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EC number: 940-411-0 | CAS number: 1353749-74-2
- 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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Remarks:
- Conducted according to guideline in effect at time of study conduct
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Remarks:
- Conducted according to guideline in effect at time of study conduct
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- Remarks:
- Conducted according to guideline in effect at time of study conduct
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-amino-3-hydroxy-N'-[(E)-(2,3,4-trihydroxyphenyl)methylidene]propanehydrazide hydrochloride
- EC Number:
- 940-411-0
- Cas Number:
- 1353749-74-2
- Molecular formula:
- C10H14ClN3O5
- IUPAC Name:
- 2-amino-3-hydroxy-N'-[(E)-(2,3,4-trihydroxyphenyl)methylidene]propanehydrazide hydrochloride
- Details on test material:
- - Purity: 100%
Constituent 1
Method
- Target gene:
- histidine
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor-induced rat liver S9.
- Test concentrations with justification for top dose:
- Initial toxicity-mutation assay: 1.5, 5.0, 15, 50, 150, 500, 1500 and 5000 μg per plate.
Confirmatory mutagenicity assay: 50, 150, 500, 1500, 2000 and 5000 μg per plate. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: sterile distilled water
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- methylmethanesulfonate
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: incubated for 48 to 72 hours at 37±2°C
- Fixation time (start of exposure up to fixation or harvest of cells): 48 to 72 hours
NUMBER OF REPLICATIONS: Initial: 2 reps; Confirmatory: 3 reps
DETERMINATION OF CYTOTOXICITY: The condition of the bacterial background lawn was evaluated for evidence of test substance toxicity by using a dissecting microscope. - Evaluation criteria:
- For the test substance to be evaluated positive, it must cause a dose-related increase in the mean revertants per plate of at least one tester strain over a minimum of two increasing concentrations of test substance. Data sets for tester strains TA1535 and TA1537 were judged positive if the increase in mean revertants at the peak of the dose response was greater than or equal to 3.0-times the mean vehicle control value. Data sets for tester strains TA98, TA100 and WP2 uvrA were judged positive if the increase in mean revertants at the peak of the dose response was greater than or equal to 2.0-times the mean vehicle control value.
The following criteria must be met for the initial toxicity-mutation and confirmatory mutagenicity assays to be considered valid. All Salmonella tester strain cultures must demonstrate the presence of the deep rough mutation (rfa) and the deletion in the uvrB gene. Cultures of tester strains TA98 and TA100 must demonstrate the presence of the pKM101 plasmid R-factor. All WP2 uvrA cultures must demonstrate the deletion in the uvrA gene. All cultures must demonstrate the characteristic mean number of spontaneous revertants in the vehicle controls as follows (inclusive): TA98, 10 - 50; TA100, 80 - 240; TA1535, 5 - 45; TA1537, 3 - 21; WP2 uvrA, 10 - 60. To ensure that appropriate numbers of bacteria are plated, tester strain culture titers must be greater than or equal to 0.3x10e9 cells/mL. The mean of each positive control must exhibit at least a 3.0-fold increase in the number of revertants over the mean value of the respective vehicle control. A minimum of three non-toxic dose levels is required to evaluate assay data. - Statistics:
- Revertant colonies for a given tester strain and activation condition, except for positive controls, were counted either entirely by automated colony counter or entirely by hand unless the plate exhibited toxicity. For each replicate plating, the mean and standard deviation of the number of revertants per plate were calculated and are reported.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 μg per plate (all strains only in the absence of S9)
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- without
- Genotoxicity:
- ambiguous
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 μg per plate
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 μg per plate
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- In the Initial Toxicity-Mutation Assay, the maximum dose tested was 5000 μg per plate; this dose was achieved using a concentration of 50 mg/mL and a 100 μL plating aliquot. The dose levels tested were 1.5, 5.0, 15, 50, 150, 500, 1500 and 5000 μg per plate. Positive mutagenic responses (ranging from 2.4- to 6.4-fold maximum increases) were observed with all tester strains in the absence of S9 activation and with tester strains TA98, TA100, TA1535 and WP2 uvrA in the presence of S9 activation. A dose-responsive increase (2.8-fold maximum increase) was observed with tester strain TA1537 in the presence of S9 activation; however, this increase did not meet all criteria required for evaluation as positive (i.e., a maximum response of at least 3.0-times the mean vehicle control value). No precipitate was observed. Toxicity was observed at 5000 μg per plate with all tester strains in the absence of S9 activation and with tester strain WP2 uvrA in the presence of S9 activation. Based on the findings of the initial toxicity-mutation assay, the maximum dose plated in the confirmatory mutagenicity assay was 5000 μg per plate.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
In the Confirmatory Mutagenicity Assay, positive mutagenic responses (ranging from 2.6- to 6.7-fold maximum increases) were observed with all tester strains in the presence of S9 activation and all Salmonella tester strains in the absence of S9 activation. A non-dose responsive increase (1.7-fold maximum increase) was observed with tester strain WP2 uvrA in the absence of S9 activation. Toxicity was observed at 5000 μg per plate with all tester strains in the absence of S9 activation and with tester strain WP2 uvrA in the presence of S9 activation.
Confirmatory Mutagenicity Assay Without S9 Activation
|
||||||
Strain |
Substance |
Dose level per plate |
Mean revertants per plate |
Standard Deviation |
Ratio treated/ solvent |
Individual revertant colony counts and background codes |
TA98 |
H-30744 |
5000 µg |
0 |
0 |
0.0 |
0M 4, 0M 4, 0M 4 |
|
|
2000µg |
49 |
6 |
2.6 |
49M, 55M, 44M |
|
|
1500µg |
36 |
2 |
1.9 |
33M, 37M, 37M |
|
|
500µg |
22 |
8 |
1.2 |
18M, 31M, 18M |
|
|
150µg |
17 |
2 |
0.9 |
19M, 16M, 17M |
|
|
50µg |
18 |
3 |
0.9 |
21M, 16M, 17M |
|
Water |
100µL |
19 |
7 |
|
27M, 14M, 17M |
|
|
|
|
|
|
|
TA100 |
H-30744 |
5000 µg |
0 |
0 |
0.0 |
0M 4, 0M 4, 0M 4 |
|
|
2000µg |
559 |
23 |
5.9 |
533A, 565A, 578A |
|
|
1500µg |
428 |
46 |
4.5 |
395A, 408A, 481A |
|
|
500µg |
350 |
14 |
3.7 |
335A, 351A, 363A |
|
|
150µg |
186 |
4 |
2.0 |
189A, 183A, WDN# |
|
|
50µg |
117 |
12 |
1.2 |
126A, 103A, 122A |
|
Water |
100µL |
95 |
7 |
|
102A, 88A, 96A |
|
|
|
|
|
|
|
TA1535 |
H-30744 |
5000 µg |
0 |
0 |
0.0 |
0M 4, 0M 4, 0M 4 |
|
|
2000µg |
57 |
7 |
3.6 |
52A, 55A, 65A |
|
|
1500µg |
38 |
5 |
2.4 |
42A, 40A, 33A |
|
|
500µg |
39 |
6 |
2.4 |
45A, 33A, 38A |
|
|
150µg |
16 |
4 |
1.0 |
20A, 13A, 15A |
|
|
50µg |
16 |
1 |
1.0 |
17A, 15A, WDN# |
|
Water |
100µL |
16 |
6 |
|
19A, 19A, 9A |
|
|
|
|
|
|
|
TA1537 |
H-30744 |
5000 µg |
0 |
0 |
0.0 |
0M 4, 0M 4, 0M 4 |
|
|
2000µg |
32 |
5 |
3.2 |
37A, 33A, 27A |
|
|
1500µg |
34 |
6 |
3.4 |
29A, 31A, 41A |
|
|
500µg |
17 |
3 |
1.7 |
14A, 20A, 18A |
|
|
150µg |
14 |
4 |
1.4 |
10A, 15A, 17A |
|
|
50µg |
11 |
3 |
1.1 |
8A, 10A, 14A |
|
Water |
100µL |
10 |
3 |
|
8A, 13A, 9A |
|
|
|
|
|
|
|
WP2urvA |
H-30744 |
5000 µg |
0 |
0 |
0.0 |
0M 5, 0M 5, 0M 5 |
|
|
2000µg |
35 |
9 |
1.0 |
29A, 45A, 32A |
|
|
1500µg |
41 |
6 |
1.2 |
45A, 34A, 43A |
|
|
500µg |
52 |
5 |
1.5 |
57A, 51A, 48A |
|
|
150µg |
58 |
5 |
1.7 |
52A, 59A, 62A |
|
|
50µg |
41 |
12 |
1.2 |
37A, 31A, 54A |
|
Water |
100µL |
34 |
7 |
|
34A, 41A, 28A |
|
|
|
|
|
|
|
TA98 |
2NF |
1.0µg |
202 |
6 |
10.6 |
209A, 199A, 199A |
TA100 |
SA |
1.0µg |
522 |
27 |
5.5 |
516A, 499A, 552A |
TA1535 |
SA |
1.0µg |
474 |
50 |
29.6 |
525A, 425A, 473A |
TA1537 |
9AAD |
75µg |
160 |
49 |
16.0 |
122A, 143A, 216A |
WP2urvA |
MMS |
1000µg |
317 |
21 |
9.3 |
332A, 293A, 326A |
|
|
|
|
|
|
|
Key to Positive Controls
2NF – 2-Nitrofluorene SA – Sodium azide 9AAD – 9-Aminoacridine MMS – Methyl methanesulfonate |
Key to Automatic & Manual Count Flags
M – Manual count A – Automatic count |
Key to Plate Postfix Codes
4 – Extremely reduced background 5 – Absent background WD – Water damaged plate N# - Not counted |
For the Confirmatory Assay With S9 Activation results see below in Overall remarks, attachments
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive
This study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).
The test substance was concluded to be positive overall in this assay. - Executive summary:
The test substance was tested in the Bacterial Reverse Mutation Assay using Salmonella typhimurium tester strains TA98, TA100, TA1535 and TA1537 and Escherichia coli tester strain WP2 uvrA in the presence and absence of Aroclor-induced rat liver S9. The assay was performed in two phases, using the plate incorporation method. The first phase, the initial toxicity-mutation assay, was used to establish the dose-range for the confirmatory mutagenicity assay and to provide a preliminary mutagenicity evaluation. The second phase, the confirmatory mutagenicity assay, was used to evaluate and confirm the mutagenic potential of the test substance.
In the initial toxicity-mutation assay positive mutagenic responses (ranging from 2.4- to 6.4-fold maximum increases) were observed with all tester strains in the absence of S9 activation and with tester strains TA98, TA100, TA1535 and WP2 uvrA in the presence of S9 activation. A dose-responsive increase (2.8-fold maximum increase) was observed with tester strain TA1537 in the presence of S9 activation; however, this increase did not meet all criteria required for evaluation as positive (i.e., a maximum response of at least 3.0-times the mean vehicle control value).
In the confirmatory mutagenicity assay, positive mutagenic responses (ranging from 2.6- to 6.7-fold maximum increases) were observed with all tester strains in the presence of S9 activation and all Salmonella tester strains in the absence of S9 activation. A non-dose responsive increase (1.7-fold maximum increase) was observed with tester strain WP2 uvrA in the absence of S9 activation. The dose levels tested were 50, 150, 500, 1500, 2000 and 5000 μg per plate. No precipitate was observed. Toxicity was observed at 5000 μg per plate with all tester strains in the absence of S9 activation and with tester strain WP2 uvrA in the presence of S9 activation.
The results of the Bacterial Reverse Mutation Assay indicate that, under the conditions of this study, the test substance did exhibit reproducible mutagenic responses with tester strains TA98, TA100, TA1535 and TA1537 in the absence of Aroclor-induced rat liver S9 and with tester strains TA98, TA100, TA1535 and WP2 uvrA in the presence of Aroclor-induced rat liver S9. Therefore, the test substance was concluded to be positive with those test conditions in this assay. Since reproducible mutagenic responses were not observed with tester strain WP2 uvrA in the absence of S9 activation and with tester strain TA1537 in the presence of S9 activation, the test substance was concluded to be equivocal with those test conditions. Therefore, the test substance was concluded to be positive overall in this assay.
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