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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:
1991-1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This is a GLP OECD guideline study undertaken by the Institute of Hygiene and Epidemiology, Division of Toxicology, in Brussels, BE, in preparation for the OECD High Production Volume chemicals programme.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
3-methylpyridine
EC Number:
203-636-9
EC Name:
3-methylpyridine
Cas Number:
108-99-6
Molecular formula:
C6H7N
IUPAC Name:
3-methylpyridine
Details on test material:
98% purity

Method

Target gene:
His-
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Details on mammalian cell type (if applicable):
Standard cell lines according to OECD 471. For TA 1535: his G46 base substitution, rfa and -uvrB; for TA 100: his G46 base substitution, rfa, -uvrB and R factor; for TA 1537: his C3076 frameshift mutation, rfa and -uvrB; for TA 98: his C3052 frameshift mutation, rfa, -uvrB and R factor.
Metabolic activation:
with and without
Metabolic activation system:
S-9 fraction from livers of CD rats exposed to Arochlor 1254
Test concentrations with justification for top dose:
50 (0.51 microM), 160 (1.63 microM), 500 (5.10 microM), 1600 (16.30 microM), and 5000 nl/plate (51.00 microM)
Vehicle / solvent:
water
Controlsopen allclose all
Negative solvent / vehicle controls:
yes
Remarks:
water
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
for strain TA 1535 without S-9

Migrated to IUCLID6: 0.5 microgram/plate
Negative solvent / vehicle controls:
yes
Remarks:
water
Positive controls:
yes
Positive control substance:
other: aminoacridine, 50 microgram/plate
Remarks:
for TA 1537 without S-9
Negative solvent / vehicle controls:
yes
Remarks:
water
Positive controls:
yes
Positive control substance:
2-nitrofluorene
Remarks:
For TA 98 without S-9

Migrated to IUCLID6: 2 microgram/plate
Negative solvent / vehicle controls:
yes
Remarks:
water
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
For TA 100 without S-9

Migrated to IUCLID6: 1 microgram/plate
Negative solvent / vehicle controls:
yes
Remarks:
water
Positive controls:
yes
Positive control substance:
other: aminoanthracene, 1 microgram/plate
Remarks:
For all strains with S-9
Details on test system and experimental conditions:
Standard plate incorporation method. Two independent experiments are performed.
Evaluation criteria:
For a test to be valid, the bacteria have to meet the criteria for genotypes, the negative control plates should have a background lawn of growth, the spontaneous mutation rates should be within expected ranges, the positive controls should have induced the expected dose response and the sterility checks may not show contamination. Failure of one or more strain (or the S-9 mix) does not invalidate the remainder of the experiment. For a test compound to be scored as positive, one or both of the following criteria must be reproducibly met:
a) the compound must induce a dose-related increase in the number of revertant colonies
b) the compound must induce a doubling (or greater) in the number of revertants, at least at one dose level.
All compounds must be tested over a dose range covering at least two log intervals before being classed as negative. In the case of highly toxic compounds, care should be taken about the selection of doses around the toxic threshold. A biologically significant positive result in any tested strain is evidence of bacterial mutagenicity.
Statistics:
Mean + standard deviation

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:
not specified
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

Cytotoxicity and mutagenic activity was not observed with 3-methylpyridine in the presence and absence of metabolic activation, according to OECD 471 bacterial reverse mutation assay guidelines.