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EC number: 260-480-4 | CAS number: 56966-52-0
- 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: GLP - Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 5-chloro-2-(2,4-dichlorophenoxy)aniline
- EC Number:
- 260-480-4
- EC Name:
- 5-chloro-2-(2,4-dichlorophenoxy)aniline
- Cas Number:
- 56966-52-0
- Molecular formula:
- C12H8Cl3NO
- IUPAC Name:
- 5-chloro-2-(2,4-dichlorophenoxy)aniline
- Details on test material:
- - Name of test material (as cited in study report): FAT 80'023/G (TADE)
- Physical state: solid, grey to green
- Analytical purity: > 98 %
- Lot/batch No.: ICMDJuli 1995
- Expiration date of the lot/batch: August 31, 2000
- Stability under test conditions: In solvent: 48 hours in H2O, polyethylene glycol, and CMC
- Storage condition of test material: room temperature
Constituent 1
Method
- Target gene:
- his
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced liver S9-mix from 8 - 12 weks old male rats
- Test concentrations with justification for top dose:
- 10.0; 33.3; 100.0; 333.3; 1000.0; 2500.0; and 5000.0 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The solvent was chosen because of its solubility properties and its relative nontoxicity for the bacteria.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Remarks:
- for TA 1535, TA 100, without metabolic activation
- Positive control substance:
- sodium azide
- Remarks:
- Purity: at least 99 %, Dissolved in: aqua dest., Concentration: 10 µg/plate
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Remarks:
- TA 1537, TA 98, without metabolic activation
- Positive control substance:
- other: 4-nitro-o-phenylene-diamine, 4-NOPD
- Remarks:
- Purity: at least 99.9 %, Dissolved in: DMSO, Concentration: 10 µg/plate
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Remarks:
- TA 1535, TA 1537, TA 98, TA 100, with metabolic activation
- Positive control substance:
- other: 2-aminoanthracene, 2-AA
- Remarks:
- Purity: at least 97.5 %, Dissolved in: DMSO, Concentration: 2.5 µg/plate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar, plate incorporation test in experiment I and I A and preincubation test in experiment II
DURATION
- Preincubation period: 60 min
- Selection time (if incubation with a selection agent): 48 h
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth, reduction in the number of revertants,
POSITIVE CONTROLS
- The stability of the positive control substances in solution was unknown but a mutagenic response in the expected range is sufficient evidence of biological stability. The dilutions of the stock solutions were prepared on the day of the experiment and used immediately.
OTHER:
- The test article precipitated from 2500.0 µg/plate up to 5000.0 µg/plate in the overlay agar. The undissolved particles of the test article had no influence on the data recording. - Evaluation criteria:
- The generally accepted conditions for the evaluation of the results are:
- corresponding background growth on both negative control and test plates
- normal range of spontaneous reversion rates. Range of spontaneous reversion frequencies: TA 1535: 10 - 29; TA 1537: 5 - 28; TA 98: 15 -57; TA 100: 77 - 189
- A test article is considered positive if either a dose related and reproducible increase in the number of revertants or a significant and reproducible increase for at least one test concentration is induced.
- A test article producing neither a dose related and reproducible increase in the number of revertants nor a significant and reproducible positive response at any one of the test points is considered non-mutagenic in this system. - Statistics:
- A significant response is described as follows:
- A test article is considered mutagenic if the number of reversions is at least twice the spontaneous reversion rate in strains TA 98 and TA 100 or thrice on TA 1535 and TA 1537.
- Also, a dose-dependent and reproducible increase in the number of revertants is regarded as an indication of possibly existing mutagenic potential of the test article regardless whether the highest dose induced the criteria described above or not.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- other: S. Typhimurium TA 100 and TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- - Since overlapping mutagenic and toxic effects occurred in strain TA 1535 in the presence of metabolic activation an additional experiment was carried out as plate incorporation test using strain TA 1535 with S9 mix to verify the data (I A).
- Toxic effects, evidenced by a reduction in the number of revertants, occurred in the plate incorporation test (experiment I) and the pre-incubation test (experiment II) with and without metabolic activation in all strains used.
- At 5000.0 µg/plate an exceptionally strong background growth was observed in strain TA 1535 without metabolic activation in the first experiment. This effect might indicate a high number of mutant bacteria which could not form real colonies due to overlapping toxic effects as stated in the original report.
- Strain TA 1535: Substantial increases in revertant colony numbers were observed following treatment with FAT 80'023/G (TADE) at the higher concentrations with S9 mix in experiment I, I A, and II with as well as without S9 mix.
- Strain TA 1537: Substantial increases in revertant colony numbers were observed at the highest concentration with S9 mix in experiment II. Nevertheless in the concentration of 1000.0 µg/plate and 2500 µg/plate strongly reduced revertant number points to toxicity.
A summary of the results in detail see the attached file. - Remarks on result:
- other: other: S. typhimurium TA 1535
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Plate Incorporation test (10 - 5000 µg/plate) |
|||||
Strain |
Metabolic activation system |
mean revertants in Controls |
maximum revertant factor |
dose dependency |
Assessment |
TA 98 |
no |
31 |
1.0 |
no |
negative |
yes |
35 |
1.2 |
no |
negative |
|
TA 1537 |
no |
13 |
1.0 |
no |
negative |
yes |
16 |
1.3 |
no |
negative |
|
TA 1535 exp I exp IA |
no |
15 |
1.3 |
no |
negative |
yes |
13 |
9.5 |
yes |
positive |
|
yes |
13 |
6.7 |
yes |
positive |
|
TA 100 |
no |
116 |
1.0 |
no |
negative |
yes |
129 |
1.0 |
no |
negative |
Preincubation test (10 - 5000 µg/plate) |
|||||
Strain |
Metabolic activation system |
mean revertants in Controls |
maximum revertant factor |
dose dependency |
Assessment |
TA 98 |
no |
27 |
1.0 |
no |
negative |
yes |
37 |
1.2 |
no |
negative |
|
TA 1537 |
no |
18 |
0.7 |
no |
negative |
yes |
24 |
9.6 |
no |
positive |
|
TA 1535 |
no |
43 |
5.0 |
no |
positive |
yes |
29 |
4.4 |
yes |
positive |
|
TA 100 |
no |
145 |
0.9 |
no |
negative |
yes |
162 |
1.0 |
no |
negative |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive
Based on the study results, the substance is considered mutagenic in Salmonella typhimurium TA 1535 and TA 1537. - Executive summary:
It can be stated that during the mutagenicity test and under the experimental conditions reported, the test article induced gene mutations by base pair changes and possibly frameshifts in the genome ofthe strains TA 1535 and TA 1537. Therefore, FAT 80'023/G (TADE) is considered to be mutagenic in this Salmonella typhimurium reverse mutation assay.
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