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Toxicological information

Genetic toxicity: in vitro

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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
Study period:
08 April - 29 August, 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted according to OECD method and in accordance with GLP. Study material is well characterized.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Qualifier:
according to
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain / cell type:
other: Salmonella typhimurium: TA1535, TA1537, TA1538, TA98 and TA100.
Metabolic activation:
with and without
Metabolic activation system:
S-9 mix from Aclor 1254-induced rat liver microsomes
Test concentrations with justification for top dose:
Ten concentrations, 0.01 to 150µl per petri dish were tested for the initial assay and a range of six concentrations, 0.3 -50µl were tested in the independent repeat assay.
Vehicle / solvent:
DMSO
Controlsopen allclose all
Positive controls:
yes
Positive control substance:
2-nitrofluorene
Positive controls:
yes
Positive control substance:
other: N-methyl-N-nitro-N-nitrosoguanidine
Positive controls:
yes
Positive control substance:
other: Quinacrine mustard
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene
Details on test system and experimental conditions:
Petri plates were cultured in an incubator at approximately 37°C for 48hrs
Statistics:
Mean and standard deviation of the triplicate plate counts for each treatment were determined.

Results and discussion

Test results
Species / strain:
other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

Observations:
Compared with vehicle controls, no concentration related increase in the number of colonies per plate treated with Abbott-87440, with and without activation, were observed.

Toxicity was seen at the highest concentrations.


Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Under the activated and non-activated conditions, Abbott-87440 was concluded to be non-mutagenic in the bacterial reverse mutation assay.