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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Reaction mass of Chromate(1-), [2-(3-chlorophenyl)-2,4-dihydro-4-[[2-hydroxy-5-(methylsulfonyl)phenyl]azo]-5-methyl-3H-pyrazol-3-onato(2-)][methyl [7-hydroxy-8-[[2-hydroxy-5-(methylsulfonyl)phenyl]azo]-1-naphthalenyl]carbamato(2-)]-, sodium and sodium bis[2-(3-chlorophenyl)-2,4-dihydro-4-[[2-hydroxy-5-mesylphenyl]azo]-5-methyl-3H-pyrazol-3-onato(2-)]chromate(1-) and sodium bis[methyl [7-hydroxy-8-[[2-hydroxy-5-mesylphenyl]azo]-1-naphthyl]carbamato(2-)]chromate(1-)
EC number: 915-704-1 | CAS number: -
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
In an bacterial reverse mutation assay according to OECD Guideline 471 (with Prival modification) (BASF Colors&Effects, 2017), the test substance showed no mutagenic potential.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-01-09 to 2017-02-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997-07-21
- Deviations:
- yes
- Remarks:
- incl. Prival Modification, according to OECD Guideline 471, Paragraph 16
- Principles of method if other than guideline:
- Prival Modification
- Short description of test conditions: The Prival preincubation test is a modification of the standard Ames reverse mutation assay (1), in which flavin mononucleotide (FMN), liver S9 mix from uninduced hamsters and a preincubation step are used to facilitate azo reduction and the detection of the resulting mutagenic aromatic amines.
(1) Prival, M.J.; Mitchell, V.D.:
Analysis of a method for testing azo dyes for mutagenicity in Salmonella typhimurium in the presence of flavin monoucleotide and hamster liver S9. Mut. Res., 97, 103 - 116 (1982) - GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: 001-140902, Test substance No.: 16/0083-1
- Expiration date of the lot/batch: 2019-06-07
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
OTHER SPECIFICS: solid, brown - Target gene:
- his/trp
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Remarks:
- uvrA
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital/beta-naphthoflavone induced rat liver S9 fraction (STP)
- Test concentrations with justification for top dose:
- 1st (STP) and 2nd (Prival) experiment:
0, 33, 100, 333, 1000, 2600, and 5200 µg/plate
3rd experiment (Prival):
0, 3.3, 10, 33, 100, 333, and 1000 µg/plate
In agreement with the recommendations of current guidelines 5 mg/plate or 5 µL/plate were generally selected as maximum test dose at least in the 1st Experiment. However, this maximum dose was tested even in the case of relatively insoluble test compounds to detect possible mutagenic impurities. Furthermore, doses > 5 mg/plate or > 5 µL/plate might also be tested in repeat experiments for further clarification/substantiation. In this study, due to the purity of the test substance 5.2 mg/plate was used as top dose. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Due to the insolubility of the test substance in water, DMSO was used as vehicle, which had been demonstrated to be suitable in bacterial reverse mutation tests and for which historical control data are available. - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (2-AA)
- Remarks:
- With rat liver S9 mix: 2.5 µg/plate, TA 1535, TA 100, TA 1537, TA 98 / 60 µg/plate, Escherichia coli WP2 uvrA
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (2-AA)
- Remarks:
- With hamster liver S9 mix: 10 µg/plate, TA 1535, TA 100, TA 1537, TA 98, Escherichia coli WP2 uvrA
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- congo red
- Remarks:
- With hamster liver S9 mix: 210 µg/plate, TA 98
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: N-methyl-N'-nitro-N-nitrosoguanidine (MNNG)
- Remarks:
- Without S9 mix: 5 µg/plate, TA 1535, TA 100
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylenediamine (NOPD)
- Remarks:
- Without S9 mix: 10 µg/plate, TA 98
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Without S9 mix: 100 µg/plate, TA 1537
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- Without S9 mix: 5 µg/plate, E. coli WP2 uvrA
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (SPT); preincubation (Prival)
DURATION
- Preincubation period: 30 min (Prival)
- Exposure duration: 48 - 72 hours (SPT, Prival)
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: decrease in the number of revertants (factor < 0.6); clearing or diminution of the background lawn. - Evaluation criteria:
- Mutagenicity
Individual plate counts, the mean number of revertant colonies per plate and the standard deviations were given for all dose groups as well as for the positive and negative (vehicle) controls in all experiments. In general, six doses of the test substance were tested with a maximum of 5 mg/plate, and triplicate plating was used for all test groups at least in the 1st Experiment. Dose selection and evaluation as well as the number of plates used in repeat studies or further experiments were based on the findings of the 1st Experiment.
Toxicity
Toxicity detected by a
• decrease in the number of revertants (factor < 0.6)
• clearing or diminution of the background lawn (= reduced his- or trp- background growth)
was recorded for all test groups both with and without S9 mix in all experiments and indicated in the tables. Single values with a factor < 0.6 were not detected as toxicity in low dose groups.
Solubility
If precipitation of the test material was observed, it would be recorded and indicated in the tables. As long as precipitation did not interfere with the colony scoring, 5 mg/plate was generally selected and analyzed (in cases of nontoxic compounds) as the maximum dose at least in the 1st Experiment even in the case of relatively insoluble test compounds to detect possible mutagenic impurities. Furthermore, doses > 5 mg/plate might also be tested in repeat experiments for further clarification/substantiation. - Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5200 µg/plate, without metabolic activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- 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
- Remarks:
- ≥ 1000 µgplate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- 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
- Remarks:
- ≥ 1000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- 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
- Remarks:
- ≥ 333 µg/plate, witout metabolic activation; ≥ 2600 µg/plate with metabolic activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ≥ 1000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ≥ 333 µg/plate without metabolic activation; ≥ 1000 µg/plate with metabolic activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- 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
- Remarks:
- ≥ 2600 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- 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
- Remarks:
- ≥ 1000 µg/plate without metabolic activation; ≥ 5200 µg/plate with metabolic activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Test substance precipitation was found from about 1000 µg/plate onward with and without S9 mix. - Remarks on result:
- other: SPT
Reference
Table 1: STP without metabolic activation
Strain |
Test group |
Dose (µg/plate) |
Mean revertants per plate |
Standard deviation |
Factor |
TA 1535 |
DMSO Test item
MNNG |
- 33 100 333 1000 2600 5200 5 |
9.7 10.3 12.0 10.0 5.7 7.7 4.7 5852.7 |
2.1 2.1 5.7 2.6 1.5 0.6 2.1 151.5 |
- 1.1 1.2 1.0 0.6 P 0.8 P 0.5 P B 605.4 |
TA 100 |
DMSO Test item
MNNG |
- 33 100 333 1000 2600 5200 5 |
87.7 101.0 100.0 93.7 59.7 11.0 0.0 4626.7 |
15.9 3.6 13.1 13.6 3.8 3.6 0.0 117.8 |
- 1.2 1.1 1.1 0.7 P 0.1 P 0.0 P B 52.8 |
TA 1537 |
DMSO Test item
AAC |
- 33 100 333 1000 2600 5200 100 |
5.7 9.0 5.7 6.0 1.3 4.3 1.3 1167.0 |
2.1 0.0 2.5 6.1 0.6 2.5 0.6 281.5 |
- 1.6 1.0 1.1 0.2 P 0.8 P 0.2 P B 205.9 |
TA 98 |
DMSO Test item
NOPD |
- 33 100 333 1000 2600 5200 10 |
16.0 16.7 14.7 14.5 8.3 9.3 4.3 670.3 |
1.0 0.6 3.1 6.4 1.5 3.1 2.1 83.5 |
- 1.0 0.9 0.9 0.5 P 0.6 P 0.3 P B 41.9 |
E. coli |
DMSO Test item
4-NQO |
- 33 100 333 1000 2600 5200 5 |
25.0 25.0 26.7 24.3 12.7 20.3 24.0 1206.0 |
2.0 5.3 8.6 5.1 2.5 6.7 5.6 5.3 |
- 1.0 1.1 1.0 0.5 P 0.8 P 1.0 P 48.2 |
Key to plate postfix codes
B: Reduced background growth
P: Precipitation
Table 2: STP with metabolic activation
Strain |
Test group |
Dose (µg/plate) |
Mean revertants per plate |
Standard deviation |
Factor |
TA 1535 |
DMSO Test item
2-AA |
- 33 100 333 1000 2600 5200 2.5 |
8.3 9.3 8.7 7.3 10.7 7.7 6.3 294.3 |
1.5 1.5 2.1 3.8 2.1 1.2 0.6 22.0 |
- 1.1 1.0 0.9 1.3 P 0.9 P 0.8 P 35.3 |
TA 100 |
DMSO Test item
2-AA |
- 33 100 333 1000 2600 5200 2.5 |
107.0 121.7 116.0 104.0 108.0 52.3 3.7 2883.3 |
10.5 22.8 3.6 9.5 31.2 6.4 2.1 57.0 |
- 1.1 1.1 1.0 1.0 P 0.5 P 0.0 P 26.9 |
TA 1537 |
DMSO Test item
2-AA |
- 33 100 333 1000 2600 5200 2.5 |
7.3 5.7 4.7 5.7 4.7 3.3 4.3 185.3 |
4.2 2.1 2.1 1.2 1.5 0.6 1.2 61.8 |
- 0.8 0.6 0.8 0.6 P 0.5 P 0.6 P 25.3 |
TA 98 |
DMSO Test item
2-AA |
- 33 100 333 1000 2600 5200 2.5 |
33.7 35.3 35.3 25.7 14.7 10.7 7.0 2431.3 |
2.3 5.0 4.6 2.3 3.2 2.9 2.0 44.4 |
- 1.0 1.0 0.8 0.4 P 0.3 P 0.2 P 72.2 |
E. coli |
DMSO Test item
2-AA |
- 33 100 333 1000 2600 5200 60 |
25.0 21.0 21.3 14.7 20.7 20.0 18.3 205.7 |
7.2 1.7 2.1 1.5 4.0 3.5 6.0 19.9 |
- 0.8 0.9 0.6 0.8 P 0.8 P 0.7 P 8.2 |
Key to plate postfix codes
P: Precipitation
Table 3: Prival preincubation test without metabolic activation
Strain |
Test group |
Dose (µg/plate) |
Mean revertants per plate |
Standard deviation |
Factor |
TA 1535 |
DMSO Test item
MNNG |
- 33 100 333 1000 2600 5200 5 |
14.7 11.3 14.7 14.7 4.0 0.0 0.0 2440.3 |
1.2 2.5 1.5 5.1 0.0 0.0 0.0 127.4 |
- 0.8 1.0 1.0 0.3 P 0.0 B P 0.0 B P 166.4 |
TA 100 |
DMSO Test item
MNNG |
- 33 100 333 1000 2600 5200 5 |
125.0 115.3 117.0 104.7 69.7 11.3 0.0 1567.7 |
20.9 11.5 19.3 10.3 44.7 3.2 0.0 246.7 |
- 0.9 0.9 0.8 0.6 P 0.1 P 0.0 P B 12.5 |
TA 1537 |
DMSO Test item
AAC |
- 33 100 333 1000 2600 5200 100 |
9.3 6.0 7.0 4.7 4.3 0.0 0.0 462.7 |
4.9 3.6 3.6 2.1 1.5 0.0 0.0 225.2 |
- 0.6 0.8 0.5 B 0.5 P B 0.0 P B 0.0 P B 49.6 |
TA 98 |
DMSO Test item
NOPD |
- 33 100 333 1000 2600 5200 10 |
18.7 16.0 13.3 7.0 4.7 0.0 0.0 455.3 |
7.0 4.4 3.2 3.5 1.5 0.0 0.0 74.8 |
- 0.9 0.7 0.4 0.3 P 0.0 P B 0.0 P B 24.4 |
E. coli |
DMSO Test item
4-NQO |
- 33 100 333 1000 2600 5200 5 |
16.7 19.0 26.3 21.7 11.7 15.7 11.0 321.3 |
2.1 7.9 9.6 8.6 5.5 3.2 2.6 45.1 |
- 1.1 1.6 1.3 0.7 P 0.9 P 0.7 P 19.3 |
Key to plate postfix codes
B: Reduced background growth
P: Precipitation
Table 4: Prival preincubation test with metabolic activation
Strain |
Test group |
Dose (µg/plate) |
Mean revertants per plate |
Standard deviation |
Factor |
TA 1535 |
DMSO Test item
2-AA |
- 33 100 333 1000 2600 5200 10 |
9.3 8.7 7.0 9.0 6.0 2.7 0.0 268.3 |
2.3 2.3 1.0 3.5 1.0 0.6 0.0 27.1 |
- 0.9 0.8 1.0 0.6 P 0.3 P 0.0 P B 28.8 |
TA 100 |
DMSO Test item
2-AA |
- 33 100 333 1000 2600 5200 10 |
99.3 113.3 112.7 119.3 96.0 113.7 7.0 1035.7 |
10.1 11.4 15.3 10.6 8.7 1.5 4.0 115.4 |
- 1.1 1.1 1.2 1.0 P 1.1 P 0.1 P B 10.4 |
TA 1537 |
DMSO Test item
2-AA |
- 33 100 333 1000 2600 5200 10 |
11.0 14.0 6.0 9.7 9.3 0.0 0.0 399.3 |
5.3 2.6 4.4 5.9 3.5 0.0 0.0 27.4 |
- 1.3 0.5 0.9 0.8 P 0.0 P 0.0 P B 36.3 |
TA 98 |
DMSO Test item
2-AA CoR |
- 33 100 333 1000 2600 5200 10 210 |
25.7 25.0 21.3 26.0 8.3 2.0 0.0 635.7 269.3 |
3.1 6.2 3.2 7.8 2.3 1.0 0.0 99.9 79.2 |
- 1.0 0.8 1.0 0.3 P 0.1 P 0.0 P B 24.8 10.5 |
E. coli |
DMSO Test item
2-AA |
- 33 100 333 1000 2600 5200 10 |
20.3 16.7 11.3 31.0 15.7 15.7 14.3 536.7 |
5.7 3.2 1.5 1.7 4.7 6.5 0.6 180.4 |
- 0.8 0.6 1.5 0.8 P 0.8 P 0.7 P 26.4 |
Key to plate postfix codes
B: Reduced background growth
P: Precipitation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available (further information necessary)
Additional information
In a reverse gene mutation assay in bacteria according to OECD Guideline 471 (incl. Prival modification) (BASF Colors&Effects, 2017), 4 strains of S. typhimurium (TA98, TA100, TA1535, TA1537) and E.coli WP2 uvrA were exposed to ≥ 96 % the test substance in DMSO at concentrations of 0, 33, 100, 333, 1000, 2600, and 5200 μg/plate in the presence and absence of mammalian metabolic activation (standard plate test, SPT: phenobarbital and β-naphthoflavone induced rat liver S9 mix; Prival: uninduced hamster liver S9 fraction). The modified Bacterial Reverse Mutation Test according to Prival et al. facilitates azo reduction and is therefore the most appropriate method for the investigation of azo-dyes and diazo compounds.
The test substance was tested up to a limit concentration of 5200 µg/plate. No increased number of revertant colonies was observed. The adequate positive controls with and without metabolic activation induced the appropriate responses in the corresponding strains. Negative controls were viable. A bacteriotoxic effect was observed depending on the strain and test conditions from about 333 μg/plate onward.
Under the experimental conditions chosen here, it is concluded that the test substance is not mutagenic in the bacterial reverse mutation test in the absence and the presence of metabolic activation.
Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008.
Based on available data on genetic toxicity, the test item is not considered to be classified for genetic toxicity according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EU) No 2017/776.
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.