OTHER: No data available
Evaluation criteria:
Increase in the number of revertants, Toxicity toward the Ames Salmonella TA100 strain used was roughly estimated by visual comparison of the background lawn on the plate under a microscope, with 100% representing the same number of bacteria per unit area as the blank with no test solution (no toxicity) and 0 representing death of all bacteria.
Statistics:
No data available
Species / strain:
S. typhimurium TA 100
Metabolic activation:
not specified
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
other: strain/cell type:
Remarks:
Migrated from field 'Test system'.
Conclusions:
Interpretation of results (migrated information):
negative

The test compound failed to induce mutation in the Salmonella typhimurium TA100 and hence is not a mutagen.
Executive summary:

Ames assay was performed to evaluate the mutagenic nature of the test compound m-Methoxyacetophenone usingSalmonella typhimuriumTA100. The test compound was tested at dose levels of 103, 102, 101, 100and 10-1ug per plate.

 

The test compoundm-Methoxyacetophenonefailed to induce mutation in theSalmonella typhimuriumTA100 and hence is not a mutagen.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

Gene mutation in vitro:

Publication for the test chemical and its RA and the prediction data for the target cas have been used to determine the mutagenic nature of the test compound m-methoxyacetophenone (CAS no 537 -36 -8). The summary is as below:.

Ames assay was performed (Rapson, 1980) to evaluate the mutagenic nature of the test compound m-Methoxyacetophenone (CAS no 536-37-8) usingSalmonella typhimuriumTA100. The test compound was tested at dose levels of 103, 102, 101, 100and 10-1ug per plate. The test compound m-Methoxyacetophenone failed to induce mutation in theSalmonella typhimurium TA100 and hence is not a mutagen.

Gene mutation was predicted using SSS QSAR prediction model, 2016. The study used Salmonella typhimurium TA1535 strain and without S9 metabolic activation system. The test material 3-Methoxyacetophenone (CAS no 536-37-8) is not mutagenic in vitro in Salmonella typhimurium strain TA 1535 without S9 metabolic activation system.

 

In similar prediction data using SSS QSAR prediction model, 2016. The study used Salmonella typhimurium TA102 strain and with S9 metabolic activation system. The test material 3-Methoxyacetophenone (CAS no 536-37-8) is not mutagenic in vitro in Salmonella typhimurium strain TA 102 with S9 metabolic activation system.

 

Based on the QSAR prediction done using the Danish (Q)SAR Database (2016), the genetic toxicity was estimated to be negative on S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 for m-Methoxyacetophenone (CAS no 536-37-8) in an Ames test. Thus it can be concluded that the substance m-Methoxyacetophenone is likely to exhibit negative genetic toxicity effects.

In another QSAR prediction done using the Danish (Q)SAR Database, the genetic toxicity was estimated to be positive on Chinese hamster Ovary (CHO) Cells for m-Methoxyacetophenone (CAS no 536-37-8) in a chromosome aberration test. Thus it can be concluded that the substance m-Methoxyacetophenone is likely to have positive genetic toxicity effects.

The mutagenicity assay with Salmonella typhimurium was performed (Pfuhler, 1995) as described by Maron and Ames with the Salmonella typhimurium strains TA97, TA98, TA100, and TA102. Test material Acetosyringone (RA CAS no 2478-38-8) concentration used was 0, 10, 33, 100, 330, 1000 and 4000 µg/plate. Preincubation method was used in which bacteria and test substances was preincubated for 30 min at 37 °C in the presence or absence of S9-mix containing 10 % of S9 rat liver homogenate. At high concentrations (4000µg/plate) both test chemicals are toxic in several tester strains, the background lawn of the histidine prototroph bacteria was very thin or all bacteria died. No significant increases in the number of revertant colonies were detected in any S. typhimurium strains. Therefore, Acetosyringone is non-mutagenic in S. typhimurium strains.

Acetosyringone (RA CAS no 2478-38-8)was tested for mutagenicity with the human lymphocytes with and without metabolic activation(RAT, LIVER, S-9, and AROCLOR 1254).Test concentration used was 0, 3.3,10,33 and 100 µg/ml. Acetosyringone do not increase the number of SCEs per mitosis significantly. Substance is tested up to a dose where they reduce the proliferation index clearly (100 ug/rnl). At higher doses they avoid the growth of the lymphocytes and lead to cell death. Hence, the substance Acetosyringone is considered to be not mutagenic in human lymphocytes with and without metabolic activation.

Based on the information observed for the test chemical and its various read across and also from the predicted data for the test chemical

, it is summarized that 3-Methoxyacetophenone (CAS no 536-37-8) is not likely to exhibit genetic toxicity. Thus, the chemical is not classified as a gene mutant.


Justification for selection of genetic toxicity endpoint
Data is from peer reviewed publication

Justification for classification or non-classification

Based upon the available information, 3 -Methoxyacetophenone is not likely to exhibit genetic toxicity. Thus, the chemical is not classified as a genetic toxicant.