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EC number: 256-458-9 | CAS number: 49744-28-7
- 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:
- 2017-05-02 till 2017-05-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline-conform study under GLP without deviations
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1-[(4-methoxy-2-nitrophenyl)azo]-2-naphthol
- EC Number:
- 256-458-9
- EC Name:
- 1-[(4-methoxy-2-nitrophenyl)azo]-2-naphthol
- Cas Number:
- 49744-28-7
- Molecular formula:
- C17H13N3O4
- IUPAC Name:
- 1-[(4-methoxy-2-nitrophenyl)diazenyl]-2-naphthol
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- IIdentification: 1-((4-Methoxy-2-nitrophenyl)azo)-2-naphthol
CAS No.: 49744-28-7
EINECS / EC No.: 256-458-8
Batch: 3.April 2010 g
Purity: 99.2% (w/w) including isomer
Physical State / Appearance: Dark red powder
Expiry Date: 25 January 2027 (Statement of sponsor)
Storage Conditions: At room temperature
Certificate of Analysis: AZ 1070/Toxd1, dated 25 January 2017
Stability in Solvent: Not indicated by the Sponsor
Method
Species / strain
- Species / strain / cell type:
- other: TA 1535, TA 1537, TA 98, TA 100, and WP2 uvrA
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital/Beta-naphthoflavone induced rat liver S9 (experiment I) non- induced hamster liver S9 (experiment II)
- Test concentrations with justification for top dose:
- Pre-Experiment/Experiment I: 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
Experiment II:
All strains without S9 mix: 33; 100; 333; 1000; 2500; and 5000 µg/plate
All strains with S9 mix: 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate - Vehicle / solvent:
- Solvent used: DMF
Justification for choice of solvent: best suitable solvent, because of its solubility properties and its relative nontoxicity to the bacteria
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- congo red
- methylmethanesulfonate
- other: 4-nitro-o-phenylene-diamine, 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar plate incorporation; pre-incubation
DURATION:
Preincubation period: 30 Minutes
exposure duration: 72 hours
NUMBER OF REPLICATIONS: 3 plates for each concentration including the controls
DETERMINATION OF CYTOTOXICITY: Evident as a reduction in the number of spontaneous revertants (below the induction factor of 0.5) or a clearing of the bacterial background lawn. - Evaluation criteria:
- A test item is considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA 98, TA 100, and WP2 uvrA) or thrice (strains TA 1535 and TA 1537) the colony count of the corresponding solvent control is observed.
A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration.
An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.
A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative and solvent controls such an increase is not considered biologically relevant. - Statistics:
- According to the OECD guideline 471, a statistical analysis of the data is not mandatory.
Results and discussion
Test results
- Species / strain:
- other: TA 1535, TA 1537, TA 98, TA 100, and WP2 uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Remarks:
- strain TA 98 with non-induced hamster liver S9
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST SPECIFIC CONFOUNDING FACTORS
Effects of pH: none
Water solubility: not soluble at 50 mg/mL
Precipitation: The test item precipitated in the overlay agar in the test tubes from 100 to 5000 µg/plate with and without S9 mix in experiment I and in experiment II from 1000 to 5000 µg/plate without S9 mix and from 333 to 5000 µg/plate with S9 mix. Precipitation of the test item in the overlay agar on the incubated agar plates was observed in experiment I from 2500 to 5000 µg/plate with and without S9 mix and in experiment II from 2500 to 5000 µg/plate without S9 mix and from 1000 to 5000 µg/plate with S9 mix. The undissolved particles had no influence on the data recording.
Other confounding effects: none
COMPARISON WIT HISTORICAL CONTROL DATA: performed, no deviation
ADDITIONAL INFORMATION ON CYTOTOXICITY: no - Remarks on result:
- other: reverse mutation assay migrated from the field Test System
Any other information on results incl. tables
Summary of Experiment I
Study Name: 1839700 |
Study Code: Envigo 1839700 |
Experiment: 1839700 VV Plate |
Date Plated: 02.05.2017 |
Assay Conditions: |
Date Counted: 08.05.2017 |
Metabolic Activation |
Test Group |
Dose Level (per plate) |
TA 1535 Revertant Colony Counts (Mean ±SD) |
TA 1537 Revertant Colony Counts (Mean ±SD) |
TA 98 Revertant Colony Counts (Mean ±SD) |
TA 100 Revertant Colony Counts (Mean ±SD) |
WP2 uvrA Revertant Colony Counts (Mean ±SD) |
|
|
|
|
|
|
|
|
Without |
DMF |
|
11 ± 5 |
8 ± 3 |
20 ± 6 |
151 ± 25 |
35 ± 4 |
Activation |
Untreated |
|
8 ± 4 |
9 ± 3 |
22 ± 3 |
160 ± 21 |
40 ± 6 |
|
1-((4-Methoxy-2- |
3 µg |
8 ± 2 |
9 ± 4 |
17 ± 4 |
149 ± 6 |
38 ± 2 |
|
nitrophenyl)azo)- |
10 µg |
10 ± 1 |
12 ± 3 |
22 ± 6 |
144 ± 16 |
45 ± 9 |
|
2-naphthol |
33 µg |
11 ± 1 |
12 ± 3 |
25 ± 2 |
145 ± 22 |
36 ± 6 |
|
|
100 µg |
8 ± 4 |
10 ± 4 |
23 ± 8 |
158 ± 16 |
45 ± 8 |
|
|
333 µg |
8 ± 2 |
10 ± 2 |
19 ± 3 |
154 ± 12 |
39 ± 5 |
|
|
1000 µg |
11 ± 4 |
13 ± 4 |
19 ± 8 |
135 ± 9 |
33 ± 8 |
|
|
2500 µg |
10 ± 5P |
13 ± 1P |
19 ± 2P |
157 ± 8P |
36 ± 5P |
|
|
5000 µg |
10 ± 1P |
11 ± 1P |
22 ± 6P M |
150 ± 26P |
41 ± 11P |
|
NaN3 |
10 µg |
1164 ± 122 |
|
|
2017 ± 102 |
|
|
4-NOPD |
10 µg |
|
|
262 ± 7 |
|
|
|
4-NOPD |
50 µg |
|
78 ± 5 |
|
|
|
|
MMS |
2.0 µL |
|
|
|
|
1030 ± 98 |
|
|
|
|
|
|
|
|
With |
DMF |
|
9 ± 2 |
15 ± 3 |
24 ± 4 |
134 ± 16 |
51 ± 4 |
Activation |
Untreated |
|
10 ± 5 |
13 ± 4 |
33 ± 9 |
157 ± 18 |
53 ± 9 |
|
1-((4-Methoxy-2- |
3 µg |
9 ± 1 |
14 ± 2 |
30 ± 2 |
147 ± 8 |
52 ± 6 |
|
nitrophenyl)azo)- |
10 µg |
7 ± 2 |
17 ± 5 |
26 ± 5 |
159 ± 14 |
50 ± 10 |
|
2-naphthol |
33 µg |
11 ± 1 |
16 ± 4 |
30 ± 2 |
161 ± 14 |
58 ± 7 |
|
|
100 µg |
7 ± 1 |
16 ± 4 |
36 ± 7 |
151 ± 10 |
53 ± 5 |
|
|
333 µg |
10 ± 4 |
19 ± 3 |
34 ± 7 |
173 ± 15 |
52 ± 4 |
|
|
1000 µg |
9 ± 3 |
20 ± 2 |
30 ± 5 |
156 ± 28 |
46 ± 9 |
|
|
2500 µg |
12 ± 2P |
19 ± 6P |
32 ± 5P |
164 ± 8P |
53 ± 7P |
|
|
5000 µg |
11 ± 1P |
16 ± 4P M |
33 ± 3P M |
140 ± 14P M |
50 ± 13P |
|
2-AA |
2.5 µg |
409 ± 13 |
171 ± 4 |
3450 ± 1007 |
4360 ± 355 |
|
|
2-AA |
10.0 µg |
|
|
|
|
327 ± 57 |
|
|
|
|
|
|
|
|
Summary of Experiment II
Study Name: 1839700 |
Study Code: Envigo 1839700 |
Experiment: 1839700 HV2 Pre |
Date Plated: 11.05.2017 |
Assay Conditions: |
Date Counted: 16.05.2017 |
Metabolic Activation |
Test Group |
Dose Level (per plate) |
TA 1535 Revertant Colony Counts (Mean ±SD) |
TA 1537 Revertant Colony Counts (Mean ±SD) |
TA 98 Revertant Colony Counts (Mean ±SD) |
TA 100 Revertant Colony Counts (Mean ±SD) |
WP2 uvrA Revertant Colony Counts (Mean ±SD) |
|
|
|
|
|
|
|
|
Without |
DMF |
|
9 ± 3 |
9 ± 2 |
30 ± 7 |
147 ± 8 |
33 ± 7 |
Activation |
Untreated |
|
9 ± 3 |
9 ± 2 |
32 ± 0 |
193 ± 19 |
32 ± 1 |
|
1-((4-Methoxy-2- |
33 µg |
11 ± 3 |
10 ± 3 |
29 ± 6 |
137 ± 6 |
44 ± 7 |
|
nitrophenyl)azo)- |
100 µg |
7 ± 2 |
11 ± 1 |
24 ± 5 |
153 ± 10 |
42 ± 12 |
|
2-naphthol |
333 µg |
8 ± 2 |
13 ± 3 |
30 ± 3 |
148 ± 7 |
39 ± 10 |
|
|
1000 µg |
8 ± 2 |
8 ± 2 |
22 ± 7 |
149 ± 3 |
34 ± 18 |
|
|
2500 µg |
8 ± 2P |
8 ± 3P |
27 ± 6P |
152 ± 13P |
26 ± 4P |
|
|
5000 µg |
7 ± 2P |
11 ± 3P |
19 ± 4P M |
143 ± 1P M |
23 ± 5P M |
|
NaN3 |
10 µg |
1103 ± 46 |
|
|
2039 ± 76 |
|
|
4-NOPD |
10 µg |
|
|
267 ± 5 |
|
|
|
4-NOPD |
50 µg |
|
79 ± 8 |
|
|
|
|
MMS |
2.0 µL |
|
|
|
|
1094 ± 36 |
|
|
|
|
|
|
|
|
With |
DMF |
|
10 ± 1 |
23 ± 7 |
41 ± 1 |
138 ± 4 |
43 ± 6 |
Activation |
Untreated |
|
7 ± 2 |
21 ± 9 |
38 ± 3 |
126 ± 27 |
48 ± 6 |
|
1-((4-Methoxy-2- |
3 µg |
10 ± 2 |
28 ± 3 |
48 ± 6 |
126 ± 10 |
44 ± 3 |
|
nitrophenyl)azo)- |
10 µg |
12 ± 8 |
31 ± 10 |
52 ± 10 |
148 ± 12 |
48 ± 4 |
|
2-naphthol |
33 µg |
12 ± 1 |
23 ± 2 |
61 ± 15 |
157 ± 7 |
50 ± 11 |
|
|
100 µg |
15 ± 2 |
23 ± 3 |
81 ± 6 |
170 ± 14 |
50 ± 21 |
|
|
333 µg |
20 ± 4 |
25 ± 5 |
124 ± 17 |
205 ± 46 |
49 ± 16 |
|
|
1000 µg |
17 ± 8P |
24 ± 7P |
104 ± 14P |
219 ± 11P |
54 ± 3P |
|
|
2500 µg |
10 ± 2P |
21 ± 6P |
85 ± 12P M |
176 ± 10P M |
41 ± 7P M |
|
|
5000 µg |
16 ± 3P M |
25 ± 6P M |
78 ± 8P M |
196 ± 11P M |
36 ± 6P M |
|
2-AA |
2.5 µg |
372 ± 22 |
269 ± 9 |
|
2382 ± 92 |
|
|
2-AA |
10.0 µg |
|
|
|
|
800 ± 28 |
|
Congo red |
|
|
|
440 ± 48 |
|
|
|
|
|
|
|
|
|
|
Key to Plate Postfix Codes:
P: Precipitate
M: Manuel Count
R: Reduced Background growth
D: Densely Colored Plate
Key to positive controls:
NaN3: sodium azide
4 -NOPD: 4 -nitro-o-phenylene-diamine
MMS: methyl methane sulfonate
2-AA: 2 -aminoanthracene
Applicant's summary and conclusion
- Conclusions:
- In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did induce gene mutations by frameshifts in the genome of strain TA 98 in the presence of non-induced hamster liver S9 mix.
Therefore, 1-((4-Methoxy-2-nitrophenyl)azo)-2-naphthol is considered to be mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay. - Executive summary:
The test item 1-((4-Methoxy-2-nitrophenyl)azo)-2-naphthol was assessed for its potential to induce gene mutations according to the plate incorporation test (experiment I) and the pre-incubation test (experiment II) usingSalmonella typhimuriumstrains TA 1535, TA 1537, TA 98, TA 100, and theEscherichia colistrain WP2 uvrA.
Experiment I was performed with induced rat liver S9 mix as an exogenous metabolic activation system and Experiment II was performed with non-induced hamster liver S9 mix. Each concentration and the controls were tested in triplicate. The test item was tested at the following concentrations:
Pre-Experiment/Experiment I: 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
Experiment II:
All strains without S9 mix: 33; 100; 333; 1000; 2500; and 5000 µg/plate
All strains with S9 mix: 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
The test item precipitated in the overlay agar in the test tubes from 100 to 5000 µg/plate with and without S9 mix in experiment I and in experiment II from 1000 to 5000 µg/plate without S9 mix and from 333 to 5000 µg/plate with S9 mix. Precipitation of the test item in the overlay agar on the incubated agar plates was observed in experiment I from 2500 to 5000 µg/plate with and without S9 mix and in experiment II from 2500 to 5000 µg/plate without S9 mix and from 1000 to 5000 µg/plate with S9 mix. The undissolved particles had no influence on the data recording.
The plates incubated with the test item showed normal background growth up to 5000 µg/plate with and without S9 mix in all strains used.
No toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0.5), occurred in the test groups with and without metabolic activation.
In experiment II an increase in revertant colony numbers was observed following treatment with 1-((4-Methoxy-2-nitrophenyl)azo)-2-naphthol in strain TA 98 in the presence of metabolic activation (non-induced hamster liver S9 mix).The number of colonies exceeded the threshold of twice the number of the corresponding solvent control from 333 to 2500 µg/plate. The induction factor decreased with the increasing precipitation of the test substance and at a concentration of 5000µg/plate the threshold of twice the number of the corresponding solvent control was not reached. This effect may be based on the observed precipitation of the test item which causes a minor bio-availability of the test substance or an overlapping toxic effect.
A minor increase in revertant colony numbers, not reaching the threshold of thrice the number of the corresponding solvent control, was observed in strain TA 1535in the presence of metabolic activation (S9 mix).
Appropriate reference mutagens were used as positive controls. They showed a distinct increase in induced revertant colonies.
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