Quinoline

Genetic toxicity: in vitro

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

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

Test material information

Constituent 1

Reference substance name:

Quinoline

EC Number:

202-051-6

EC Name:

Quinoline

Cas Number:

91-22-5

Molecular formula:

C9H7N

IUPAC Name:

quinoline

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 results

Test results 1

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

Test results 2

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.