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Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

In vitro gene mutation test in bacteria (Ames test) (OECD 471)

Link to relevant study records
Reference
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
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of assay:
bacterial reverse mutation assay
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.
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
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.
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.
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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Justification for classification or non-classification

Based on the available data, Intermediate F37 is not classified for germ cell mutagenicity according to Regulation (EC) No 1272/2008