Registration Dossier

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:
2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted in GLP compliance and in accordance with OECD Guideline No 471

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Pale pink crystalline solid
Details on test material:
Purity: 99.9%
Batch no.: MR11718HR

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Test concentrations with justification for top dose:
100, 300, 1000, 3000 and 5000 µg/plate
Vehicle / solvent:
Demineralized water
Controls
Untreated negative controls:
yes
Remarks:
Demineralized water (solvent)
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
9-aminoacridine
2-nitrofluorene
sodium azide
mitomycin C
other: 2-Aminoanthracene
Evaluation criteria:
A concentration-dependent increase in the number of revertants of at least one tester strain
over the vehicle control value and/or outside the historical control range is indicative of
genotoxic activity.

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Remarks:
limit concentration: 5000µg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Additional information on results:
3-Aminopyridine did neither precipitate nor induce bacteriotoxicity up to the highest
concentration of 5000 μg/plate.
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

3-Aminopyridine caused neither base-pair substitutions nor frameshift mutations in different strains of S. typhimurium in the presence and absence of metabolic activation when tested up to the maximum recommended concentration. Based on these results it was concluded, that the test
substance is "Ames negative" in a test performed
under regulatory acceptable standards.