Methyl cyanoacetate

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

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:

Methyl cyanoacetate

EC Number:

203-288-8

EC Name:

Methyl cyanoacetate

Cas Number:

105-34-0

Molecular formula:

C4H5NO2

IUPAC Name:

methyl 2-cyanoacetate

Method

Species / strain

Species / strain / cell type:

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

Metabolic activation:

with and without

Metabolic activation system:

Arochlor 1254-induced rat liver S9 fraction

Test concentrations with justification for top dose:

50-5000 µg/plate

Vehicle / solvent:

DMSO (dimethylsulfoxide)

Controls

Controls 1

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

Controls 2

Positive controls:

yes

Positive control substance:

2-nitrofluorene

Remarks:

TA 98 without metabolic activation

Migrated to IUCLID6: 2.5 µg/plate

Controls 3

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

TA 100, TA 1535 without metabolic activation

Migrated to IUCLID6: 2.5 µg/plate

Controls 4

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

TA 1537 without metabolic activation

Migrated to IUCLID6: 25 µg/plate

Controls 5

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene, 2.5 µg/plate

Remarks:

TA 98, TA 100, TA 1537, TA 1537 with metabolic activation

Details on test system and experimental conditions:

METHOD OF APPLICATION:
1st main experiment: plate incorporation method
2nd main experiment: preincubation method

DURATION:
- 1st main experiment: 72 hours incubation (37°C)
- 2nd main experiment: 30 min preincubation (30°C), 72 hours incubation (37°C)

Evaluation criteria:

For a test compound to be considered positive, it must (in two independent experiments) cause at least a doubling in the mean revertants per plateof at least one tester strain. This increase must be accompanied by a dose response towards increasing concentrations of the test article. A test
article that does not meet these criteria will be called non-mutagenic in bacteria. Single increases in revertant frequencies, which are not
dose-related and not reproducible in two independent tests are considered non-relevant. If however these increases do occur in both tests, tbis
will be taken as an indication of a mutagenic effect.

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

Positive controls validity:

valid

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 without metabolic activation
negative with metabolic activation

Methylcyanoacteate did not induce a mutagenic effect in S. typhimurium. It is therefore not considered to be a bacterial mutagen.