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EC number: 220-701-7 | CAS number: 2871-01-4
- 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 transformation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Remarks:
- No GLP compliant, Comparable to OECD Guidance Document Method (No. 214, 2015), no details on the test substance was provided. The control results (benzo(a)pyrene) was not reported.
Data source
Reference
- Reference Type:
- publication
- Title:
- An Interlaboratory Evaluation of the Syrian Hamster Embryo Cell Transformation Assay using Eighteen Coded Chemicals
- Author:
- C.A. Jones, E. Huberman, M.F. Callaham, A. Tu, W. Halloween, S. Pallota, A. Sivak, R.A. Lubet, M.D. Avery, R.E. Kouri, J. Spalding, and R.W. Tennant,
- Year:
- 1 988
- Bibliographic source:
- Toxicol. In Vitro, 2(2): 103-116
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Fibroblasts isolated from Syrian golden hamster embryos on gestational day 13 were used in a cellular transformation assay. HC Red n° 3 was evaluated for cellular transformation capability using the Syrian Hamster Embryo cell (SHE) assay. Two independent laboratories tested HC Red n° 3 at five dosage levels up to 500 and 600 μg/ml, respectively. Duplicate assays utilizing a pH 7.4 culture protocol were performed for a duration of 7 days. Benzo[a]pyrene (B[a]P) was included as a positive control. A positive transformation response was determined using strict morphological guidelines. A positive assay response was defined as a three-fold elevation over the control level of transformation at two or more doses in at least two assays.
- GLP compliance:
- no
- Type of assay:
- in vitro mammalian cell transformation assay
Test material
- Reference substance name:
- 2-(4-amino-2-nitroanilino)ethanol
- EC Number:
- 220-701-7
- EC Name:
- 2-(4-amino-2-nitroanilino)ethanol
- Cas Number:
- 2871-01-4
- Molecular formula:
- C8H11N3O3
- IUPAC Name:
- 2-(4-amino-2-nitroanilino)ethanol
- Test material form:
- solid: particulate/powder
- Remarks:
- crystalline powder
Constituent 1
- Specific details on test material used for the study:
- No detail was provided on the test substance.
Method
Species / strain
- Species / strain / cell type:
- other: Syrian Hamster Embryo Cells (SHE)
- Details on mammalian cell type (if applicable):
- CELLS USED
- Source of cells: Cells were sampled from Pregnant Syrian golden Hamsters (from Charles River Breeding Laboatory) killed at day 13 of pregnancy. No more details
MEDIA USED
- Type and identity of media including CO2 concentration if applicable: Dulbecco's modified Eagle's medium containing 1000 mg/liter 110 mg sodium pyruvate/liter , 584 mg L-glutamine/liter and 20% foetal calf serum was used for all cell preparation and assays.
- Properly maintained: not specified
- Periodically checked for Mycoplasma contamination: not specified
- Periodically checked for karyotype stability: not specified
- Periodically 'cleansed' against high spontaneous background: not specified
- Metabolic activation:
- without
- Test concentrations with justification for top dose:
- Five concentrations were selected with the highest concentration giving not less than 10% survival, based on the results of clonal survival assay.
Selecred doses were : 0, 100, 200, 400, 600 µg/mL for the Laboratory A and 0, 16, 31 63, 125, 250, 500 µg/mL for the Laboratory C. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: no justification was provided
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
- Cell density at seeding (if applicable): 300 target and 6x104 feeder cells in 8mL medium
DURATION
- Exposure duration: Laboratory A method : 7 days ; Laboratory C : 3 days
- Fixation time (start of exposure up to fixation or harvest of cells):7 Days
STAIN (for cytogenetic assays): Giemsa
NUMBER OF REPLICATIONS: One replicate was used per dose level in two independant studies, results for a same dose level were pooled for assessment.
METHODS OF SLIDE PREPARATION AND STAINING TECHNIQUE USED: Plates were rinsed, fixed with methanol and stained with Giemsa
NUMBER OF CELLS EVALUATED: more than 100 cells per condition
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency - Evaluation criteria:
- A positive response was defined as a level of transformation at two or more chemically treated doses that exceeded three times the level of spontaneous transformation. In addition morphological transformants had to be scored in more than a single assay. An assay in which this level of transformation was observed at only one dose was deemed equivocal. A lower level or no transformation in repeat was considered negative provided that the benzo(a)pyrene result was positive.
Results and discussion
Test results
- Key result
- Species / strain:
- other: Syrian Hamster Embryo Cells (SHE)
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- not specified
- Remarks:
- Data on the positive control was not reported
- Additional information on results:
- No morphological transformation was induced by the HC Red 3 in assays conducted by the Laboratory A and C. Dose dependent toxicity was observed in both laboratories for this chemical.
Any other information on results incl. tables
Table 1 :Summaryof theresults
|
|
Assay1 |
|
|
Assay2 |
|
|
|
|
Dose (µg/mL) |
RCE |
SC |
T(MA) |
RCE |
SC |
T(MA) |
Overall%T |
LaboratoryA |
0 |
1 |
1795 |
0(0) |
1 |
2061 |
0(0) |
0 |
|
100 |
0.78 |
755 |
0(0) |
0.87 |
960 |
0(0) |
0 |
|
200 |
0.4 |
357 |
0(0) |
0.72 |
803 |
0(0) |
0 |
|
400 |
0.07 |
50 |
0(0) |
0.38 |
386 |
0(0) |
0 |
|
600 |
0.07 |
60 |
0(0) |
0.14 |
130 |
0(0) |
0 |
LaboratoryC |
0 |
1 |
1024 |
0(0) |
1 |
1804 |
0(1) |
0 |
|
16 |
1 |
122 |
0(0) |
ND |
ND |
|
0 |
|
31 |
0.95 |
464 |
0(0) |
1.05 |
812 |
0(0) |
0 |
|
63 |
0.77 |
281 |
0(0) |
1.21 |
928 |
0(2) |
0 |
|
125 |
0.44 |
194 |
0(0) |
0.9 |
692 |
0(0) |
0 |
|
250 |
0.26 |
126 |
0(2) |
0.18 |
140 |
0(0) |
0 |
|
500 |
Toxic |
|
|
Toxic |
|
|
0 |
RCE :Relative Cloning Efficiency
SC :Number ofscorablecolonies
MA :Number or morphologically altered colony
ND : Not determinable
Applicant's summary and conclusion
- Conclusions:
- Under the experimental conditions of the study, HC Red n° 3 did not induce transformation at any dosage level in the high pH SHE assay in either laboratory.
- Executive summary:
This No-GLP compliant study was performed in order to evaluate HC Red n°3 for cellular transformation capability using the Syrian Hamster Embryo cell (SHE) assay.
Fibroblasts isolated from Syrian golden hamster embryos on gestational day 13 were used in a cellular transformation assay. Two independent laboratories tested HC Red n° 3 at five dosage levels up to 500 and 600 μg/ml, respectively. Duplicate assays utilizing a pH 7.4 culture protocol were performed for a duration of 7 days. Benzo[a]pyrene (B[a]P) was included as a positive control. A positive transformation response was determined using strict morphological guidelines. The transformation activity was determined by pooling the data for the same dose level in both assays. The response was first determined within each laboratory, then between the laboratories. A positive assay response was defined as a three-fold elevation over the control level of transformation at two or more doses in at least two assays.
Under the experimental conditions of the study, HC Red n° 3 did not induce transformation at any dosage level in the high pH SHE assay in either laboratory.
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