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EC number: 212-832-3 | CAS number: 872-85-5
- 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
- Study period:
- 17 February - 28 May 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Isonicotinaldehyde
- EC Number:
- 212-832-3
- EC Name:
- Isonicotinaldehyde
- Cas Number:
- 872-85-5
- Molecular formula:
- C6H5NO
- IUPAC Name:
- pyridine-4-carbaldehyde
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report) : Pyridine-4-aldehyde
- Physical state : clear yellowish liquid
- Analytical purity :98,7% (GC)
- Lot/batch No. : 1120126/001
- Stability under test conditions : not analysed
- Storage condition of test material : Refrigerator at ca. 4°C , in the dark , under nitrogen
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium, other: TA97a
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Species / strain / cell type:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Metabolic activation system:
- see at "any other information on materials and methods incl. tables"
- Test concentrations with justification for top dose:
- The concentrations for the first experiment were set according to a preliminary toxicity test .
In the preliminary experiment the test substance prevented the growth of the bacterial background lawn at concentrations of 556 µg/plate and higher . It was therefore decided to use 900 µg/plate as the highest concentration which would be toxic and to use 6 instead of the required 5 concentrations . Each of the other 5 concentrations was 1/3 of the preceding one .
In the first experiment clear toxicity was only seen in the highest concentrations of strains TA98 and TA1535 . According to these results a concentration of 2700 µg/plate was added in the second experiment .
The test substance was tested without as well as with an external metabolising system (S9-mix) . The results were verified by a second , independent experiment . Triplicate repetitions were run for each dose group in each of the two separate experiments that were conducted , for the control groups six-fold repetitions were run .
see also at "any other information on materials and methods incl. tables" - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO (for test substance and for the negative control group)
Controls
- Untreated negative controls:
- yes
- Remarks:
- The solvent , DMSO was used for the negative control group
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- 2-nitrofluorene
- sodium azide
- other: 4-Nitro-o-phenylene-diamine ; t-Butyl-hydroperoxide ; 2-Aminoanthracene ; 1,8-Dihydro-anthraquinone
- Details on test system and experimental conditions:
- METHOD OF APPLICATION : in agar (plate incorporation)
CONDITIONS OF CULTIVATION : One day before the Ames test was performed , a small amount from each of the frozen bacterial cultures (stored in small portions in a solution of 6% DMSO in phosphate buffered saline in liquid nitrogen) was transferred to nutrient broth . The liquid cultures were incubated overnight at 37°C and then used for the exposure .
EXPOSURE TECHNIQUE : The exposure was performed according to the ´Plate Incorporation Assay´, in which bacteria test substance (and microsomes) are in contact on the plate without preceding incubation in the liquid state . The number of viable cells in the overnight-cultures is in the range of 2 x 10E8 cells per ml .
For each sample the following solutions were combined :
- 0,1 ml of the overnight culture of the bacteria
- 0,5 ml of S9-mix (or phosphate buffered saline for samples without metabolic activation)
- 0,1 ml of the appropriate test- or reference substance solution and
- 2 ml of top agar
The combined solutions were mixed and spread over a plate with minimal agar (9cm diameter) . After the top agar had solidified , the plates were incubated at 37°C until the colonies were visible (2 days) .
COUNTING OF COLONIES :
The plates with less than about 50 revertant colonies , i.e. the plates of TA98 and TA1535 with the exception of the positive controls , were counted visually by marking the colonies with a felt tipped pen . The other plates were photographed with a video camera and the picture files were scanned for colonies by a computer program . - Evaluation criteria:
- The criteria for a positive result are :
A reproducible increase of the number of revertants to more than the following threshold values for at least one of the concentrations :
- For the strains with a low spontaneous revertant rate , i.e. TA98 and TA1535 : The 2 1/2 fold of the amount of the spontaneous revertants .
- For the strains with a high spontaneous revertant rate , i.e. TA97a, TA100 and TA102 : The 1 2/3 fold of the amount of the spontaneous revertants .
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium, other: TA97a
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- Microcolonies instead of a bacterial background lawn was observed at concentration of 2700 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- Microcolonies instead of a bacterial background lawn were observed at 900 µg/plate with and without metabolisation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- Microcolonies instead of a bacterial background lawn was observed at concentration of 2700 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- Microcolonies instead of a bacterial background lawn was observed at concentration of 2700 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- Microcolonies instead of a bacterial background lawn were observed at concentrations of 2700 µg/plate with and without metabolisation and at 900 µg/plate without metabolisation.
- 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 seen in any concentration groups .
RANGE-FINDING/SCREENING STUDIES : The concentrations for the first experiment were set according to a preliminary toxicity test .
In the preliminary experiment the test substance prevented the growth of the bacterial background lawn at concentrations of 556 µg/plate and higher . It was therefore decided to use 900 µg/plate as the highest concentration which would be toxic and to use 6 instead of the required 5 concentrations . Each of the other 5 concentrations was 1/3 of the preceding one .
COMPARISON WITH HISTORICAL CONTROL DATA : see at "any other information on results incl. tables"
Any other information on results incl. tables
COMPARISON WITH HISTORICAL CONTROL DATA :
Genetic properties : (The tests were performed in September 2000 . The strains were stored in liquid nitrogen since that time)
strain: | TA97a | TA98 | TA100 | TA102 | TA1535 |
Sensitive against crystal violet | yes | yes | yes | yes | yes |
Sensitive against ampicillin | no | no | no | no | yes |
Sensitive against ampicillin/tetracycline | -- | yes | -- | no | -- |
Sensitive against UV | yes | yes | yes | no | yes |
-- : not tested
Mutation frequency : (historic data of mean revertants per petri dish , standard SD and number of tests N)
without metabolisation | with metabolisation (S9 -mix) | |||||||
strain : | substance, concentration (µg/plate) | revertants/plate | substance, concentration (µg/plate) | revertants/plate | ||||
mean | SD | N | mean | SD | N | |||
TA97a | Control | 80 | 14 | 92 | Control | 111 | 17 | 92 |
4-NoPD, 10 µg | 488 | 113 | 92 | DMBA, 10 µg | 388 | 157 | 92 | |
TA98 | Control | 8,4 | 2,0 | 92 | Control | 11,6 | 2,5 | 92 |
2-Nitro-fluorene, 2 µg | 197 | 54 | 92 | 2-Aminoanthracene, 1 µg | 481 | 171 | 92 | |
TA100 | Control | 68,7 | 18,5 | 92 | Control | 79,9 | 15,2 | 92 |
Na-azide, 2 µg | 494 | 131 | 92 | 2-Aminoanthracene, 2 µg | 1624 | 425 | 92 | |
TA102 | Control | 175 | 31 | 92 | Control | 238 | 33 | 92 |
tBHPO, 50 µg | 542 | 154 | 92 | DHA, 50 µg | 692 | 189 | 92 | |
TA1535 | Control | 10,3 | 5,7 | 92 | Control | 11,0 | 4,6 | 92 |
Na-azide, 1 µg | 250 | 88 | 92 | 2-Aminoanthracene, 2 µg | 157 | 79 | 92 |
DHA = 1,8-Dihydroxy-anthraquinone
4-NoPD = 4-Nitro-o-phenylene-diamine
tBHPO = tert.-Butyl-hydroperoxide
DMBA = 7,12-Dimethylbenz[a]anthracene
Table 1 : Mean number of revertants per plate for strain TA97a (Mean, standard deviation SD and number of plates N)
Without metabolisation
first experiment | second experiment | ||||||
conc. µg/plate | revertants/plate | conc. µg/plate | revertants/plate | ||||
mean | SD | N | mean | SD | N | ||
- | - | - | - | 2700 | toxic | - | 3 |
900 | 177,7 | 22,5 | 3 | 900 | 57,0 | 7,5 | 3 |
300 | 171,7 | 5,5 | 3 | 300 | 67,7 | 11,9 | 3 |
100 | 166,0 | 23,6 | 3 | 100 | 87,0 | 20,5 | 3 |
33 | 182,3 | 27,3 | 3 | 33 | 83,0 | 1,7 | 3 |
11 | 177,3 | 4,6 | 3 | 11 | 100,0 | 27,5 | 3 |
3,7 | 162,0 | 6,9 | 3 | 3,7 | 71,7 | 13,3 | 3 |
solvent | 178,8 | 15,5 | 6 | solvent | 74,7 | 15,9 | 6 |
positive | 406,3 | 30,9 | 3 | positive | 334,7 | 63,4 | 3 |
Metabolisation with S9 -mix
first experiment | second experiment | ||||||
conc. µg/plate | revertants/plate | conc. µg/plate | revertants/plate | ||||
mean | SD | N | mean | SD | N | ||
- | - | - | - | 2700 | toxic | - | 3 |
900 | 178,3 | 4,2 | 3 | 900 | 90,0 | 4,6 | 3 |
300 | 159,0 | 6,1 | 3 | 300 | 109,0 | 1,7 | 3 |
100 | 183,3 | 13,2 | 3 | 100 | 106,0 | 39,9 | 3 |
33 | 164,7 | 19,7 | 3 | 33 | 114,3 | 15,5 | 3 |
11 | 189,0 | 19,9 | 3 | 11 | 105,3 | 6,7 | 3 |
3,7 | 170,3 | 32,3 | 3 | 3,7 | 106,3 | 17,0 | 3 |
solvent | 192,0 | 10,1 | 6 | solvent | 101,5 | 20,9 | 6 |
positive | 421,7 | 7,4 | 3 | positive | 255,3 | 19,6 | 3 |
solvent : DMSO
positive : without metabolisation : 4 -Nitro-o-phenylene-diamine (10 µg/plate) ; with metabolisation : 7,12-Dimethylbenz[a]anthracene (10 µg/plate)
toxic : only microcolonies instead of a bacterial background lawn
Table 2 :Mean number of revertants per plate for strain TA98(Mean, standard deviation SD and number of plates N)
Without metabolisation
first experiment | second experiment | ||||||
conc. µg/plate | revertants/plate | conc. µg/plate | revertants/plate | ||||
mean | SD | N | mean | SD | N | ||
- | - | - | - | 2700 | toxic | - | 3 |
900 | toxic | - | 3 | 900 | toxic | - | 3 |
300 | 6,0 | 2,6 | 3 | 300 | 4,0 | 1,7 | 3 |
100 | 11,3 | 0,6 | 3 | 100 | 8,0 | 3,6 | 3 |
33 | 9,0 | 3,0 | 3 | 33 | 6,3 | 1,5 | 3 |
11 | 7,7 | 1,5 | 3 | 11 | 8,7 | 1,2 | 3 |
3,7 | 6,0 | 3,6 | 3 | 3,7 | 8,7 | 3,1 | 3 |
solvent | 8,7 | 1,0 | 6 | solvent | 8,5 | 3,4 | 6 |
positive | 156,7 | 29,4 | 3 | positive | 251,3 | 31,2 | 3 |
Metabolisation with S9 -mix
first experiment | second experiment | ||||||
conc. µg/plate | revertants/plate | conc. µg/plate | revertants/plate | ||||
mean | SD | N | mean | SD | N | ||
- | - | - | - | 2700 | toxic | - | 3 |
900 | toxic | - | 3 | 900 | toxic | - | 3 |
300 | 11,7 | 1,5 | 3 | 300 | 12,7 | 5,5 | 3 |
100 | 11,7 | 2,9 | 3 | 100 | 11,0 | 1,7 | 3 |
33 | 10,0 | 2,6 | 3 | 33 | 12,0 | 5,6 | 3 |
11 | 14,3 | 2,5 | 3 | 11 | 12,3 | 4,7 | 3 |
3,7 | 11,3 | 4,2 | 3 | 3,7 | 11,7 | 4,5 | 3 |
solvent | 13,7 | 2,5 | 6 | solvent | 11,3 | 2,7 | 6 |
positive | 353,3 | 11,6 | 3 | positive | 330,7 | 36,5 | 3 |
solvent : DMSO
positive : without metabolisation : 2-Nitrofluorene (2 µg/plate) ; with metabolisation : 2-Amino-anthracene (1 µg/plate)
toxic : only microcolonies instead of a bacterial background lawn
Table 3 :Mean number of revertants per plate for strain TA100(Mean, standard deviation SD and number of plates N)
Without metabolisation
first experiment | second experiment | ||||||
conc. µg/plate | revertants/plate | conc. µg/plate | revertants/plate | ||||
mean | SD | N | mean | SD | N | ||
- | - | - | - | 2700 | toxic | - | 3 |
900 | 116,7 | 11,5 | 3 | 900 | 29,0 | 7,9 | 3 |
300 | 88,7 | 3,2 | 3 | 300 | 48,3 | 9,1 | 3 |
100 | 63,7 | 7,6 | 3 | 100 | 69,0 | 16,5 | 3 |
33 | 66,0 | 13,9 | 3 | 33 | 78,3 | 25,1 | 3 |
11 | 73,3 | 11,5 | 3 | 11 | 69,7 | 4,9 | 3 |
3,7 | 75,7 | 7,6 | 3 | 3,7 | 85,0 | 14,0 | 3 |
solvent | 70,3 | 10,9 | 6 | solvent | 66,3 | 10,0 | 6 |
positive | 647,7 | 105,3 | 3 | positive | 408,0 | 21,7 | 3 |
Metabolisation with S9 -mix
first experiment | second experiment | ||||||
conc. µg/plate | revertants/plate | conc. µg/plate | revertants/plate | ||||
mean | SD | N | mean | SD | N | ||
- | - | - | - | 2700 | toxic | - | 3 |
900 | 105,0 | 8,5 | 3 | 900 | 72,0 | 3,5 | 3 |
300 | 102,0 | 12,0 | 3 | 300 | 87,3 | 8,5 | 3 |
100 | 71,3 | 2,1 | 3 | 100 | 92,7 | 13,3 | 3 |
33 | 89,0 | 16,1 | 3 | 33 | 79,7 | 14,2 | 3 |
11 | 87,3 | 5,5 | 3 | 11 | 90,3 | 12,7 | 3 |
3,7 | 86,0 | 13,0 | 3 | 3,7 | 92,0 | 10,4 | 3 |
solvent | 87,8 | 8,4 | 6 | solvent | 90,3 | 12,6 | 6 |
positive | 1786,3 | 67,4 | 3 | positive | 1572,0 | 31,4 | 3 |
solvent : DMSO
positive : without metabolisation : Sodium azide (2 µg/plate) ; with metabolisation : 2-Amino-anthracene (2 µg/plate)
toxic : only microcolonies instead of a bacterial background lawn
Table 4 :Mean number of revertants per plate for strain TA102(Mean, standard deviation SD and number of plates N)
Without metabolisation
first experiment | second experiment | ||||||
conc. µg/plate | revertants/plate | conc. µg/plate | revertants/plate | ||||
mean | SD | N | mean | SD | N | ||
- | - | - | - | 2700 | toxic | - | 3 |
900 | 91,0 | 20,8 | 3 | 900 | 58,7 | 18,1 | 3 |
300 | 139,3 | 8,5 | 3 | 300 | 111,0 | 12,1 | 3 |
100 | 147,3 | 11,2 | 3 | 100 | 129,0 | 17,5 | 3 |
33 | 172,0 | 9,6 | 3 | 33 | 146,0 | 20,8 | 3 |
11 | 163,0 | 13,7 | 3 | 11 | 161,0 | 19,3 | 3 |
3,7 | 183,3 | 4,9 | 3 | 3,7 | 133,7 | 31,2 | 3 |
solvent | 167,8 | 22,3 | 6 | solvent | 146,7 | 23,3 | 6 |
positive | 783,7 | 104,7 | 3 | positive | 340,3 | 75,1 | 3 |
Metabolisation with S9 -mix
first experiment | second experiment | ||||||
conc. µg/plate | revertants/plate | conc. µg/plate | revertants/plate | ||||
mean | SD | N | mean | SD | N | ||
- | - | - | - | 2700 | toxic | - | 3 |
900 | 159,3 | 30,9 | 3 | 900 | 114,0 | 6,2 | 3 |
300 | 188,7 | 18,7 | 3 | 300 | 190,3 | 26,2 | 3 |
100 | 243,7 | 18,7 | 3 | 100 | 196,7 | 25,4 | 3 |
33 | 258,3 | 35,2 | 3 | 33 | 211,7 | 14,6 | 3 |
11 | 250,7 | 10,3 | 3 | 11 | 231,7 | 30,9 | 3 |
3,7 | 264,0 | 36,8 | 3 | 3,7 | 200,7 | 27,2 | 3 |
solvent | 253,5 | 21,7 | 6 | solvent | 234,4 | 18,5 | 6 |
positive | 821,3 | 21,1 | 3 | positive | 753,7 | 41,9 | 3 |
solvent : DMSO
positive : without metabolisation : t-Butyl-hydroperoxide (50 µg/plate) ; with metabolisation : 1,8-Dihydroxy-anthraquinone (50 µg/plate)
toxic : only microcolonies instead of a bacterial background lawn
Table 5:Mean number of revertants per plate for strain TA1535(Mean, standard deviation SD and number of plates N)
Without metabolisation
first experiment | second experiment | ||||||
conc. µg/plate | revertants/plate | conc. µg/plate | revertants/plate | ||||
mean | SD | N | mean | SD | N | ||
- | - | - | - | 2700 | toxic | - | 3 |
900 | toxic | - | 3 | 900 | toxic | - | 3 |
300 | 7,3 | 2,1 | 3 | 300 | 7,7 | 3,2 | 3 |
100 | 9,3 | 4,7 | 3 | 100 | 15,3 | 6,4 | 3 |
33 | 9,7 | 3,2 | 3 | 33 | 13,3 | 3,2 | 3 |
11 | 7,0 | 1,0 | 3 | 11 | 8,7 | 1,5 | 3 |
3,7 | 9,7 | 5,8 | 3 | 3,7 | 10,0 | 2,0 | 3 |
solvent | 10,5 | 2,3 | 6 | solvent | 8,3 | 2,6 | 6 |
positive | 307,3 | 31,7 | 3 | positive | 265,3 | 33,6 | 3 |
Metabolisation with S9 -mix
first experiment | second experiment | ||||||
conc. µg/plate | revertants/plate | conc. µg/plate | revertants/plate | ||||
mean | SD | N | mean | SD | N | ||
- | - | - | - | 2700 | toxic | - | 3 |
900 | 7,0 | 0,0 | 3 | 900 | 7,0 | 2,6 | 3 |
300 | 9,7 | 2,3 | 3 | 300 | 10,3 | 5,8 | 3 |
100 | 7,0 | 4,4 | 3 | 100 | 6,0 | 1,0 | 3 |
33 | 9,7 | 2,5 | 3 | 33 | 8,7 | 2,5 | 3 |
11 | 7,0 | 1,0 | 3 | 11 | 9,0 | 1,0 | 3 |
3,7 | 8,0 | 1,0 | 3 | 3,7 | 8,3 | 4,0 | 3 |
solvent | 8,7 | 2,6 | 6 | solvent | 7,3 | 3,8 | 6 |
positive | 114,0 | 17,7 | 3 | positive | 106,3 | 9,1 | 3 |
solvent : DMSO
positive : without metabolisation : Sodium azide (1 µg/plate) ; with metabolisation : 2-Amino-anthracene (2 µg/plate)
toxic : only microcolonies instead of a bacterial background lawn
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative without metabolic activation
negative with metabolic activation
The study was performed according to the OECD Guideline 471 without deviations and according to the principles of the good laboratory practice and therefore considered to be of the highest quality (reliability Klimisch 1). All positive control groups showed significantly increased mutation frequencies which demonstrate the sensitivity of the test system. According to the results obtained in this study, "PYRIDINE-4-ALDEHYDE" is non-mutagenic in the Ames test with the strains TA97a, TA98, TA100, TA102 and TA1535 up to the limit of toxicity. - Executive summary:
Pyridine-4-aldehyde was tested for mutagenic activity with the "Salmonella typhimurium Reverse Mutation Test" (Ames Test). The study was conducted in accordance with the OECD-guideline 471 and directive 2000/32/EC, part B.13/14. The test substance, dissolved in DMSO, was tested at concentrations ranging from 3.7 µg to 2700 µg per plate according to the "direct plate incorporation method" without external metabolisation as well as with an external metabolising system (S9 -mix). As test system the bacterial strains Salmonella typhimurium TA97a, TA98, TA100, TA102 and TA1535 were used. Negative and positive controls were included. An independent repetition of the experiment was performed.
All positive control groups showed significantly increased mutation frequencies which demonstrate the sensitivity of the test system. Microcolonies instead of a bacterial background lawn were observed in all strains at concentrations of 2700 µg/plate, at 900 µg/plate in strain TA98 with and without metabolisation and in strain TA1535 without metabolisation. No precipitation of the test substance was seen in any of the concentration groups. In none of the concentrations tested and with none of the strains used an increase of the mutation frequency to more than the threshold values (250 % of the controls for strains TA98 and TA1535, 167 % of the controls for strains TA97a, TA100 and TA102) was obtained. Metabolic activation did not change these results.
According to the results obtained in this study, Pyridine-4 -aldehyde is non-mutagenic in the Ames testwith the strains TA97a, TA98, TA100, TA102 and TA1535 up to the limit of toxicity.
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