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Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information
MATMD was tested in 3 different studies: Bacterial Reverse Mutation Assay acording to OECD Guideline 471 with GLP compliance In vitro mammalian cell micronucleus test according to the OECD guideline 487 with GLP compliance In vitro mammalian cell gene mutation test according to the OECD guideline 476 with GLP compliance
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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted in compliance with GLP and according to the OECD guideline 471 (bacterial reverse mutation assay).
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Deviations:
no
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay
Target gene:
TA100: hisG46/R-factor, Base pair substitutions
TA98: hisD3052/R-factor, Frameshift
TA1535: hisG46, Base-pair substitutions
TA1537: hisC3076, Frameshift
WP2uvrA: Base-pair substitutions
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Metabolic activation system:
S9 mix (rat)
Test concentrations with justification for top dose:
3, 10, 33, 100, 333, 1000, 3330 and 5000 µg/plate
Vehicle / solvent:
DMSO: for the test substance, for the positive controls 2-nitrofluorene, methylmethanesulfonate and 4-nitroquinoline N-oxide (all without metabolic activation) as well as 2-aminoanthracene (with metabolic activation)
Saline: for sodium Azide (without metabolic activation)
Milli-Q water: for 9-aminoacridine (without metabolic activation)
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
DMSO for the test substance
True negative controls:
no
Positive controls:
yes
Positive control substance:
4-nitroquinoline-N-oxide
9-aminoacridine
2-nitrofluorene
sodium azide
methylmethanesulfonate
other: 2-aminoanthracene
Evaluation criteria:
A test substance is considered negative (not mutagenic) in the test if:
a) the total number of revertants in tester strain TA100 is not greater than two (2) times the concurrent control, and the total number of revertants in tester strains TA1535, TA1537, TA98 and WP2uvrA is not greater than three (3) times the concurrent control.
b) The negative response should be reproducible in at least one independently repeated experiment.

A test substance is considered positive (mutagenic) in the test if:
a) The total number of revertants in the tester strain TA100 is greater than two (2) times the concurrent control, or the total number of revertants in tester strains TA1535, TA1537, TA98 or WP2uvrA is greater than three (3) times the concurrent control.
b) In case a positive response will be repeated, the positive response should be reproducible in at least one independently repeated experiment.
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
TA100: >333 µg/plate for with and without metabolic activation, WP2uvrA: at 3330 µg/plate without metabolic activation and at 5000 µg/plate with metabolic activation
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
Conclusions:
Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation

Based on the results of this study it is concluded that MATMD is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the
Escherichia coli reverse mutation assay with and without metabolic activation using rat S9-mix.
Executive summary:

Based on the results of this study it is concluded that MATMD is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay with and without metabolic activation using rat S9-mix.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

MATMD was tested in 3 different studies:

Bacterial Reverse Mutation Assay acording to OECD Guideline 471 with GLP compliance

In vitro mammalian cell micronucleus test according to the OECD guideline 487 with GLP compliance

In vitro mammalian cell gene mutation test according to the OECD guideline 476 with GLP compliance.

All of the 3 studies gave no indications for a mutagenic potential of MATMD.

Justification for classification or non-classification