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EC number: 205-711-1 | CAS number: 148-24-3
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- Ecotoxicological Summary
- Aquatic toxicity
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- Long-term toxicity to aquatic invertebrates
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Ames test (OECD 471): negative in S. typhimurium TA1535, TA1537, TA98, TA100 and TA102 with and without metabolic activation
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 31 Jul - 18 Aug 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 21 Jul 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayrisches Landesamt für Arbeitsschutz, Arbeitsmedizin und Sicherheitstechnik, München, Germany
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- his operon
- 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:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of male rats treated with phenobarbital (80 mg/kg bw) and β-naphtoflavone (100 mg/kg bw)
- Test concentrations with justification for top dose:
- Pre-experiment: 3.16, 10.0, 31.6, 100, 316, 1000, 2500 and 5000 µg/plate with and without metabolic activation (TA98 and TA100)
Experiment I: 1.0, 3.16, 10.0, 31.6, 100, 316 and 1000 µg/plate with and without metabolic activation
Experiment II: 0.5, 1.58, 5.0, 15.8, 50, 158 and 500 µg/plate with and without metabolic activation - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: -S9: sodium azide (10 µg/plate) for TA100 and TA1535; methyl methane sulfonate (1 µL/plate) for TA102; 4-nitro-o-phenylendiamine (10 or 40 µg/plate) for TA98 and TA1537, respectively; +S9: 2 aminoanthracene (2.5 or 10 µg/plate) for all strains
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: triplicates each in two independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: diminution of the background lawn, reduction in the number of revertants (reduction in revertants smaller or equal to 50%) - Rationale for test conditions:
- A test is considered acceptable if for each strain:
- the bacteria demonstrate their typical response to ampicillin (TA98, TA100, TA102)
- the control plates with and without S9 mix are within the following ranges (mean values of the spontaneous reversion frequency are within the historical control data range):
without metabolic activation: TA98 (18 - 54), TA100 (75 - 167), TA1535 (5 - 29), TA1537 (5 - 30) and TA102 (165 - 391)
with metabolic activation: TA98 (18 - 71), TA100 (81 - 168), TA1535 (6 - 31), TA1537 (6 - 36) and TA102 (163 - 594)
- corresponding background growth on negative control, solvent control and test plates is observed.
- the positive controls show a distinct enhancement of revertant rates over the control plate. - Evaluation criteria:
- A test item is considered as mutagenic if:
- a clear and dose-related increase in the number of revertants occurs and/or
- a biologically relevant positive response for at least one of the dose groups occurs
in at least one tester strain with or without metabolic activation.
A biologically relevant increase is described as follows:
- if in tester strains TA100 and TA102 the number of reversions is at least twice as high
- if in tester strains TA98, TA1535 and TA 1537 the number of reversions is at least three times higher than the reversion rate of the solvent control.
According to OECD guidelines, the biological relevance of the results is the criterion for the interpretation of results, a statistical evaluation of the results is not regarded as necessary.
A test item producing neither a dose related increase in the number of revertants nor a reproducible biologically relevant positive response at any of the dose groups is considered to be non-mutagenic in this system. - Statistics:
- Mean values and standard deviations were calculated.
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- starting at ≥ 100 µg/plate (without S9 mix) and at 316 µg/plate (with S9 mix)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- starting at 316 µg/plate (with and without S9 mix)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- starting at 316 µg/plate (with and without S9 mix)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- starting at 316 µg/plate (with and without S9 mix)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- starting at ≥ 100 µg/plate (without S9 mix) and at 316 µg/plate (with S9 mix)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No precipitation of the test substance was observed in any tester strain used in Experiment I and II with and without metabolic activation.
RANGE-FINDING/SCREENING STUDIES:
The toxicity of the test substance was determined in tester strains TA98 and TA100 at concentrations of 3.16, 10.0, 31.6, 100, 316, 1000, 2500 and 5000 µg/mL with and without metabolic activation. A reduced or no background lawn was observed starting at a concentration of 316 µg/ml in both strains with and without metabolic activation. Furthermore, a reduced number of revertant colonies was observed starting at 100 µg/plate. Based on these results, 1000 and 500 µg/plate were selected for Experiment I and II, respectively.
HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)
- Positive historical control data: The determined values of the positive controls fall within the range of the historical control data, please refer to Table 3.
- Negative (solvent) historical control data: The determined values of the solvent controls fall within the range of the historical control data, except tester strain TA 102 in experiment I, in which the number of mutants (149 +/-12.3) was slightly below the mean value of the historical control data (163 - 594). Considering the standard deviation, the reduced number of colonies in the vehicle control is not considered to affect the validity of the study, please refer to Table 3. - Conclusions:
- It can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the Salmonella strains used.
Reference
Table 1: Test results of experiment I
With or without S9-Mix | Test substance concentration | Mean number of revertant colonies per plate | ||||
(μg/plate) | (average of 3 plates ± Standard deviation) | |||||
Base-pair substitution type | Frameshift type | |||||
TA 100 | TA1535 | TA102 | TA98 | TA1537 | ||
– | DMSO | 114 ± 13.0 | 22 ± 2.6 | 188 ± 16.9 | 28 ± 4.0 | 10 ± 2.9 |
– | Aqua dest. | 112 ± 8.7 | 16 ± 5.5 | 221 ± 11.1 | 32 ± 3.2 | 11 ± 3.0 |
– | 1.00 | 112 ± 5.3 | 20 ± 3.5 | 237 ± 7.8 | 36 ± 5.3 | 9 ± 1.7 |
– | 3.16 | 106 ± 15.3 | 21 ± 2.9 | 202 ± 9.3 | 34 ± 6.6 | 10 ± 3.6 |
– | 10.0 | 118 ± 6.7 | 26 ± 8.1 | 212 ± 5.7 | 28 ± 2.3 | 9 ± 2.6 |
– | 31.6 | 115 ± 4.7 | 21 ± 8.2 | 172 ± 24.5 | 29 ± 4.2 | 11 ± 3.2 |
– |
100.0 |
114 ± 31.2 |
9 ± 3.8 |
39 ± 7.9 |
24 ± 4.2 |
11 ± 3.8 |
– |
316 |
0 ± 0.0 B/N |
0 ± 0.0 N |
0 ± 0.0 N |
0 ± 0.0 B/N |
0 ± 0.0 N |
– |
1000 |
0 ± 0.0 N |
0 ± 0.0 N |
0 ± 0.0 N |
0 ± 0.0 N |
0 ± 0.0 N |
Positive controls, –S9 |
Name |
NaN3 |
NaN3 |
MMS |
4-NOPD |
4-NOPD |
Concentrations (μg/plate) |
10 |
10 |
1 |
10 |
40 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
1192 ± 68.9 |
1546 ± 129.7 |
2191 ± 85.6 |
646 ± 89.3 |
183 ± 39.9 |
|
+ |
DMSO |
108 ± 5.3 |
13 ± 2.1 |
149 ± 12.3 |
37 ± 9.5 |
6 ± 2.0 |
+ |
Aqua dest. |
109 ± 19.2 |
13 ± 3.1 |
276 ± 15.7 |
38 ± 4.4 |
8 ± 1.5 |
+ |
1.00 |
109 ± 10.0 |
9 ± 1.0 |
255 ± 4.7 |
44 ± 6.7 |
11 ± 3.8 |
+ |
3.16 |
110 ± 15.9 |
11 ± 4.0 |
233 ± 3.8 |
38 ± 4.7 |
12 ± 4.0 |
+ |
10.0 |
121 ± 5.3 |
13 ± 3.5 |
257 ± 2.1 |
27 ± 4.6 |
10 ± 2.9 |
+ |
31.6 |
131 ± 16.2 |
14 ± 7.0 | 200 ± 67.4 | 31 ± 8.4 | 13 ± 7.1 |
+ | 100.0 | 98 ± 6.5 | 9 ± 1.5 | 193 ± 49.1 | 30 ± 10.0 | 10 ± 3.6 |
+ | 316 | 0 ± 0.0 B | 0 ± 0.0 | 0 ± 0.0 N | 0 ± 0.0 | 0 ± 0.0 |
+ | 1000 | 0 ± 0.0 N | 0 ± 0.0 N | 0 ± 0.0 N | 0 ± 0.0 N | 0 ± 0.0 N |
Positive controls, +S9 | Name | 2AA | 2AA | 2AA | 2AA | 2AA |
Concentrations (μg/plate) | 2.5 | 2.5 | 10 | 2.5 | 2.5 | |
Mean No. of colonies/plate (average of 3 ± SD) | 3103 ± 388.4 | 227 ± 12.2 | 874 ± 189.7 | 2824 ± 495 | 371 ± 71.3 |
NaN3 = Sodium azide
4NOPD = 4-nitro-o-phenylene-diamine
2AA = 2-Aminoanthracene
B = Background lawn reduced
N = No background lawn
Table 2: Test results of experiment II
With or without S9-Mix | Test substance concentration | Mean number of revertant colonies per plate | ||||
(μg/plate) | (average of 3 plates ± Standard deviation) | |||||
Base-pair substitution type | Frameshift type | |||||
TA 100 | TA1535 | TA102 | TA98 | TA1537 | ||
– | DMSO | 109 ± 8.0 | 16 ± 5.5 | 199 ± 12.7 | 19 ± 2.1 | 8 ± 1.0 |
Aqua dest. | 114 ± 15.4 | 14 ± 3.6 | 188 ± 17.0 | 28 ± 5.3 | 8 ± 3.2 | |
– | 0.50 | 100 ± 6.1 | 16 ± 3.5 | 154 ± 21.4 | 20 ± 3.8 | 11 ± 3.2 |
– | 1.58 | 101 ± 4.6 | 20 ± 1.7 | 166 ± 7.0 | 26 ± 4.7 | 10 ± 3.1 |
– | 5.0 | 105 ± 18.9 | 22 ± 5.3 | 201 ± 2.1 | 24 ± 1.5 | 13 ± 4.6 |
– | 15.8 | 108 ± 18.5 | 26 ± 8.4 | 193 ± 16.3 | 23 ± 3.2 | 13 ± 2.1 |
50 | 126 ± 11.4 | 28 7.2 | 213 ± 34.8 | 18 ± 5.3 | 12 ± 1.7 | |
158 | 0 ± 0.0 | 0 ± 0.0 | 0 ± 0.0 B | 0 ± 0.0 | 9 ± 2.5 | |
– | 500 | 0 ± 0.0 N | 0 ± 0.0 N | 0 ± 0.0 N | 0 ± 0.0 N | 0 ± 0.0 N |
Positive controls, –S9 | Name | NaN3 | NaN3 | MMS | 4-NOPD | 4-NOPD |
Concentrations (μg/plate) | 10 | 10 | 1 | 10 | 40 | |
Mean No. of colonies/plate (average of 3 ± SD) | 1278 ± 24.6 | 1364 100.7 | 1068 ± 111.8 | 1038 ± 238.3 | 208 ± 25.2 | |
+ | DMSO | 110 ± 6.9 | 12 ± 2.0 | 223 ± 5.0 | 29 ± 4.7 | 11 ± 2.1 |
+ | Aqua dest. | 110 ± 5.5 | 15 ± 1.0 | 217 ± 8.9 | 35 ± 3.6 | 10 ± 0.0 |
+ | 0.50 | 103 ± 7.0 | 9 ± 1.5 | 198 ± 6.0 | 27 ± 5.7 | 8 ± 2.0 |
+ | 1.58 | 102 ± 15.0 | 10 ± 2.6 | 187 ± 25.0 | 26 ± 3.2 | 10 ± 1.2 |
+ | 5.0 | 107 ± 18.9 | 10 ± 5.5 | 232 ± 23.2 | 28 ± 4.4 | 12 ± 5.5 |
15.8 | 113 ± 7.0 | 10 ± 5.1 | 244 ± 19.9 | 27 ± 5.7 | 12 ± 2.5 | |
50 | 132 ± 11.0 | 14 ± 3.1 | 291 ± 20.6 | 26 ± 2.0 | 10 ± 7.1 | |
158 | 0 ± 0.0 | 1 ± 1.10 | 44 ± 13.44 | 7 ± 6.2 | 8 ± 4.7 | |
+ | 500 | 0 ± 0.0 B | 0 ± 0.0 B | 0 ± 0.0 | 0 ± 0.0 N | 0 ± 0.0 B |
Positive controls, +S9 | Name | 2AA | 2AA | 2AA | 2AA | 2AA |
Concentrations (μg/plate) | 2.5 | 2.5 | 10 | 2.5 | 2.5 | |
Mean No. of colonies/plate (average of 3 ± SD) | 3103 ± 388.4 | 224 ± 21.1 | 1117 ± 97.4 | 2824 ± 495 | 392 ± 16.7 |
NaN3 = Sodium azide
4NOPD = 4-nitro-o-phenylene-diamine
2AA = 2-Aminoanthracene
B = Background lawn reduced
N = No background lawn
Table 3: Historical laboratory control data
Historical Laboratory Contral Data of the Negative Control without S9 | |||||
TA 100 | TA1535 | TA102 | TA98 | TA1537 | |
Mean | 109.3 | 15.1 | 250.4 | 26.8 | 12.0 |
SD | 14.4 | 4.4 | 50.7 | 6.0 | 3.7 |
Min | 75 | 5 | 165 | 18 | 5 |
Max | 167 | 29 | 391 | 54 | 30 |
RSD (%) | 13.1 | 32.4 | 20.3 | 22.2 | 31.0 |
n | 751 | 738 | 547 | 751 | 723 |
Historical Laboratory Contral Data of the Positive Control without S9 | |||||
TA 100 | TA1535 | TA102 | TA98 | TA1537 | |
Mean | 906.1 | 933.3 | 1879.5 | 704.6 | 169.1 |
SD | 304.6 | 215.6 | 437.1 | 316.6 | 56.1 |
Min | 235.0 | 79 | 710 | 269 | 48 |
Max | 66552 | 1630 | 3357 | 2420 | 1132 |
RSD (%) | 33.6 | 23.1 | 23.3 | 44.9 | 33.2 |
n | 748 | 737 | 548 | 749 | 721 |
Historical Laboratory Contral Data of the Negative Control with S9 | |||||
TA 100 | TA1535 | TA102 | TA98 | TA1537 | |
Mean | 113.6 | 11.8 | 309.6 | 37.2 | 13.1 |
SD | 14.6 | 3.2 | 67.6 | 8.1 | 4.0 |
Min | 81 | 6 | 163 | 18 | 6 |
Max | 168 | 31 | 594 | 71 | 36 |
RSD (%) | 12.9 | 27.0 | 21.8 | 21.9 | 30.6 |
n | 759 | 735 | 548 | 748 | 729 |
Historical Laboratory Contral Data of the Positive Control with S9 | |||||
TA 100 | TA1535 | TA102 | TA98 | TA1537 | |
Mean | 1938.7 | 115.7 | 1040.7 | 2058.1 | 260.3 |
SD | 585.1 | 58.0 | 320.0 | 703.7 | 96.4 |
Min | 253 | 26 | 117 | 121 | 41 |
Max | 3167 | 872 | 2102 | 3430 | 509 |
RSD (%) | 30.2 | 50.2 | 546 | 34.2 | 37.0 |
n | 757 | 733 | 427 | 746 | 726 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Genetic toxicity
The mutagenic properties of quinolin-8-ol (CAS 148-24-3) were assessed in a bacterial reverse mutation assay (Ames test) according to GLP criteria and OECD TG 471 (reference 7.6.1-1). The mutagenic potential of the test substance was assessed in S. typhimurium tester strains TA 98, 100, 102, 1535 and 1537 at concentrations up to 500 and 1000 µg/plate, respectively, in 2 independent experiments. No precipitation of the test substance was observed in any experiment with and without metabolic activation. Cytotoxicity was observed with and without metabolic activation at least at the highest concentration tested. Quinolin-8-ol did not induce an increase in reversions in any of the S. typhimurium strains tested with or without metabolic activation. The vehicle and positive controls were valid and lay within the range of historical control data. Based on the results in the conducted study, quinolin-8-ol (CAS 148-24-3) did not exhibit mutagenic properties in bacteria.
Justification for classification or non-classification
Based on the available data on genetic toxicity, there is no indication that quinolin-8-ol induces genetic toxicity in bacteria. However, no final decision on classification for genetic toxicity according to Regulation (EC) 1272/2008 can be made, as no information on chromosomal aberration and mutagenicity in mammalian cells/in vivo is available.
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