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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

 AMES Test_Salmonella Typhimurium and Escherichia Coli Reverse Mutation Test with ACN_ 20.12.2005_ KBL/2005/1516 RM

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:
31 Aug - 20 Dec 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay
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:
Plate incorporation method without metabolic activation [µg/plate]:
10, 50, 100, 500, 1000, 5000 S. typhimurium TA 1535 and E. coli WP2uvrA
1, 5, 10, 50, 100, 500, 1000, 5000 S. typhimurium TA 1537 and TA 100
5, 10, 50, 100, 500, 1000, 5000 S. typhimurium TA 98


Plate incorporation method with metabolic activation [µg/plate]:
5, 10, 50, 100, 500, 1000, 5000 S. typhimurium TA 1535 and TA 98
1, 5, 10, 50, 100, 500, 1000 S. typhimurium TA 100 and TA 1537
10, 50, 100, 500, 1000, 5000 E. coli WP2uvrA

Pre-incubation method without metabolic activation [µg/plate]:
1, 5, 10, 50, 100, 500, 1000 S. typhimurium TA 1535
0.5, 1, 5, 10, 50, 100 S. typhimurium TA 1537
0.5, 1, 5, 10, 50, 100, 500 S. typhimurium TA 98
0.1, 0.5, 1, 5, 10,50, 100 S. typhimurium TA 100
10, 50, 100, 500, 1000 E. coli WP2uvrA

Pre-incubation method with metabolic activation [µg/plate]:
1, 5, 10, 50, 100, 500 S. typhimurium TA 1535
0.5, 1, 5, 10, 50, 100 S. typhimurium TA 1537
0.5, 1, 5, 10, 50, 100, 500 S. typhimurium TA 98
0.1, 0.5, 1, 5, 10, 50 S. typhimurium TA 100
10, 50, 100, 500, 1000, 5000 E. coli WP2uvrA

Species / strain:
other: 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:
at higher concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Conclusions:
Interpretation of results:
negative

Based on the results of the reported study it is concluded that ACN does not induce gene mutation in Salmonella typhimurium and Escherichia coli under the
experimental conditions described. Therefore, ADB is considered to be non-motagenie in the bacterial reverse mutation test.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Justification for classification or non-classification