Reaction mass of 1-phenylethanone and 2-phenylpropanal and 1,4-diphenylbut-2-ene-1,4-dione

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August - October 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Acetophenone

EC Number:

202-708-7

EC Name:

Acetophenone

Cas Number:

98-86-2

Molecular formula:

C8H8O

IUPAC Name:

1-phenylethanone

Details on test material:

- Name of test material (as cited in study report): acetophenone
- Physical state: liquid
- Analytical purity: 99.36 %
- Lot/batch No.: E38/06

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 102

Metabolic activation:

with and without

Metabolic activation system:

phenobarbital/ß-naphthoflavone induced rat liver S9

Test concentrations with justification for top dose:

Experiment 1: 3, 10, 33, 100, 333, 1000, 2500, 5000 µg/plate
Experiment 2: 33, 100, 333, 1000, 2500, 5000 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: solubility

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

other: sodium azide for TA1535, TA100; 4-nitro-o-phenylenediamine for TA1537, TA98; methylmethanesulfonate for TA102

Details on test system and experimental conditions:

METHOD OF APPLICATION: experiment 1 plate incorporation assay; experiment 2 preincubation

DURATION
- Preincubation period: 60 min
- Exposure duration: atmleast 48 hrs

NUMBER OF REPLICATIONS: triplicates, 2 experiments

Evaluation criteria:

mutagenic response if revertant rate is twice the solvent control for strain TA98, TA100, TA102 and thrice the solvent control for strain TA1535 and TA1537

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

COMPARISON WITH HISTORICAL CONTROL DATA: all assays with the test substance and negative and positive controls in the range of historical control data

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

There was no indication of genotoxic activity in the Salmonella reverse mutation assay with S. typhimurium strains TA98, TA100, TA102, TA1535 and TA1537 both without and with metabolic activation.

Executive summary:

There was no indication of genotoxic activity in the Salmonella reverse mutation assay with S. typhimurium strains TA98, TA100, TA102, TA1535 and TA1537 both without and with metabolic activation when acetophenone was tested according to OECD Guideline 471 at concentrations up to 5000 µg/plate .

No tests are available with the substance Reaction mass of acetophenone and hydratropaldehyde and (E)-1,4-diphenyl-2-butene-1,4-dione. However, the main constituent Acetophenone is regarded as most relevant for the evaluation of the multi constituent substance. Therefore, the results of the test with Acetophenone were presented. The procedure laid down in the CLP regulation (1272/2008/EG) to base the classification and labeling on the available data and classification of the known main and relevant constituents was used. A detailed description of the evaluation used for this endpoint can be found in the "Endpoint summary" for "Genetic toxicity". Based on this evaluation no further testing is indicated to be necessary.