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EC number: 204-933-6 | CAS number: 129-16-8
- 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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data from handbook or collection of data
Data source
Reference
- Reference Type:
- publication
- Title:
- Mutagenicity Testing of Some Drug and Cosmetic Dye Lakes with the Salmonella-Mammalian Microsome Assay
- Author:
- J.P. Brown, P.S. Dietrich and C.M. Bakner
- Year:
- 1 979
- Bibliographic source:
- Mutation Research, 66 ,181-185, 1979
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The Ames Salmonella/mammalian-microsome assay was used to evaluate the bacterial mutagenicity of test substance.
- GLP compliance:
- not specified
- Type of assay:
- other: Salmonella/mammalian microsome assay
Test material
- Reference substance name:
- 3,4,5,6-tetrachloro-2-(1,4,5,8-tetrabromo-6-hydroxy-3-oxoxanthen-9-yl)benzoic acid
- EC Number:
- 242-355-6
- EC Name:
- 3,4,5,6-tetrachloro-2-(1,4,5,8-tetrabromo-6-hydroxy-3-oxoxanthen-9-yl)benzoic acid
- Cas Number:
- 18472-87-2
- Molecular formula:
- C20H4Br4Cl4O5.2Na
- IUPAC Name:
- 2',4',5',7'-tetrabromo-4,5,6,7-tetrachloro-3',6'-dihydroxy-3H-spiro[2-benzofuran-1,9'-xanthen]-3-one
- Test material form:
- solid: particulate/powder
- Details on test material:
- SOURCE OF TEST MATERIAL
- Test Item: 3,4,5,6-tetrachloro-2-(1,4,5,8-tetrabromo-6-hydroxy-3-oxoxanthen-9-yl)benzoic acid (CAS No.18472-87-2)
- Source of test material: Sustainability Support Services (Europe) AB
- Lot/batch No.of test material: FG/15-16/0790
- Manufacturing Date: June, 2015
- Expiration date of the lot/batch: May, 2023
- Purity test date: No data
- Consistency: Solid, powder
- Colour: Red
RADIOLABELLING INFORMATION (Not applicable)
- Radiochemical purity: N/A
- Specific activity: N/A
- Locations of the label: N/A
- Expiration date of radiochemical substance: N/A
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Test Item was stored at ambient temperature.
- Stability under test conditions: No data
- Solubility and stability of the test substance in the solvent/vehicle: No data
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: No data
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Test item was dissolved in distilled water. Test item was dissolved in distilled water.
The formulation was prepared fresh on the day of dosing.
- Preliminary purification step (if any): No data
- Final dilution of a dissolved solid, stock liquid or gel: No data
- Final preparation of a solid: No data
FORM AS APPLIED IN THE TEST (if different from that of starting material) : No data
OTHER SPECIFICS:
Safety Precautions: Safety precautions included use of protective clothing, gloves, masks and eye protection (glasses).
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Phloxine B
- Molecular formula: C20H2Br4Cl4O5Na2
- Molecular weight: 829.66 g/mol
- Substance type: Organic
- Physical state: Red powder
- Purity: 7-9%
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA1535, TA100, TA1537, TA1538,TA98
- Details on mammalian cell type (if applicable):
- Not applicable.
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver-microsome preparation from rats injected with Aroclor 1254, 0.25 ml "S-9 mix"-plate with 0.2 ml S9/ml 'S9 mix'.
- Test concentrations with justification for top dose:
- 10,50 and 100 µg/plate
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- ethylmethanesulphonate
- methylmethanesulfonate
- other: Anthragallol (For strains TA-1538 and TA98 without S9); 2-Anthramine (For all strains with S9)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar
DURATION
- Preincubation period: No data available
- Exposure duration:3 days - Evaluation criteria:
- Mutations in Salmonella typhimurium i.e. Number of His + Revertants/plate
- Statistics:
- Rounded mean ± standard deviation
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA1535, TA100, TA1537, TA1538 and TA98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: Slight toxicity was noted
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- COMPARISON WITH HISTORICAL CONTROL DATA: Yes, historical negative control were used.
- Remarks on result:
- other: no mutagenic potential
Any other information on results incl. tables
Table: Mutagenicity Testing Of D And C Red No. 27 With The Salmonella/Microsome Test
Chemical |
Dose |
Microsome activation |
Number of His+Revertants/plate |
||||
TA1535 |
TA100 |
TA1537 |
TA1538 |
TA98 |
|||
Negative controls |
|||||||
A) |
|
- |
35±22 (265) |
98 ± 26 (271) |
8 ± 5 (297) |
13 ± 5 (297) |
33 ± 20 (282) |
|
|
± |
20 ± 19 (239) |
90 ± 25 (252) |
11 ± 4 (283) |
34 ± 15 (280) |
27 ± 13 (308) |
B) This study |
|
- |
42 ± 14 (9) |
126 ± 24 (12) |
11 ± 5 (9) |
13 ± 2 (9) |
24 ± 8 (9) |
|
|
± |
20 ± 19 (8) |
104 ± 27 (11) |
12 ± 4 (9) |
24 ± 6 (12) |
28 ± 10 (12) |
Positive controls |
|||||||
EMS |
2µL |
- |
440 |
- |
- |
- |
- |
MMS |
1µL |
- |
- |
4860 |
- |
- |
- |
9 AA |
100 |
- |
- |
- |
103 |
- |
- |
Anthragallol |
50 |
- |
- |
- |
- |
47 |
81 |
2- Anthramine |
1 |
± |
824 |
7600 |
488 |
6400 |
7600 |
D and C Red No. 27 |
10 |
- |
43 |
113 |
8 |
12 |
14h |
|
± |
7 |
114 |
16h |
30 |
24 |
|
50 |
- |
51 |
30 |
9 |
18 |
11 |
|
|
± |
6 |
98 |
12 |
19 |
23 |
|
100 |
- |
41 |
109 |
7 |
11 |
11h |
|
|
± |
16 |
90 |
5 |
19 |
24 |
Applicant's summary and conclusion
- Conclusions:
- The test substance did not showed any mutagenic activity at concentrations up to 100 μg/plate in S.typhimurium strains TA1535, TA100, TA1537, TA1538 and TA98 in the presence and absence of S9 metabolic activation system and hence, it can be concluded that test substance is non genotoxic.
- Executive summary:
The Ames Salmonella/mammalian-microsome assay was used to evaluate the bacterial mutagenicity of test substance . The test substance did not showed any mutagenic activity at concentrations up to 100 μg/plate in S.typhimurium strains TA1535, TA100, TA1537, TA1538 and TA98 in the presence and absence of S9 metabolic activation system and hence the test substance is non genotoxic.
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