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EC number: 807-621-3 | CAS number: 1428450-95-6
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted in 1997
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N-[4-(2,4-dihydroxyphenyl)-1,3-thiazol-2-yl]-2-methylpropanamide
- EC Number:
- 807-621-3
- Cas Number:
- 1428450-95-6
- Molecular formula:
- C13H14N2O3S
- IUPAC Name:
- N-[4-(2,4-dihydroxyphenyl)-1,3-thiazol-2-yl]-2-methylpropanamide
- Test material form:
- solid: particulate/powder
Constituent 1
Method
- Target gene:
- his operon
Species / strain
- 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) prepared from the livers of Aroclor 1254-induced rats
- Test concentrations with justification for top dose:
- Experiment 1: 5, 15.81, 50, 158.1, 500, 1581 and 5000 µg/plate with and without metabolic activation
Experiment 2: for strains TA98 and TA1535: 20.48, 51.2, 128, 320, 800 and 2000 µg/plate with and without metabolic activation; for strains TA100, TA102 and TA1537: 8.192, 20.48, 51.2, 128, 320 and 800 µg/plate with and without metabolic activation - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Preliminary solubility data indicated that the test substance was soluble in DMSO at concentrations of at least 100 mg/mL.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- mitomycin C
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
Experiment 1: in agar (plate incorporation)
Experiment 2: preincubation
DURATION
- Preincubation period: 20 min
- Exposure duration: 72 h
NUMBER OF REPLICATIONS: two separate experiments using triplicate plates with and without metabolic activation
DETERMINATION OF CYTOTOXICITY
- Method: clearing of background lawn - Evaluation criteria:
- The test substance was considered positive in this assay if all of the following criteria were met:
- When assessed using Dunnett's test, an increase in revertant numbers gave a significant response (p ≤ 0.01) which was concentration related.
- The positive trend/effects described above were reproducible. - Statistics:
- Dunnett's test was used to compare the counts at each concentration with the control.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Precipitation of the test substance was observed in both experiments at 2000 µg/plate and above.
COMPARISON WITH HISTORICAL CONTROL DATA: All negative controls were in the range of the historical control data.
ADDITIONAL INFORMATION ON CYTOTOXICITY: Cytotoxic effects of the test substance were observed in all tester strains, starting for TA102 and TA1537 at 320 µg/plate with metabolic activation and 500 µg/plate without metabolic activation, for TA100 at 500 µg/plate with and without metabolic activation and for TA98 and TA1535 at 800 µg/plate with metabolic activation and 1581 µg/plate without metabolic activation. The cytotoxic effects ranged from slight diminution of the back ground lawn to complete extermination of the test bacteria at higher concentrations.
Any other information on results incl. tables
Table 1. Test results of experiment 1 (plate incorporation).
Bacterial Reverse Mutation Assay, mean revertants colonies/plate ± standard deviation |
|||||
EXPERIMENT 1 (plate incorporation) |
|||||
S9-Mix |
Without
|
||||
Test item (µg/plate) |
T98 |
TA100 |
TA1535 |
TA1537 |
TA102 |
DMSO |
23.8 ± 6.1 |
94.8 ± 3.6 |
14.0 ± 4.1 |
6.0 ± 2.5 |
275.4 ± 33.5 |
5 |
24.0 ± 7.0 |
103.7 ± 7.6 |
13.3 ± 3.1 |
6.7 ± 2.5 |
276.7 ± 11.7 |
15.81 |
20.3 ± 4.5 |
102.3 ± 4.0 |
16.3 ± 2.5 |
6.3 ± 2.5 |
280.3 ± 34.3 |
50 |
19.7 ± 1.2 |
80.0 ± 6.0 |
22.0 ± 5.0 * |
7.3 ± 1.5 |
275.3 ± 10.3 |
158.1 |
19.3 ± 3.8 |
84.7 ± 8.5 |
16.0 ± 4.6 |
7.3 ± 2.9 |
270.7 ± 11.0 |
500 |
16.3 ± 4.5 |
80.3 ± 5.5 S |
15.7 ± 4.5 |
4.7 ± 0.6 S |
217.7 ± 35.2 S |
1581 |
5.3 ± 3.5 S |
T |
5.0 ± 1.0 V |
T |
T |
5000 |
P, T |
P, T |
P, T |
P, T |
P, T |
2NF |
905.0 ± 37.0 |
--- |
--- |
--- |
--- |
NaN3 |
--- |
614.3 ± 58.6 |
549.7 ± 82.0 |
--- |
--- |
AAC |
--- |
--- |
--- |
158.7 ± 31.2 |
--- |
MMC |
--- |
--- |
--- |
--- |
850.3 ± 133.3 |
S9-Mix
|
With |
||||
Test item (µg/plate) |
TA98 |
TA100 |
TA1535 |
TA1537 |
TA102 |
DMSO |
30.4 ± 7.6 |
98.6 ± 9.0 |
18.0 ± 5.0 |
13.2 ± 5.0 |
251.6 ± 10.1 |
5 |
34.7 ± 5.1 |
110.3 ± 10.8 |
19.3 ± 4.9 |
18.7 ± 4.7 |
237.7 ± 14.4 |
15.81 |
43.0 ± 11.3 |
113.7 ± 5.5 |
16.7 ± 3.1 |
17.0 ± 6.1 |
254.0 ± 14.7 |
50 |
36.7 ± 2.5 |
106.7 ± 11.7 |
21.0 ± 9.5 |
16.0 ± 1.0 |
247.0 ± 13.1 |
158.1 |
39.0 ± 9.2 |
93.7 ± 12.4 |
19.0 ± 2.0 |
13.0 ± 2.6 |
228.7 ± 21.1 |
500 |
26.0 ± 5.3 |
73.7 ± 12.7 S |
11.7 ± 2.9 |
8.3 ± 4.0 S |
181.3 ± 23.2 S |
1581 |
15.0 ± 2.6 S |
T |
5.3 ± 4.0 V |
T |
T |
5000 |
P, T |
P, T |
P, T |
P, T |
P, T |
BaP |
297.7 ± 110.2 |
--- |
--- |
--- |
--- |
AAN |
--- |
1081.7 ± 192.8 |
265.7 ± 3.8 |
198.3 ± 24.4 |
1387.3 ± 79.5 |
P: precipitation of the test substance observed S: slight thinning of background bacterial lawn V: very thin background bacterial lawn T: toxic, no revertant colonies
Positive controls: 2NF = 2-nitrofluorene NaN3 = sodium azide AAC = 9-aminoacridine MMC = Mitomycin C BaP = benzo[a]pyrene AAN = 2-aminoanthracene |
|||||
* p<0.05 |
Table 2. Test results of experiment 2 (pre-incubation).
Bacterial Reverse Mutation Assay, mean revertants colonies/plate ± standard deviation |
|||||
EXPERIMENT 2 (pre-incubation) |
|||||
S9-Mix |
Without
|
||||
Test item (µg/plate) |
T98 |
TA100 |
TA1535 |
TA1537 |
TA102 |
DMSO |
22.2 ± 5.2 |
94.8 ± 14.6 |
17.6 ± 2.9 |
11.2 ± 4.2 |
233.4 ± 12.6 |
8.192 |
--- |
94.7 ± 14.0 |
--- |
10.0 ± 4.0 |
243.3 ± 8.1 |
20.48 |
24.3 ± 8.1 |
70.7 ± 8.7 |
22.7 ± 6.8 |
9.7 ± 3.5 |
236.7 ± 4.6 |
51.2 |
16.7 ± 4.9 |
87.7 ± 5.8 |
14.7 ± 5.8 |
9.0 ± 2.6 |
221.3 ± 0.6 |
128 |
20.3 ± 2.3 |
96.3 ± 17.2 |
16.0 ± 2.6 |
8.0 ± 3.6 |
201.0 ± 22.1 |
320 |
20.3 ± 3.2 |
87.0 ± 9.8 |
11.7 ± 3.8 |
10.3 ± 4.5 |
180.7 ± 15.0 |
800 |
10.3 ± 2.5 |
47.3 ± 6.7 |
11.3 ± 4.7 |
4.7 ± 1.5 |
102.7 ± 5.7 V |
2000 |
5.3 ± 2.1 P, V |
--- |
2.3 ± 0.6 P, V |
--- |
--- |
2NF |
735.7 ± 87.9 |
--- |
--- |
--- |
--- |
NaN3 |
--- |
671.7 ± 94.0 |
686.7 ± 24.1 |
--- |
--- |
AAC |
--- |
--- |
--- |
100.3 ± 34.8 |
--- |
MMC |
--- |
--- |
--- |
--- |
715.0 ± 99.3 |
S9-Mix
|
With |
||||
Test item (µg/plate) |
TA98 |
TA100 |
TA1535 |
TA1537 |
TA102 |
DMSO |
33.8 ± 6.1 |
120.0 ± 9.9 |
20.6 ± 4.5 |
17.0 ± 4.0 |
225.2 ± 23.6 |
8.192 |
--- |
114.0 ± 18.5 |
--- |
19.3 ± 1.5 |
261.3 ± 11.6 * |
20.48 |
39.3 ± 4.7 |
112.7 ± 7.5 |
15.7 ± 0.6 |
18.7 ± 2.5 |
249.0 ± 15.6 |
51.2 |
39.0 ± 7.5 |
126.7 ± 14.0 |
17.7 ± 5.5 |
16.7 ± 1.2 |
259.0 ± 15.6 * |
128 |
32.3 ± 6.7 |
125.7 ± 7.4 |
16.3 ± 3.5 |
21.0 ± 3.0 |
232.7 ± 13.7 |
320 |
28.3 ± 5.9 |
119.0 ± 5.6 |
12.7 ± 2.5 |
19.3 ± 0.6 S |
229.7 ± 2.3 S |
800 |
15.0 ± 3.5 S |
T |
2.3 ± 0.6 V |
T |
T |
2000 |
P, T |
--- |
P, T |
--- |
--- |
BaP |
339.0 ± 28.2 |
--- |
--- |
--- |
--- |
AAN |
--- |
1414.7 ± 33.5 |
257.7 ± 10.4 |
260.0 ± 13.9 |
942.3 ± 199.4 |
P: precipitation of the test substance observed S: slight thinning of background bacterial lawn V: very thin background bacterial lawn T: toxic, no revertant colonies
Positive controls: 2NF = 2-nitrofluorene NaN3 = sodium azide AAC = 9-aminoacridine MMC = Mitomycin C BaP = benzo[a]pyrene AAN = 2-aminoanthracene |
|||||
* p<0.05 |
Applicant's summary and conclusion
- Conclusions:
- It was concluded that W630 (Sample ID: 26480) did not induce mutation in five
histidine-requiring strains (TA98, TA100, TA1535, TA1537 and TA102) of
Salmonella typhimurium when tested under the conditions of this study. These
conditions included treatments at concentrations up to 5000 μg/plate (the maximum
recommended concentration according to current regulatory guidelines) or toxic
concentrations, in the absence and in the presence of a rat liver metabolic activation
system (S-9). - Executive summary:
W630 (Sample ID: 26480) was assayed for mutation in five histidine-requiring strains
(TA98, TA100, TA1535, TA1537 and TA102) of Salmonella typhimurium, both in
the absence and in the presence of metabolic activation by an Aroclor 1254-induced
rat liver post-mitochondrial fraction (S-9), in two separate experiments.
All W630 (Sample ID: 26480) treatments in this study were performed using
formulations prepared in anhydrous analytical grade dimethyl sulphoxide (DMSO).
Experiment 1 treatments of all the tester strains were performed in the absence and in
the presence of S-9, using final concentrations of W630 (Sample ID: 26480) at 5,
15.81, 50, 158.1, 500, 1581 and 5000 μg/plate, plus negative (vehicle) and positive
controls. Following these treatments, evidence of toxicity was observed at 500 and/or
1581 μg/plate and above in all strains in the absence and presence of S-9.
Experiment 2 treatments of all the tester strains were performed in the absence and in
the presence of S-9. For strains TA98 and TA1535, the maximum test concentration
was reduced to 2000 μg/plate and for strains TA100, TA1537 and TA102 the
maximum test concentration was reduced to 800 μg/plate, based on toxicity observed
in Experiment 1. Narrowed concentration intervals were employed covering the
ranges 20.48 – 2000 μg/plate or 8.192 – 800 μg/plate respectively, in order to
examine more closely those concentrations of W630 (Sample ID: 26480) approaching
the maximum test concentration. In addition, all treatments in the presence of S-9
were further modified by the inclusion of a pre-incubation step. Following these
treatments, evidence of toxicity was observed at 320 μg/plate and above in strain
TA1537 and TA102 in the presence of S-9; 800 μg/plate and above in strain TA98 in
the absence and presence of S-9 and strain TA1535 in the presence of S-9; and 800
and/or 2000 μg/plate in strain TA100 in the absence and presence of S-9, and strains
TA1535, TA1537 and TA102 in the absence of S-9.
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