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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:
No data
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Fewer strains than recommended by the guideline were used but for this substance it has no negative impact because the most relevant strain has been used. The quality criteria of the guideline are all checked and are valid. No positive control for the test without metabolic activation but it has no impact on the result for quinoline.

Data source

Reference
Reference Type:
publication
Title:
Salmonella / human S9 mutagenicity test: a collaborative study with 58 compounds
Author:
Hakura A, Shimada H, Nakajima M, Sui H, Kitamoto S, Suzuki S, Satoh T
Year:
2005
Bibliographic source:
Mutagenesis 20(3): 217-228

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Deviations:
yes
Remarks:
only 3 strains, no positive control for the test without metabolic activation
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Supplier Sigma, purity 96%
No further data

Method

Species / strain
Species / strain / cell type:
S. typhimurium, other: TA98 and TA100 or YG7108
Additional strain / cell type characteristics:
other: YG7108: hisG46/rfa/delta uvrB/delta adast/delta ogtst
Metabolic activation:
with and without
Metabolic activation system:
From rat and human
Test concentrations with justification for top dose:
78 to 5000 µg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: none
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
benzo(a)pyrene
Remarks:
Migrated to IUCLID6: 27 µg/plate
Details on test system and experimental conditions:
METHOD OF APPLICATION: preincubation


DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h


NUMBER OF REPLICATIONS:


NUMBER OF CELLS EVALUATED:


DETERMINATION OF CYTOTOXICITY
- Method: no data


Evaluation criteria:
Positive if the number of revertants is 2-fold or more relative to the negative control + a dose-dependent increase in the number of revertants is observed + the dose-finding and main assays produced reproducible results.
Negative if no increase in the number of revertants is observed.
If the positive and negative criteria were not met then the results are equivoqual.
Statistics:
no data

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 100
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not valid
Positive controls validity:
valid
Additional information on results:
TEST-SPECIFIC CONFOUNDING FACTORS
not studied

RANGE-FINDING/SCREENING STUDIES: performed, no details


COMPARISON WITH HISTORICAL CONTROL DATA: no


ADDITIONAL INFORMATION ON CYTOTOXICITY:
Cytotox from 1250 µg/plate
Remarks on result:
other: other: with S9 from rat or of human origin
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Results shown are only for TA100: Induced revertants/µg/plate:

0 without S9mix,

3.0 with S9 from rat

1.6 with S9 HLS-014

0.83 with pooled S9

Results of the negative control: Mean number of revertants per plate:

126 +/- 30 in presence of rat S9

124 +/- 29 in presence of HLS-014 S9

130 +/- 29 in presence of pooled S9

Results of the positive control: Mean number of revertants per plate:

827 +/- 294 in presence of rat S9

796 +/- 284 in presence of HLS-014 S9

245 +/- 68 in presence of pooled S9

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative without metabolic activation
positive with metabolic activation

Quinoline is positive with metabolic acitivation from rat or of human origin but the metabolizing activity is better with rat S9.
Executive summary:

Quinoline has been tested according to the Ames test with and without metabolic activation from rat and of human origin, up to 5000 µg/plate on Salmonella typhimurium TA98 and TA100.

Quinoline gives positive results with metabolic activation on TA100. The rat metabolizing system is more efficient than the human one.