Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 229-104-6 | CAS number: 6410-38-4
- 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:
- 2017-07-19 till 2017-10-02
- 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:
- 4-[(2,5-dichlorophenyl)azo]-3-hydroxy-N-(2-methoxyphenyl)naphthalene-2-carboxamide
- EC Number:
- 229-104-6
- EC Name:
- 4-[(2,5-dichlorophenyl)azo]-3-hydroxy-N-(2-methoxyphenyl)naphthalene-2-carboxamide
- Cas Number:
- 6410-38-4
- Molecular formula:
- C24H17Cl2N3O3
- IUPAC Name:
- 4-[(2,5-dichlorophenyl)azo]-3-hydroxy-N-(2-methoxyphenyl)naphthalene-2-carboxamide
- Test material form:
- solid: nanoform, no surface treatment
- Details on test material:
- Name of test material (as cited in study report): Part of several studies carried out by Envigo (see study record for report name); Pigment Red 9;
Analytical purity: 99.7%
Constituent 1
- Specific details on test material used for the study:
- IIdentification: Pigment Red 9
Batch: JPIB000140ger
CAS No.: 6410-38-4
EINECS / EC No.: 229-104-6
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 II9
- Test concentrations with justification for top dose:
- Pre-Experiment/Experiment I: 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
Experiment II: 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate - Vehicle / solvent:
- Solvent used: DMSO
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 30°C
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:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- strains TA 1535, TA 1537 and TA 98 (experiment I)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Additional information on results:
- TEST SPECIFIC CONFOUNDING FACTORS
Effects of pH: none
Water solubility: not soluble
Precipitation: The test item precipitated in the overlay agar in the test tubes from 333 to 5000 µg/plate in both experiments. Precipitation of the test item in the overlay agar on the incubated agar plates was observed from 1000 to 5000 µg/plate in experiment I and from 333 to 5000 µg/plate in experiment II. The undissolved particles had no influence on the data recording.
Other confounding effects: 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, except strain TA 98 in experiment II in the absence and presence of metabolic activation. The tester strain TA 98 showed an extensive bacterial background growth indicated by a more dense background lawn. Thus, in experiment II all plates incubated with strain TA 98 were scored manually. The revertant rates of both negative control groups each were within our laboratory’s historical negative control range for strain TA 98 and, therefore, this observation has to be regarded to have no detrimental impact on the validity and outcome of the study.
COMPARISON WIT HISTORICAL CONTROL DATA: performed, no deviations
ADDITIONAL INFORMATION ON CYTOTOXICITY: Toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0.5), occurred in several strains with and without metabolic activation in experiment I (plate incubation method) at the top dose of 5000 µg/plate. - 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: 1802502 |
Study Code: Envigo 1802502 |
Experiment: 1802502 VV Plate |
Date Plated: 19.09.2017 |
Assay Conditions: |
Date Counted: 22.09.2017 |
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 100Revertant Colony Counts (Mean ± SD) |
WP2 uvrA Revertant Colony Counts (Mean ± SD) |
|
|
|
|
|
|
|
|
Without |
DMSO |
|
14 ± 2 |
8 ± 2 |
28 ± 8 |
129 ± 16 |
29 ± 3 |
|
Untreated |
|
14 ± 2 |
12 ± 2 |
22 ± 2 |
156 ± 9 |
43 ± 5 |
Activation |
Pigment |
3 µg |
15 ± 5 |
9 ± 4 |
26 ± 9 |
129 ± 9 |
31 ± 4 |
|
Red 9 |
10 µg |
12 ± 5 |
10 ± 4 |
28 ± 11 |
117 ± 8 |
41 ± 1 |
|
|
33 µg |
15 ± 4 |
11 ± 4 |
24 ± 2 |
133 ± 8 |
31 ± 5 |
|
|
100 µg |
12 ± 3 |
11 ± 5 |
24 ± 8 |
117 ± 16 |
40 ± 7 |
|
|
333 µg |
11 ± 4 |
9 ± 3 |
19 ± 3 |
120 ± 3 |
39 ± 11 |
|
|
1000 µg |
11 ± 3P |
7 ± 2P |
27 ± 9P |
113 ± 4P |
28 ± 7P |
|
|
2500 µg |
13 ± 6P |
7 ± 2P |
24 ± 7P |
118 ± 12P |
42 ± 7P |
|
|
5000 µg |
7 ± 1P M |
4 ± 2P M |
12 ± 2P M |
99 ± 8P M |
18 ± 3P M |
|
NaN3 |
10 µg |
1115 ± 98 |
|
|
1923 ± 66 |
|
|
4-NOPD |
10 µg |
|
|
375 ± 33 |
|
|
|
4-NOPD |
50 µg |
|
79 ± 3 |
|
|
|
|
MMS |
2.0 µL |
|
|
|
|
1003 ± 107 |
|
|
|
|
|
|
|
|
With |
DMSO |
|
15 ± 7 |
13 ± 4 |
40 ± 12 |
105 ± 5 |
47 ± 2 |
Activation |
Untreated |
|
17 ± 4 |
12 ± 5 |
28 ± 2 |
132 ± 6 |
57 ± 11 |
|
Pigment |
3 µg |
11 ± 1 |
17 ± 2 |
36 ± 4 |
107 ± 11 |
38 ± 2 |
|
Red 9 |
10 µg |
15 ± 7 |
16 ± 2 |
32 ± 2 |
104 ± 12 |
51 ± 4 |
|
|
33 µg |
13 ± 4 |
11 ± 3 |
35 ± 9 |
111 ± 18 |
47 ± 4 |
|
|
100 µg |
11 ± 1 |
11 ± 1 |
35 ± 6 |
111 ± 20 |
43 ± 4 |
|
|
333 µg |
13 ± 4 |
12 ± 6 |
40 ± 9 |
103 ± 19 |
45 ± 7 |
|
|
1000 µg |
14 ± 4P |
8 ± 3P |
29 ± 8P |
100 ± 20P |
39 ± 4P |
|
|
2500 µg |
10 ± 2P M |
9 ± 3P |
28 ± 3P |
104 ± 6P |
42 ± 9P |
|
|
5000 µg |
4 ± 1P M |
3 ± 1P M |
14 ± 3P M |
67 ± 5P M |
28 ± 5P M |
|
2-AA |
2.5 µg |
387 ± 22 |
130 ± 14 |
3164 ± 115 |
3389 ± 140 |
|
|
2-AA |
10.0 µg |
|
|
|
|
441 ± 111 |
|
|
|
|
|
|
|
|
Summary of Experiment II
Study Name: 1802502 |
Study Code: Envigo 1802502 |
Experiment: 1802502 HV2 Pre |
Date Plated: 26.09.2017 |
Assay Conditions: |
Date Counted: 02.10.2017 |
Metabolic Activation |
Test |
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 |
DMSO |
|
9 ± 2 |
9 ± 2 |
15 ± 2B M |
151 ± 4 |
40 ± 4 |
Activation |
Untreated |
|
10 ± 3 |
11 ± 4 |
14 ± 2B M |
187 ± 15 |
34 ± 3 |
|
Pigment |
10 µg |
7 ± 1 |
9 ± 4 |
19 ± 4B M |
163 ± 30 |
37 ± 8 |
|
Red 9 |
33 µg |
10 ± 1 |
10 ± 2 |
19 ± 2B M |
166 ± 5 |
27 ± 3 |
|
|
100 µg |
7 ± 2 |
10 ± 1 |
16 ± 1B M |
158 ± 10 |
32 ± 4 |
|
|
333 µg |
7 ± 2P |
9 ± 3P |
17 ± 3P B M |
152 ± 14P |
34 ± 2P |
|
|
1000 µg |
9 ± 3P |
8 ± 2P |
17 ± 0P B M |
157 ± 4P |
33 ± 5P |
|
|
2500 µg |
10 ± 2P M |
8 ± 2P M |
13 ± 3P B M |
140 ± 5P M |
29 ± 6P M |
|
|
5000 µg |
8 ± 2P M |
7 ± 1P M |
14 ± 4P B M |
132 ± 5P M |
29 ± 3P M |
|
NaN3 |
10 µg |
1357 ± 116 |
|
|
2093 ± 303 |
|
|
4-NOPD |
10 µg |
|
|
395 ± 21B M |
|
|
|
4-NOPD |
50 µg |
|
91 ± 5 |
|
|
|
|
MMS |
2 µL |
|
|
|
|
1135 ± 38 |
|
|
|
|
|
|
|
|
With |
DMSO |
|
12 ± 4 |
15 ± 4 |
16 ± 1B M |
134 ± 3 |
35 ± 7 |
Activation |
Untreated |
|
11 ± 4 |
18 ± 2 |
12 ± 1B M |
140 ± 9 |
40 ± 3 |
|
Pigment |
10 µg |
9 ± 2 |
14 ± 6 |
18 ± 3B M |
129 ± 9 |
38 ± 7 |
|
Red 9 |
33 µg |
10 ± 4 |
12 ± 5 |
13 ± 3B M |
143 ± 10 |
35 ± 7 |
|
|
100 µg |
13 ± 2 |
21 ± 1 |
13 ± 2B M |
151 ± 13 |
40 ± 5 |
|
|
333 µg |
8 ± 3P |
18 ± 6P |
17 ± 2P B M |
130 ± 11P |
38 ± 9P |
|
|
1000 µg |
11 ± 6P |
21 ± 2P |
17 ± 3P B M |
156 ± 9P |
38 ± 8P |
|
|
2500 µg |
7 ± 2P M |
14 ± 2P M |
13 ± 1P B M |
147 ± 4P M |
26 ± 1P M |
|
|
5000 µg |
10 ± 1P M |
20 ± 3P M |
11 ± 1P B M |
120 ± 7P M |
22 ± 2M P |
|
2-AA |
2.5 µg |
|
|
|
2218 ± 122 |
|
|
2-AA |
2.5 µg |
378 ± 9 |
238 ± 21 |
|
|
|
|
2-AA |
10 µg |
|
|
|
|
777 ± 45 |
|
Congo red |
500 µg |
|
|
2027 ± 161B M |
|
|
|
|
|
|
|
|
|
|
Key to Plate Postfix Codes:
P: Precipitate
M: Manuel Count
B: Extensive bacterial colny growth
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 not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.
Therefore, Pigment Red 9 is considered to be non-mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay. - Executive summary:
The test item Pigment Red 9 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:
Experiment I: 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
Experiment II: 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
The test item precipitated in the overlay agar in the test tubes from 333 to 5000 µg/plate in both experiments. Precipitation of the test item in the overlay agar on the incubated agar plates was observed from 1000 to 5000 µg/plate in experiment I and from 333 to 5000 µg/plate in experiment II. 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, except strain TA 98 in experiment II in the absence and presence of metabolic activation. The tester strain TA 98 showed an extensive bacterial background growth indicated by a more dense background lawn. Thus, in experiment II all plates incubated with strain TA 98 were scored manually. The revertant rates of both negative control groups each were within our laboratory’s historical negative control range for strain TA 98 and, therefore, this observation has to be regarded to have no detrimental impact on the validity and outcome of the study.
Toxic effects, evident as a reduction in the number of revertants (below the induction factor of 0.5), were observed at the following concentrations (µg/plate):
Strain
Experiment I without S9 mix
Experiment I with S9 mix
Experiment II without S9 mix
Experiment II with S9 mix
TA 1535
/
5000
/
/
TA 1537
/
5000
/
/
TA 98
5000
5000
/
/
TA 100
/
/
/
/
WP2 uvrA
/
/
/
/
No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with Pigment Red 9 at any concentration level, neither in the presence nor absence of metabolic activation (rat or hamster S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance.
Appropriate reference mutagens were used as positive controls. They showed a distinct increase in induced revertant colonies.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.