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EC number: 941-122-2 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study, 4 instead of 5 strains tested (old OECD protocol)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Pyridine, alkyl derivs., hydrochlorides
- EC Number:
- 271-753-2
- EC Name:
- Pyridine, alkyl derivs., hydrochlorides
- Cas Number:
- 68607-19-2
- IUPAC Name:
- 68607-19-2
- Test material form:
- other: liquid
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: TA 98: hisD3052, rfa, uvrB, pKM101; TA 100: hisG46, rfa, uvrB, pKM101; TA 1535: hisG46, rfa, uvrB; TA 1537: hisC3076, rfa, uvrB
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix (rat)
- Test concentrations with justification for top dose:
- 50 - 5000 µg/plate
- Vehicle / solvent:
- Water: test item and positive control sodium azide
DMSO: positive control 2-nitrofluorene and 9-aminoacridine
Controlsopen allclose all
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- Positive controls:
- yes
- Remarks:
- 2.5 µg/plate
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA98 with and without metabolic activation
- Positive controls:
- yes
- Remarks:
- 2.5 µg/plate
- Positive control substance:
- sodium azide
- Remarks:
- TA100 with and without metabolic activation
- Positive controls:
- yes
- Remarks:
- 2.5 µg/plate
- Positive control substance:
- sodium azide
- Remarks:
- TA1535 with and without metabolic activation
- Positive controls:
- yes
- Remarks:
- 25 µg/plate
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA1537 with and without metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: 1st main experiment: in agar (plate incorporation); 2nd main experiment: preincubation
DURATION
- 1st main experiment: 72 hours incubation (37°C)
- 2nd main experiment: 30 min preincubation (30°C), 72 hours incubation (37°C)
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; determination of background lawn - Evaluation criteria:
- The following criteria must be met for the mutagenicity assay to be considered valid:
- In the solvent control, each tester strain culture must exhibit a characteristic mean number of spontaneaus revertants.
- To ensure that appropriate numbers of bacteria are plated, overnight culture titers must be in excess of 10^8 bacteria/ml
- The mean of each positive control must exhibit a significant increase in the number of revertants over the mean value of the respective vehicle control
- Normally, at least four non-toxic dose Ievels are required to evaluate assay data, deviations from this requirement must be justified.
For a test compound to be considered positive, it must (in two independent experiments) cause at least a doubling in the mean revertants per plate of at least
one tester strain. This increase must be accompanied by a dose response to increasing concentrations of the test article. A test article that does not meet these
criteria will be called non-motagenie in bacteria. Single increases in revertant frequencies, which are not dose-related and not reproducible in two independent tests are considered non-relevant. lf however these increases do occur in both tests, this will be taken as an indication of a mutagenic effect.
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:
- other: A reduced growth of the bacterial background lawn, indicative of test compound induced cytotoxicity was detectable only with TA 1537 in the preincubation test -S9 mix (at the highest test compound concentration of 5000 µg/plate).
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Plate lncorporation test, with metabolic activation
Dose |
Tester strains |
||||||||
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
|
|||||
R/P |
MF |
R/P |
MF |
R/P |
MF |
R/P |
MF |
|
|
Negative control (water) |
37± 6 |
1.0 |
165±19 |
1.0 |
12±2 |
1.0 |
17±4 |
1.0 |
|
Positiv control 2-Aminoanthracene 2.5 µg/plate |
1570 ± 283 |
42.4 |
1729±506 |
10.5 |
202±12 |
16.4 |
341±24 |
19.7 |
|
50 µg/plate |
49±11 |
1.3 |
153± 8 |
0.9 |
11±4 |
0.9 |
16±3 |
0.9 |
|
160 µg/plate |
50±5 |
1.4 |
181±14 |
1.1 |
11±3 |
0.9 |
21±1 |
1.2 |
|
500 µg/plate |
51±16 |
1.4 |
158±26 |
1.0 |
10±1 |
0.8 |
16±2 |
0.9 |
|
1600 µg/plate |
41± 3 |
1.1 |
153± 6 |
0.9 |
14±3 |
1.2 |
19±4 |
1.1 |
|
5000 µg/plate |
41± 5 |
1.1 |
163± 6 |
1.0 |
10±2 |
0.8 |
14±5 |
0.8 |
|
Plate lncorporation test, without metabolic activation
Dose |
Tester strains |
||||||||
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
|
|||||
R/P |
MF |
R/P |
MF |
R/P |
MF |
R/P |
MF |
|
|
Negative control (water) |
40 ± 8 |
1.0 |
159±27 |
1.0 |
11±2 |
1.0 |
9±3 |
1.0 |
|
50 µg/plate |
167±19 |
1.0 |
167±19 |
1.0 |
9±2 |
0.9 |
8±2 |
0.9 |
|
160 µg/plate |
159±19 |
1.0 |
159±19 |
1.0 |
10±3 |
1.0 |
6±1 |
0.7 |
|
500 µg/plate |
155±13 |
1.0 |
155±13 |
1.0 |
13±6 |
1.2 |
7±2 |
0.8 |
|
1600 µg/plate |
158±18 |
1.0 |
158±18 |
1.0 |
16±2 |
1.5 |
7±3 |
0.8 |
|
5000 µg/plate |
148±13 |
0.9 |
148±13 |
0.9 |
11±5 |
1.1 |
7±3 |
0.8 |
|
Positive control |
146 ± 10 (2-Nitrofluorene) 2.5µg/plate |
0.8 |
520± 2 Sodiumazide 2.5µg/plate |
3.3 |
478±40 Sodiumazide 2.5µg/plate |
44.8 |
50±12 9-Aminoacridine 25µg/plate |
5.8 |
|
R/P: number of revertants/plate (mean values)
MF: mutation factor
Preincubation test, with metabolic activation
Dose |
Tester strains |
||||||||
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
|
|||||
R/P |
MF |
R/P |
MF |
R/P |
MF |
R/P |
MF |
|
|
Negative control (water) |
39± 4 |
1.0 |
139±13 |
1.0 |
11±6 |
1.0 |
13±4 |
1.0 |
|
50 µg/plate |
45±14 |
1.2 |
149±21 |
1.1 |
9±4 |
0.9 |
12±1 |
0.9 |
|
160 µg/plate |
40±1 |
1.0 |
118±12 |
0.8 |
14±2 |
1.3 |
14±5 |
1.1 |
|
500 µg/plate |
38±6 |
1.0 |
123±13 |
0.9 |
11±2 |
1.0 |
14±0 |
1.1 |
|
1600 µg/plate |
33± 9 |
0.8 |
143±14 |
1.0 |
10±3 |
0.9 |
15±6 |
1.2 |
|
5000 µg/plate |
40±4 |
1.20 |
135±19 |
1.0 |
11±2 |
1.0 |
12±3 |
0.9 |
|
Positive control (2-Aminoanthracene) 2.5µg/plate |
1081±328 |
27.7 |
1453±59 |
10.4 |
169±16 |
15.8 |
188±33 |
14.4 |
|
Preincubation test,
without metabolic activation
Dose |
Tester strains |
||||||||
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
|
|||||
R/P |
MF |
R/P |
MF |
R/P |
MF |
R/P |
MF |
|
|
Negative control (water) |
30±8 |
1.0 |
140±13 |
1.0 |
7±2 |
1.0 |
9±4 |
1.0 |
|
50 µg/plate |
34±8 |
1.1 |
168±13 |
1.2 |
6±2 |
1.2 |
10±1 |
0.9 |
|
160 µg/plate |
34±3 |
1.1 |
146± 7 |
1.0 |
8±3 |
1.2 |
11±3 |
0.7 |
|
500 µg/plate |
31±2 |
1.0 |
137±17 |
1.0 |
6±2 |
1.5 |
13±4 |
0.8 |
|
1600 µg/plate |
30±9 |
1.0 |
140± 6 |
1.0 |
6±2 |
0.6 |
5±1 |
0.8 |
|
5000 µg/plate |
28±7 |
0.9 |
172±11 |
1.2 |
6±1 |
0.3 |
3±1 |
0.8 |
|
Positive control |
193±26 (2-Nitrofluorene) 2.5µg/plate |
6.4 |
388±31 Sodiumazide 2.5µg/plate |
2.8 |
287±47 Sodiumazide 2.5µg/plate |
43.1 |
51±9 9-Aminoacridine 25µg/plate |
5.8 |
|
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative without metabolic activation
negative with metabolic activation
Under the experimental conditions of this test the test item did not induce a mutagenic effect in S. typhimurium.
lt is therefore not considered to be a bacterial mutagen.
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