[(3-Oxo-butyryl)-phenyl-amino]-acetic acid ethyl ester

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

n-phenyl n-acetoacetyl glycine ethyl ester

IUPAC Name:

n-phenyl n-acetoacetyl glycine ethyl ester

Test material form:

liquid

Specific details on test material used for the study:

TEST MATERIAL NAME (as stated in study report): Intermediate F-37

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Valtris Specialty Chemicals / Batch/Lot No. W042272
- Expiration date of the lot/batch: November 21, 2019
- Purity: 84.5%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Ambient temperature. In original container as supplied by the Sponsor. Containers were kept tightly closed in a dry, cool and well ventilated place.

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Details on mammalian cell type (if applicable):

CELLS USED
- Source of cells: Molecular Toxicology Inc., 157 Industrial Park Dr. Boone, NC 28607, U.S.A.

Metabolic activation:

with and without

Metabolic activation system:

Arochlor 1254-induced rat liver S9 fraction

Test concentrations with justification for top dose:

Initial Toxicity-Mutation Test: 0.0015 - 5 µL/plate
Confirmatory Mutation Test: 0.13 - 4 µL/plate

The top dose in the confirmatory mutation test was chosen based on cytotoxicity observed in the initial toxicity-mutation test.

Vehicle / solvent:

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

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

2-nitrofluorene

sodium azide

mitomycin C

Details on test system and experimental conditions:

METHOD OF APPLICATION: in medium; in agar (plate incorporation)

DURATION
- Exposure duration: 48 h

NUMBER OF REPLICATIONS: three

DETERMINATION OF CYTOTOXICITY
- Method: inhibition of the background bacterial lawn and/or reduction in the number of revertant colonies

Rationale for test conditions:

per guidelines

Evaluation criteria:

per guidelines

Statistics:

Simple linear regression analysis was performed to assess the dose dependent nature of any increase in revertant colonies.

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA1537, TA1535, TA98, TA100, TA102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

Precipitation was not observed at the concentration of 5 µL/plate.

Applicant's summary and conclusion

Conclusions:

Under guideline (OECD 471) test conditions, Intermediate F37 was not mutagenic in the Bacterial Reverse Mutation Test at concentrations up to 5 µL/plate, with and without exogenous metabolic activation.