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EC number: 205-391-3 | CAS number: 140-01-2
- 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 cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 March - 17 July 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No data on batch number and composition; basic data given, comparable to guidelines/standards (max reliability score can be 2)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- yes
- Remarks:
- exposure duration with S9 mix was 2 hours rather than 3-6 hours
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- 7216-95-7
- Cas Number:
- 7216-95-7
- IUPAC Name:
- 7216-95-7
- Details on test material:
- - Name of test material (as cited in study report): GLYCINE N-N BIS [2-[BIS(CARBOXYMETHYL) AMINO] ETHYL] - PENTA
POTASSIUM SALT
- Physical state: white solid
- Analytical purity: not indicated
- Impurities (identity and concentrations): not indicated
- Lot/batch No.: not indicated
- Expiration date of the lot/batch: not indicated
- Storage condition of test material: room temperature in the dark
- Date of receipt: not indicated
Constituent 1
Method
- Target gene:
- Structural chromosomal aberrations
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: in Hams F12 medium supplemented with 5% foetal calf serum
- Properly maintained: yes, at 37 degr. C in a humid atmosphere
containing 5% CO2
- Periodically checked for Mycoplasma contamination: not indicated - Additional strain / cell type characteristics:
- other: strain K1-BH4
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix (rat liver Aroclor 1254 induced)
- Test concentrations with justification for top dose:
- without S9 mix: 0, 1, 2, 4, 8 µg/ml
with S9 mix: 0, 25, 125, 200, 250 µg/ml - Vehicle / solvent:
- Vehicle: sterile distilled water
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- with S9 mix
Migrated to IUCLID6: 20 µg/ml
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- without S9 mix
Migrated to IUCLID6: 0.4 µg/ml
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: 24 hours
- Exposure duration: 20 hours (- S9 mix) 2 hours with test compound + 18 hours without (+ S9 mix)
- Expression time (cells in growth medium): 20 hours
- Fixation time (start of exposure up to fixation or harvest of cells): 23 hours
SPINDLE INHIBITOR (cytogenetic assays): colchicine (0.25 µg/ml), 3 hours before end of 20-h period
STAIN (for cytogenetic assays): 10% Giemsa
NUMBER OF REPLICATIONS: two cultures per concentration and for the positive control; four cultures for the solvent
control
NUMBER OF CELLS EVALUATED: ca. 100 metaphases for each culture (200 in total for test and positive control; 400 for solvent
control), with normally a maximum of 25 from each slide
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index
OTHER EXAMINATIONS:
- Determination of polyploidy: not reported
- Determination of endoreplication: not reported - Evaluation criteria:
- Statistically sgnificant increase above control values.
- Statistics:
- Fisher's test
Results and discussion
Test results
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: none
- Effects of osmolality: none
- Evaporation from medium: none
- Water solubility: good
- Precipitation: none
RANGE-FINDING/SCREENING STUDIES: due to very high toxicity in the first test withouit S9 - mix, the test was repeated at lower
concentrations (see above).
Any other information on results incl. tables
Results
Compound |
Concentration (µg/ml) |
Number of cells examined |
No. aberrant cells (excl. gaps) (%) |
No. aberrant cells (incl. gaps) (%) |
Mitotic index (mean %) |
- S9 mix |
|||||
Vehicle |
0 |
400 |
4 (1) |
4 (1) |
9.1 |
Test |
1 2 4 8 |
200 200 200 151 |
2 (1) 1 (0.5) 0 (0) 0 (0) |
1 (0.5) 0 (0) 1 (0.5) 0 (0) |
10.3 10.1 8.9 1.0 |
Mitomycin C |
0.4 |
177 |
93 (52.5) *** |
93 (52.5) *** |
|
+ S9 mix |
|||||
Vehicle |
0 |
400 |
4 (1) |
6 (1.5) |
8.4 |
Test |
25 125 200 250 |
200 200 200 200 |
2 (1) 1 (0.5) 0 (0) 0 (0) |
2 (1) 2 (1) 0 (0) 0 (0) |
9.2 6.8 8.4 8.8 |
Cyclophosphamide |
20 |
200 |
49 (24.5) *** |
49 (24.5) *** |
Statistics: Fisher’s test; *** p0.001
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test compound did not show clastogenic activity in this in vitro cytogenetic system. - Executive summary:
Glycine N-N bis[2 -[bis(carboxymethyl)amino]ethyl]-pentapotassium salt was tested in vitro to determine whether it would cause chromosomal aberrations in a mammalian cell line derived from Chinese hamster ovary tissue. The cells were routinely grown and subcultured in tissue culture medium at 37'C in a humid atmosphere containing 5% carbon dioxide. They were incubated with the test compound both with and without supplementary metabolic activation (rat S-9 mix).
A preliminary toxicity test was carried out to assess the effect of the compound on the mitotic index of cultured CHO cells. In the absence of S-9 mix, all of the concentrations tested in the preliminary test proved extremely toxic. A second toxicity test was carried out using a lower range of concentrations. The results of this test indicated that the concentration required to reduce the mitotic index by 50% of control levels (EC50) was approximately 8 µg/ml. This concentration was chosen as the highest dose level for metaphase analysis, with additional dose levels of 1, 2 and 4 µg/ml. In the presence of S-9 mix, the results of the preliminary toxicity test suggested an EC50 of approximately 300 µg/ml. This concentration was used as the highest dose level for metaphase analysis, and additional cultures were also treated with 30, 150, 200 and 250 µg/ml. When slides from this test were examined, 300 µg/ml was found to be extremely toxic. The next two dose levels, 250 and 200 µg/ml, showed erratic toxicity and poor reproducibility between duplicate cultures. The test was repeated using concentrations of 250, 200, 125 and 25 µg/ml, which were subsequently analysed for chromosome damage.
Cultures treated with Glycine N-N bis[2-[bis(carboxymethyl)amino] ethyl]-pentapotassium salt showed no significant increases in the incidence of chromosomal aberrations at any dose level, in either the absence or presence of supplementary metabolic activation.
Both positive control compounds mitomycin C and cyclophosphamide, caused large, statistically highly significant increases in the incidence of chromosomal damage, thus demonstrating the sensitivity of the test system and the efficacy of the S-9 mix.
It is concluded that Glycine N-N bis[2-[bis(carboxymethyl)amino] ethyl]-pentapotassium salt has shown no evidence of clastogenic activity in this in vitro cytogenetic test system.
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